Phase
Condition
Prostate Cancer
Prostate Cancer, Early, Recurrent
Urologic Cancer
Treatment
Cetrelimab
JNJ-78278343
Enzalutamide
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Part 1 A-G (all combination treatments) and Parts 2B-C (cabazitaxel, docetaxel):Metastatic castration-resistant prostate cancer (mCRPC) with confirmedadenocarcinoma of the prostate as defined by prostate cancer working group 3 (PCWG3); Parts 2D-G (apalutamide, enzalutamide, darolutamide, abiraterone acetate +prednisone [AAP]): mCRPC: Histologically confirmed adenocarcinoma of the prostate asdefined by PCWG3, with a minimum PSA of 2 nanogram [ng]/milliliter (mL); Part 2H (apalutamide): (a) metastatic hormone-sensitive prostate cancer(mHSPC) withnon-castrate levels of testosterone (greater than [>] 150 ng/ deciliter [dL]) and aminimum PSA of 2 ng/milliliter [mL]; (b) Metastatic disease documented by greaterthan equal to (>=) 1 bone lesion(s) on technetium-99m (99m^Tc) bone scan. Nodefinitive evidence of metastatic visceral disease
Measurable or evaluable disease
(a) Part 1A (cetrelimab) - Prior treatment for mCRPC with at least 1 prior androgenreceptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide,enzalutamide, darolutamide), or chemotherapy (example, docetaxel). (b) Part 1C and 2C (docetaxel), Part 1D (apalutamide), Part 1E and 2E (enzalutamide), Part 1F and 2F (darolutamide), and Part 1G and 2G (AAP)- Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate). (C) Part 1B and 2B (cabazitaxel) - Prior treatment with at least 1 prior ARPI (ie,abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel. (d)Part 2D (apalutamide) - Prior treatment with at least 1 prior ARPI (e) Part 2H (apalutamide)- Participant must not have received prior cytotoxic chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ functions
Exclusion
Exclusion Criteria:
Active autoimmune disease within the 12 months prior to signing consent thatrequires systemic immunosuppressive medications
Toxicity related to prior anticancer therapy that has not returned to Grade lessthan or equal to (<=) 1 or baseline levels (except for alopecia, vitiligo, Grade <=2peripheral neuropathy)
Solid organ or bone marrow transplantation
Known allergies, or intolerance to any of the components (example, excipients) ofJNJ-78278343, cetrelimab (Part 1A), cabazitaxel, Part 1B and 2B , docetaxel Part 1Cand 2C , apalutamide (Part 1D and 2D and Part 2H), enzalutamide (Part 1E and 2E),darolutamide (Part 1F and 2F), or AAP (Part 1G and 2G)
Significant infections or serious lung, heart or other medical conditions
Study Design
Connect with a study center
Icon Cancer Centre Kurralta Park
Kurralta Park, 5037
AustraliaActive - Recruiting
Macquarie University
Macquarie University, 2109
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, 3000
AustraliaActive - Recruiting
Princess Alexandra Hospital
Woolloongabba, 4102
AustraliaActive - Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Florida Cancer Specialists
Sarasota, Florida 34232
United StatesActive - Recruiting
Start Midwest
Grand Rapids, Michigan 49546
United StatesActive - Recruiting
Washington University School Of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Perlmutter Cancer Center at NYU Langone Brooklyn
Brooklyn, New York 11223
United StatesActive - Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501
United StatesActive - Recruiting
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
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