NCT07631325 Nivolumab Metastatic melanoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07631325 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 7 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07631325 is a hot trial to watch
Metastatic melanoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07631325 is notable because it evaluates Nivolumab in a Phase 1/2 design sponsored by University of Pittsburgh. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07631325 |
| Official title | Axelopran and Nivolumab in PD-1-Refractory Metastatic Melanoma (MORALE-MM) |
| Phase / status | Phase 1/2 / Not yet recruiting |
| Intervention | Nivolumab |
| Sponsor | University of Pittsburgh |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | Adverse Events Related to Treatment |
| Endpoint time frame | Up to 30 days post end of treatment |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This first-in-human study will evaluate the safety, clinical activity, and immunologic effects of combining axelopran with nivolumab in patients with PD-1-refractory unresectable or metastatic cutaneous melanoma. Exploratory analyses incorporating opioid exposure history and post-hoc OPRM1 genotyping will inform future precision immuno-oncology strategies.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Adverse Events Related to Treatment (Up to 30 days post end of treatment) — Adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation or death, and severity of AEs as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) determined to be possibly, probably or definitely related to study treatment.
- Best objective response rate (BORR) (Up to 3 years) — The proportion of subjects with a confirmed best objective response of Complete Response (CR) or Partial Response (PR) based on RECIST v1.1. CR: Disappearance of all target lesions. Pathological lymph nodes must decrease to a short axis of \< 10 mm. All non-target lesions must have disappeared, and tumor markers must have normalized. PR: At least a 30% decrease in the sum of diameters of target lesions, using baselin
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Nivolumab is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: University of Pittsburgh is resolved to a normalized organization record in ALLEGHENY COUNTY, United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07631325 provides a focused lens on Metastatic melanoma development. Its value will be determined by whether Nivolumab can convert the current Phase 1/2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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