Study on Cabazitaxel, Carboplatin, and Cetrelimab Followed by Niraparib With or Without Cetrelimab for Treating Aggressive Metastatic Prostate Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT04592237

Provider View

This clinical trial is exploring a combination of chemotherapy and immunotherapy drugs to treat aggressive prostate cancer that has spread to other parts of the body. The study aims to see if this treatment can help control the cancer and improve patient outcomes.

Patient Parameters

Program Overview

This study is testing a combination of treatments for aggressive prostate cancer that has spread beyond the prostate. The treatment includes chemotherapy drugs cabazitaxel and carboplatin, an immunotherapy drug cetrelimab, and a PARP inhibitor called niraparib. These drugs work together to stop cancer cells from growing and spreading. The study will see if adding cetrelimab to niraparib after initial chemotherapy can help control the cancer better.

Description

The study has two main parts: induction and maintenance.

In the induction phase, patients receive chemotherapy drugs cabazitaxel and carboplatin through an IV, along with cetrelimab starting from the second cycle. This phase lasts for up to 6 cycles unless the cancer progresses or side effects become too severe.

In the maintenance phase, patients continue with niraparib taken orally every day. Some patients will also continue receiving cetrelimab through an IV. This phase repeats every 28 days as long as the treatment is effective and tolerable.

The study aims to measure how long patients can live without the cancer getting worse, how many patients complete the initial treatment, and the overall survival rate. It will also look at the safety of the treatment and how the cancer responds to it. Patients will be followed up for several months after completing the treatment to monitor their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Must agree to participate and provide tissue samples for research.
  • Must have confirmed prostate cancer that has spread to other parts of the body.
  • Must meet specific criteria for aggressive prostate cancer, such as certain types of metastases or genetic markers.
  • Must show evidence of cancer progression, such as rising PSA levels or new tumors.
  • Must have low testosterone levels due to medical or surgical treatment.
  • Must be in relatively good health with a performance status of 0 to 2.
  • Must have adequate blood counts and organ function.
  • Must be able to swallow pills.
  • Must agree to use effective birth control during and after the study if they have partners who can become pregnant.

Exclusion Criteria

  • Previous treatment with certain chemotherapy or immunotherapy drugs for prostate cancer.
  • More than one previous chemotherapy regimen.
  • Unresolved side effects from previous cancer treatments.
  • History of certain blood disorders or active infections.
  • Other cancers with a high risk of recurrence.
  • Medical conditions that could interfere with the study or increase risks.
  • Inability to swallow pills or absorb the study medication.
  • Uncontrolled brain metastases or spinal cord compression.
  • Known allergies to the study drugs.
  • Recent use of immunosuppressive medications.
  • Active autoimmune or inflammatory disorders, with some exceptions.
  • Recent live vaccinations.
  • Incarcerated individuals or those under compulsory detention.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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