Nivolumab NCT06963905 Clinical Landscape 2026

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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: 15 October 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Phase 1/2

Clinical phase

Recruiting

Recruitment status

not reported

Planned enrollment

2030-12-01

Primary-completion proxy

Executive view

NCT06963905 evaluates Nivolumab in Metastatic Triple-Negative Breast Carcinoma. The disclosed sponsor is Yale University, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Incidence and severity of dose limiting toxicities in patients treated with sacituzumab govitecan combinations, assessed over Three weeks post-Cycle 1 Day 1 (each cycle is 21 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 NCT06963905 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Metastatic Triple-Negative Breast Carcinoma landscape. Drug & Asset MCP drug_fetch was queried for Nivolumab, while Company & Deal Intelligence MCP organization_fetch was queried for Yale University.

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
NCT06963905	Nivolumab	Phase 1/2 / Recruiting	Yale University	United States	Incidence and severity of dose limiting toxicities in patients treated with sacituzumab govitecan combinations Three weeks post-Cycle 1 Day 1 (each cycle is 21 days)	2030-12-01
NCT06977542	Ivonescimab	Phase 2 / Not yet recruiting	Fudan University	Geography not reported	pathological complete response rate (pCR) Up to approximately 24 weeks	2029-01-01
NCT06975644	Albumin-Bound Paclitaxel	Not Applicable / Not yet recruiting	Zhejiang Provincial Peoples Hospital	Geography not reported	Pathological complete response six months	2026-09-01
NCT06976944	Albumin-Bound Paclitaxel	Phase 2 / Recruiting	Japanese Foundation for Cancer Research	Japan	Progression free survival Through protocol treatment discontinuation, approximately 9 months	2029-09-01
NCT06966700	Olaparib	Phase 3 / Recruiting	Merck Sharp & Dohme LLC	Singapore, Hong Kong, Czechia, United States, Malaysia, Thailand, Portugal, Saudi Arabia, Greece, Vietnam, Sweden, South Korea, China, Turkey, Poland, Guatemala, Brazil, France, Chile, Colombia, Argentina, Romania, Hungary, Philippines, Japan, Ukraine, United Kingdom, Spain, India, New Zealand, Canada, Belgium, Norway, Taiwan Province, Finland, South Africa, Italy, Israel, Australia, Peru, Germany	Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery Up to approximately 30 weeks	2033-03-23

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

NCT06963905 is a Phase 1/2, recruiting study with not reported planned participants. Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment.

The primary endpoint is “Incidence and severity of dose limiting toxicities in patients treated with sacituzumab govitecan combinations” over “Three weeks post-Cycle 1 Day 1 (each cycle is 21 days).” The retrieved endpoint description is: The primary outcome measure is the incidence of dose-limiting toxicities (DLTs) observed three weeks after the first cycle of treatment with sacituzumab govitecan in combination with nivolumab, or sacituzumab govitecan in combination with nivolumab and relatlimab fixed-dose combination in patients with advanced triple-negative breast cancer in the second-line setting. The assessment will include the frequency and severity of DLTs to evaluate the safety and tolerability of the treatment regimens..

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 not reported should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.

The protocol identifies Nivolumab, Nivolumab/Relatlimab as control therapy. 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

0 recent result records were selected as contextual evidence for Metastatic Triple-Negative Breast Carcinoma. These records do not establish direct evidence for NCT06963905 unless the registration number matches.

Indexed evidence status

No directly comparable result record was retrieved for this disease query. This is a monitoring gap, not evidence of absence.

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.

Yale University is indexed in an unreported country with the website http://www.yale.edu.libproxy1.nus.edu.sg Yale University is a research and education institution that prioritizes its students. The record lists 87 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: NCT06963905
Protocol source: https://clinicaltrials.gov/study/NCT06963905
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: 15 October 2026.

Nivolumab in Metastatic Triple-Negative Breast Carcinoma is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Incidence and severity of dose limiting toxicities in patients treated with sacituzumab govitecan combinations and 2030-12-01 the leading decision points.

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