22 recruiting, 11 active not recruiting, 7 terminated, 6 withdrawn. 38 Phase 2, 15 Phase 1, 4 Phase 3, 2 Early Phase 1.
Follow balstilimab: new trials by email Literature Review of balstilimab trials Research Report on balstilimab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Cancer, Combat Trial Balstilimab, Biopsy Procedure, Biospecimen Collection - Colorectal Adenocarcinoma, Stage II Colorectal Cancer AJCC v8 | Phase 2 | Recruiting | National Cancer Institute (NCI) | 20 | 2027-05-25 | 2026-09-29 |
| Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Renal Cell Carcinoma, NEO RoBOT Trial Balstilimab, Biospecimen Collection, Botensilimab - Clear Cell Renal Cell Carcinoma, Stage II Renal Cell Cancer AJCC v8 | Phase 2 | Recruiting | National Cancer Institute (NCI) | 16 | 2027-05-17 | 2026-10-21 |
| RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer Botensilimab, Balstilimab - Early Rectal Cancer, Stage I Rectal Cancer | Phase 2 | Recruiting | Dana-Farber Cancer Institute | 16 | 2026-09-01 | 2026-08-18 |
| Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3 Balstilimab, Biospecimen Collection, Botensilimab - Advanced Colon Adenocarcinoma, Advanced Colorectal Adenocarcinoma | Phase 2 | Recruiting | City of Hope Medical Center | 100 | 2026-07-01 | 2026-10-19 |
| BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases Balstilimab (BAL), Botensilimab (BOT), agenT-797 - Colorectal Cancer Metastatic | Phase 2 | Recruiting | Darren Sigal, MD | 17 | 2026-06-10 | 2026-08-10 |
| Botensilimab, Balstilimab, and SBRT in Colorectal Cancer Stereotactic Body Radiation Therapy (SBRT), Botensilimab, Balstilimab - Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis | Early Phase 1 | Recruiting | Massachusetts General Hospital | 15 | 2026-05-12 | 2026-05-13 |
| Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma Best Supportive Care, Balstilimab, Botensilimab - Colorectal Cancer | Phase 3 | Terminated | Canadian Cancer Trials Group | 21 | 2026-03-31 | 2026-07-16 |
| Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373 - Colorectal Cancer Metastatic | Early Phase 1 | Recruiting | Northwell Health | 10 | 2025-12-10 | 2026-06-24 |
| Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas Balstilimab, Botensilimab, Folfox Protocol - Gastric Cancer, MSI-H | Phase 3 | Recruiting | Centre Leon Berard | 132 | 2025-12-08 | 2026-06-25 |
| A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy Botensilimab, Balstilimab, Placebo - Colorectal Cancer, Rectal Cancer | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 284 | 2025-11-07 | 2026-09-22 |
| The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation Stereotactic Body Radiation Therapy, Botensilimab, Balstilimab - Metastatic Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer | Phase 2 | Recruiting | Benjamin Spieler | 20 | 2025-06-18 | 2026-08-21 |
| Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer AGEN2373, Balstilimab, Cyclophosphamide - Pancreatic Cancer | Phase 1 / Phase 2 | Recruiting | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 38 | 2025-05-27 | 2025-12-03 |
| FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery Balstilimab, Biospecimen Collection, Botensilimab - Rectal Adenocarcinoma, Stage IIA Rectal Cancer AJCC v8 | Phase 2 | Recruiting | City of Hope Medical Center | 26 | 2025-05-20 | 2026-06-29 |
| A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma Balstilimab, Botensilimab - Microsatellite Stable Rectal Carcinoma, Locally Advanced Rectal Adenocarcinoma | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 40 | 2025-02-20 | 2026-06-16 |
| Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer Balstilimab, Biospecimen Collection, Botensilimab - Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8 | Phase 1 | Recruiting | University of Southern California | 15 | 2025-01-15 | 2026-03-17 |
| The Seven Trial: Exploiting the Unfolded Protein Response Botensilimab, Balstilimab, Chloroquine Phosphate - Pancreatic Cancer Metastatic, Pancreatic Adenocarcinoma Metastatic | Phase 1 | Terminated | HonorHealth Research Institute | 6 | 2025-01-09 | 2026-06-23 |
| A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab Evofosfamide, Zalifrelimab, Balstilimab - Metastatic Prostate Cancer, Metastatic Head and Neck Squamous Cell Carcinoma | Phase 1 / Phase 2 | Recruiting | ImmunoGenesis | 71 | 2025-01-08 | 2025-01-21 |
| Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC) SR-8541A - Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC) | Phase 2 | Recruiting | Stingray Therapeutics | 70 | 2024-11-20 | 2026-08-12 |
| Botensilimab and Balstilimab Optimization in Colorectal Cancer Botensilimab, Balstilimab, Oxaliplatin - Colorectal Cancer | Phase 2 | Active not recruiting | Nicholas DeVito, MD | 16 | 2024-11-18 | 2026-02-05 |
| KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer KRAS Vaccine with Poly-ICLC adjuvant, Balstilimab, Botensilimab - Colorectal Cancer, Pancreatic Cancer | Phase 1 | Recruiting | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 54 | 2024-11-04 | 2026-07-31 |
Showing 20 of 53. Sign in to see all of them.
Colorectal Neoplasms (17) · Pancreatic Neoplasms (6) · Rectal Neoplasms (6) · Uterine Cervical Neoplasms (5) · Colonic Neoplasms (4) · Carcinoma, Non-Small-Cell Lung (3) · Neoplasm Metastasis (3) · Neoplasms (3) · Prostatic Neoplasms (3) · Stomach Neoplasms (3) · Diabetes Mellitus, Insulin-Dependent, 12 (2) · Hemangiosarcoma (2) · Melanoma (2) · Ovarian Neoplasms (2) · Sarcoma (2)
Agenus Inc. (13) · City of Hope Medical Center (5) · Memorial Sloan Kettering Cancer Center (3) · Immune Oncology Research Institute (2) · National Cancer Institute (NCI) (2) · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (2) · Weill Medical College of Cornell University (2) · Ann & Robert H Lurie Children's Hospital of Chicago (1) · Benjamin Spieler (1) · Canadian Cancer Trials Group (1) · Centre Leon Berard (1) · Dana-Farber Cancer Institute (1) · Darren Sigal, MD (1) · Groupe Oncologie Radiotherapie Tete et Cou (1) · Gruppo Oncologico del Nord-Ovest (1)
United States (39) · Brazil (5) · France (5) · Italy (4) · Spain (4) · Armenia (3) · Belgium (3) · Australia (2) · Georgia (2) · Poland (2) · Russia (2) · United Kingdom (2) · Canada (1) · Chile (1) · China (1)
Marwan G Fakih (3) · Gevorg Tamamyan, MD, PhD, DSc (2) · Manish Shah, M.D. (2) · Samvel Bardakhchyan, MD, PhD (2) · Adam Sonabend, MD (1) · Adanma Anji Ayanambakkam Attanathi (1) · Andrea Cercek, MD (1) · Anup Kasi (1) · Aparna R. Parikh, MD (1) · Ashley Plant-Fox, MD (1) · Astghik Voskanyan, MD (1) · Benjamin Schlecher, MD (1) · Benjamin Spieler, MD (1) · Breelyn Wilky, MD (1)
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P30CA033572 (5), 2023 (1), P30CA014089 (1), R01CA296410 (1), UM1CA186688 (1), UM1CA186689 (1)