Summary
Atezolizumab 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 Atezolizumab to Colorectal Cancer: 2 are currently recruiting; 1 is active or not yet recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT02291289). It plans or enrolled 1044 participants. Registration activity spans 2015 to 2025. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2023 to 2025. 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.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 73.5 (trials 23.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 2 recruiting, 1 active / not yet recruiting, 3 completed, 2 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 2 randomised controlled trial publications, 1 meta-analysis) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | ARID1A |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT05118724 | Atezolizumab in Patients With MSI-h/MMR-D Stage II High Risk and Stage III Colorectal Cancer Ineligible for Oxaliplatin 2021 | active, not recruiting | Phase 2 | 80 |
| NCT02291289 | A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC) 2015 | completed | Phase 2 | 1,044 |
| NCT06555133 | Y-90, Capecitabine, and Atezolizumab for Oligometastatic CRC 2025 | recruiting | Phase 2 | 18 |
| NCT02992912 | Atezolizumab With Stereotactic Ablative Radiotherapy in Patients With Metastatic Tumours 2016 | status unknown | Phase 2 | 138 |
| NCT03841110 | FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors 2019 | completed | Phase 1 | 37 |
| NCT03256344 | Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases 2018 | completed | Phase 1 | 36 |
| NCT05395052 | FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors 2022 | terminated | Phase 1 | 5 |
| NCT05944237 | HTL0039732 in Participants With Advanced Solid Tumours 2023 | recruiting | PHASE1, PHASE2 | 150 |
Published literature
- Clinical trial publication Efficacy and safety of atezolizumab plus bevacizumab in MSI-like metastatic colorectal cancer: a multicenter, single-arm, phase II, open-label clinical trialElez E, Siena S, Sartore-Bianchi A et al. · ESMO open · 2025 · PMID 41337858
- Clinical trial publication Zanzalintinib plus atezolizumab versus regorafenib in refractory colorectal cancer (STELLAR-303): a randomised, open-label, phase 3 trialHecht JR, Park YS, Tabernero J et al. · Lancet (London, England) · 2025 · PMID 41130252
- Clinical trial publication Liver metastases do not predict resistance to the addition of atezolizumab to first-line FOLFOXIRI plus bevacizumab in proficient MMR metastatic colorectal cancer: a secondary analysis of the AtezoTRIBE studyAntoniotti C, Carullo M, Rossini D et al. · ESMO open · 2025 · PMID 39908699
- Cochrane review Efficacy and safety of first-line targeted and immunotherapy for metastatic colorectal cancer: a network meta-analysisHuo L, Yue H, Yang R et al. · Frontiers in immunology · 2025 · PMID 41262255
- Cochrane review The efficacy of targeted therapy and/or immunotherapy with or without chemotherapy in patients with colorectal cancer: A network meta-analysisGuo H, Miao L, Yu C · European journal of pharmacology · 2025 · PMID 39716565
- Clinical trial publication Upfront Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan Plus Bevacizumab With or Without Atezolizumab for Patients With Metastatic Colorectal Cancer: Updated and Overall Survival Results of the ATEZOTRIBE StudyAntoniotti C, Rossini D, Pietrantonio F et al. · Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 · PMID 38865678
- Clinical trial publication Efficacy and Safety of Atezolizumab and Bevacizumab in Appendiceal AdenocarcinomaHornstein NJ, Zeineddine MA, Gunes BB et al. · Cancer research communications · 2024 · PMID 38709066
- Cochrane review Evaluation of the efficacy and safety of first- and second-line immunotherapy in patients with metastatic colorectal cancer: a systematic review and network meta-analysis based on randomized controlled trialsChen K, Chen W, Yue R et al. · Frontiers in immunology · 2024 · PMID 39359729
- Cochrane review First line therapy in stage IV BRAF mutated colorectal cancerPetrelli F, Antista M, Dottorini L et al. · Heliyon · 2024 · PMID 39263130
- Cochrane review A network meta-analysis of efficacy and safety for first-line and maintenance therapies in patients with unresectable colorectal liver metastasesJiang Y, Shao T, Zhao M et al. · Frontiers in pharmacology · 2024 · PMID 39130637
- Meta-analysis Comparative efficacy of later-line therapies for metastatic colorectal cancer: a network meta-analysis of survival curvesObeng-Kusi M, Martin JR, Roe D et al. · Expert review of pharmacoeconomics & outcomes research · 2024 · PMID 38845342
- Randomized controlled trial An Immune-Related Gene Expression Signature Predicts Benefit from Adding Atezolizumab to FOLFOXIRI plus Bevacizumab in Metastatic Colorectal CancerAntoniotti C, Boccaccino A, Seitz R et al. · Clinical cancer research : an official journal of the American Association for Cancer Research · 2023 · PMID 37022350
- Randomized controlled trial Clinical and exploratory biomarker findings from the MODUL trial (Cohorts 1, 3 and 4) of biomarker-driven maintenance therapy for metastatic colorectal cancerDucreux M, Tabernero J, Grothey A et al. · European journal of cancer (Oxford, England : 1990) · 2023 · PMID 36921494
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 Atezolizumab approved for Colorectal Cancer?
Atezolizumab 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 Atezolizumab in clinical trials for Colorectal Cancer?
ClinicalTrials.gov lists 8 registered trials linking Atezolizumab to Colorectal Cancer: 2 are currently recruiting; 1 is active or not yet recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT02291289). It plans or enrolled 1044 participants. Registration activity spans 2015 to 2025.
What does the evidence show for Atezolizumab in Colorectal Cancer?
Atezolizumab 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
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.