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

NCT03338790

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
  • Official Title: A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: CA209-9KD
  • NCT ID: NCT03338790

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
NivolumabBMS-936558Arm A
DocetaxelArm B
EnzalutamideArm C
RucaparibArm A
PrednisoneArm B

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalNivolumab in combination with Rucaparib
  • Nivolumab
  • Rucaparib
Arm BExperimentalNivolumab in combination with Docetaxel
  • Nivolumab
  • Docetaxel
  • Prednisone
Arm CExperimentalNivolumab in combination with Enzalutamide
  • Nivolumab
  • Enzalutamide

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Approximately 12 months
Safety Issue:
Description:Assessed per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)

Secondary Outcome Measures

Measure:Radiographic progression-free survival (rPFS)
Time Frame:Approximately 12 months
Safety Issue:
Description:Assessed per PCWG3
Measure:Time to response (TTR)
Time Frame:Approximately 12 months
Safety Issue:
Description:Assessed per PCWG3
Measure:Duration of response (DOR)
Time Frame:Approximately 12 months
Safety Issue:
Description:Assessed per PCWG3
Measure:Time to prostate-specific antigen progression (TTP-PSA)
Time Frame:Approximately 12 months
Safety Issue:
Description:Assessed per PCWG3
Measure:Overall Survival (OS)
Time Frame:Up to 5 years
Safety Issue:
Description:Time between treatment initiation and the date of death from any cause
Measure:Incidence of adverse events (AEs)
Time Frame:Approximately 12 months
Safety Issue:
Description:
Measure:Incidence of serious adverse events (SAEs)
Time Frame:Approximately 12 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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