West Cancer Center

PROSTATE: METASTATIC: Castration Resistant: 2nd Line Hormonal: MK-5684-004

A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA)

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Malignancy

Prostate Cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

2nd Line Hormonal Therapy

Investigational Agent

MK-5684

Drug Class

CYP11A1 inhibitor

PI

Brad Somer, MD

Sponsor

Merck Sharp and Dohme

Path

Castration-Resistant

Key Eligibility Criteria Details

Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography scan (CT)/magnetic resonance imaging (MRI)
Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before Screening
Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) metastatic hormone sensitive prostate cancer (mHSPC) or non metastatic hormone sensitive prostate cancer (nmHSPC), for at least 8 weeks (at least 14 weeks for participants with bone progression) Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than six cycles of docetaxel and had no radiographic disease progression while receiving docetaxel
ECOG PS 0-1
Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM)
Has had prior treatment with Poly polymerase inhibitors (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
Has adequate organ function
Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed
Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy are eligible
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
No presence of gastrointestinal condition
No history of pituitary dysfunction
No poorly controlled diabetes mellitus
No active or unstable cardio/cerebro-vascular disease, including thromboembolic events
Has not received a taxane-based chemotherapy and or NHA for metastatic castration-resistant prostate cancer (mCRPC)
Has not received prior treatment with radium for prostate cancer
Does not have a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
No known active central nervous system (CNS) metastases

PROSTATE: METASTATIC: Pembro+Lenvatinib: 2nd or 3rd line chemo: KEYNOTE-365 ARM E

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

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Malignancy

Prostate

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

> or - 2nd line

Investigational Agent

Pembrolizumab, Lenvatinib

Drug Class

PD-1 inhibitor, VEG-F TKI

PI

Dan Vaena, MD

Sponsor

Merck Sharp and Dohme

Path

Prostate Adenocarcinoma without small cell histology

Key Eligibility Criteria Details

Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features
Must provide a core or excisional biopsy from soft tissue or bone biopsy from soft tissue within 1 year of screening and after developing mCRPC
Has prostate cancer progression within 6 months prior to screening by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on RECIST criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression.
Ongoing androgen deprivation with serum testoterone <50ng/dL
Stable doses of bone resorptive therapy
ECOG PS 0-1
Has previously received docetaxel for mCRPC. Prior treatment with one other chemotherapy is allowed. Up to 2 second-generation hormonal agents (eg. abiraterone, enzalutimide, etc.) are allowed. Prior ketoconazole is allowed. Docetaxel used more than once is considered as 1 therapy.
No diagnosis of immunodeficiency or systemic steroid therapy
No autoimmune disease within last 2 years
No known HBV/HCV/HIV
No known active CNS mets
No superscan bone scan
No active cardiovascular disease
No gastrointestinal malabsortion
No active hemoptysis

PROSTATE: METASTATIC: NEUROENDOCRINE >/= 1st Line: Pembro+Lenvatinib: KEYNOTE-365 ARM F

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

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Malignancy

Prostate

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st or later

Investigational Agent

Pemrbolizumab and Lenvatinib

Drug Class

PD-1 inhibitor, VEGF TKI

PI

Dan Vaena, MD

Sponsor

Merck Sharp and Dohme

Path

Neuroendocrine castration resistant prostate cancer

Key Eligibility Criteria Details

Has treated or de novo neuroendocrine metastatic prostate cancer defined by ≥1% neuroendocrine cells that are located in discrete regions of a recent biopsy specimen from a metastasis as determined by the investigational site and confirmed by central histology review prior to enrollment
Must provide a core or excisional biopsy from soft tissue or a bone biopsy. For de novo metastatic neuroendocrine prostate participants, biopsies must be performed within 1 year of screening. Participants with bone metastasis only must provide an archival tumor tissue specimen.
Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on RECIST criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression. Participants with de novo neuroendocrine prostate cancer will not need to provide evidence of progression within 6 months
Has ongoing androgen deprivation with serum testosterone <50 ng/dL
Patients receiving bone resorptive therapy must be on stable doses
ECOG PS 0-1
Participants must have received prior treatment with androgen deprivation therapy (ADT) for metastatic disease. Participants must also have received prior treatment with an NHA (eg, abiraterone acetate, apalutamide, etc.) or docetaxel for mHSPC or mCRPC. Prior treatment with up to a total of 2 chemotherapies for mCRPC is allowed, as well as up to 2 second-generation hormonal manipulations for mCRPC. Participants who received prior ketoconazole for metastatic disease may be enrolled. Docetaxel for mHSPC is allowed in addition to docetaxel for mCRPC. If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy. A limited number of de novo patients may enroll after consultation with the sponsor.
No prior treatment with Radium or Lutitium
No immunodeficiency or systemic steroids
No autoimmune disease within the last 2 years
No known HIV/HBV/HCV
No known CNS mets
No superscan bone scan
No active cardiovascular disease
No active hemoptysis

PROSTATE: METASTATIC: 2nd line or greater: Pembro/Vibostolimab: KEYNOTE-365 ARM G

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

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Malignancy

Prostate

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd line or greater

Investigational Agent

Pembrolizumab Vibostolimab coformulation

Drug Class

PD-1 inhibitor + Anti-TIGIT

PI

Dan Vaena, MD

Sponsor

Merck Sharp and Dohme

Path

Adenocarcinoma

Key Eligibility Criteria Details

Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
Must provide a core or excisional biopsy from soft tissue or bone biopsy within 1 year of screening and after developing mCRPC. Participants with bone metastasis only must provide an archival tumor tissue specimen.
Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on RECIST criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression.
Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
Patients receiving bone resorptive therapy must be on stable doses
ECOG PS 0-1
Has received docetaxel for mCRPC. Prior treatment with 1 other chemotherapy for mCRPC is allowed. Up to 2 second-generation hormonal manipulations (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide or other next-generation hormonal agents [NHA]) are allowed. Participants who received prior ketoconazole for metastatic disease may be enrolled. If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy. Prior docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC) is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to Day 1 of Cycle 1
No immunodeficiency or systemic steroid use
No active autoimmune disease within 2 years
No known HIV/HBV/HCV
No known CNS mets
No superscan bone scan
No symptomatic ascites or pleural effusion

PROSTATE: METASTATIC: NEUROENDOCRINE: treated or de novo: Pembro/Carbo/Etop: KEYNOTE-365 ARM I

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

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Malignancy

Prostate

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Treated or de novo

Investigational Agent

Pembrolizumab, Carboplatin, Etoposide or Carbo/Etoposide alone

Drug Class

PD-1 inhibitor, chemo

PI

Dan Vaena, MD

Sponsor

Merck Sharp and Dohme

Path

Prostate cancer with neuroendocrine features

Key Eligibility Criteria Details

Has treated or de novo metastatic neuroendocrine prostate cancer defined by ≥1% neuroendocrine cells that are located in discrete regions of a recent biopsy specimen from a metastasis as determined by the investigational site and confirmed by central histology review prior to enrollment
Must provide a core or excisional biopsy from soft tissue or a bone biopsy. For de novo metastatic neuroendocrine prostate participants, biopsies must be performed within 1 year of screening. Participants with bone metastasis only must provide an archival tumor tissue specimen.
Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on RECIST criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression. Participants with de novo neuroendocrine prostate cancer will not need to provide evidence of progression within 6 months
Has ongoing androgen deprivation with serum testosterone <50 ng/dL
Patients receiving bone resorptive therapy must be on stable doses
ECOG PS 0-1
Participants must have received prior treatment with androgen deprivation therapy (ADT) for metastatic disease. Participants must also have received prior treatment with an NHA (eg, abiraterone acetate, apalutamide, darolutamide, enzalutamide, or other NHA) or docetaxel for mHSPC or mCRPC. Prior treatment with up to a total of 2 chemotherapies for mCRPC is allowed, as well as up to 2 second-generation hormonal manipulations for mCRPC. Participants who received prior ketoconazole for metastatic disease may be enrolled. Docetaxel for mHSPC is allowed in addition to docetaxel for mCRPC. If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy. A limited number of de novo patients will be allowed to enroll based on consultation with the study team.
No immunodeficiency or systemic steroid use
No autoimmune disease within last 2 years
No known HIV/HBV/HCV
No known active CNS mets
No superscan bone scan
No symptomatic ascited or pleural effusion
No prior treatment with platinum containing compounds for prostate cancer

PROSTATE: METASTATIC: NEUROENDOCRINE >/= 1st Line: Pembro/Vibostolimab: KEYNOTE-365 ARM H

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

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Malignancy

Prostate

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line chemo or later

Investigational Agent

Pembrolizumab/Vibostolimab

Drug Class

PD-1/anti-TIGIT coformulation

PI

Dan Vaena, MD

Sponsor

Merck Sharp and Dohme

Path

Prostate Adenocarcinoma without small cell histology

Key Eligibility Criteria Details

Has treated or de novo neuroendocreine metastatic prostate cancer defined by ≥1% neuroendocrine cells that are located in discrete regions of a recent biopsy specimen from a metastasis as determined by the investigational site and confirmed by central histology review prior to enrollment
Must provide a core or excisional biopsy from soft tissue or a bone biopsy. For de novo metastatic neuroendocrine prostate participants, biopsies must be performed within 1 year of screening. Participants with bone metastasis only must provide an archival tumor tissue specimen.
Has prostate cancer progression within 6 months prior to screening, as determined by the investigator, by means of one of the following: PSA progression as defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each assessment where the PSA value at screening should be ≥2 ng/mL; radiographic disease progression in soft tissue based on Response Evaluation Criteria In Solid Tumors Version 1.1 criteria with or without PSA progression; radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression. Participants with de novo neuroendocrine prostate cancer will not need to provide evidence of progression within 6 months
Has ongoing androgen deprivation with serum testosterone <50 ng/dL
Patients receiving bone resorptive therapy must be on stable doses
ECOG PS 0-1
Participants must have received prior treatment with androgen deprivation therapy (ADT) for metastatic disease. Participants must also have received prior treatment with an NHA (eg, abiraterone acetate, apalutamide, darolutamide, enzalutamide, or other NHA) or docetaxel for mHSPC or mCRPC. Prior treatment with up to a total of 2 chemotherapies for mCRPC is allowed, as well as up to 2 second-generation hormonal manipulations for mCRPC. Participants who received prior ketoconazole for metastatic disease may be enrolled. Docetaxel for mHSPC is allowed in addition to docetaxel for mCRPC. If docetaxel chemotherapy is used more than once (eg, once for metastatic hormone-sensitive and once for mCRPC), it will be considered as 1 therapy. A limited number of de novo neuroendrcine CRPC patients will be allowed to enroll with consultation with the study team.
No immunodeficiency or systemic steroid use
No autoimmune disease within last 2 years
No known HIV/HBV/HCV
No known CNS mets
No superscan bone scan
No symptomatic ascites or pleural effusion

ADVANCED SOLID TUMORS: METASTATIC: TSC1/TSC2 alterations: last line: PRECISION 1

A Phase 2 Multi-center Open-label Basket Trial of Nab-sirolimus for Adult and Adolescent Patients With Malignant Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 or TSC2 Genes.

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Malignancy

Breast, lung, colon, prostate, bladder, RCC, kidney, skin, melanoma, gastric, pancreatic, HCC, rectal, sarcoma, head and neck, esophagus, biliary tract

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Last line

Investigational Agent

nab-sirolimus

Drug Class

MTOR inhibitor

PI

Dan Vaena, MD

Sponsor

Aadi Bioscience, Inc.

Path

TSC1 or TSC2 alterations

Key Eligibility Criteria Details

Malignant solid tumor with pathogenic inactivating TSC1 or TSC2 alterations. GEnetic alterations should be identified using NGS in tumor tissue or liquid biopsy
Metastatic or locally advanced solid tumors
Must have received all standard therapies appropriate for their tumor type and stage of disease or, in the opinion of the investigator, the patient would b e unlikely to tolerate or derive clinically meaningful benefit from appropriate SOC therapy
Measurable disease
ECOG PS 0-1
Fasting tryglecerid must be < or = 300; fast serus cholesterol must be < or = to 350
No prior treatment with MTOR inhibitor
No primary brain tumors
No known HIV

ADVANCED SOLID TUMORS: Phase 1: PD-L1 + novel agent: GO43860

A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

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Malignancy

Esophageal, Gastric, Cervical, clear cell renal cell cancer, RCC, hepatocellular carcinoma, HCC, liver cancer, HNSCC, head and neck cancer, oropharyngeal, larynx, hypopharyngeal, oral cavity, melanoma, urothelial carcinoma, bladder cancer, triple-negative breast cancer, TNBC, non-small cell lung cancer, NSCLC, colon, prostate

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

>1st line

Investigational Agent

RO7502175

Drug Class

Anti-CCR8 antibody

PI

Dan Vaena, MD

Sponsor

Genentech, Inc.

Path

Carcinoma

Key Eligibility Criteria Details

Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumors
Must have tumor specimen available
Measurable disease
ECOG PS 0-1
Life expectancy at least 12 weeks
Phase 1a- must have exhausted all standard therapies for their disease
Phase 1b- must have disease that has progressed after at least one available standard therapy
Some cohorts are tumor-type specific- please contact study team to see if tumor type is eligible at any time during the study
No active HBV/HCV or chronic or acute EBV
No history of autoimmune disease
No symptomatic or actively progressing CNS mets