Floatz Rating
BB64/100
Confidence
Indicative
Sponsor
Fred Hutchinson Cancer Center
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 |
|---|---|---|---|---|---|
NCT07432295CT.gov Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2) | — | Recruiting | — | — | — |
NCT05919264CT.gov FOG-001 in Locally Advanced or Metastatic Solid Tumors | — | Recruiting | — | — | — |
NCT05502315CT.gov Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer | — | 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 | — | — | — |
NCT05076760CT.gov MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT05267626CT.gov Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer | — | Recruiting | — | — | — |
NCT04840589CT.gov Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors | — | Suspended | — | — | — |
NCT04887870CT.gov Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study | — | Completed | — | — | — |
NCT04785287CT.gov Anti-CTLA4-NF mAb (BMS986218), Nivolumab, and Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Malignancies | — | Terminated | — | — | — |
NCT04317105CT.gov Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN | — | Active Not Recruiting | — | — | — |
Show 19 more trialsShow fewer
NCT04263090CT.gov Rigosertib Plus Nivolumab for KRAS+ NSCLC Patients Who Progressed on First-Line Treatment | — | Completed | — | — | — |
NCT03878524CT.gov Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | — | Terminated | — | — | — |
NCT04208958CT.gov Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer | — | Completed | — | — | — |
NCT04200963CT.gov A Phase 1a/b Study of IK-175 as a Single Agent and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma | — | Completed | — | — | — |
NCT04021043CT.gov BMS-986156, Ipilimumab, and Nivolumab With or Without Stereotactic Body Radiation Therapy in Treating Patients With Advanced or Metastatic Lung/Chest or Liver Cancers | — | Completed | — | — | — |
NCT03793166CT.gov Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study | — | Active Not Recruiting | — | — | — |
NCT03758781CT.gov IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors | — | Completed | — | — | — |
NCT03570619CT.gov Immunotherapy in Patients With Metastatic Cancers and CDK12 Mutations | — | Completed | — | — | — |
NCT03651271CT.gov Nivolumab With or Without Ipilimumab in Advanced Metastatic Cancer | — | Completed | — | — | — |
NCT03502733CT.gov Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma | — | Active Not Recruiting | — | — | — |
NCT03525925CT.gov Ibrutinib and Nivolumab in Treating Participants With Metastatic Solid Tumors | — | Completed | — | — | — |
NCT03326258CT.gov Glembatumumab Vedotin, Nivolumab, and Ipilimumab in Treating Patients With Advanced Metastatic Solid Tumors That Cannot Be Removed by Surgery | — | Withdrawn | — | — | — |
NCT03388632CT.gov Recombinant Interleukin-15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in People With Refractory Cancers | — | Completed | — | — | — |
NCT03406871CT.gov Regorafenib and Nivolumab Simultaneous Combination Therapy | — | Completed | — | — | — |
NCT03229278CT.gov Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma | — | Completed | — | — | — |
NCT03119428CT.gov A Study of OMP-313M32 in Subjects With Locally Advanced or Metastatic Solid Tumors | — | Terminated | — | — | — |
NCT03126110CT.gov Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies | — | Completed | — | — | — |
NCT02408861CT.gov Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery | — | Terminated | — | — | — |
NCT02419495CT.gov Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies | — | Terminated | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
73High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Metastatic Malignant Neoplasm
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Nivolumab (this asset) | Fred Hutchinson Cancer Center | P3 | BB · 64 |
| Fluorouracilum | I-Mab Biopharma US Limited | P3 | BB |
| Irinotecan | Incyte Corporation | P3 | BB |
| Nivestim | Mayo Clinic | P3 | BB |
| Cyclophosphamide | InSilico Medicine Hong Kong Limited | P2/3 | BB |
| Pembrolizumab | InSilico Medicine Hong Kong Limited | P2/3 | BB |
| Letrozole | UNICANCER | P3 | BB |
| Enfortumab Vedotin (Fully Human Monoclonal Antibody Conjugated To A Cytotoxic Agent Monomethyl Auristatin E (Mmae) Targeting Nectin-4) | National Cancer Institute (NCI) | P2/3 | BB |
| Anastrozole | UNICANCER | P3 | BB |
+42 more in the Metastatic Malignant Neoplasm 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 Metastatic Malignant Neoplasm. 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-metastatic-malignant-neoplasm
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