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AGEN2034

DRUG5 trials

Sponsors

Agenus Inc., The University of Texas Health Science Center at San Antonio, Rottapharm Biotech

Conditions

Advanced CancerAngiosarcomaCervical CancerGastric CancerMetastatic GI CancersMetastatic Microsatellite-stable Colorectal CancerMismatch Repair Protein ProficientRefractory Metastatic Colorectal Cancer

Phase 1

A Study of AGEN2034 in Advanced Tumors and Cervical Cancer
CompletedNCT03104699
Agenus Inc.Advanced Cancer, Cervical Cancer
Start: 2017-04-11End: 2022-06-15Updated: 2025-07-30
Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers
Active, not recruitingNCT05205330
Rottapharm BiotechGastric Cancer, Metastatic GI Cancers, Metastatic Microsatellite-stable Colorectal Cancer +3
Start: 2021-11-23End: 2027-06-30Target: 107Updated: 2025-10-29

Phase 2

RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer
TerminatedNCT03894215
Agenus Inc.Cervical Cancer
Start: 2019-06-01End: 2025-03-26Updated: 2026-03-27
AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer
TerminatedNCT04430036
The University of Texas Health Science Center at San AntonioUrinary Bladder Neoplasms
Start: 2020-10-14End: 2022-03-14Updated: 2024-04-04
AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma
WithdrawnNCT04607200
Agenus Inc.Angiosarcoma
Start: 2021-02-28End: 2021-09-13Updated: 2022-01-11

Related Papers

Phase I/II study of the EP4 antagonist vorbipiprant combined with anti-PD-1 immunotherapy: Safety and efficacy results in metastatic gastrointestinal non-colorectal cancers.
Journal of Clinical Oncology2025-05-28
Updated results and subgroup analysis by presence of liver metastases of a phase I/II study of the EP4 antagonist vorbipiprant with the anti-PD-1 balstilimab in mismatch-repair-proficient and microsatellite stable (pMMR/MSS) chemorefractory metastatic colorectal cancer (mCRC).
Journal of Clinical Oncology2024-06-011 citations
Balstilimab and other immunotherapy for recurrent and metastatic cervical cancer.
2022-01-2911 citations
Dual PD-1 and CTLA-4 Checkpoint Blockade Using Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer: An Open-Label Phase II Study
Journal of Clinical Oncology2021-12-21169 citations
RaPiDS (GOG-3028): Randomized Phase II Study of Balstilimab Alone or in Combination with Zalifrelimab in Cervical Cancer
Future Oncology2021-08-1928 citations
Differentiated activity profile for the PD-1 inhibitor balstilimab.
Journal of Clinical Oncology2021-05-202 citations
256 Single-agent zalifrelimab (anti-CTLA-4) shows clinical benefit in rare tumors – case report from phase 2 study (NCT03104699)
Regular and Young Investigator Award Abstracts2020-11-013 citations
267 Pseudoprogression patterns: Analysis from 2 independent phase-2 studies with immunotherapy for recurrent cervical cancer
Regular and Young Investigator Award Abstracts2020-11-01
Antibodies to watch in 2020.
2020-01-01328 citations
Phase I/II, open-label, multiple ascending dose trial of AGEN2034, an anti–PD-1 monoclonal antibody, in advanced solid malignancies: Results of dose escalation in advanced cancer and expansion cohorts in subjects with relapsed/refractory cervical cancer
Annals of Oncology2018-10-016 citations
Phase 1/2 open-label, multiple ascending dose trial of AGEN2034, an anti-PD-1 monoclonal antibody, in advanced solid malignancies: Results of dose escalation.
Journal of Clinical Oncology2018-05-207 citations