Nivolumab NCT07031765 Clinical Landscape 2026

Explore the PatSnap Life Sciences MCP marketplace

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 1

Clinical phase

Active, not recruiting

Recruitment status

12

Planned enrollment

2030-12-01

Primary-completion proxy

Executive view

NCT07031765 evaluates Nivolumab in Ependymoma. The disclosed sponsor is University of Florida, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Rate of DLTs in treated participants, assessed over At the end of Cycle 1 (each cycle is 28 days).

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 NCT07031765 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Ependymoma landscape. Drug & Asset MCP drug_fetch was queried for Nivolumab, while Company & Deal Intelligence MCP organization_fetch was queried for University of Florida.

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

Trial	Asset / intervention	Phase / status	Sponsor	Geography	Primary endpoint	Readout proxy
NCT07031765	Nivolumab	Phase 1 / Active, not recruiting	University of Florida	United States	Rate of DLTs in treated participants At the end of Cycle 1 (each cycle is 28 days)	2030-12-01
NCT07134842	Ipilimumab	Phase 1 / Recruiting	University College London	United Kingdom	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] From trial registration to 3 months post ipilimumab administration	2027-01-01
NCT07100730	Lomustine	Phase 3 / Recruiting	Telix Pharmaceuticals Ltd.	Netherlands, Austria, Belgium, Australia	Safety and Tolerability Through study completion, an average of 2 years	2027-07-01
NCT07093814	Recombinant oncolytic virus M1(Guangzhou Vitron)	Phase 1/2 / Recruiting	Guangzhou Virotech Pharmaceutical Co Ltd.	China	Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with recurrent/progressive glioblastoma About 2 years	2028-12-31
NCT07089641	ERAS-801	Phase 1 / Recruiting	Jonsson Comprehensive Cancer Center	United States	Fludeoxyglucose F-18 (FDG) tumor uptake (Cohort A) At baseline, prior to initiation of study treatment and after study t…	2027-07-30

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.

Reproduce the trial-to-asset workflow with PatSnap MCP

Protocol design and endpoint interpretation

NCT07031765 is a Phase 1, active, not recruiting study with 12 planned participants. Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment.

The primary endpoint is “Rate of DLTs in treated participants” over “At the end of Cycle 1 (each cycle is 28 days).” The retrieved endpoint description is: Rate of DLTs in participants treated with exHSCs + αPD-1. Cycle 1 Day 1 is the first day exHSCs + Nivo is given..

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 12 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 Ependymoma. These records do not establish direct evidence for NCT07031765 unless the registration number matches.

Phase 1 dose-escalation trial combining sulfasalazine and stereotactic radiosurgery in patients with recurrent glioblastoma

Phase 1; n=12; AE = Of 20 adverse events, two were grade 3 (transient lymphocytopenia), four grade 2, and fourteen grade 1 ; AE = Of 20 adverse events, two were grade 3 (transient lymphocytopenia), four grade 2, and fourteen grade 1 Source: https://pubmed.ncbi.nlm.nih.gov/42229231/

Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide i…

Phase 2; n=624; Median Survival Time (Within Center Group)(Median): Cox Proportional Hazard = 0.95(70% CI, 0.81 - 1.10), P-Value = 0.25; Cox Proportional Hazard = 0.81(70% CI, 0.67 - 0.98), P-Value = 0.11; Median Survival Time (Within Center Group)(Median) = 22.8 months (95% Confidence Interval, 20.0 - 28.6) Source: https://clinicaltrials.gov/ct2/show/results/NCT02179086

Intracranial delivery of B7-H3-targeting CAR-T cells for recurrent glioblastoma: a phase 1 trial

Phase 1; n=15; TRAE(grade 3) = Three grade 3 TRAEs considered serious adverse events occurred (elevated intracranial pressure, epilepsy and depressed consciousness), two at DL3. Source: https://pubmed.ncbi.nlm.nih.gov/42562965/

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

Nivolumab is indexed as Monoclonal antibody with PD-1 biology and a global stage of Approved. The asset profile lists Ono Pharmaceutical Co., Ltd. as an originator or developer.

University of Florida is indexed in United States with the website https://www.ufl.edu. University of Florida is a public land-grant research university in Gainesville, Florida. The record lists 124 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

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.
Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
Sequencing white space. Clarify whether Nivolumab 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: NCT07031765
Protocol source: https://clinicaltrials.gov/study/NCT07031765
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.

Nivolumab in Ependymoma is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Rate of DLTs in treated participants and 2030-12-01 the leading decision points.

Build and refresh clinical landscape reports with PatSnap MCP