A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer
- Conditions
- Metastatic Castration-resistant Prostate Neoplasms
- Interventions
- Registration Number
- NCT05818683
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of JNJ-78278343 and combination agent in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 213
- Part 1 A-G (all combination treatments) and Parts 2B-C (cabazitaxel, docetaxel): Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma 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 as defined by PCWG3, with a minimum PSA of 2 nanogram [ng]/milliliter (mL); Part 2H (apalutamide): (a) metastatic hormone-sensitive prostate cancer(mHSPC) with non-castrate levels of testosterone (greater than [>] 150 ng/ deciliter [dL]) and a minimum PSA of 2 ng/milliliter [mL]; (b) Metastatic disease documented by greater than equal to (>=) 1 bone lesion(s) on technetium-99m (99m^Tc) bone scan. No definitive evidence of metastatic visceral disease
- Measurable or evaluable disease
- (a) Part 1A (cetrelimab) - Prior treatment for mCRPC with at least 1 prior androgen receptor 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
- Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications
- Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (<=) 1 or baseline levels (except for alopecia, vitiligo, Grade <=2 peripheral neuropathy)
- Solid organ or bone marrow transplantation
- Known allergies, or intolerance to any of the components (example, excipients) of JNJ-78278343, cetrelimab (Part 1A), cabazitaxel, Part 1B and 2B , docetaxel Part 1C and 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
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion) Cetrelimab Participants will receive JNJ-78278343 and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone) during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive JNJ-78278343 and combination agent treatment at the putative RP2R in Part 2 (dose expansion). JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion) Docetaxel Participants will receive JNJ-78278343 and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone) during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive JNJ-78278343 and combination agent treatment at the putative RP2R in Part 2 (dose expansion). JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion) Darolutamide Participants will receive JNJ-78278343 and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone) during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive JNJ-78278343 and combination agent treatment at the putative RP2R in Part 2 (dose expansion). JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion) Abiraterone acetate plus prednisone (AAP) Participants will receive JNJ-78278343 and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone) during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive JNJ-78278343 and combination agent treatment at the putative RP2R in Part 2 (dose expansion). JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion) JNJ-78278343 Participants will receive JNJ-78278343 and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone) during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive JNJ-78278343 and combination agent treatment at the putative RP2R in Part 2 (dose expansion). JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion) Cabazitaxel Participants will receive JNJ-78278343 and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone) during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive JNJ-78278343 and combination agent treatment at the putative RP2R in Part 2 (dose expansion). JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion) Apalutamide Participants will receive JNJ-78278343 and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone) during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive JNJ-78278343 and combination agent treatment at the putative RP2R in Part 2 (dose expansion). JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion) Enzalutamide Participants will receive JNJ-78278343 and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone) during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive JNJ-78278343 and combination agent treatment at the putative RP2R in Part 2 (dose expansion).
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants With Dose Limiting Toxicity (DLT) Up to 21 days after first dose of combination agent DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity Up to 2 years 11 months An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) Up to 2 years 11 months ORR is defined as the percentage of participants who have a partial response (PR) or better without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3) criteria.
Duration of Response (DOR) Up to 2 years 11 months DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first.
Prostate Specific Antigen (PSA) Response Rate Up to 2 years 11 months PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline.
Radiographic Progression-free Survival (rPFS) Up to 2 years 11 months rPFS is defined time from the date of first dose of JNJ-78278343 until the date of objective disease progression or death, whichever comes first.
Time to Response (TTR) Up to 2 years 11 months TTR is defined for the responders as the time from the date of first dose of to the date of first documented response that is subsequently confirmed.
Trial Locations
- Locations (11)
Icon Cancer Centre Kurralta Park
🇦🇺Kurralta Park, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Australia
Perlmutter Cancer Center at NYU Langone Brooklyn
🇺🇸Brooklyn, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
🇺🇸Mineola, New York, United States
Florida Cancer Specialists
🇺🇸Sarasota, Florida, United States
Start Midwest
🇺🇸Grand Rapids, Michigan, United States
Washington University School Of Medicine
🇺🇸Saint Louis, Missouri, United States
NYU Langone Health
🇺🇸New York, New York, United States
Sidney Kimmel Cancer Center - Jefferson Health
🇺🇸Philadelphia, Pennsylvania, United States
Macquarie University
🇦🇺Macquarie University, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Australia