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 the 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