Floatz Rating
BB68/100
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.
57High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT06319196CT.gov Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma | — | Recruiting | — | — | — |
NCT07631325CT.gov Axelopran in Patients With Anti-PD-1 Refractory Metastatic or Locoregionally Unresectable Cutaneous Melanoma | — | Not Yet Recruiting | — | — | — |
NCT06999980CT.gov Neo IRENIE (NEOadjuvant Ipilimumab, RElatlimab, NIvolumab Evaluation) | — | Recruiting | — | — | — |
NCT07155317CT.gov Time-of-Day Specified Immunotherapy for Advanced Melanoma, The TIME Trial | — | Recruiting | — | — | — |
NCT05717140CT.gov Aerosolized Sargramostim Added to Immunotherapy for the Treatment of Patients With Metastatic Melanoma to the Lung | — | Withdrawn | — | — | — |
NCT06743126CT.gov SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma | — | Recruiting | — | — | — |
NCT05896839CT.gov Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer | — | Recruiting | — | — | — |
NCT06377111CT.gov A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma | — | Active Not Recruiting | — | — | — |
NCT06640530CT.gov Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin | — | Active Not Recruiting | — | — | — |
NCT05655312CT.gov MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma | — | Recruiting | — | — | — |
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NCT05704647CT.gov Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases | — | Recruiting | — | — | — |
NCT05341349CT.gov Stereotactic Radiosurgery and Immune Checkpoint Inhibitors With NovoTTF-200M for the Treatment of Melanoma Brain Metastases | — | Terminated | — | — | — |
NCT05169957CT.gov Hepatic Ablation of Melanoma Metastases to Enhance Immunotherapy Response, a Phase I Clinical Trial (HAMMER I) | — | Completed | — | — | — |
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 | — | — | — |
NCT05200143CT.gov Study of Ipilimumab, Nivolumab, and Cabozantinib in Patients With Cutaneous Melanoma | — | Terminated | — | — | — |
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 | — | — | — |
NCT04901988CT.gov Circulating Tumour DNA guidEd Therapy for Stage IIB/C mElanoma After surgiCal resecTION | — | Terminated | — | — | — |
NCT04697576CT.gov Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma | — | Recruiting | — | — | — |
NCT04940299CT.gov Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma | — | Active Not Recruiting | — | — | — |
NCT04967196CT.gov Ipilimumab and Nivolumab for the Treatment of Stage III-IV Unresectable Metastatic Melanoma | — | Terminated | — | — | — |
NCT04902040CT.gov Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies | — | Terminated | — | — | — |
NCT04462406CT.gov Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial | — | Active Not Recruiting | — | — | — |
NCT04511013CT.gov A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases | — | Recruiting | — | — | — |
NCT04375527CT.gov Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V600 Wildtype Melanoma | — | Terminated | — | — | — |
NCT03929029CT.gov Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma | — | Active Not Recruiting | — | — | — |
NCT04410445CT.gov Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence | — | Terminated | — | — | — |
NCT03816332CT.gov Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers | — | Active Not Recruiting | — | — | — |
NCT03949153CT.gov Cryotherapy With in Situ Immunotherapy in Melanoma Metastasis | — | Completed | — | — | — |
NCT03719131CT.gov Rituximab and Hyaluronidase Human in Patients With Advanced Melanoma Undergoing Nivolumab and Ipilimumab Therapy | — | Active Not Recruiting | — | — | — |
NCT03589339CT.gov NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy | — | Active Not Recruiting | — | — | — |
NCT03769155CT.gov VX15/2503 With or Without Ipilimumab and/or Nivolumab in Patients With Resectable Stage IIIB-D Melanoma | — | Active Not Recruiting | — | — | — |
NCT03620019CT.gov Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma | — | Completed | — | — | — |
NCT03633110CT.gov Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine | — | Completed | — | — | — |
NCT03425461CT.gov Anti-SEMA4D Monoclonal Antibody VX15/2503 With Nivolumab or Ipilimumab in Treating Patients With Stage III or IV Melanoma | — | Terminated | — | — | — |
NCT03543969CT.gov Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma | — | Active Not Recruiting | — | — | — |
NCT03326258CT.gov Glembatumumab Vedotin, Nivolumab, and Ipilimumab in Treating Patients With Advanced Metastatic Solid Tumors That Cannot Be Removed by Surgery | — | Withdrawn | — | — | — |
NCT03033576CT.gov Testing Treatment With Ipilimumab and Nivolumab Compared to Treatment With Ipilimumab Alone in Advanced Melanoma | — | Completed | — | — | — |
NCT03229278CT.gov Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma | — | Completed | — | — | — |
NCT03767348CT.gov Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) | — | Active Not Recruiting | — | — | — |
NCT03050060CT.gov Image Guided Hypofractionated Radiation Therapy, Nelfinavir Mesylate, Pembrolizumab, Nivolumab and Atezolizumab in Treating Patients With Advanced Melanoma, Lung, or Kidney Cancer | — | Terminated | — | — | — |
NCT02910700CT.gov Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma | — | Active Not Recruiting | — | — | — |
NCT02652455CT.gov Combining PD-1 Blockade, CD137 Agonism and Adoptive Cell Therapy for Metastatic Melanoma | — | Completed | — | — | — |
NCT02941744CT.gov A Clinical Trial: Adjuvant Low-dose Ipilimumab + Nivolumab After Resection of Melanoma Macrometastases | — | Completed | — | — | — |
NCT02519322CT.gov Neoadjuvant and Adjuvant Checkpoint Blockade | — | Completed | — | — | — |
NCT02339571CT.gov A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma | — | Active Not Recruiting | — | — | — |
NCT02224781CT.gov Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma | — | Active Not Recruiting | — | — | — |
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 | — | — | — |
NCT02304458CT.gov Nivolumab With or Without Ipilimumab in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Sarcomas | — | Completed | — | — | — |
NCT01940809CT.gov Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery | — | Terminated | — | — | — |
NCT01176474CT.gov Vaccine Combining Multiple Class I Peptides and Montanide ISA 51VG With Escalating Doses of Anti-PD-1 Antibody Nivolumab or Ipilimumab With Nivolumab For Patients With Resected Stages IIIC/ IV Melanoma | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
89High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Cutaneous Melanoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Nivolumab (this asset) | Fred Hutchinson Cancer Center | P3 | BB · 68 |
| Alpha-Interferon | MIPO Clinic | P3 | BBB |
| Tyrosinase Peptide | University of Southern California | P3 | BBB |
| TIL | City of Hope Medical Center | P2 | BBB |
| Cis-Diamminedichloroplatinum Ii | MIPO Clinic | P3 | BBB |
| Dacarbazine | Linnaeus Therapeutics, Inc. | P3 | BBB |
| Nivestim | Vastra Gotaland Region | P3 | BB |
| Multi-Epitope Melanoma Peptide Vaccine | Craig L Slingluff, Jr | P2 | BB |
| Ifa | Craig L Slingluff, Jr | P2 | BB |
+42 more in the Cutaneous Melanoma 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 Cutaneous Melanoma. 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-cutaneous-melanoma
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