Phase 2
Completed N=8
Nivolumab in Combination With Talazoparib in Melanoma and Mutations in BRCA or BRCA-ness Genes
Metastatic or Unresectable Melanoma
Source: ClinicalTrials.gov NCT04187833 ↗
Enrolled (actual)
8
Serious AEs
12.5%
Results posted
Jan 2025
Primary outcomePrimary: Best Overall Response as Defined by RECIST 1.1 Criteria — 0 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response as Defined by RECIST 1.1 Criteria |
— | — |
| SECONDARY Progression Free Survival (PFS) |
12 | — |
| SECONDARY Number of Participants With Treatment-related Adverse Events |
7 | — |
| SECONDARY Immune-related Overall Response (irOR) Defined by irRECIST |
— | — |
| SECONDARY Immune-related Progression Free Survival (irPFS) |
12 | — |
| SECONDARY Overall Survival (OS) |
72 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must have a germline or somatic DNA damage repair mutation including any one of the following: BRCA1, BRCA2, ATM, CHEK1, CHEK2, PALB2, RAD50, RAD51, NBN, BLM, BRIP1, ATR, PARP1, MDC1, DSS1, ERCC3, MRE11, HDAC2, FANCA, MLH3, MLH1, EMSY, BAP1, LIG4, LIG3, PRKDC, XRCC6. The result may have been obtained from one of the following test providers: Myriad Genetics, Invitae, Ambry, Quest, Color Genomics, IMPACT, Foundation Medicine (tissue or ctDNA based), Guardant, or another CLIA approved tissue and/or serum based next generation sequencing-based assay.
- Subjects must have histologically or cytologically confirmed diagnosis of primary or recurrent metastatic melanoma.
- Subjects must have received prior checkpoint inhibitor therapy (defined as anti-CTLA4 or anti-PD-1 or combination anti-CTLA4/anti-PD-1), either for metastatic or unresectable disease or adjuvant therapy.
- ECOG Performance status ≤ 2.
- Subjects must have normal organ and marrow function as defined below:
- Hemoglobin ≥ 9.0 g/dl
- Absolute neutrophil count ≥ 1,500/mcL
- Platelet count ≥ 90,000/mcL
- Bilirubin ≤ 1.5 x ULN (except in subjects with Gilbert Syndrome, who can have a total bilirubin Grade 1.
Data sourced from ClinicalTrials.gov (NCT04187833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.