Study on Chemoimmunotherapy for Treating Men with Neuroendocrine or Aggressive Variant Metastatic Prostate Cancer

Sponsor: Andrew J. Armstrong, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04709276

This clinical trial is testing a combination of drugs, including nivolumab, ipilimumab, cabazitaxel, and carboplatin, to see if they are safe and effective in treating men with certain types of advanced prostate cancer. The study will also look at how these drugs affect the cancer and the immune system.

Patient Parameters

Program Overview

The aim of this study is to evaluate the safety and effectiveness of a drug combination—nivolumab, ipilimumab, cabazitaxel, and carboplatin—in men with neuroendocrine prostate cancer (NEPC) or other aggressive forms of prostate cancer (AVPC). Researchers will also study biomarkers to understand how these drugs impact the cancer and the immune system. Participants will receive up to 10 cycles of the drug combination, followed by maintenance treatment with nivolumab and ipilimumab. Treatment will continue until the cancer progresses, severe side effects occur, the participant withdraws consent, three years have passed since starting the study, or the study ends, whichever comes first. Participants will be monitored for three years from the start of treatment.

Eligibility Criteria

Inclusion Criteria

  • Have neuroendocrine-like prostate cancer based on specific medical criteria or aggressive prostate cancer with certain risk features.
  • Must provide tumor samples for review and study.
  • Have progressive metastatic castration-resistant prostate cancer (CRPC) as determined by specific medical criteria.
  • Have low testosterone levels or ongoing androgen deprivation therapy (ADT).
  • Have a performance status score of 70 or higher, indicating the ability to carry out daily activities.
  • Meet acceptable laboratory test results within 14 days before starting treatment.
  • Be over 18 years old.
  • Agree to use effective contraception if they have a partner who can become pregnant.
  • Be willing to provide written informed consent and authorization for the release of personal health information.
  • Have a life expectancy of more than three months as determined by the treating physician.

Exclusion Criteria

  • Have received certain prostate cancer treatments within two weeks before starting the study.
  • Have received prior treatment with specific immune checkpoint inhibitors or other investigational drugs within four weeks before starting the study.
  • Have had more than one chemotherapy regimen for metastatic CRPC.
  • Have received radiation therapy within two weeks before starting the study and have not recovered from related side effects.
  • Have received a live vaccine within 30 days before starting the study.
  • Are currently participating in another clinical trial or have used an investigational device within four weeks before starting the study.
  • Have a diagnosis of immunodeficiency or are receiving high-dose steroid therapy or other immunosuppressive treatments.
  • Have a history of another cancer unless treated and in remission for at least two years.
  • Have untreated or unstable brain metastases or carcinomatous meningitis.
  • Have active autoimmune disease requiring treatment in the past two years.
  • Have a history of lung inflammation requiring steroids or current lung inflammation.
  • Have an active infection requiring treatment.
  • Have uncontrolled HIV infection or active hepatitis B or C infection.
  • Have active tuberculosis.
  • Have significant nerve damage (Grade 2 or higher neuropathy).
  • Have any condition or treatment that might interfere with the study or is not in the participant's best interest.
  • Have psychiatric or substance abuse disorders that would interfere with study participation.
  • Have had an organ transplant.

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