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Closed (no longer recruiting)Last updated: 2 February 2024

CA209-650: This is a phase II trial evaluating the effectiveness of using targeted therapies, either alone (Ipilimumab) or in combination (Ipilimumab and Nivolumab), in comparison with chemotherapy (Cabazitaxel) to treat patients with metastatic castration-resistant prostate cancer who have progressed after previous chemotherapy treatment with DocetaxelA Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer

Clinical summary

Summary

Patients eligible to participate in this study will receive specified doses of either Ipilimumab alone, Nivolumab and Ipilimumab, or Cabazitaxel and Prednisone.

Conditions

This trial is treating patients with Prostrate Cancer.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

II

Trial Acronym

CA209-650

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI).
  • Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of ≤1.73nmol/L (50ng/dL)

For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:

  • Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization

Exclusion

  • Presence of visceral metastases in the liver
  • Active brain metastases or leptomeningeal metastases
  • Active, known, or suspected autoimmune disease or infection
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:

  • Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab
  • Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel)

Other protocol-defined inclusion/exclusion criteria apply

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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