Disease × agent evidence record

Nivolumab for Colorectal Cancer: evidence, trials and status

Nivolumab has both completed registered trials and synthesis-level publications linked to Colorectal Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit.

8 registered trials 1 recruiting 18 publications Evidence tier A · Strong Score 67.5
Research Tracker › Pairs › Colorectal Cancer › Nivolumab
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Nivolumab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Colorectal Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Colorectal Cancer. ClinicalTrials.gov lists 8 registered trials linking Nivolumab to Colorectal Cancer: 1 is currently recruiting; 1 is active or not yet recruiting; 2 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT07223424). It plans or enrolled 880 participants. Registration activity spans 2006 to 2025. The literature layer holds 18 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 1 systematic review, 4 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2022 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.

The RepurpOS disease-intelligence file for Colorectal Cancer ranks 1212 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Essentially zero; 5-year survival stage I: ~90% (resectable); stage IV: ~15% overall, ~20-30% with modern therapy and liver metastasis resection.

Open in Repurposing ExplorerColorectal Cancer hubColorectal Cancer biomarkers & interventions

Evidence table

Evidence tierA · Strong
Evidence score67.5 (trials 17.5, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 1 recruiting, 1 active / not yet recruiting, 2 completed, 4 other
Linked publications18 (5 Cochrane reviews, 5 clinical trial publications, 4 randomised controlled trial publications, 3 meta-analyses, 1 systematic review)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classNot recorded
Data sourcesDGIdb
Linked via biomarker / targetARID1A
How the evidence score is calculated
  • Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
  • Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
  • The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
  • Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
  • The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.

Registered clinical trials

NCT IDTitleStatusPhaseEnrolment
NCT07223424Patient Preference for Subcutaneous vs. Intravenous Immune Therapy
2025
recruitingPhase 2880
NCT03631641Nivolumab in Preventing Colon Adenomas in Participants With Lynch Syndrome and a History of Partial Colectomy
2018
terminatedPhase 23
NCT03879811Determining the Effects of Temozolomide Followed by Nivolumab in Patients With Colorectal Cancer
2019
withdrawnPhase 2—
NCT00441337A Study of MDX-1106 in Patients With Selected Refractory or Relapsed Malignancies
2006
completedPhase 139
NCT05395052FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors
2022
terminatedPhase 15
NCT04599140SX-682 and Nivolumab for the Treatment of RAS-Mutated, MSS Unresectable or Metastatic Colorectal Cancer, the STOPTRAFFIC-1 Trial
2020
active, not recruitingPHASE1, PHASE251
NCT06011330Fruquintinib Plus PD-1 in Refractory MSS Metastatic Colorectal Cancer
2019
completedNot applicable70
NCT04771715Regorafenib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Patients With Advanced Colorectal Cancer
2019
status unknownNot applicable100

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Published literature

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Mechanism and notes

No mechanism of action is recorded for this pair in the source databases.

OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ARID1A. The tier describes how well the drug-disease link is documented, not how well the drug works.

Frequently asked questions

Is Nivolumab approved for Colorectal Cancer?

Nivolumab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Colorectal Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Colorectal Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.

Is Nivolumab in clinical trials for Colorectal Cancer?

ClinicalTrials.gov lists 8 registered trials linking Nivolumab to Colorectal Cancer: 1 is currently recruiting; 1 is active or not yet recruiting; 2 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT07223424). It plans or enrolled 880 participants. Registration activity spans 2006 to 2025.

What does the evidence show for Nivolumab in Colorectal Cancer?

Nivolumab has both completed registered trials and synthesis-level publications linked to Colorectal Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ARID1A. The tier describes how well the drug-disease link is documented, not how well the drug works.

Cite this page

Open Source Medicine Foundation. Nivolumab for Colorectal Cancer: evidence, trials and status. OSMF Research Tracker. Updated 2026-07-05. https://research.opensourcemed.info/pairs/colorectal-cancer/nivolumab.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.

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This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.