19 and older, any sex, with Metastatic or Unresectable Melanoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Best Overall Response as Defined by RECIST 1.1 CriteriaPrimary· up to 24 months after treatment through study completion, an average of 2 years
Best overall response, defined as complete response (CR) and partial response (PR) by RECIST 1.1 criteria.
Complete response (CR) is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Group
Value
95% CI
Nivolumab + Talazoparib
0
Progression Free Survival (PFS)Secondary· up to 24 months after treatment through study completion, an average of 2 years
PFS, defined as the time from the first dose of study treatment to the date of disease progression by RECIST 1.1 or death due to any cause, whichever occurs first.
Progressive disease (PD) is defined as a ≥20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Group
Value
95% CI
Nivolumab + Talazoparib
12
6 – 24
Number of Participants With Treatment-related Adverse EventsSecondary· 30 days after start of treatment
Number of participants with treatment-related adverse events, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Group
Value
95% CI
Nivolumab + Talazoparib
7
Immune-related Overall Response (irOR) Defined by irRECISTSecondary· up to 24 months after treatment through study completion, an average of 2 years
Immune-related overall response (irOR), defined as immune-related complete response (irCR) and immune-related partial response (irPR) by irRECIST
Group
Value
95% CI
Nivolumab + Talazoparib
0
Immune-related Progression Free Survival (irPFS)Secondary· up to 24 months after treatment through study completion, an average of 2 years
irPFS, defined as the time from the first dose of study treatment to the date of disease progression by irRECIST
Group
Value
95% CI
Nivolumab + Talazoparib
12
6 – 24
Overall Survival (OS)Secondary· up to 24 months after treatment
Overall survival (OS)
Group
Value
95% CI
Nivolumab + Talazoparib
72
21 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: On or after Cycle 1 Day 1(each cycle is 28 days) through 30 days after the final dose of study drug, through study completion, an average of 3 years and 4 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
· Phase 2
· not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
· Phase 2
· not yet recruiting
Other recruiting trials for Metastatic or Unresectable Melanoma
Currently open trials in the same condition.
NCT05107674 — A Study of NX-1607 in Adults With Advanced Malignancies
· Phase 1
· recruiting
Other Case Comprehensive Cancer Center trials
Trials by the same sponsor.
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· recruiting
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· recruiting
NCT07044362 — Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis
· NA
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Case Comprehensive Cancer Center
Last refreshed: 14 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04187833.