18 completed, 13 recruiting, 12 terminated, 9 active not recruiting. 41 Phase 2, 22 Phase 1, 7 Phase 3, 1 Early Phase 1.
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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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| AGEN1423 and Botensilimab w/ or w/o Chemo in PDAC AGEN1423, Botensilimab, Gemcitabine - Advanced Pancreatic Ductal Adenocarcinoma, Pancreatic Ductal Adenocarcinoma | Phase 2 | Active not recruiting | Bruno Bockorny | 24 | 2024-08-08 | 2026-07-09 |
| Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008) Botensilimab + Balstilimab - Non-small Cell Lung Cancer | Phase 2 | Active not recruiting | Immune Oncology Research Institute | 45 | 2024-06-13 | 2026-06-08 |
| Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases Botensilimab, Balstilimab, AGEN1423 - Colorectal Cancer Metastatic, Liver Metastases | Phase 2 | Recruiting | Weill Medical College of Cornell University | 24 | 2024-03-26 | 2026-05-15 |
| Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations botensilimab, balstilimab, FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel) - Resectable MMR-deficient Solid Tumors, Resectable MMR-proficient Solid Tumors | Phase 2 / Phase 3 | Recruiting | The Netherlands Cancer Institute | 133 | 2024-01-29 | 2026-03-05 |
| Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma Balstilimab, Botensilimab, Liposomal Doxorubicin - Newly Diagnosed Glioblastoma, Glioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype | Phase 2 | Active not recruiting | Northwestern University | 25 | 2024-01-19 | 2026-09-29 |
| A Study of ONCOS-102 in Combination With Other Novel Immune-therapies in Advanced Treatment-resistant Melanoma Patients ONCOS-102, Balstilimab - Melanoma | Phase 2 | Withdrawn | Targovax Oy | 2024-01-01 | 2023-06-22 | |
| ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study Anti-PD-1 antibody balstilimab - Cervical Cancer | Phase 1 | Unknown | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | 30 | 2024-01-01 | 2023-10-23 |
| BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients Balstilimab - HPV, Oropharyngeal Cancer | Phase 2 | Withdrawn | M.D. Anderson Cancer Center | 2023-10-18 | 2026-05-12 |
Showing 20 of 62. Sign in to see all of them.
Colorectal Neoplasms (10) · Neoplasms (7) · Pancreatic Neoplasms (6) · Uterine Cervical Neoplasms (6) · Carcinoma, Non-Small-Cell Lung (5) · Melanoma (5) · Carcinoma, Renal Cell (4) · Glioblastoma (3) · Kidney Neoplasms (3) · Neoplasm Metastasis (3) · Prostatic Neoplasms (3) · Brain Neoplasms (2) · Central Nervous System Neoplasms (2) · Diabetes Mellitus, Insulin-Dependent, 12 (2) · Gliosarcoma (2)
balstilimab (36) · vitespin (8) · Gemcitabine (5) · Ipilimumab (5) · spartalizumab (4) · 130-nm albumin-bound paclitaxel (2) · Bevacizumab (2) · Craniotomy (2) · Heat-Shock Response (2) · Nivolumab (2) · Radiosurgery (2) · Taxes (2) · liposomal doxorubicin (2) · pembrolizumab (2) · poly ICLC (2)
United States (47) · Spain (6) · United Kingdom (6) · Brazil (5) · France (5) · Australia (4) · Belgium (4) · Canada (4) · Italy (4) · Poland (4) · Armenia (3) · Russia (3) · Georgia (2) · Hungary (2) · Netherlands (2)
Gevorg Tamamyan, MD, PhD, DSc (2) · Jennifer Clarke, MD (2) · Manish Shah, M.D. (2) · Samvel Bardakhchyan, MD, PhD (2) · Adam Sonabend, MD (1) · Andrea Cercek, MD (1) · Aparna R. Parikh, MD (1) · Astghik Voskanyan, MD (1) · Benjamin Schlecher, MD (1) · Benjamin Spieler, MD (1) · Breelyn Wilky, MD (1) · Bruno Bockorny, MD (1)
PMID 11224527, PMID 15240681, PMID 16382236, PMID 18586928, PMID 18602688, PMID 19097774, PMID 20516428, PMID 21074063, PMID 21525385, PMID 23728179, PMID 23897982, PMID 24335700, PMID 25539810, PMID 25619164, PMID 25922725, PMID 26398076, PMID 26403783, PMID 26558876, PMID 26858122, PMID 27141885, PMID 27269741, PMID 27717298, PMID 27932067, PMID 28040721, PMID 28193626, PMID 28228726, PMID 28607581, PMID 28636851, PMID 28678668, PMID 28835386, PMID 29423118, PMID 29617360, PMID 29657128, PMID 29731394, PMID 34409858, PMID 34932394, PMID 38172595, PMID 38191175, PMID 38871975, PMID 39028616, PMID 39869830, PMID 41502912, PMID 7165009
P50CA097257 (1), R01CA164714 (1), R01CA296410 (1), U10CA031946 (1)