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Closed (no longer recruiting)Last updated: 30 January 2024

CheckMate 9KD: This phase II trial is trying to determine the best drug (out of three drugs) to use in combination with Nivolumab (a type of immunotherapy) in the treatment of castration-resistant prostate cancer that has spreadA Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer

Clinical summary

Summary

The purpose of this study is to determine which combination of Nivolumab plus either Rucaparib, Docetaxel, or Enzalutamide is the most effective in treating metatstatic, Castration-resistant Prostate Cancer. This is a non-randomized study and participants will be allocated into Arm A (Rucaparib), Arm B (Docetaxel) or Arm C (Enzalutamide), receiving specified doses on specified days.

Conditions

This trial is treating patients with prostate cancer.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

II

Trial Acronym

CheckMate 9KD

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 2 Study of Nivolumab in Combination With Either Rucaparib, Docetaxel, or Enzalutamide in Men With Castration-resistant Metastatic Prostate Cancer

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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