An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CheckMate 9KD)

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 2

Conditions: Prostate Cancer

Treatments: Biological: nivolumab; Drug: docetaxel; Drug: prednisone; Drug: rucaparib; Drug: enzalutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03338790

CA209-9KD

Details and patient eligibility

About

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

Enrollment: 292 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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292 participants in 3 patient groups

nivolumab + rucaparib

Experimental group

Description:

Specified dose on specified days

Treatment:

Drug: rucaparib

Biological: nivolumab

nivolumab + docetaxel + prednisone

Experimental group

Description:

Specified dose on specified days

Treatment:

Drug: prednisone

Drug: docetaxel

Biological: nivolumab

nivolumab + enzalutamide

Experimental group

Description:

Specified dose on specified days

Treatment:

Drug: enzalutamide

Biological: nivolumab