Prostate Cancer Clinical Trial

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

Summary

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.

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Full Description

This study is of participants originally diagnosed with adenocarcinoma of the prostate who have now developed mCRPC and who have progressed on therapy with abiraterone acetate plus prednisone/prednisolone (AA-P), apalutamide, darolutamide, or enzalutamide. Participants with treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) assessed by the screening biopsy may be considered for this study. Participants must have confirmed prostate-specific antigen (PSA) progression per Prostate Cancer Clinical Trials Working Group (PCWG3) criteria. The primary hypothesis is that treatment with cetrelimab and apalutamide is safe and leads to improvement in the 12-week PSA response rate. The study consists of an Optional Pre-screening Period, Screening period (28 days prior to Cycle 1 Day 1), Treatment Period, End-of-Treatment Visit (performed after the last dose of study drug is administered), and Follow-up Period (participants will have Follow-up assessment every 12 weeks after the End-of-Treatment Visit). The efficacy, safety, and pharmacokinetics of cetrelimab in combination with apalutamide will be evaluated.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

33

Study ID:

NCT03551782

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

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There are 34 Locations for this study

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University of California San Francisco (UCSF) - Prostate Cancer Center
San Francisco California, 94158, United States
Regional Urology LLC
Shreveport Louisiana, 71106, United States
University of Michigan Health System
Ann Arbor Michigan, 48109, United States
Washington University
Bay Saint Louis Mississippi, 63110, United States
New York University Langone Medical Center
New York New York, 10016, United States
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg
New York New York, 10029, United States
Levine Cancer Institute, Carolinas HealthCare System
Charlotte North Carolina, 28204, United States
Centers for Advanced Urology, LLC; d/b/a MidLantic Urology
Bala-Cynwyd Pennsylvania, 19004, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
University of Texas, MD Anderson Cancer Center
Houston Texas, 77030, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Grand Hôpital de Charleroi, site Notre Dame
Charleroi , 6000, Belgium
AZ Maria Middelares
Gent , 9000, Belgium
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
University of Toronto
Toronto Ontario, M5G 2, Canada
Centre de Recherche du CHUM
Montreal Quebec, H2X 0, Canada
Istituto Europeo di Oncologia Servizio Radioterapia
Milano , 20141, Italy
NKI-AVL, Amsterdam
Amsterdam , 1066 , Netherlands
UMC Radboud
Nijmegen , 6525A, Netherlands
Sint Franciscus Gasthuis
Rotterdam , 3045 , Netherlands
Moscow City Clinical Hospital # 62
Moscow , 12513, Russian Federation
Hertzen Oncology Research Institute
Moscow , 12528, Russian Federation
Clinical Oncology Dispensary
Omsk , 64401, Russian Federation
Non-State Healthcare Institution 'Road Clinical Hospital of Russian Railways'
Saint Petersburg , 19527, Russian Federation
Russian Scientific Center of Radiology and Surgical Technologies
Sankt-Peterburg , 19775, Russian Federation
Hosp. Univ. Vall D Hebron
Barcelona , 8035, Spain
Hosp. Gral. Univ. Gregorio Marañon
Madrid , 28009, Spain
Hosp. Univ. Ramon Y Cajal
Madrid , 28034, Spain
Hosp. Univ. Fund. Jimenez Diaz
Madrid , 28040, Spain
Hosp. Univ. Hm Sanchinarro
Madrid , 28050, Spain
Hosp. Virgen de La Victoria
Málaga , 29010, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcon , 28223, Spain
Hosp. Univ. Marques de Valdecilla
Santander , 39008, Spain
Instituto Valenciano de Oncologia
Valencia , 46009, Spain

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

33

Study ID:

NCT03551782

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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