Floatz Rating
B59/100
Confidence
Indicative
Sponsor
Jennifer Zhang
Modality
monoclonal_antibody
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
59High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07319195CT.gov Window Study of Intratumoral Mitazalimab in Breast Cancer (WINIT-BC) | — | Recruiting | — | — | — |
NCT06618287CT.gov A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT05098210CT.gov Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer | — | Recruiting | — | — | — |
NCT05395052CT.gov FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors | — | Terminated | — | — | — |
NCT04591431CT.gov The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy | — | Unknown | — | — | — |
NCT04132817CT.gov A Study of Multiple Immune and Disease Treatment Combinations in Participants With ER+HER2- Breast Cancer That Has Spread | — | Completed | — | — | — |
NCT03878524CT.gov Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | — | Terminated | — | — | — |
NCT04159818CT.gov Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients | — | Recruiting | — | — | — |
NCT03546686CT.gov Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT04075604CT.gov A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer | — | Completed | — | — | — |
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NCT03815890CT.gov Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO | — | Recruiting | — | — | — |
NCT04185311CT.gov Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted | — | Terminated | — | — | — |
NCT03952325CT.gov Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Triple-Negative MBC and Tesetaxel Monotherapy in Patients With HER2-Negative MBC | — | Terminated | — | — | — |
NCT03818685CT.gov Evaluate the Clinical Benefit of a Post-operative Treatment Associating Radiotherapy + Nivolumab + Ipilimumab Versus Radiotherapy + Capecitabine for Triple Negative Breast Cancer Patients With Residual Disease | — | Unknown | — | — | — |
NCT03742986CT.gov Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC) | — | Completed | — | — | — |
NCT03650894CT.gov Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients | — | Active Not Recruiting | — | — | — |
NCT03789110CT.gov NIMBUS: Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT03667716CT.gov COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. | — | Completed | — | — | — |
NCT03523572CT.gov Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer | — | Completed | — | — | — |
NCT03326258CT.gov Glembatumumab Vedotin, Nivolumab, and Ipilimumab in Treating Patients With Advanced Metastatic Solid Tumors That Cannot Be Removed by Surgery | — | Withdrawn | — | — | — |
NCT03432741CT.gov Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer | — | Terminated | — | — | — |
NCT03342417CT.gov Combination of Nivolumab and Ipilimumab in Breast, Ovarian and Gastric Cancer Patients | — | Terminated | — | — | — |
NCT03409198CT.gov Phase IIb Study Evaluating Immunogenic Chemotherapy Combined With Ipilimumab and Nivolumab in Breast Cancer | — | Completed | — | — | — |
NCT03316586CT.gov A Phase II Study of Nivolumab in Combination With Cabozantinib for Metastatic Triple-negative Breast Cancer | — | Completed | — | — | — |
NCT04659551CT.gov Neoadjuvant Chemo-endocrine Therapy and Immunotherapy for Pre-menopausal Luminal B Breast Cancer Patients | — | Completed | — | — | — |
NCT02826434CT.gov Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT02833233CT.gov A Study of Pre-Operative Treatment With Cryoablation and Immune Therapy in Early Stage Breast Cancer | — | Completed | — | — | — |
NCT02453620CT.gov Entinostat, Nivolumab, and Ipilimumab in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Locally Advanced or Metastatic HER2-Negative Breast Cancer | — | Active Not Recruiting | — | — | — |
NCT02499367CT.gov Nivolumab After Induction Treatment in Triple-negative Breast Cancer (TNBC) Patients | — | Unknown | — | — | — |
NCT02393794CT.gov Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC) | — | Active Not Recruiting | — | — | — |
NCT02009449CT.gov A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors | — | Completed | — | — | — |
NCT01256567CT.gov A Study of Ramucirumab (IMC-1121B) in Participants With Breast Cancer | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Breast Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Nivolumab (this asset) | Jennifer Zhang | P3 | B · 59 |
| Darolutamide | Vandana Abramson | P2 | BBB |
| Pertuzumab | SWOG Cancer Research Network | P4 | BB |
| Palbociclib | Hoffmann-La Roche | P4 | BB |
| Trastuzumab Duocarmazine | Byondis B.V. | P3 | BB |
| Goserelin | TerSera Therapeutics LLC | P4 | BB |
| Ribociclib | National Cancer Institute (NCI) | P4 | BB |
| Oxaliplatin | Beijing Biostar Pharmaceuticals Co., Ltd. | P4 | BB |
| Eribulin Monomethanesulfonate | Henan Cancer Hospital | P4 | BB |
+42 more in the Breast Cancer cohort
Other indications for Nivolumab
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Renal Carcinoma | — | P4 | BBB · 72 |
| Metastatic Melanoma | — | P4 | BB · 70 |
| Non-Small Cell Lung Carcinoma | — | P4 | BB · 70 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Nivolumab in Breast Cancer. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/nivolumab-breast-cancer
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