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Trial ID CA209-9KD  |   NCT03338790

An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer

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Summary

  • Phase 2
  • Male Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to assess the safety and efficacy of nivolumab in combination with rucaparib, docetaxel, or enzalutamide in participants with castration-resistant prostate cancer that has spread.

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Key Eligibility Criteria

Inclusion Criteria: - Histologic confirmation of adenocarcinoma of the prostate - Evidence of stage IV disease on previous bone, CT, and/or MRI scan - Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy - Mandatory plasma and fresh or archival tumor tissue must be submitted Exclusion Criteria: - Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast - Participants with active brain metastases - Participants must have recovered from the effects of major surgery requiring general anesthesia or significant traumatic injury at least 14 days before treatment arm assignment Other protocol defined inclusion/exclusion criteria could apply

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: nivolumab + docetaxel + prednisone

ASSIGNED INTERVENTION
  • Drug: prednisone, docetaxel
  • Biological: nivolumab

Study Arms

Experimental: nivolumab + enzalutamide

ASSIGNED INTERVENTION
  • Drug: enzalutamide
  • Biological: nivolumab

Study Arms

Experimental: nivolumab + rucaparib

ASSIGNED INTERVENTION
  • Drug: rucaparib
  • Biological: nivolumab