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Virginia Oncology Associates

Virginia Oncology Associates

USO 24288

Phase 2 Study of Zelenectide Pevedotin in Participants with NECTIN4 Amplified Advanced Breast Cancer (BT8009-201)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

• Histologically or cytologically confirmed recurrent unresectable or
metastatic HER2-negative BC
• Cohort A: HR+/HER2-negative BC (HER2 IHC 2+/ISH-; IHC 1+
or IHC 0), resistant/refractory to ET
• Cohort B: TNBC, including ER-low BC (1-10% cells HR+ by IHC)
• Previously documented HER2-positive BC excluded
• Confirmed NECTIN4 gene amplification by central testing
• Prior lines of therapy (may include topoisomerase inhibitor)
• Cohort A: Up to 3 prior lines of non-ET for MBC
• Cohort B: 1-3 prior lines of systemic therapy for MBC
• Prior tx with ADC containing any MMAE payload are excluded
• Measurable disease per RECIST v1.1

For more information on this trial CLICK HERE.

Available at:

USO 24114

A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy (20230005)

 

Disease Types: Genitourinary Cancer Research

Eligibility Requirements:

• Histologically, pathologically, and/or cytologically confirmed prostate cancer
• Metastatic disease with ≥ 1 lesion
• Subjects must have prior treatment with at least 1 ARDT & 1 taxane therapy
• Prior treatment with docetaxel in the hormone-sensitive setting is permitted. Prior therapy with ≥2 regimens in the castrate-resistant setting not permitted
• Prior treatment with RLT, radionuclide therapy(Radium-223), PARP inhibitor, or ICIs is permitted.
• Prior radionuclide therapy within 2 months of first dose of study treatment is excluded
• Prior STEAP1-targeted therapy is excluded 

For more infomation on this trial CLICK HERE.

Available at:

USO 24208

An Open-label Randomized Phase 2 Study to Evaluate Safety and Efficacy of Patritumab Deruxtecan Plus Pembrolizumab Administered Either Before or After Carboplatin/Paclitaxel Plus Pembrolizumab Compared With Pembrolizumab in Combination With Chemotherapy Followed by Surgery and Adjuvant Pembrolizumab for High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer (HERTHENA-Breast03) (MK-1022-010)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

Has locally advanced, non-metastatic (M0), breast cancer, defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee on Cancer (AJCC) criteria: cT1c, N1-N2; cT2, N0-N2; cT3, N0-N2; or cT4a-d, N0-N2
Has centrally confirmed diagnosis of breast cancer that is triple-negative or HR-low+/HER2- breast cancer that will be treated according to the triple-negative breast cancer (TNBC) paradigm
Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 28 days prior to allocation/randomization
Has left ventricular ejection fraction (LVEF) of ≥50% or ≥ lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigate acquisition scan (MUGA) scan

For more information about this trial, CLICK HERE. 

Available at:

uso 23049

A PHASE Ib/II, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, ACTIVITY, AND PHARMACOKINETICS OF GDC-6036 IN COMBINATION WITH OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH A KRAS G12C MUTATION. (BO44426)

 

Disease Types: Lung Cancer Research

Eligibility Requirements:

• Unresectable advanced or metastatic NSCLC.
• Validated tissue or blood testing of KRAS G12C+.
• No prior treatment for advanced unresectable or metastaticNSCLC.
• Prior therapy for non-metastatic disease is allowed if patient
presents at least 12 months of treatment-free interval before
study enrollment.
• PD-L1 expression ≥1% in tumor tissue.
• Pre-treatment tumor tissue report must be provided.
• No other oncogenic driver with available targeted
treatment .

Available at:

uso 23272

Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I) (01-PS-001)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

• Histologically documented TNBC (ER ≤10% by IHC, PR ≤10% by IHC and HER2 0 or
1+ by IHC or FISH ratio <2 or HER2 gene copy number of <6)
• Early-stage (stage I-III) TNBC scheduled to undergo NAC treatment with curative
intent
• Be willing to provide blood samples before and during treatment
• Have available biopsy tissue
• Pts with current or history of another primary cancer within 5 years of study entry are
excluded
• Pt that started systemic therapy for BC are excluded
• No blood transfusion within two weeks before collection of blood for central ctDNA
testing

Available at:

uso 21320

A Phase 1/2 Open-Label, Dose-Escalation and Clinical Response Study of Quaratusugene Ozeplasmid in Combination with Osimertinib in Patients with Advanced, EGFR-Mutant, Metastatic Non-Small Cell Lung Cancer who have Progressed after Treatment with Osimertinib (ONC-003)

 

Disease Types: Lung Cancer Research

Eligibility Requirements:

Unresectable stage III or IV NSCLC
• EGFR mutation-positive
• Phase 2: measurable disease per RECIST 1.1.
• Phase 2a:
• Cohort 1 must have progression on osimertinib
alone
• Cohort 2 must have progression after treatment
with osimertinib, pemetrexed and a platin or single
agent osimertinib followed by combination
pemetrexed and a platin with or without osimertinib
• Phase 2b: osimertinib treatment must be the only
prior systemic treatment. 

Available at:

USO 24139

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) versus Treatment of Investigators Choice (IC) in Patients with Platinum Resistant Ovarian Cancer (GCT1184-02)

 

Disease Types: GYN Cancer Research

Eligibility Requirements:

• Histologically or cytologically confirmed high grade serous or
endometrioid epithelial OC/FP/PPC
• 1 to 4 prior lines of therapy, must include:
• Platinum chemotherapy
• Prior bevacizumab
• PARP inhibitor as maint for pts w/ germline BRCA mutations and who
achieved CR/PR to plt-based chemo
• Mirvetuximab soravtansine if indicated
• Pt must have platinum-resistant disease
• FRα expression result per Ventana FOLR1-2.1 RxDx Assay must
be available prior to randomization
• Measurable disease per RECIST v1.1
• No prior tx with ADC containing topoisomerase I inhibitor

Available at:

USO 24247

A Phase 3, Two-stage, Randomized, Multicenter, Open-label Study Comparing Mezigdomide (CC-92480/BMS-986348), Carfilzomib, and Dexamethasone (MeziKd) Versus Carfilzomib and Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma (RRMM):SUCCESSOR-2 (CA057008)

 

Disease Types: Multiple Myeloma

Eligibility Requirements:

• Documented diagnosis of MM that is measurable
• Subject should have received at least 1 prior line of therapy
• Received treatment with lenalidomide and at least 2
cycles of an anti-CD38 mAb
• Achieved MR or better to at least 1 LOT
• Have documented disease progression during or
after last treatment regimen
• ECOG ≤ 2
• Subjects that have received prior treatment with
mezigdomide or carfilzomib are excluded
• Subjects that received allogeneic stem cell transplantation
or autologous stem cell transplantation within 12 weeks
prior to study intervention are excluded

Available at:

USO 24112

A Phase 2 Study Evaluating The Efficacy And Safety Of TORL-1-23 In Women With Advanced Platinum Resistant Epithelial Ovarian Cancer (Including Primary Peritoneal And Fallopian Tube Cancers) Expressing Claudin 6 (CLND6) (TORL123-002)

 

Disease Types: GYN Cancer Research

Eligibility Requirements:

• Histologically or cytologically confirmed diagnosis of advanced
(unresectable) or metastatic high grade serous OC/PP/FPC
• High-grade endometrioid permitted
• Clear cell, mucinous, sarcomatous (including carcinosarcoma),
mixed histology, or low-grade, borderline ovarian tumors or nonepithelial ovarian cancers are excluded
• Pt must have platinum-resistant disease
• Primary plt-refractory excluded
• 1-3 prior systemic lines of therapy, eligible for single-agent as next tx
• Tumor must be CLDN6+
• >30% tumor cell membrane staining of any intensity by IHC
• Measurable disease per RECIST v1.1
• Prior tx with CLDN6-targeting agent or MMAE-containing ADC excluded

Available at:

USO 24106

A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM)(Excaliber-RRMM)(CC-220-MM-002)

 

Disease Types: Multiple Myeloma

Eligibility Requirements:

• Documented diagnosis of MM and measurable disease
• Subject has received 1 to 2 prior lines of therapy and achieved
partial response or better to at least 1
• ECOG score of ≤ 2
• Subjects with prior CD38-directed & bortezomib therapy if
below are fulfilled:
a) Best response achieved was at least MR(bortezomib)
or PR(CD38)
b) Did not progress while receiving therapy
c) Did not discontinue due to a related AE(CD38)
d) Last dose of daratumumab was ≥ 3 months prior to
randomization(CD38)
• Subjects that received prior therapy with Iberdomide are
excluded

Available at:

USO 24145

A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM):Successor-1 (CA057-001)

 

Disease Types: Multiple Myeloma

Eligibility Requirements:

• Documented diagnosis of MM that is measurable

• Subject must have received 1-3 prior lines of therapy
• One line can contain several phases
• Prior treatment with a lenalidomide required
• Achieved at least MR during 1 prior therapy
• Documented disease progression after last regimen
• ECOG ≤ 2
• Subjects that received prior treatment with mezigdomide or
pomalidomide are excluded
• Subjects that received a prior bortezomib-containing regimen & either
did not achieve at least MR, or had to discontinue bortezomib due to
toxicity are excluded
• Subjects that experienced disease progression either during
treatment with a proteasome inhibitor or within 60 days after the last
dose are excluded
• Protocol 

Available at:

USO 24151

Elacestrant versus Standard Endocrine Therapy in Women and Men with Node -positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)(STML-ELA-0422)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

• Women or men with confirmed ER-positive (≥10% by IHC), HER2-negative [IHC = 0
or 1, or (IHC = 2 and ISH-negative)] early stage resected BC without evidence of
recurrence or distant metastases
• Pts should be between 2 to 6 years from the date of curative surgical resection
• Pts should have received ≥24 mo and <60 mo of ET(AIs or tamoxifen) with/without a
CDK4/6i and with/without an LHRH agonist
• Pts who received prior CDK4/6i or PARP inhibitor must have already
completed or discontinued these treatments
• Pt must be considered candidate for additional 5 years of ET
• Pts considered at high risk of recurrence at initial staging
• ≥ 4 positive axillary lymph nodes or
• 1-3 positive axillary lymph nodes and
• Histologic grade 3 disease or
• Tumor size ≥ 5 cm.
• Male pts receiving AI or elacestrant must receive an LHRH agonist

For more information on about this trial, CLICK HERE.

Available at:

USO 24086

A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination with Rituximab in Participants with Newly Diagnosed Advanced Stage Follicular Lymphoma (GOLSEEK-2) (CA0731022)

 

Disease Types: Lymphoma & Hematologic

Eligibility Requirements:

Histologically confirmed Grade 1, 2, or 3a FL or classic FL
• No prior therapy for disease
• Prior radiation or surgery for Stage I disease is
permitted
• ECOG ≤ 2. 3 is allowed if disease related and not due to
comorbidities
• Ann Arbor stage II-IV disease
• Subject must have indication requiring treatment,
determined by treating investigator
• Subjects with transformed lymphoma, follicular large cell or
Grade 3b follicular lymphoma are excluded
• Subjects with presence or history of CNS involvement by
lymphoma are excluded

Available at:

USO 22095

A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of DSP-5336 in Adult Patients with Acute Leukemia and Other Selected Hematologic Malignancies, with and without Mixed Lineage Leukemia (MLL) rearrangement or Nucleophosmin 1 (NPM1) Mutation (DSP-5336-101)

 

Disease Types: Leukemia & Lymphoma Research

Available at:

USO 23335

A PHASE 3 STUDY OF FIXED DOSE COMBINATIONS OF FIANLIMAB AND CEMIPLIMAB VERSUS RELATLIMAB AND NIVOLUMAB IN PARTICIPANTS WITH UNRESECTABLE OR METASTATIC MELANOMA (R3767-ONC-22122)

 

Disease Types: Melanoma Research

Available at:

USO 23164

A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients with Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER) (CB10A)

 

Disease Types: CAR-T

Available at:

USO 22320

A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) with or without Durvalumab compared with Investigator's Choice of Chemotherapy (Paclitaxel/Nab-paclitaxel or Gemcitabine+ Carboplatin) in combination with Pembrolizumab in Patients with PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPIONBreast05)(D7630C00001)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

• Locally recurrent inoperable or metastatic TNBC
• ER, PgR IHC < 1%, HER2 IHC 0, 1+ or 2+ with ISH-
• de novo mTNBC eligible if anthracycline is contraindicated
• PD-L1+ by 22C3 assay, CPS ≥10 IHC (centrally confirmed)
• No prior chemo or targeted systemic tx in metastatic setting
• PD must be ≥6 months after completion of tx with curative intent
• Adjuvant radiation therapy not considered tx with curative intent for
DFI
• (Neo)adjuvant anthracycline required unless contraindicated
• Prior (neo)adjuvant tx with PD-(L)1 inhibitor allowed
• Germline BRCAm with no other tx option are eligible
• Metastatic tumor sample must be collected ≤3 months prior to consent
• Measurable disease per RECIST v1.1
• No prior tx w/ topo I inhibitor-targeted therapy (incl ADC) nor TROP2-targeted
therapy

For more information about this study, CLICK HERE. 

Available at:

USO 23245

A Phase 2, Open-Label, Multicenter Study of BMS-986393, a GPRC5D-directed CAR T Cell Therapy in Adult Participants with Relapsed or Refractory Multiple Myeloma

 

Disease Types: Cellular & Gene

Eligibility Requirements:

  • Subject must have received at least 4 classes of treatment

(including an IMiD, PI, anti-CD38 mAb, and anti-BCMA therapy)
 • Must have undergone at least 2 consecutive cycles of
treatment for each treatment class, unless PD was the best
response or unacceptable toxicity
• Subjects must have at least 3 prior lines of therapy
• Subjects must have documented disease progression during or
after their last regimen
• Subjects with known active or history of CNS involvement of MM
are excluded
• Subjects that received prior GPRC5D-targeted therapy or
treatment for MM without the required washout prior to
leukapheresis are excluded

Available at:

USO 24050

A Phase 1 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363 or KITE-753, Autologous Anti-CD19/CD20 CAR T-cell Therapies, in Subjects With Relapsed and/or Refractory B-cell Lymphoma (KT-US-499-0150)

 

Disease Types: Cellular & Gene

Eligibility Requirements:

1) Subjects with any of the following B-cell lymphomas as defined by the WHO 2022 criteria
{Alaggio 2022}, as determined by the investigator, are eligible for the study as defined
in full protocol, section 4.2.

2)  At least 1 measurable lesion according to the International Working Group (IWG) Lugano
Response Criteria for Malignant Lymphoma {Cheson 2014}. Lesions that have been
previously irradiated will be considered measurable only if progression has been documented
following completion of radiation therapy. If the only measurable disease is lymph-node
disease, at least 1 lymph node should be ≥ 1.5 cm.

3) The following washout periods must be satisfied, see full protocol, section 4.2.

4) Prior anti-CD19 and anti-CD20 targeted therapies are allowed if administered at least 28
days (if mAb) or 3 months (if CAR T-cell product) before the KITE-363 or KITE-753
administration. CD19 and/or CD20 expression must be confirmed, as per local review, after
receiving the most recent anti-CD19 or anti-CD20 therapies. If expression is confirmed via
biopsy after the most recent anti-CD19/CD20 therapy, this will meet criteria.

5) Toxicities due to immediate prior therapy must be stable and have recovered to Grade 1 or
lower (except for clinically nonsignificant toxicities such as alopecia)

6) Age 18 years or older

7) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

8) Adequate bone marrow function as evidenced by, see full protocol, section 4.2.

9) Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by, see full protocol, section 4.2.

10) Females of childbearing potential must have a negative serum or urine pregnancy test
(females who have undergone surgical sterilization or have been postmenopausal for at least
2 years before enrollment are not considered to be of childbearing potential). Additionally,
see Section 12.4.2 for UK-specific requirements

Available at:

USO 23079

A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin versus no HIPEC at the Time of Interval Cytoreductive Surgery followed by Niraparib Maintenance in Patients with Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Hyperthermic Ovarian Treatment Trial) (GOG-3068/HOTT)

 

Disease Types: GYN Cancer Research

Eligibility Requirements:

Pathologic diagnosis of high grade serous or endometroid
epithelial OC/FP/PPC
• Stage III or IV documented on CT/MRI
• Recommended to undergo neoadjuvant chemotherapy
• Candidate for iCRS
• Stage IV must have complete response of extra-abdominal
disease or deemed resectable with iCRS
• No gross residual disease or disease larger than 1 cm
following iCRS prior to randomization
• Myriad myChoice® HRD results available
• Prior treatment for OC other than 3-4 cycles of Plt-based
neoadjuvant chemo excluded

Available at:

USO 24026

Phase 1b/2 open-label trial of 225 Ac-DOTATATE (RYZ101) alone and in combination with pembrolizumab in subjects with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 (HER2) negative, locally advanced and unresectable or metastatic breast cancer expressing somatostatin receptors (SSTRs) and progressed after antibody-drug conjugates and/or chemotherapy (TRACY-1).(RYZ101-201)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

 ER+/ HER2- MBC
• ER ≥1%, HER2 IHC 0 or 1+, or 2+ and ISH negative
• Archival or fresh tumor tissue for central biomarker analysis
• Endocrine refractory
• Documented progression after 2-4 prior chemo or ADC
regimens in metastatic setting (at least 1 prior line of therapy
must be ADC)
• Prior anti PD-(L)1 or PD-L2 therapy or agent directed to
another stimulatory or co-inhibitory T-cell receptor excluded
• ≥1 measurable lesion (RECIST v1.1) that is SSTR-PET positive
• At least 80% of measurable lesions are SSTR-PET positive
within 90 days of enrollment

Available at:

USO 23333

A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naive Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib (KRT-232-115)

 

Disease Types: Lymphoma & Hematologic

Eligibility Requirements:

1. Adults ≥ 18 years of age able to provide informed consent.
2. Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by the treating
physician according to the World Health Organization (WHO) criteria.
3. IPSS risk category of Intermediate-1, Intermediate-2, or High.
4. Spleen measuring ≥ 450 cm3 by MRI or CT scan (central review).
5. MF symptoms as defined by a baseline TSS of ≥ 10. Baseline TSS will be calculated as a
7-day average per MFSAF v4.0.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
7. Adequate hematological, hepatic, and renal organ function (as per protocol definition and
within 28 days prior to the first dose of ruxolitinib monotherapy): 
8. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential must both use a highly effective contraception method during the study. In addition, after the last dose of study drug, female subjects must continue to use a highly effective method of contraception for one month and one week, and male subjects must continue to use a highly effective method of contraception for three months and one week. A woman is considered of childbearing potential (ie, fertile) following menarche and until becoming post-menopausal unless permanently sterile.

Available at:

USO 24065

A Phase 2 study of BPM31510 with Vitamin K1 in subjects with newly diagnosed glioblastoma (GB) (BPM31510IV-11)

 

Disease Types: Neurology

Eligibility Requirements:

Newly diagnosed, pathologically verified glioblastoma
(WHO 2016 or C-IMPACT, update 6) with any
evidence of residual disease
• No prior RT, chemo, IO, or targeted agents for the
lesion being treated
• KPS ≥60
• Day 1 must be min of 15 days and max of 50 days
from definitive neurosurgery

Available at:

USO 24007

A phase III randomized, open label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs. pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma (MCLA-158-CL03)

 

Disease Types: Head & Neck Cancer Research

Eligibility Requirements:

• Metastatic or locally recurrent HNSCC
• HNSCC primary tumor locations in oropharynx,
oral cavity, hypopharynx, and larynx are eligible
• No prior systemic therapy for metastatic disease
• Prior systemic therapy for LA disease is allowed if
PD was ≥6 months after last chemo dose
• Central testing for PD-L1, CPS ≥1, (OPC only:
p16)
• Measurable disease as defined by RECIST v1.1
• Tumor sample from metastatic or recurrent
primary site needs to be provided
• Life expectancy ≥ 12 weeks

Available at:

USO 23336

A randomized, open-label Phase 3 study in patients with previously treated unresectable or metastatic NRAS mutant cutaneous melanoma comparing the combination of naporafenib + trametinib to physician's choice of therapy (dacarbazine, temozolomide or trametinib monotherapy) with a dose optimization lead-in [SEACRAFT-2] (ERAS-254-02)

 

Disease Types:

Eligibility Requirements:

• Confirmed unresectable Stage III - IV cutaneous
(includes acral) melanoma not amenable to local
therapy
• uveal or mucosal melanoma not eligible
• Locally validated NRAS mutation
• Must have received SOC ICI therapy as defined by
local institutional standards
• PD either while receiving therapy or within 12 weeks
of the last dose of the most recent SOCI ICI therapy
• No Prior ERK, MEK, RAF, or RAS inhibitor treatment

Available at:

USO 24030

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy (GS-US-682-6769)

 

Disease Types: GYN Cancer Research

Eligibility Requirements:

• Recurrent endometrial cancer (carcinoma or carcinosarcoma)
• Up to 3L prior tx for endometrial cancer including Plt-based
chemotherapy and anti-PD-(L)1 therapy separately or in combo
• Prior hormonal/hormonal-based therapy not counted as prior line
• Pts who are ineligible for anti-PD-(L)1 therapy due to medical
comorbidities not required to have prior tx with anti-PD-(L)1 agent
• Radiologically evaluable disease per RECIST v1.1 (measurable or
non-measurable)
• Documented progression during or after most recent therapy
• Tumor tissue (archival or fresh) for assessment of TROP2 and
other biomarkers
• Prior tx with TROP2-directed ADC or ADC containing
topoisomerase 1 inhibitor excluded

Available at:

USO 20345

A PHASE 1/3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SELINEXOR, A SELECTIVE INHIBITOR OF NUCLEAR EXPORT, IN COMBINATION WITH RUXOLITINIB IN TREATMENT-NAIVE PATIENTS WITH MYELOFIBROSIS (XPORT-MF-034)

 

Disease Types: Hematology

Available at:

USO 23133

A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292) (D361DC00001)

 

Disease Types: Breast Cancer Research

Available at:

USO 22041

A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab monotherapy in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) when Administered in the Outpatient Setting (M23-362)

 

Disease Types: Lymphoma & Hematologic

Eligibility Requirements:

Inclusion Criteria:

Diagnosis of Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) or R/R Follicular Lymphoma (FL) grade 1, 2, or 3a, with documented CD20+ mature B-cell neoplasm according to World Health Organization (WHO) classification 2016 or WHO classification 2008 based on representative pathology report:

Participants with double-hit or triple-hit DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Other double-/triple-hit lymphomas are not eligible.

Relapsed or refractory disease and previously treated with at least 2 prior systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody-containing therapy.

Must have 1 or more measurable disease sites:

Fluorodeoxyglucose (FDG)-avid lymphomas: Measurable disease with computerized tomography (CT) (or magnetic resonance imaging [MRI]) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm (or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis > 1.0 cm) AND FDG positron emission tomography (PET) scan demonstrating positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites.

FDG-nonavid lymphomas: Measurable disease with CT (or MRI) scan with involvement of 2 or more clearly demarcated lesions/nodes with a long axis > 1.5 cm and short axis > 1.0 cm or 1 clearly demarcated lesion/node with a long axis > 2.0 cm and short axis > 1.0 cm.

Must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

Adequate organ function.

Exclusion Criteria:

Central nervous system (CNS) involvement.

Available at:

USO 24073

A Phase 3 Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma who have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide (MajesTEC-9) (64007957MMY3006)

 

Disease Types: Multiple Myeloma

Available at:

USO 23129

Randomized Study of ONC-392 plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who Progressed on Androgen Receptor (AR) Pathway Inhibition (PRESERVE-006)

 

Disease Types: Genitourinary Cancer Research

Available at:

USO 24063

A Phase 2 Multiple-Dose, Multiple-Arm, Parallel Assignment Study to evaluate the Safety, Tolerability, and Preliminary Efficacy of XmAb20717 Alone or in Combination with Chemotherapy or Targeted Therapies in Selected Subjects with Metastatic Castration-Resistant Prostate Cancer (XmAb20717-04)

 

Disease Types: Genitourinary Cancer Research

Available at:

USO 22333

Phase 2 Single Arm Trial with a Safety Lead-in of Tucatinib in Combination with Doxil for the Treatment of HER2+ Metastatic Breast Cancer (BRE 381)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

Inclusion Criteria:

- Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses
- At least 18 years-of-age at the time of signature of the informed consent form (ICF)
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Have a confirmed diagnosis of locally advanced/metastatic HER2+ breast cancer (based on local laboratory testing per American Society of Clinical Oncology (ASCO)/College of American - - Pathologists (CAP) guidelines immunohistochemistry 3+ (IHC3+) or fluorescence in situ hybridization + (FISH+))
- Have had prior treatment with at least 1 line of anti-HER2 therapy for locally advanced/metastatic disease or relapsed within 6 months of completion of adjuvant anti-HER2 therapy. Prior treatment with tucatinib in the metastatic setting is allowed
- Measurable disease as measured by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Females of child-bearing potential should be using adequate contraceptive measures from the time of screening until 6 months following the last dose of study drug(s), should not be breast feeding and must have a negative pregnancy test prior to start of dosing, or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
- Post-menopausal: defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation
- Women under 50 years-of-age will be considered postmenopausal if they have been amenorrheic for at least 12 months following the cessation of exogenous hormonal treatments, and have serum follicle-stimulating hormone and luteinizing hormone levels in the postmenopausal range for the institution.
- Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 6 months following last dose. Male patients must also refrain from donating sperm during their participation in the study.
- Adequate hematologic function
- Absolute neutrophil count (ANC)>1500
- Platelet count >100,000 (no transfusions allowed to meet this requirement)
- Hemoglobin >g/dL (at least 2-week washout from any transfusion)
- Adequate hepatic function
- Total bilirubin <1.5 upper limit of normal (ULN). Exception: participants with known history of Gilbert's Syndrome who have a direct bilirubin 1.5 <ULN in addition to a normal aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are eligible.
- AST and ALT <2.5 ULN (<5 ULN if liver metastases are present)
- Estimated glomerular filtration rate (eGFR) >50 mL/min/1.73 m2
- Left ventricular ejection fraction (LVEF) >50% based on screening echocardiogram (ECHO)/multigated acquisition (MUGA)
- Central nervous system (CNS) Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), patients must have one of the following:
- No evidence of brain metastases
- Untreated brain metastases not needing immediate local therapy. For patients with untreated CNS lesions >2.0 cm on screening contrast brain MRI, discussion with and approval from the --- - Medical Monitor is required prior to enrollment.
- Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions.
- Previously treated brain metastases:
- Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy in the opinion of the Investigator.
- Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if all of the following criteria are met:
- Time since whole brain radiotherapy (WBRT) is >14 days prior to first dose of treatment, time since stereotactic radiosurgery (SRS) is >7 days prior to first dose of treatment, or time since surgical resection is >28 days
- Other sites of disease assessable by RECIST 1.1 are present
 

Exclusion Criteria:
- Treatment with any of the following:
- Any systemic anti-cancer chemotherapy or small molecule, biologic, or hormonal agent from a previous treatment regimen or clinical study within 21 days or 5 half-lives (whichever is longer) prior to the first dose of study drugs. At least 10 days must have elapsed between the last dose of such agent and the first dose of study drugs.
- Prior treatment with anthracycline in any setting
- Major surgery (excluding placement of vascular access) within 28 days of first dose of study drugs Palliative radiation therapy within 14 days of first dose of study drugs
- Based on screening brain MRI, patients must not have any of the following:
- Any untreated brain lesions >2.0 cm in size, unless discussed with the Medical Monitor and approval for enrollment is granted
- Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of >2 mg of dexamethasone (or equivalent). However, patients on a chronic stable dose of < 2 mg total daily of dexamethasone (or equivalent) may be eligible with discussion and approval by the Medical Monitor
- Any brain lesion thought to require immediate local therapy, including (but not limited to) a lesion in an anatomic site where increase in size or possible treatment-related edema may pose risk to patient (e.g., brain stem lesions). Patients who undergo local treatment for such lesions identified by screening contrast brain MRI may still be eligible for the study based on criteria described under CNS inclusion criteria 14c
- Known or suspected leptomeningeal disease (LMD) as documented by the Investigator
- Have poorly controlled (>1 week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases, notwithstanding CNS-directed therapy.
- Use of a strong cytochrome P450 (CYP)2C8-inhibitor or use of a strong CYP3A4 or use of a CYP2C8 inducer within 5 days prior to the first dose of study treatment
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment. Note: patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible with approval by the Medical Monitor.

Available at:

USO 23277

A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects with Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305) (20200041)

 

Disease Types: Lung Cancer Research

Eligibility Requirements:

Inclusion:
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Age >= 18 years (or >= legal adult age within the country if it is older than 18 years).
- Histologically or cytologically documented extensive-stage disease (American Joint Committee on Cancer, 2017, IV small-cell lung cancer (SCLC) [T any, N any, M1 a/b]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
- Completed 3-4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab as first-line treatment of extensive-stage (ES)-SCLC prior to enrollment, without disease progression (ongoing response or stable disease) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
- Minimum life expectancy > 12 weeks.
- Toxicities attributed to prior anti-cancer therapy resolved to grade < 1, unless otherwise specified, excluding alopecia or fatigue.
- Adequate organ function
 

Exclusion:
- Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease. Participants with treated brain metastases are eligible as per protocol
- Prior history of severe or life-threatening events from any immune-mediated therapy. History of other malignancy withing the past 2 years, with some exceptions as per protocol.
- Active or prior documented autoimmune or inflammatory disorders as per protocol
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months of first dose of study treatment.
- History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months of first dose of study treatment.
- Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis.
- History of solid organ transplant.
- Major surgical procedures within 28 days of first dose of study treatment.
- Known human immunodeficiency virus (HIV) infection (participants with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study), hepatitis C infection (participants with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (participants with hepatitis B surface antigen [HBsAg] or core antibody that achieve sustained virologic response with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study).
 

Available at:

USO 23076

A PHASE III, MULTICENTER, RANDOMIZED, OPEN LABEL STUDY COMPARING THE EFFICACY AND SAFETY OF GLOFITAMAB (RO7082859) IN COMBINATION WITH POLATUZUMAB VEDOTIN PLUS RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE (POLA-R-CHP) VERSUS POLA R CHP IN PREVIOUSLY UNTREATED PATIENTS WITH LARGE B-CELL LYMPHOMA (GO44145)

 

Disease Types: Lymphoma & Hematologic

Eligibility Requirements:

• Previously untreated participants with CD20 positive
LBCL
• IPI score 2-5
• ECOG status of ≤ 2
• At least one bi-dimensionally measurable lesion, defined
as > 1.5 cm in its longest dimension as measured by CT
or MRI
• Patients with prior solid organ transplantation are
excluded
• Patients with contraindication to any of the individual
components of Pola-R-CHP or Glofitamab, including
prior receipt of anthracyclines are excluded

Available at:

USO 24075

A Phase 3, randomized, open-label, multicenter, controlled study to evaluate the efficacy and safety of zanidatamab in combination with physician's choice chemotherapy compared to trastuzumab in combination with physician's choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous trastuzumab deruxtecan treatment (JZP598-303)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

Women and men with HER2-positive metastatic breast cancer
• Central testing of HER2 status must be performed w/in 6 mo prior to C1D1
• Most recent archival tissue or fresh biopsy must be submitted to confirm
HER2 status by sponsor-designated central lab prior to randomization
• If pt meets all eligibility criteria but HER2 status is not confirmed, pts with
previously assessed IHC 3+ HER2+ status will be randomized while tissue is
submitted to central lab for HER2 confirmation
• Pt must have progressed on, or is intolerant to, previous T-DXd treatment
• Pt must have received 2-4 lines of HER2-directed tx in metastatic setting
• Prior HER2-targeted (neo)adj therapy that resulted in relapse w/in 6 mo
considered line of therapy for metastatic disease
• Post-T-DXd therapy allowed (for ex: tucatinib-based regimen and/or T-DM1)
• Measurable disease per RECIST v1.1

Available at:

USO 22106

A Phase 2 Study of XmAb20717 in Patients With Selected Gynecological Malignancies and High-Risk Metastatic Castration-Resistant Prostate Cancer (XmAb20717-05)

 

Disease Types: Genitourinary Cancer Research

Eligibility Requirements:

Able to provide written informed consent

Adult (age > 18 years)

Cancer must have progressed after treatment with all approved and medically appropriate therapies or have no appropriate available therapies

Histologically confirmed diagnosis of one of the following tumor types, along with clinical/pathologic confirmation of the additional requirements for each indication, as appropriate:


1. Persistent or recurrent clear cell carcinoma of the ovary, peritoneum, or endometrium after treatment with platinum-based systemic chemotherapy
2. Persistent or recurrent high-grade serous carcinoma of the ovary, fallopian tube, or peritoneum after treatment with platinum-based systemic chemotherapy (except subjects with a diagnosis of carcinosarcoma)
3.Recurrent or metastatic cervical carcinoma previously treated with standard-of-care systemic chemotherapy and FDA-approved immunotherapy, if eligible
4. Advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) in patients who are not candidates for curative surgery or radiation, and that has progressed following treatment with no more than one prior line of systemic therapy and prior treatment with FDA-approved combination therapy consisting of a checkpoint inhibitor and a targeted agent
5.High-risk metastatic castration-resistant prostate cancer:

Castration resistance defined as progressive disease after surgical castration, or progression in the setting of medical androgen ablation with a castrate level of testosterone (< 50 ng/dL)

High-risk disease is any visceral, soft tissue, or lymph node metastasis(es) with/without bone metastases

Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST 1.1)

Adequate available archival formalin-fixed paraffin-embedded block(s)/slides containing tumor and/or adequate predose fresh tumor biopsy tissue

Eastern Cooperative Oncology Group performance status of 0 or 1

Female subjects of childbearing potential must agree to use a highly effective method of birth control during and for 4 weeks after completion of study. Women are considered to be of childbearing potential unless it is documented that they are over the age of 60 OR postmenopausal by history with no menses for 1 year and confirmed by follicle-stimulating hormone (using local reference ranges) OR have a history of hysterectomy and/or bilateral oophorectomy OR have a history of bilateral tubal ligation. Highly effective methods of birth control include hormonal birth control (oral, intravaginal, or transdermal), or progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or intrauterine), intrauterine devices (IUDs), intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner (provided partner is the sole sexual partner and there has been a medical assessment of surgical success), or sexual abstinence

Fertile male subjects must be willing to practice a highly effective method of birth control during and for 4 weeks after completion of study

Male subjects must agree not to donate sperm from screening through 4 weeks after completion of study

Able and willing to complete the entire study according to the study schedule

Available at:

USO 23234

A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig as Sequential Therapy Versus Observation in Participants with Unresected Locally Advanced-Head and Neck Squamous Cell Carcinoma (LA-HNSCC) Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC), D798EC00001

 

Disease Types: Head & Neck Cancer Research

Eligibility Requirements:

* Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0).

* Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system).

* Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent within 12 weeks prior to randomization.

Available at:

USO 24014

A RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF CEMACABTAGENE ANSEGEDLEUCEL IN PARTICIPANTS WITH MINIMAL RESIDUAL DISEASE AFTER RESPONSE TO FIRST LINE THERAPY FORLARGE B-CELL LYMPHOMA (ALPHA3) [ALLO-501A-202]

 

Disease Types: Cellular & Gene

Available at:

USO 22298

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer (20180146)

 

Disease Types: Genitourinary Cancer Research, Cellular & Gene

Eligibility Requirements:

Parts 1, 2, and 5: Participants with histologically or cytologically confirmed metastatic castration-resistant prostate cancer (mCRPC) who are refractory to a novel antiandrogen therapy (abiraterone acetate and/or enzalutamide, apalutamide, or darolutamide) and have failed at least 1 (but not more than 2) taxane regimens including for metastatic hormone-sensitive prostate cancer (mHSPC) (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Note: A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. Any NHT that has been administered and has been stopped for reasons other than progression will not be counted as an additional line of treatment.

 

1.Dose exploration phase: Novel antiandrogen therapy must have been given for treatment of metastatic disease.
2.Dose expansion phase: participants must not have had more than 2 NHTs and 2 taxane regimens in any setting, and an additional up to 2 other systemic anti-cancer treatments are allowed (eg, anti-PD1, PARP inhibitors, radioligand therapies, sipuleucel-T, experimental agents) Note: Combinations are considered one systemic anti-cancer treatment.

Parts 4A and 4B:

1.Participants with histologically or cytologically confirmed mCRPC who have received no or 1 prior NHT (given in any disease setting), and no or 1 taxane (given for hormone sensitive prostate cancer).
2.4A: Participants planning to receive abiraterone acetate for the first time (participants who received prior abiraterone acetate are not eligible).
3.4B: Participants planning to receive enzalutamide for the first time (participants who received prior enzalutamide/apalutamide or daralutamide are not eligible).

Available at:

USO 22067

Phase 1/2 Study of PRO1184 in Patients with Locally Advanced and/or Metastatic Solid Tumors (PRO1184-001)

 

Disease Types: GYN Cancer Research

Eligibility Requirements:

- Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer, breast cancer (hormone receptor positive, HER2-negative and triple-negative), mesothelioma

- Previously received therapies known to confer clinical benefit

- Willing to provide a tumor sample (archive tissue or fresh biopsy)

- ECOG performance status 0 or 1

- Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline

- Adequate hematologic, hepatic, renal and cardiac function

- For Part B, evidence of folate receptor alpha expression in tumor cells

Available at:

USO 23047

An International, Prospective, Open-label, Multi-center, Randomized Phase III Study comparing lutetium (177Lu) vipivotide tetraxetan versus Observation to delay castration or disease recurrence in adult male patients with prostate-specific membrane antigen (PSMA) positive Oligometastatic Prostate Cancer (OMPC) (CAAA617D12302)

 

Disease Types: Genitourinary Cancer Research

Eligibility Requirements:

- Signed informed consent must be obtained prior to participation in the study

- Participants must be adults >18 years of age at the time of informed consent

- ECOG performance status of 0 or 1 at screening

- Participants must have a life expectancy >24 months as determined by the Investigator at screening

- Histologically confirmed prostate cancer prior to randomization

- Participants must have biochemically recurrent disease after definitive treatment to prostate by RP, (alone or with post-operative radiation to prostate bed/pelvic nodes) or XRT, (prostate alone or prostate with seminal vesicle and/or pelvic nodes) and/or brachytherapy prior to randomization. Biochemical recurrence is defined as: nadir PSA + 2 ng/mL post XRT (if participant received-radiation therapy to intact prostate) and PSA > 0.2 ng/mL and rising post RP (with or without post-operation RT)

Available at:

USO 22090

AN OPEN-LABEL MULTICENTER PHASE 1b-2 STUDY OF ELACESTRANT IN COMBINATION WITH ABEMACICLIB IN WOMEN AND MEN WITH BRAIN METASTASIS FROM ESTROGEN RECEPTOR POSITIVE, HER-2 NEGATIVE BREAST CANCER (ELECTRA) (ELA-0121)

 

Disease Types: Breast Cancer Research

Available at:

USO 23055

ICT01-101: A first-in-human, two-part, open-label, clinical study to assess the safety, tolerability and activity of intravenous doses of ICT01 as monotherapy and in combination with an immune checkpoint inhibitor, in patients with advanced-stage, relapsed/refractory cancer (EVICTION Study) (ICT01-101)

 

Disease Types: Cellular & Gene

Eligibility Requirements:

1.Voluntarily signed informed consent form.
2.Relapsed/refractory patients with histologically or cytologically confirmed diagnosis of advanced-stage or recurrent cancer, including:

Group A: bladder, breast, colon, gastric, melanoma, ovarian, prostate and PDAC Group B: hematologic malignancies including acute myeloid leukemia, acute lymphocytic leukemia, Diffuse large B cell lymphoma and follicular lymphoma Group C: melanoma, cervical, bladder, gastric, head and neck SCC, and lymphoma (according to the approved package labeling of the ICI) Part 2, Group D: Ovarian cancer (2L/3L) with baseline g9d2 T cells > 20K Part 2, Group E: metastatic castrate resistant prostate cancer (2L/3L) with baseline g9d2 T cells > 20K Part 2, Group G: checkpoint-refractory metastatic melanoma with g9d2 T cells >5K Part 2, Group H: chemotx-refractory or Pt-ineligible urotherlial cancer (bladder) with g9d2 T cells >5K Part 2, Group I: checkpoint-refractory, metastatic HNSCC with g9d2 T cells >5K

3.Eastern Cooperative Oncology Group (ECOG) performance status < 1
4.Life expectancy > 3 months as assessed by the Investigator
5.At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST)/ Response Evaluation Criteria in Lymphoma (RECIL) or >5% marrow blasts

Available at:

USO 23080

Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers that Progressed on PD-1/PD-L1 Inhibitors (PRESERVE-003)

 

Disease Types: Lung Cancer Research

Eligibility Requirements:

1. Adult (> 18 years), all genders, capable of signing informed consent.
2. Histologically- or cytologically- confirmed diagnosis of metastatic NSCLC, metastasis can be regional lymph nodes or distant organs.
3. Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b:
1. At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy;
2. Prior treatment with at least 2 cycles of a platinum-based chemotherapy, followed by at least 12 weeks of standard doses of PD-1 or PD-L1 inhibitor-based immunotherapy.
Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1/PD-L1 inhibitor are allowed. 4. At least one measurable tumor lesion according to RECIST 1.1. 5. ECOG score of 0 or 1. 6. Adequate organ functions. Serum LDH level < 2xULN. 7. Life expectancy > 3 months.

Available at:

USO 22331

Multicohort Study to Customize Ibrutinib Treatment Regimens for Patients with Previously Untreated Chronic Lymphocytic Leukemia (TAILOR) (54179060CLL2032)

 

Disease Types: Leukemia & Lymphoma Research

Eligibility Requirements:

- Diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) as per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 diagnostic criteria

- For ibruinib + venetocIax (I+V) cohorts: eastern cooperative oncology group (ECOG) performance status of 0-1. For ibrutinib monotherapy cohorts: ECOG performance status of 0-2

- Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node greater than and equal to (>=) 1.5 centimeters (cm) in longest diameter

- A participant using oral contraceptives must use an additional contraceptive method

- A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study treatment

Available at:

uso 22326

CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-high or High risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease (D8535C00001)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

-Women and Men, >18 years at the time of screening (or per national guidelines)                                                                                                                                                                              -Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol.                                                                                                                                                                                                                                                                                                  -Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy                                --Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)                                                                                                                                          -Eastern Cooperative Oncology Group (ECOG) performance status of < 1                                                                                                                                                                                          -Adequate organ and marrow function

Available at:

USO 22329

A Phase 1b/2, Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer (ELEVATE) (STML-ELA-0222)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

- Patient has signed the informed consent before all study specific activities are conducted.

- Women or men aged > 18 years (or the minimum age of consent in accordance with the local law), at the time of informed consent signature. Female patients may be either postmenopausal, premenopausal, or perimenopausal.

-Postmenopausal status is defined by:

- Age >60 years

Age <60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) or a follicle-stimulating hormone (FSH) value >40 mIU/mL and an estradiol value<40 pg/mL (140 pmol/L) or in postmenopausal ranges per local reference ranges

- Documentation of prior surgical sterilization (i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, at least 1 month before first dose of trial therapy).

- Premenopausal and perimenopausal women and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist initiated at least 4 weeks before the start of trial therapy and are planning to continue LHRH agonist treatment during the study.

- For perimenopausal women to be considered of non-childbearing potential, FSH levels must be >40 mIU/ml.

- Histopathologically or cytologically confirmed ER+, HER2-, breast cancer, per local laboratory, as per the American Society of Clinical Oncology (ASCO)/College of American Pathologists(CAP) guidelines (Allison et al, 2020, Wolff et al, 2018).Note: In the context of this trial, ER status will be considered positive if > 10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry.

- At least one measurable lesion as per RECIST version 1.1 or a mainly lytic bone lesion. Note: Patients with stable brain or subdural metastases are allowed if the patient has completed local therapy and was on a stable or decreasing dose of corticosteroids at baseline for management of brain metastasis for at least 4 weeks before starting treatment in this study. The dose must be < 2.0 mg/day of dexamethasone or equivalent. Any signs (e.g., radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.

- ECOG performance status of 0 or 1

Available at:

USO 18263

A Phase 2, Multicenter, Single-arm Study of Zanubrutinib (BGB-3111) in Patients with Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment with Ibrutinib and/or Acalabrutinib (BGB-3111-215)

 

Disease Types:

Eligibility Requirements:

- Confirmed diagnosis with at least one criterion for treatment according to IWCLL

- ECOG performance status of 0-2

- Measurable disease by contrast enhanced CT/MRI

- Previously treated with a minimum of 1 prior line of standard chemotherapy-containing regimen (with completion of >2 treatment cycles).

- Documented failure to achieve at least partial response (PR) or documented disease progression after response to the most recent treatment regimen. Refractory disease is defined as treatment failure (stable disease, non-response, progressive disease [PD]) or disease progression within 6 months after the most recent prior therapy (Hallek et al, 2008).

- Neutrophils > 0.75 x 109/L independent of growth factor support within 7 days of study entry

- Platelets > 50 x 109/L, independent of growth factor support or transfusion within 7 days of study entry

- Creatinine clearance of > 30 ml/min (as estimated by the Cockcroft-Gault equation or estimated glomerular filtration rate [eGFR] from the Modification of Diet in Renal Disease [MDRD])

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3 x ULN

- Bilirubin <2 x ULN (unless documented Gilbert's syndrome)

- International normalized ratio (INR) <1.5 and activated partial thromboplastin time (APTT) <1.5 x ULN.

- Participants may be enrolled who relapse after autologous stem cell transplant if they are at least 6 months after transplant.

- Life expectancy of >4 months

- LVEF >50% by ECHO

Available at:

USO 23095

A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous NSCLC (HARMONi-3)(SMT112-3003)

 

Disease Types: Lung Cancer Research

Eligibility Requirements:

- Age > 18 years old at the time of enrollmen

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

- Expected life expectancy > 3 months

- Metastatic (Stage IV) NSCLC

- Histologically or cytologically confirmed squamous NSCLC

- Tumor Proportion Score (TPS) with PD-L1 expression percent

- At least one measurable noncerebral lesion according to RECIST 1.1

- No prior systemic treatment for metastatic NSCLC

Available at:

USO 22074

A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma (KT-US-473-0133)

 

Disease Types: Cellular & Gene

Eligibility Requirements:

- Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)

- Clinical indication for treatment.

- At least 1 measurable lesion per the Lugano Classification {Cheson 2014}

- Adequate renal, hepatic, pulmonary, and cardiac function

Available at:

USO 22002

A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advanced or Metastatic Solid Tumors (XL092-002)

 

Disease Types: Solid Tumors Research

Eligibility Requirements:

- Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.

- Recovery to baseline or < Grade 1 CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.

- Karnofsky Performance Status (KPS) >= 70%.

- Adequate organ and marrow function.

- Sexually active fertile subjects and partner agree to use highly effective methods of contraception.

- Female subjects of childbearing potential must not be pregnant at screening.

Available at:

USO 22083

A Phase 1, Multicenter, Open-Label Study of CNTY-101 in Subjects with Relapsed or Refractory CD19-Positive B-Cell Malignancies (CNTY-101-111-01 (ELiPSE-1)

 

Disease Types: Leukemia & Lymphoma Research

Eligibility Requirements:

-  Diagnosis of CD19-positive relapsed or refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL).

Must have met the following criteria for prior treatment:

- Participants with aggressive NHL must have received at least 2 lines of systemic therapy (if not intended for transplant, have already undergone or be unwilling or unable to undergo chimeric antigen receptor [CAR] T-cell therapy to be eligible), or at least 3 lines of systemic therapy. Previous therapy must have included a CD20-targeted agent and an anthracycline or alkylator.

- Participants with follicular lymphoma (FL) must have received at least 2 lines of systemic therapy and have high-risk disease. Previous therapy must have included a CD20-targeted agent and an alkylator.

- Participants with marginal zone lymphoma (MZL) must have received at least 2 prior systemic therapies.

- Measurable disease on screening evaluations.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Adequate organ function.

Available at:

USO 22201

IMGN853-0421: Randomized, Multicenter, Open-Label, Phase 3 Study Of Mirvetuximab Soravtansine In Combination With Bevacizumab Versus Bevacizumab Alone As Maintenance Therapy For Patients With Folate Receptor Alpha-Positive Recurrent Platinum-Sensitive Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-Based Chemotherapy Plus Bevacizumab (IMGN853-0421 GOG-3078)

 

Disease Types: GYN Cancer Research

Available at:

USO 22159

A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1) (CELC-G-301)

 

Disease Types: Breast Cancer Research

Available at:

USO 22033

A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 Tablet in Adult Patients with Advanced Cholangiocarcinoma (TT420C1206)

 

Disease Types: Lymphoma & Hematologic

Available at:

USO 21546

TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination with Nivolumab to Tivozanib Monotherapy in Subjects with Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line has an Immune Checkpoint Inhibitor (AV-951-20-304)

 

Disease Types: Genitourinary Cancer Research

Available at:

USO 22101

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence (J2J-MC-JZLH)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

-ER+, HER2 –  early stage, resected, invasive breast cancer without evidence of distant metastasis, must have undergone definitive loco-regional treatment, bilateral breast cancer diagnosed in both breasts simultaneously or within 6 months allowed if all tumors in both breasts are ER+, HER 2 -  and adequate surgery has been completed in both breasts, must have received at least 24 months but not more than 60 months of any adjuvant endocrine therapy, have an increased risk of disease recurrence based on clin-path features

-No: metastatic disease, inflammatory breast cancer at primary diagnosis, local or distant recurrence, different primary breast cancer, more than a 6 month consecutive gap in adjuvant endocrine therapy, completed or discontinued prior adjuvant endocrine therapy ˃ 6 months prior to screening, received endocrine therapy for breast cancer prevention (tamoxifen or aromatase inhibitors) or raloxifene, have serious pre-existing condition that in the opinion of the treating investigator would preclude participation in study, received a stem cell transplant, active bacterial or fungal infection or detectable viral infection

Available at:

USO 21173

A Phase 3, double-blind, randomized study to assess the efficacy and safety of switching to AZD9833 (an oral SERD) + CDK4/6 inhibitors (palbociclib or abemaciclib) vs continuing aromatase inhibitor + CDK4/6 inhibitors in patients with acquired ESR1 mutation without radiological progression during 1L treatment with AI + CDK4/6i for HR+/HER2- mBC-ctDNA guided early switch study (SERENA 6) (D8534C00001)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

-ER +/Her 2 - recurrent or metastatic breast cancer not amenable to surgery or radiation therapy with curative intent
-Currently on aromatase inhibitor (AI) letrozole or anastrozole + CDK4/6 inhibitor (palbociclib or abemaciclib) ± Luteinizing hormone-releasing hormone (LHRH) agonist as initial endocrine treatment for advanced disease
-No: known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease; evidence of severe or uncontrolled systemic diseases; known or family history of severe heart disease; previous treatment with investigational Selective estrogen receptor degraders (SERDs) or fulvestrant; persistent non-hematological toxicities (Grade > 2) caused by CDK4/6 inhibitor and/or AI treatment. 

Available at:

uso 21207

(PSMAddition): An international Prospective Open-label, Randomized, Phase III Study comparing [177Lu]Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)(CAAA617C12301)

 

Disease Types: Genitourinary Cancer Research

Eligibility Requirements:

- Metastatic hormone sensitive adenocarcinoma of the prostate

- No: prior systemic cancer therapy for prostate cancer (LHRH agonist/antagonist, CYP 17 inhibitor or ARDT treatment of up to 45 days allowed); previous treatment within 6 months of randomization with Strontium-89, Samarium-153,                                                                                                                                                                                                                          Rhenium-186 or 188, Radium-223, hemibody irradiation, or previous PSMA targeted radioligand therapy; CNS metastasis that is unstable, symptomatic, or requires corticosteroid treatment; active hepatitis B or C; active clinically significant cardiac disease; unable to maintain raised arm position (if can maintain raised arms with positioning allowed)

Available at:

uso 20408

A Phase Ill, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy And Safety Of Adjuvant Giredestrant Compared With Physician's Choice Of Adjuvant Endocrine Monotherapy In Patients With Estrogen Receptor - Positive, Her2‑Negative Early Breast Cancer (Go42784)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

- ER+, HER2 – Breast Cancer, must have under definitive surgery for disease and completed adjuvant therapy prior to randomization 

- No:  active cardiac disease or history of cardiac dysfunction, metastatic breast cancer; clinically significant liver disease or active hepatitis B or C; coagulopathy or thromboembolism; inability to swallow or absorb oral medication

Available at:

USO 21225

A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients Whose Disease is Resistant or Refractory to T-DM1, and/or T-DXd, and/or Tucatinib-containing Regimens (ACE-Breast-03)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

-Her 2+ metastatic breast cancer with measurable disease, must have prior therapy with ado-trastuzumab (T-DM1), and/or trastuzumab deruxtecan (T-Dxd), and/or tucatinib containing regimen, and trastuzumab + taxane.
-No: clinically significant lung disease within the last 12 months, history of interstitial lung disease or pneumonitis; congestive heart failure, unstable angina, unstable atrial fibrillation, or cardiac arrhythmia in the last 12 months and myocardial infarction within last 6 months; unstable central nervous metastasis; peripheral neuropathy grade 2 or higher; known active HIV, Hep B, or Hep C; or ocular conditions such as keratopathy, dry eye, keratitis, corneal disorders, or current ocular infection. 

Available at:

D9673C00007 (DESTINY-Breast12)

“An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously-Treated Advanced/Metastatic HER2-Positive Breast Cancer(DESTINY-Breast12)”

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

-Her2+, unresectable advanced or metastatic breast cancer with disease progression on trastuzumab, pertuzumab, or T-DM1
-No more than 2 lines of therapy in metastatic setting, brain metastasis allowed if stable or not needing immediate therapy
-No: leptomeningeal disease; prior tucatinib therapy; chronic GI disease, refractory nausea/vomiting, significant bowel resection; known active HIV, Hep B, or Hep C;
myocardial infarction within previous 6 months, symptomatic congestive heart failure, unstable angina, recent cardiovascular event including stroke within previous 6 months; long QT syndrome,

QT prolongation requiring medication discontinuation or associated with concurrent medication, history of clinically significant arrythmia that is symptomatic or requires treatment, uncontrolled atrial fibrillation, ventricular tachycardia; history of interstitial lung disease that required steroids, current interstitial lung disease, or pneumonitis, clinically significant lung or pulmonary disease or conditions such as severe asthma or severe COPD, autoimmune or connective tissue or inflammatory disorder or disease with pulmonary involvement, prior pneumonectomy. 

Available at:

USO 19151

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001) STAR

 

Disease Types: Solid Tumors Research

Eligibility Requirements:

-NSCLC (squamous or non-squamous; mixed histology not allowed) or colorectal solid tumors with KRAS G12c mutations 
-must have unresectable or metastatic disease with no standard of care treatment options available
-NSCLC patients must have had platinum based chemotherapy & treatment with a check point inhibitor 
-no active brain metastasis, carcinomatous meningitis, significant hemoptysis or hemorrhage within last 4 weeks, GI condition or disease that prevents absorption of oral medication, significant heart disease, history of stroke or TIA within last 6 months, or known HIV, active Hep B or Hep C

Available at:

USO 18283

A Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/PD-L1 Based Immunotherapy (IMMU-132-06)

 

Disease Types: Genitourinary Cancer Research

Eligibility Requirements:

-locally advanced or metastatic urothelial cancer with measurable disease
-No: immunodeficiency disease; prior anti-cancer with mono-clonal antibodies within last 4 weeks; prior treatment with irinotecan; known active CNS metastasis or carcinomatous meningitis; active serious cardiac disease (MI or unstable angina within last 6 months, serious ventricular arrhythmia, congestive heart failure class 3 or 4, ejection failure less than 40%); chronic ulcerative colitis, Crohn’s disease, or history of bowel obstruction; prior history of significant bleeding, intestinal obstruction, or GI perforation within last 6 months; known HIV, Hep B or Hep C

Available at:

Virginia Oncology Associates