NCT07715565 Ipilimumab Kidney Neoplasms Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07715565 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: 21 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07715565 is a hot trial to watch
Kidney Neoplasms is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07715565 is notable because it evaluates Ipilimumab in a Phase 2 design sponsored by West China Hospital. 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 | NCT07715565 |
| Official title | Ipilimumab N01 Plus Sintilimab and Lenvatinib as First-line Therapy for Locally Advanced or Metastatic TFE3-Rearranged Renal Cell Carcinoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Trial |
| Phase / status | Phase 2 / Not yet recruiting |
| Intervention | Ipilimumab |
| Sponsor | West China Hospital |
| Geography | China |
| Enrollment | 66 |
| Primary endpoint | Objective Response Rate (ORR) |
| Endpoint time frame | 3 years |
| Primary completion / readout proxy | 2029-12-01 |
Protocol design and endpoint interpretation
This phase II, multicenter, single-arm, open-label study evaluates first-line ipilimumab N01 plus sintilimab and lenvatinib in patients with locally advanced or metastatic TFE3-rearranged renal cell carcinoma (TFE3-rRCC), a rare subtype lacking established first-line systemic therapy. Eligible patients (age ≥14 years, ECOG ≤2, measurable disease per RECIST v1.1, no prior systemic therapy) will receive ipilimumab N01 1 mg/kg Q6W for 4 cycles, sintilimab 200 mg Q3W for up to 35 cycles, and lenvatinib 12 mg or 8 mg QD continuously. The primary endpoint is objective response rate (ORR) per RECIST v1.1. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, safety per NCI CTCAE v5.0, and quality of life. Exploratory biomarker analyses will assess potential predictors of treatment response.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 66 participants across China 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.
- Objective Response Rate (ORR) (3 years) — Objective response rate is the proportion of participates with complete response (CR) or partial response (PR), based on RECIST1.1.
Readout outlook and evidence gap
The current protocol points to 2029-12-01 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
Trial-sourced asset: Ipilimumab. The Drug & Asset MCP enrichment step is designed to add normalized targets, modality and global development status when an exact asset match is available.
Trial-sourced sponsor: West China Hospital. Company & Deal Intelligence MCP is the companion workflow for resolving organization identity, corporate profile and partnering context.
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
NCT07715565 provides a focused lens on Kidney Neoplasms development. Its value will be determined by whether Ipilimumab can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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