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 |
|---|---|---|---|---|---|
NCT07518043CT.gov A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors | — | Not Yet Recruiting | — | — | — |
NCT07532902CT.gov A Study of BMS-986504 With Standard-of-Care Therapy for People With Solid Tumor Cancer | — | Recruiting | — | — | — |
NCT06983210CT.gov Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma | — | Recruiting | — | — | — |
NCT06047379CT.gov Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis | — | Recruiting | — | — | — |
NCT06034860CT.gov Study of MT-8421 as Monotherapy and in Combination With Nivolumab in Patients With Selected Advanced Solid Cancer Types | — | Terminated | — | — | — |
NCT05496192CT.gov A Study of Nivolumab Intravenous (IV) to Subcutaneous (SC) Switch in Adjuvant Melanoma and Bladder Cancer | — | Withdrawn | — | — | — |
NCT04637594CT.gov Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy | — | Active Not Recruiting | — | — | — |
NCT05176483CT.gov Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors | — | Recruiting | — | — | — |
NCT04953104CT.gov ARID1A and/or KDM6A Mutation and CXCL13 Expression | — | Active Not Recruiting | — | — | — |
NCT04848519CT.gov Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma | — | Active Not Recruiting | — | — | — |
Show 19 more trialsShow fewer
NCT04114136CT.gov Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies | — | Recruiting | — | — | — |
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 | — | — | — |
NCT04180371CT.gov Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression | — | Active Not Recruiting | — | — | — |
NCT03980041CT.gov Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) | — | Completed | — | — | — |
NCT04044859CT.gov ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS) | — | Active Not Recruiting | — | — | — |
NCT03829436CT.gov TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers | — | Completed | — | — | — |
NCT03841110CT.gov FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors | — | Completed | — | — | — |
NCT03758781CT.gov IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors | — | Completed | — | — | — |
NCT03639714CT.gov A Study of a Personalized Neoantigen Cancer Vaccine | — | Completed | — | — | — |
NCT03228667CT.gov QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors | — | Active Not Recruiting | — | — | — |
NCT03606174CT.gov A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma | — | Terminated | — | — | — |
NCT03633110CT.gov Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine | — | Completed | — | — | — |
NCT03523572CT.gov Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer | — | Completed | — | — | — |
NCT03511391CT.gov CHEckpoint Inhibition in Combination With an Immunoboost of External Beam Radiotherapy in Solid Tumors | — | Completed | — | — | — |
NCT03311334CT.gov A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors | — | Terminated | — | — | — |
NCT03190174CT.gov Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers | — | Completed | — | — | — |
NCT02983045CT.gov A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors | — | Completed | — | — | — |
NCT03115801CT.gov A Phase II Randomized Trial of Immunotherapy Plus Radiotherapy in Metastatic Genitourinary Cancers | — | Terminated | — | — | — |
NCT02426125CT.gov A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer | — | Completed | — | — | — |
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 · Urothelial Carcinoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Nivolumab (this asset) | Fred Hutchinson Cancer Center | P3 | BB · 64 |
| Cyclophosphamide | Beijing Biotech | P3 | BB |
| Durvalumab | Alliance for Clinical Trials in Oncology | P3 | BB |
| Cis-Diamminedichloroplatinum Ii | Nagoya University | P3 | BB |
| Pembrolizumab | Sutro Biopharma, Inc. | P3 | BB |
| Enfortumab Vedotin (Fully Human Monoclonal Antibody Conjugated To A Cytotoxic Agent Monomethyl Auristatin E (Mmae) Targeting Nectin-4) | Vasgene Therapeutics, Inc | P2/3 | BB |
| Immunoglobulin G1, Anti-(Human Vascular Endothelial Growth Factor Receptor Type Vegfr-2 Extracellular Domain) (Human Monoclonal Imc-1121B .Gamma.-Chain), Disulphide With Human Monoclonal Imc-1121B .Kappa.-Chain, Dimer | Eli Lilly and Company | P3 | BB |
| Retifanlimab | Incyte Corporation | P2 | BB |
| Docetaxel | NuCana plc | P3 | BB |
+42 more in the Urothelial Carcinoma 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
- CyclophosphamideBeijing BiotechBB
- DurvalumabAlliance for Clinical Trials in OncologyBB
- Cis-Diamminedichloroplatinum IiNagoya UniversityBB
- PembrolizumabSutro Biopharma, Inc.BB
- Enfortumab Vedotin (Fully Human Monoclonal Antibody Conjugated To A Cytotoxic Agent Monomethyl Auristatin E (Mmae) Targeting Nectin-4)Vasgene Therapeutics, IncBB
Citation
Floatz Terminal. Nivolumab in Urothelial Carcinoma. 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-urothelial-carcinoma
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