A Study of Cetrelimab (JNJ-63723283), a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, Administered in Combination With Apalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer
Castration-Resistant Prostatic Neoplasms
About this trial
This is an interventional treatment trial for Castration-Resistant Prostatic Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Pathologically confirmed adenocarcinoma of the prostate. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) on screening biopsy may be eligible for cohort 5
- Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). CT-portion of positron emission tomography (PET)/CT scan may be used for eligibility. If lymph node metastasis is the only evidence of metastatic disease, it must be greater than (>=) 1.0 centimeter (cm) in the short axis and above the level of the iliac bifurcation
- Progressed while on therapy with abiraterone acetate plus prednisone/prednisolone (AA-P), enzalutamide, darolutamide, or apalutamide for mCRPC. No washout is required and no additional therapy may have been administered between discontinuation of AR-targeted the agent and study treatment. Participants will be assigned to cohorts based on the results of the biomarker panel. Cohort 1: Biomarker-negative or biomarker-unknown participants with adenocarcinoma (and not t-SCNC) who progressed on abiraterone acetate plus prednisone/prednisolone (AA-P); Cohort 2: Biomarker-negative or biomarker-unknown participants with adenocarcinoma (and not t-SCNC) who progressed on apalutamide, darolutamide, or enzalutamide; Cohort 3: Biomarker-positive participants who progressed on AA-P; Cohort 4: Biomarker-positive participants who progressed on apalutamide, darolutamide, or enzalutamide; Cohort 5: Biomarker-negative participants with t-SCNC who progressed on treatment with AA-P, apalutamide, darolutamide, or enzalutamide
- Surgical or medical castration, with testosterone levels of less than (<)50 nanogram per deciliter (ng/dL). If the participant is being treated with gonadotropin-releasing hormone (GnRH) analogs (participant who has not undergone bilateral orchiectomy), this therapy must have been initiated at least 4 weeks prior to first dose of study drug and must be continued throughout the study
- Eastern Cooperative Oncology Group Performance Status (ECOG) prostate-specific (PS) grade of 0 or 1
Exclusion Criteria:
- Initial diagnosis of primary prostatic neuroendocrine or small cell carcinoma
- Brain metastases
- Prior treatment with an anti-programmed cell death receptor-1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody
- Prior chemotherapy, except for docetaxel for hormone-sensitive prostate cancer (HSPC)
- Prior therapy with poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors
Sites / Locations
- University of California San Francisco (UCSF) - Prostate Cancer Center
- Regional Urology LLC
- University of Michigan Health System
- Washington University
- New York University Langone Medical Center
- Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
- Levine Cancer Institute, Carolinas HealthCare System
- Centers for Advanced Urology, LLC; d/b/a MidLantic Urology
- Thomas Jefferson University
- University of Texas, MD Anderson Cancer Center
- Virginia Oncology Associates
- Grand Hôpital de Charleroi, site Notre Dame
- AZ Maria Middelares
- Cross Cancer Institute
- University of Toronto
- Centre de Recherche du CHUM
- Istituto Europeo di Oncologia Servizio Radioterapia
- NKI-AVL, Amsterdam
- UMC Radboud
- Sint Franciscus Gasthuis
- Moscow City Clinical Hospital # 62
- Hertzen Oncology Research Institute
- Clinical Oncology Dispensary
- Non-State Healthcare Institution 'Road Clinical Hospital of Russian Railways'
- Russian Scientific Center of Radiology and Surgical Technologies
- Hosp. Univ. Vall D Hebron
- Hosp. Gral. Univ. Gregorio Marañon
- Hosp. Univ. Ramon Y Cajal
- Hosp. Univ. Fund. Jimenez Diaz
- Hosp. Univ. Hm Sanchinarro
- Hosp. Virgen de La Victoria
- Hosp. Quiron Madrid Pozuelo
- Hosp. Univ. Marques de Valdecilla
- Instituto Valenciano de Oncologia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Biomarker-negative or biomarker-unknown participants with adenocarcinoma (and not treatment-emergent small-cell neuroendocrine prostate cancer [t-SCNC]) who progressed on abiraterone acetate plus prednisone/prednisolone (AA-P) will be enrolled in this cohort. Participants will receive cetrelimab 480 milligram (mg) plus apalutamide 240 mg daily starting Cycle 1 (each cycle of 28 days).
Biomarker-negative or biomarker-unknown participants with adenocarcinoma (and not t-SCNC) who progressed on apalutamide, darolutamide, or enzalutamide will be enrolled in this cohort. Participants will receive cetrelimab 480 mg plus apalutamide 240 mg daily starting Cycle 1.
Biomarker-positive participants who progressed on AA-P will be enrolled in this cohort. Participants will receive cetrelimab 480 mg plus apalutamide 240 mg daily starting Cycle 1 (each cycle of 28 days).
Biomarker-positive participants who progressed on apalutamide, darolutamide, or enzalutamide will be enrolled in this cohort. Participants will receive cetrelimab 480 mg plus apalutamide 240 mg daily starting Cycle 1 (each cycle of 28 days).
Biomarker-negative participants with t-SCNC who progressed on treatment with AA-P, apalutamide, darolutamide, or enzalutamide will be enrolled in this cohort. Participants will receive cetrelimab 480 mg plus apalutamide 240 mg daily starting Cycle 1 (each cycle of 28 days).