Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT04592237

Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for the Treatment of Aggressive Variant Metastatic Prostate Cancer

Randomized Phase II Study of Platinum-Taxane-Cetrelimab Induction Followed by Niraparib Plus or Minus Cetrelimab Maintenance in Men With Aggressive Variant Prostate Cancers

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies the effect of cabazitaxel, carboplatin, and cetrelimab followed by niraparib with or without cetrelimab in treating patients with aggressive variant prostate cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as cabazitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as niraparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Immunotherapy with monoclonal antibodies, such as cetrelimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib with or without cetrelimab, after treatment with cabazitaxel, carboplatin, and cetrelimab, may help control aggressive variant prostate cancer.

Detailed description

PRIMARY OBJECTIVES: I. Estimate the progression free survival of men with aggressive variant prostate carcinoma (AVPC) treated with induction cabazitaxel-carboplatin and cetrelimab followed by maintenance niraparib with or without cetrelimab. II. Evaluate changes in the density and localization of immune markers and cell subsets in AVPC tumors treated with or without cetrelimab added to cabazitaxel-carboplatin induction and niraparib maintenance, and screen for their association with outcomes. SECONDARY OBJECTIVES: I. Determine the percentage of patients that are able to complete the 6 cycles of induction chemoimmunotherapy. II. Estimate the Response Evaluation Criteria in Solid Tumors (RECIST), prostate specific antigen (PSA) and circulating tumor cells (CTC) responses in men with AVPC treated with induction cabazitaxel-carboplatin and cetrelimab followed by maintenance niraparib with or without cetrelimab. III. Estimate the overall survival of men with AVPC treated with induction cabazitaxel-carboplatin and cetrelimab followed by maintenance niraparib with or without cetrelimab. IV. Determine the safety and tolerability of each of the regimens. V. Determine the frequency of PD-L1 expression in tumors treated with cabazitaxel-carboplatin induction and niraparib maintenance and its association with outcomes. VI. Collect and archive solid and liquid tumor samples from study patients for later hypothesis generating associations. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: INDUCTION: Patients receive cabazitaxel intravenously (IV) over 60 minutes and carboplatin IV over 60 minutes on day 1. Beginning cycle 2, patients also receive cetrelimab IV over 30-60 minutes on day 1. Treatment repeats for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive niraparib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. GROUP II: INDUCTION: Patients receive cabazitaxel IV over 60 minutes and carboplatin IV over 60 minutes on day 1. Beginning cycle 2, patients also receive cetrelimab IV over 30-60 minutes on day 1. Treatment repeats for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive cetrelimab IV over 30 minutes on day 1 and niraparib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment patients are followed up for 30 to 90 days (after last dose cetrelimab), and then every 6 months thereafter.

Conditions

Interventions

TypeNameDescription
DRUGCabazitaxelGiven IV
DRUGCarboplatinGiven IV
BIOLOGICALCetrelimabGiven IV
DRUGNiraparibGiven PO

Timeline

Start date
2020-12-29
Primary completion
2027-12-31
Completion
2027-12-31
First posted
2020-10-19
Last updated
2025-12-23

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04592237. Inclusion in this directory is not an endorsement.