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ClinicalTrials.gov public records Last synced Oct 17, 2026, 10:23 PM EDT

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Showing 1–24 of 41 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Balstilimab Clear all
Completed Phase 1Phase 2 Interventional Results available

A Study of Zalifrelimab and Balstilimab for Treatment of Participants With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical)

NCT03495882
View directory record Official record
Conditions
Cervical Cancer
Interventions
Zalifrelimab, Balstilimab
Drug
Lead sponsor
Agenus Inc.
Industry
Eligibility
18 Years and older
Enrollment
175 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
13
States / cities
Goodyear, Arizona • Duarte, California • Miami, Florida + 10 more
Source: ClinicalTrials.gov public record
Updated Aug 11, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Terminated Phase 2 Interventional

RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer

NCT03894215
View directory record Official record
Conditions
Cervical Cancer
Interventions
AGEN2034, AGEN1884
Drug
Lead sponsor
Agenus Inc.
Industry
Eligibility
18 Years and older · Female only
Enrollment
211 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2025
U.S. locations
42
States / cities
Birmingham, Alabama • Mobile, Alabama • Phoenix, Arizona + 36 more
Source: ClinicalTrials.gov public record
Updated Mar 27, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Available No phase listed Expanded access

Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)

NCT05572970
View directory record Official record
Conditions
Cancer
Interventions
Balstilimab, Zalifrelimab
Drug
Lead sponsor
Agenus Inc.
Industry
Eligibility
18 Years and older
U.S. locations
7
States / cities
Birmingham, Alabama • Tucson, Arizona • Newport Beach, California + 4 more
Source: ClinicalTrials.gov public record
Updated May 6, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Active, not recruiting Phase 2 Interventional

Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas

NCT04028063
View directory record Official record
Conditions
Metastatic Soft Tissue Sarcoma, Advanced Soft Tissue Sarcoma
Interventions
Balstilimab, Zalifrelimab, Doxorubicin, Botensilimab
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years to 100 Years
Enrollment
65 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated Apr 20, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Active, not recruiting Phase 2 Interventional

Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

NCT05864534
View directory record Official record
Conditions
Newly Diagnosed Glioblastoma, Glioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype, Gliosarcoma, Glioblastoma Multiforme
Interventions
Balstilimab, Botensilimab, Liposomal Doxorubicin, Sonocloud-9 (SC-9)
Drug · Device
Lead sponsor
Northwestern University
Other
Eligibility
18 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2031
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Sep 29, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Recruiting Phase 1 Interventional

rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG

NCT04943848
View directory record Official record
Conditions
Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
Interventions
rHSC-DIPGVax, Balstilimab, Zalifrelimab
Biological · Drug
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Other
Eligibility
12 Months to 18 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
3
States / cities
Orange, California • Chicago, Illinois • Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Mar 17, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Recruiting Phase 1Phase 2 Interventional

Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer

NCT06782932
View directory record Official record
Conditions
Pancreatic Cancer
Interventions
AGEN2373, Balstilimab, Cyclophosphamide, GVAX, AGEN2373 (RP2D), mKRASvax
Drug
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
18 Years and older
Enrollment
38 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Dec 3, 2025 · Synced Oct 17, 2026, 10:23 PM EDT
Recruiting Early Phase 1 Interventional

Botensilimab, Balstilimab, and SBRT in Colorectal Cancer

NCT07128355
View directory record Official record
Conditions
Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis
Interventions
Stereotactic Body Radiation Therapy (SBRT), Botensilimab, Balstilimab
Radiation · Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 13, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Recruiting Phase 2 Interventional

A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy

NCT07227636
View directory record Official record
Conditions
Colorectal Cancer, Rectal Cancer
Interventions
Botensilimab, Balstilimab, Placebo
Drug · Other
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
284 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
7
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Montvale, New Jersey + 4 more
Source: ClinicalTrials.gov public record
Updated Sep 22, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Completed Phase 1Phase 2 Interventional Results available

A Study of AGEN2034 in Advanced Tumors and Cervical Cancer

NCT03104699
View directory record Official record
Conditions
Advanced Cancer, Cervical Cancer
Interventions
AGEN2034
Drug
Lead sponsor
Agenus Inc.
Industry
Eligibility
18 Years and older · Female only
Enrollment
211 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
12
States / cities
Scottsdale, Arizona • Duarte, California • Los Angeles, California + 9 more
Source: ClinicalTrials.gov public record
Updated Jul 30, 2025 · Synced Oct 17, 2026, 10:23 PM EDT
Recruiting Phase 1Phase 2 Interventional

A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab

NCT06782555
View directory record Official record
Conditions
Metastatic Prostate Cancer, Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Pancreatic Cancer
Interventions
Evofosfamide, Zalifrelimab, Balstilimab
Drug
Lead sponsor
ImmunoGenesis
Industry
Eligibility
18 Years and older
Enrollment
71 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jan 21, 2025 · Synced Oct 17, 2026, 10:23 PM EDT
Active, not recruiting Phase 2 Interventional

A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma

NCT05529316
View directory record Official record
Conditions
Advanced Melanoma
Interventions
Botensilimab, Balstilimab
Drug
Lead sponsor
Agenus Inc.
Industry
Eligibility
18 Years and older
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2028
U.S. locations
7
States / cities
Scottsdale, Arizona • Fullerton, California • Santa Monica, California + 4 more
Source: ClinicalTrials.gov public record
Updated Jan 16, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Recruiting Phase 1 Interventional

Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer

NCT06336902
View directory record Official record
Conditions
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8
Interventions
Balstilimab, Biospecimen Collection, Botensilimab, Computed Tomography, Dietary Intervention, Magnetic Resonance Imaging, Vitamin C
Biological · Procedure · Other + 1 more
Lead sponsor
University of Southern California
Other
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
3
States / cities
Fullerton, California • Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Mar 17, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Active, not recruiting Phase 2 Interventional

Botensilimab and Balstilimab Optimization in Colorectal Cancer

NCT06268015
View directory record Official record
Conditions
Colorectal Cancer
Interventions
Botensilimab, Balstilimab, Oxaliplatin, Leucovorin, Fluorouracil, Bevacizumab, Panitumumab
Drug
Lead sponsor
Nicholas DeVito, MD
Other
Eligibility
18 Years and older
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Feb 5, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy

NCT05672316
View directory record Official record
Conditions
Advanced Colorectal Adenocarcinoma, Advanced Microsatellite Stable Colorectal Carcinoma, Metastatic Colorectal Adenocarcinoma, Metastatic Microsatellite Stable Colorectal Carcinoma, Stage III Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8
Interventions
Balstilimab, Biospecimen Collection, Botensilimab, Computed Tomography, Regorafenib
Biological · Procedure · Drug
Lead sponsor
City of Hope Medical Center
Other
Eligibility
18 Years and older
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
1
States / cities
Duarte, California
Source: ClinicalTrials.gov public record
Updated Sep 1, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Recruiting Phase 2 Interventional

BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases

NCT07550088
View directory record Official record
Conditions
Colorectal Cancer Metastatic
Interventions
Balstilimab (BAL), Botensilimab (BOT), agenT-797
Drug
Lead sponsor
Darren Sigal, MD
Other
Eligibility
18 Years and older
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
La Jolla, California
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Recruiting Phase 2 Interventional

Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Cancer, Combat Trial

NCT07551596
View directory record Official record
Conditions
Colorectal Adenocarcinoma, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8
Interventions
Balstilimab, Biopsy Procedure, Biospecimen Collection, Botensilimab, Radiographic Examination
Biological · Procedure
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2027 – 2029
U.S. locations
2
States / cities
New Orleans, Louisiana • Houston, Texas
Source: ClinicalTrials.gov public record
Updated Sep 29, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Recruiting Phase 1 Interventional

Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors

NCT04064359
View directory record Official record
Conditions
Solid Tumor
Interventions
OBT076, a CD205-directed antibody-drug conjugate
Drug
Lead sponsor
Oxford BioTherapeutics Ltd
Industry
Eligibility
18 Years and older
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2027
U.S. locations
10
States / cities
Phoenix, Arizona • Los Angeles, California • Santa Monica, California + 7 more
Source: ClinicalTrials.gov public record
Updated Sep 16, 2025 · Synced Oct 17, 2026, 10:23 PM EDT
Recruiting Phase 1 Interventional

KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer

NCT06411691
View directory record Official record
Conditions
Colorectal Cancer, Pancreatic Cancer
Interventions
KRAS Vaccine with Poly-ICLC adjuvant, Balstilimab, Botensilimab
Drug
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Other
Eligibility
18 Years and older
Enrollment
54 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Jul 31, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Active, not recruiting Phase 1Phase 2 Interventional

FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer

NCT05627635
View directory record Official record
Conditions
Metastatic Colon Adenocarcinoma, Metastatic Colorectal Adenocarcinoma, Metastatic Microsatellite Stable Colorectal Carcinoma, Metastatic Rectal Adenocarcinoma, Stage IV Colon Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IV Rectal Cancer AJCC v8
Interventions
Balstilimab, Bevacizumab, Biospecimen Collection, Botensilimab, Computed Tomography, Fluorouracil, Leucovorin Calcium, Magnetic Resonance Imaging, Oxaliplatin, Positron Emission Tomography, X-Ray Imaging
Biological · Procedure · Drug
Lead sponsor
City of Hope Medical Center
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
1
States / cities
Duarte, California
Source: ClinicalTrials.gov public record
Updated Sep 1, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Completed Phase 2 Interventional Results available

Combination Immunotherapy in Colorectal Cancer

NCT05571293
View directory record Official record
Conditions
Colorectal Neoplasms
Interventions
Botensilimab, Balstilimab
Drug
Lead sponsor
Weill Medical College of Cornell University
Other
Eligibility
18 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
3
States / cities
Brooklyn, New York • Flushing, New York • New York, New York
Source: ClinicalTrials.gov public record
Updated Oct 9, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Active, not recruiting Phase 2 Interventional

A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer

NCT06251973
View directory record Official record
Conditions
Metastatic Esophageal Carcinoma, Advanced Unresectable Gastric Adenocarcinoma, Metastatic Gastric Cancer, Metastatic Gastroesophageal Junction Adenocarcinoma, Metastatic Esophageal Cancer, Metastatic Esophageal Adenocarcinoma, Metastatic Gastric Adenocarcinoma, Metastatic Gastric Carcinoma, Unresectable Esophageal Cancer, Unresectable Esophageal Adenocarcinoma, Unresectable Gastric Carcinoma, Unresectable Gastric Adenocarcinoma, Unresectable Gastroesophageal Junction Adenocarcinoma
Interventions
AgenT-797, Botensilimab, Balstilimab, Ramucirumab, Paclitaxel
Biological · Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
7
States / cities
Basking Ridge, New Jersey • Middletown, New Jersey • Montvale, New Jersey + 4 more
Source: ClinicalTrials.gov public record
Updated May 15, 2026 · Synced Oct 17, 2026, 10:23 PM EDT
Terminated Phase 2 Interventional Results available

AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer

NCT04430036
View directory record Official record
Conditions
Urinary Bladder Neoplasms
Interventions
AGEN1884, AGEN2034, Cisplatin, Gemcitabine
Drug
Lead sponsor
The University of Texas Health Science Center at San Antonio
Other
Eligibility
18 Years and older
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Apr 4, 2024 · Synced Oct 17, 2026, 10:23 PM EDT
Completed Phase 1 Interventional

Study of AGEN1571 in Participants With Advanced Solid Tumors

NCT05377528
View directory record Official record
Conditions
Advanced Solid Tumor
Interventions
AGEN1571, Balstilimab, Botensilimab
Drug
Lead sponsor
Agenus Inc.
Industry
Eligibility
18 Years and older
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
6
States / cities
Los Angeles, California • Denver, Colorado • Sarasota, Florida + 3 more
Source: ClinicalTrials.gov public record
Updated Apr 30, 2025 · Synced Oct 17, 2026, 10:23 PM EDT