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

Completed · Phase 1

Conditions studied: Castration-Resistant Prostatic Neoplasms

In brief

The purpose of this study is to evaluate the safety of the combination of cetrelimab, with apalutamide and to define a population of participants with metastatic castration-resistant prostate cancer (mCRPC) who respond to treatment with the combination of cetrelimab and apalutamide.

Key facts

Study ID

NCT03551782

Run by

Janssen Research & Development, LLC

People needed

33

Starts

2018-06-28

Expected to finish

2021-11-11

Last updated by the study team

2022-02-25

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California San Francisco (UCSF) - Prostate Cancer Center — San Francisco, California, United States
• Regional Urology LLC — Shreveport, Louisiana, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Washington University — Bay Saint Louis, Mississippi, United States
• New York University Langone Medical Center — New York, New York, United States
• Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg — New York, New York, United States
• Levine Cancer Institute, Carolinas HealthCare System — Charlotte, North Carolina, United States
• Centers for Advanced Urology, LLC; d/b/a MidLantic Urology — Bala-Cynwyd, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Grand Hôpital de Charleroi, site Notre Dame — Charleroi, Belgium
• AZ Maria Middelares — Ghent, Belgium
• Cross Cancer Institute — Edmonton, Alberta, Canada
• University of Toronto — Toronto, Ontario, Canada
• Centre de Recherche du CHUM — Montreal, Quebec, Canada
• Istituto Europeo di Oncologia Servizio Radioterapia — Milan, Italy
• NKI-AVL, Amsterdam — Amsterdam, Netherlands
• UMC Radboud — Nijmegen, Netherlands
• Sint Franciscus Gasthuis — Rotterdam, Netherlands
• Moscow City Clinical Hospital # 62 — Moscow, Russia
• Hertzen Oncology Research Institute — Moscow, Russia
• Clinical Oncology Dispensary — Omsk, Russia
• Non-State Healthcare Institution 'Road Clinical Hospital of Russian Railways' — Saint Petersburg, Russia
• Russian Scientific Center of Radiology and Surgical Technologies — Saint Petersburg, Russia

Full record on ClinicalTrials.gov

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