Floatz Rating
B63/100
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.
65High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07620574CT.gov Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study | — | Not Yet Recruiting | — | — | — |
NCT07527858CT.gov Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer | — | Recruiting | — | — | — |
NCT07328087CT.gov COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer | — | Recruiting | — | — | — |
NCT07403877CT.gov Neoadjuvant Immunotherapy ± Radiotherapy in MSI-H/dMMR Locally Advanced Colorectal Cancer | — | Not Yet Recruiting | — | — | — |
NCT06948448CT.gov A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer | — | Recruiting | — | — | — |
NCT07223424CT.gov Patient Preference for Subcutaneous vs. Intravenous Immune Therapy | — | Recruiting | — | — | — |
NCT06410534CT.gov A Phase II Study Evaluating an Organ Preservation Strategy Using Immune Checkpoint Blockade for Participants With Primary Colorectal or Gastroesophageal Cancer | — | Withdrawn | — | — | — |
NCT07011550CT.gov Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer | — | Suspended | — | — | — |
NCT07376707CT.gov A Phase 1 Study of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced/Metastatic Solid Tumors | — | Recruiting | — | — | — |
NCT07542262CT.gov Low-dose Immunotherapy in Metastatic and Locally Advanced Colorectal and Gastric MSI/dMMR Cancers | — | Enrolling By Invitation | — | — | — |
Show 61 more trialsShow fewer
NCT06245356CT.gov Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer | — | Recruiting | — | — | — |
NCT06362369CT.gov A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy | — | Recruiting | — | — | — |
NCT07523763CT.gov Neoadjuvant Low-dose Immunotherapy in Locally Advanced MMR-deficient Colorectal Cancer | — | Active Not Recruiting | — | — | — |
NCT06047379CT.gov Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis | — | Recruiting | — | — | — |
NCT05919264CT.gov FOG-001 in Locally Advanced or Metastatic Solid Tumors | — | Recruiting | — | — | — |
NCT05845450CT.gov Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) | — | Recruiting | — | — | — |
NCT05350501CT.gov EO2040 in Combination With Nivolumab, for Treatment of Patients With Minimal Residual Disease of Colorectal Cancer | — | Terminated | — | — | — |
NCT05395052CT.gov FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors | — | Terminated | — | — | — |
NCT05310643CT.gov Nivolumab and Ipilimumab in Anti-PD1-Resistant dMMR/MSI mCRC | — | Recruiting | — | — | — |
NCT05176483CT.gov Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors | — | Recruiting | — | — | — |
NCT04907539CT.gov A Study to Assess Efficacy of RXC004 +/- Nivolumab in Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer After Progression on Standard of Care (SOC) | — | Completed | — | — | — |
NCT04963283CT.gov Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer | — | Active Not Recruiting | — | — | — |
NCT04999761CT.gov AB122 Platform Study | — | Recruiting | — | — | — |
NCT04730544CT.gov Two Combination Treatment Regimens of Nivolumab and Ipilimumab in Patients With dMMR and / or MSI mCRC. | — | Active Not Recruiting | — | — | — |
NCT04912765CT.gov Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC | — | Recruiting | — | — | — |
NCT04729322CT.gov Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders | — | Active Not Recruiting | — | — | — |
NCT04044430CT.gov Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer | — | Terminated | — | — | — |
NCT04166383CT.gov VB-111 in Combination With Nivolumab in People With Metastatic Colorectal Cancer (mCRC) | — | Terminated | — | — | — |
NCT04117087CT.gov Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Resected Mismatch Repair Protein (MMR-p) Colorectal and Pancreatic Cancer | — | Active Not Recruiting | — | — | — |
NCT04362839CT.gov Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer | — | Completed | — | — | — |
NCT04278144CT.gov A First-in-human Study Using BDC-1001 as a Single Agent and in Combination With Nivolumab in Advanced HER2-Expressing Solid Tumors | — | Terminated | — | — | — |
NCT03576963CT.gov Guadecitabine and Nivolumab in Treating Refractory Metastatic Colorectal Cancer | — | Withdrawn | — | — | — |
NCT04208958CT.gov Study of VE800 and Nivolumab in Patients With Selected Types of Advanced or Metastatic Cancer | — | Completed | — | — | — |
NCT03791398CT.gov BrUOG 379 Phase Ib/II Trial ONC201 + Nivolumab in MSS mCRC | — | Terminated | — | — | — |
NCT04126733CT.gov Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable) | — | Completed | — | — | — |
NCT04008030CT.gov A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) | — | Active Not Recruiting | — | — | — |
NCT03953235CT.gov A Study of a Personalized Cancer Vaccine Targeting Shared Neoantigens | — | Completed | — | — | — |
NCT04017650CT.gov Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer | — | Active Not Recruiting | — | — | — |
NCT03785210CT.gov Nivolumab (Anti-PD1), Tadalafil and Oral Vancomycin in People With Refractory Primary Hepatocellular Carcinoma or Liver Dominant Metastatic Cancer From Colorectal or Pancreatic Cancers | — | Terminated | — | — | — |
NCT03798626CT.gov Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers | — | Completed | — | — | — |
NCT03872947CT.gov A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors | — | Active Not Recruiting | — | — | — |
NCT03832621CT.gov NIVOLUMAB Plus IPILIMUMAB and TEMOZOLOMIDE in Microsatellite Stable, MGMT Silenced Metastatic Colorectal Cancer | — | Completed | — | — | — |
NCT03829436CT.gov TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers | — | Completed | — | — | — |
NCT04110093CT.gov Regorafenib Plus PD-1 Inhibitor in Patients With Colorectal Cancer | — | Unknown | — | — | — |
NCT03841110CT.gov FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors | — | Completed | — | — | — |
NCT03639714CT.gov A Study of a Personalized Neoantigen Cancer Vaccine | — | Completed | — | — | — |
NCT03520946CT.gov RAMucirumab in Combination Wth TAS102 vs. TAS102 Alone in Chemotherapy Refractory Metastatic Colorectal Cancer Patients | — | Completed | — | — | — |
NCT03507699CT.gov Combined Immunotherapy and Radiosurgery for Metastatic Colorectal Cancer | — | 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 | — | — | — |
NCT03307603CT.gov Yttrium-90 Radioembolization + Nivolumab for Liver + Extra-hepatic Metastases From Colorectal Cancer | — | Withdrawn | — | — | — |
NCT03712943CT.gov Regorafenib and Nivolumab in Mismatch Repair (MMR) Refractory Colorectal Cancer | — | Completed | — | — | — |
NCT03667716CT.gov COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. | — | Completed | — | — | — |
NCT03169777CT.gov QUILT-3.050: NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC | — | Withdrawn | — | — | — |
NCT03547999CT.gov A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC | — | Terminated | — | — | — |
NCT03993626CT.gov A Trial of CXD101 in Combination With Nivolumab in Patients With Metastatic Microsatellite-Stable Colorectal Cancer | — | Unknown | — | — | — |
NCT03435640CT.gov REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies | — | Terminated | — | — | — |
NCT03377361CT.gov An Investigational Immuno-therapy Study Of Nivolumab In Combination With Trametinib With Or Without Ipilimumab In Participants With Previously Treated Cancer of the Colon or Rectum That Has Spread | — | Completed | — | — | — |
NCT03373188CT.gov VX15/2503 and Immunotherapy in Resectable Pancreatic and Colorectal Cancer | — | Completed | — | — | — |
NCT03271047CT.gov Study of Binimetinib + Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation | — | Completed | — | — | — |
NCT03190174CT.gov Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers | — | Completed | — | — | — |
NCT03184870CT.gov A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors | — | Completed | — | — | — |
NCT03104439CT.gov Nivolumab and Ipilimumab and Radiation Therapy in MSS and MSI High Colorectal and Pancreatic Cancer | — | Active Not Recruiting | — | — | — |
NCT02745769CT.gov A Study in Advanced Cancers Using Ramucirumab (LY3009806) and Other Targeted Agents | — | Completed | — | — | — |
NCT02860546CT.gov A Study Evaluating TAS-102 Plus Nivolumab in Patients With MSS CRC | — | Completed | — | — | — |
NCT02636036CT.gov Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors | — | Completed | — | — | — |
NCT02335918CT.gov A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors | — | Completed | — | — | — |
NCT02327078CT.gov A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204) | — | Completed | — | — | — |
NCT02060188CT.gov A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread | — | Completed | — | — | — |
NCT01079780CT.gov Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing Chemotherapy | — | Completed | — | — | — |
NCT01183780CT.gov A Study in Second Line Metastatic Colorectal Cancer | — | Completed | — | — | — |
NCT00441337CT.gov A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies | — | 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 · Colorectal Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Nivolumab (this asset) | Fred Hutchinson Cancer Center | P3 | B · 63 |
| Desflurane | Peter MacCallum Cancer Centre, Australia | P4 | BBB |
| Marble Dust | James Varani | P2/3 | BB |
| Oxaliplatin | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | P4 | BB |
| Orectalip | Sinphar Pharmaceutical Co., Ltd | P4 | BB |
| Fluorouracilum | UNICANCER | P4 | BB |
| Levofolinic Acid | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | P3 | BB |
| Fentanyl | Mansoura University | P4 | BB |
| Panitumumab | MSPU des 3 Provinces | P3 | BB |
+42 more in the Colorectal 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 Colorectal 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-colorectal-cancer
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