Ipilimumab in Mucosal Melanoma: NCT07230613 Clinical Landscape Report 2026

28 September 2026
9 min read

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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.

Data snapshot: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Phase 2

Clinical phase

Recruiting

Recruitment status

50

Planned enrollment

2027-12-01

Primary-completion proxy

Executive view

NCT07230613 evaluates Ipilimumab in Mucosal Melanoma. The disclosed sponsor is UNICANCER, the design is Interventional, and the geographic footprint is France. The first listed primary endpoint is The primary objective is to evaluate the efficacy of the intratumoral combination of ipilimumab and nivolumab in terms of pCR or MPR in patients with resectable stage III cutaneous or mucosal melanoma., assessed over Between 6 and 8 weeks upon end of the treatment.

The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.

PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.

How the MCP evidence stack was assembled

Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07230613 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Mucosal Melanoma landscape. Drug & Asset MCP drug_fetch was queried for Ipilimumab, while Company & Deal Intelligence MCP organization_fetch was queried for UNICANCER.

This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.

Trial landscape table

TrialAsset / interventionPhase / statusSponsorGeographyPrimary endpointReadout proxy
NCT07230613IpilimumabPhase 2 / RecruitingUNICANCERFranceThe primary objective is to evaluate the efficacy of the intratumoral combination of ipilimumab and nivolumab in terms…
Between 6 and 8 weeks upon end of the treatment
2027-12-01
NCT07280832SYS-6090Phase 1/2 / RecruitingShanghai JMT Biological Technology Co LtdChinaDose-Limiting Toxicity (DLT) (Phase I)
Approximately 28 days.
2026-11-30
NCT07276386TebentafuspPhase 2 / RecruitingH. Lee Moffitt Cancer Center & Research Institute, Inc.United StatesProgression Free Survival (PFS)
Up to 24 months
2030-12-01
NCT07260591VSV-02Phase 1 / RecruitingThe First Affiliated Hospital of Xinxiang Medical CollegeChinaObjective Response Rate (ORR)
From enrollment until the first occurrence of disease progression or…
2026-09-30
NCT07252479AN-9025Phase 1 / RecruitingHangzhou Adlai Nortye Biopharma Co. Ltd.United States• Nature and frequency of dose limiting toxicities (DLTs)
21 days after first dose
2028-01-31

The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.

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Protocol design and endpoint interpretation

NCT07230613 is a Phase 2, recruiting study with 50 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.

The primary endpoint is “The primary objective is to evaluate the efficacy of the intratumoral combination of ipilimumab and nivolumab in terms of pCR or MPR in patients with resectable stage III cutaneous or mucosal melanoma.” over “Between 6 and 8 weeks upon end of the treatment.” The retrieved endpoint description is: The primary efficacy endpoint is defined as a pathological complete response (pCR) rate defined as the percentage of patients with pCR defined as the complete absence of viable tumor cells, or the major pathologic response (MPR) defined as less than 10% of surviving tumor cells in tumor biopsy of the surgical specimen..

Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 50 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.

No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.

Indexed readouts in the surrounding landscape

5 recent result records were selected as contextual evidence for Mucosal Melanoma. These records do not establish direct evidence for NCT07230613 unless the registration number matches.

A mixed inflammatory peripheral signature defines clinical outcomes in a phase II trial combining pembrolizumab with paclitaxel and carboplatin in melanoma

Phase 2; n=30; AE(Grade 3 and higher) = 50.0 % Source: https://pubmed.ncbi.nlm.nih.gov/41732954/

A Phase II Study to Evaluate the Safety and Efficacy of Rigosertib (ON 01910) Plus Pembrolizumab in Patients With Metastatic Melanoma Refractory to Immune Checkpoint Blockade

Phase 2; n=7; ORR = 0 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05764395

A Phase 2 Study of Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Patients With Percutaneously Accessible Lesions With Advanced Melanoma Refractory to PD-1…

Phase 2; n=23; CR = 0 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT04796194

Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.

Asset and sponsor context

Ipilimumab is indexed as Monoclonal antibody with CTLA4 biology and a global stage of Approved. The asset profile lists Bristol Myers Squibb Co. as an originator or developer.

UNICANCER is indexed in France with the website https://www.unicancer.fr. Unicancer is a hospital network helping patients fight against cancer through its various centers. The record lists 1 development-stage drug assets.

For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.

Development white space

  1. Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
  2. Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
  3. Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
  4. Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
  5. Sequencing white space. Clarify whether Ipilimumab is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.

White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.

Strategic implications and next readouts

For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.

For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.

Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.

Source trail and bottom line

Anchor trial: NCT07230613
Protocol source: https://clinicaltrials.gov/study/NCT07230613
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 28 September 2026.

Ipilimumab in Mucosal Melanoma is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes The primary objective is to evaluate the efficacy of the intratumoral combination of ipilimumab and nivolumab in terms of pCR or MPR in patients with resectable stage III cutaneous or mucosal melanoma. and 2027-12-01 the leading decision points.

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