Nivolumab in Combination With Talazoparib in Melanoma and Mutations in BRCA or BRCA-ness Genes

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT04187833
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic or Unresectable Melanoma

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    480mg intravenously every 4 weeks (28 days)
  • Talazoparib — DRUG
    1mg orally daily

Study Details

The purpose of this study is to evaluate how effective the study drugs, nivolumab (also known as Opdivo®) and talazoparib (also known as Talzenna®) are when given as a combination treatment for unresectable or metastatic melanoma. The study team wants to know the effectiveness of these drugs together in treating cancer than if each study drug was given by itself.

Key Dates

Start date
Jun 5, 2020
Status verified
Jan 2025
Primary completion
Oct 13, 2023
Completion
Oct 13, 2023

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab + Talazoparib
    Nivolumab 480mg intravenously every 4 weeks (28 days) + Talazoparib 1mg orally daily

Primary Outcome Measure

Best Overall Response as Defined by RECIST 1.1 Criteria [ Time Frame: up to 24 months after treatment through study completion, an average of 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer CenterClevelandOhio44195-

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By research site
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center· Cleveland, OH

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