New immunotherapy combo takes on tough pancreatic cancer

NCT ID NCT05630183

Disease control Sponsor: Agenus Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested whether adding an immunotherapy drug called botensilimab to standard chemotherapy could help people with metastatic pancreatic cancer who had already progressed on a common chemo regimen (FOLFIRINOX). The study enrolled 81 participants and compared the combination to chemotherapy alone. The goal was to see if the combination could slow cancer growth or improve survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: botensilimab (an immunotherapy drug) plus standard chemotherapy (nab-paclitaxel and gemcitabine)
What this could lead to: If it works, this could point toward a new treatment option for people with metastatic pancreatic cancer who have already tried standard chemotherapy.
What could go wrong: This is a small, early-phase trial (81 people) with no results yet. The drug may not improve outcomes and could cause additional side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

81 people

The number who actually took part.

Started

Mar 2023

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed diagnosis of pancreatic ductal adenocarcinoma. Note: fine needle aspirate/cytology of tumor in the presence of a pancreatic mass that confirms ductal adenocarcinoma is acceptable. * Must have had disease progression on any version of FOLFIRINOX for metastatic disease (including onivyde + oxaliplatin + 5-fluorouracil \[5-FU\] + leucovorin \[NALIRIFOX\]). Clarification: Participant with initial diagnosis of locally advanced disease may be eligible if upon retrospective review of initial scans, previously unappreciated metastases are able to be identified; Investigator must provide documentation that participant had metastatic disease at the time the participant received FOLFIRINOX. Notes: Progression on a reduced or maintenance fluoropyrimidine based regimen in the metastatic setting is allowed (for example, leucovorin + 5-FU + oxaliplatin \[FOLFOX\], leucovorin + 5-FU + irinotecan \[FOLFIRI\], 5-FU, or capecitabine), provided the participant received at least 1 dose of all of the drugs in a FOLFIRINOX regimen. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Life expectancy of at least 3 months. * Measurable disease on baseline imaging per RECIST 1.1 criteria. * A \< Grade 2 pre-existing peripheral neuropathy per National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0). Because NCI CTCAE v5.0 grading for peripheral neuropathy does not include guidance for "mild" neuropathy, these cases can be graded per the NCI CTCAE v5.0 grading for general adverse events which includes "mild" under Grade 1. * Acceptable coagulation status as indicated by an international normalized ratio ≤ 1.5 x institutional ULN, except participants on anticoagulation who can be included at the discretion of the investigator. * Adequate organ function. * Women of childbearing potential must have a negative urine or serum pregnancy test at screening (within 72 hours of first dose of study drugs). * Male participants with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study. Exclusion Criteria: * Received more than one prior regimen (that is, FOLFIRINOX) for their metastatic disease. (Progression on a reduced or maintenance fluoropyrimidine-based regimen in the metastatic setting is allowed. \[for example, FOLFOX, FOLFIRI, 5-FU, or capecitabine\], provided the participant received at least 1 dose of all of the drugs in a FOLFIRINOX regimen.) * History of central nervous system (CNS) metastasis or active CNS metastasis. * Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study drugs (that is, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years prior to first dose of study drugs and the participant has no evidence of disease). Participants with history of prior early-stage basal/squamous cell skin cancer or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible. * Uncontrolled intercurrent illness, including but not limited to clinically significant (that is, active) cardiovascular disease. * Active, uncontrolled infections, requiring systemic intravenous anti-infective treatment within 2 weeks prior to first dose of study drugs. * Major surgery within 4 weeks prior to signing of informed consent form (ICF). * Prior treatment with an immune checkpoint inhibitor. * Refractory ascites. * Partial or complete bowel obstruction within the last 3 months prior to signing of ICF, signs/symptoms of bowel obstruction, or known radiologic evidence of impending obstruction. * Clinically significant gastrointestinal disorders. * Treatment with one of the following classes of drugs within the delineated time window prior to first dose of study drugs: * Cytotoxic agent within 3 weeks or 5 half-lives (whichever is greater). * Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or investigational drug, within 4 weeks, or 5 half-lives, whichever is shorter. * Small molecule targeted therapies/tyrosine kinase inhibitors within 14 days or 5 half-lives (whichever is greater). * Radiotherapy within 7 days. * Previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to first dose of study drugs. * Received a vaccine, including SARS-CoV-2 vaccine, \< 7 days prior to first dose of study drugs. * Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. * Symptomatic interstitial lung disease (ILD), history of ILD, or any lung disease which may interfere with detection and management of new immune-mediated pulmonary toxicity. * History of allogeneic organ transplant. * Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. * Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 milligrams \[mg\] daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days prior to the first dose of study drugs. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent), are permitted in the absence of active autoimmune disease. * Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years prior to first dose of study drugs (that is, with use of disease-modifying agents or immunosuppressive drugs). * Pregnant or breastfeeding participants. * Uncontrolled infection with human immunodeficiency virus. * Known to be positive for hepatitis B (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. * Known active hepatitis C as determined by positive serology and confirmed by polymerase chain reaction. * Dependence on total parenteral nutrition. * Participants with concurrent diarrhea \> grade 1 at time of randomization despite optimal treatment with standard of care pancreatic enzymes. * Known active or latent tuberculosis. * Any condition in the opinion of the principal investigator that might interfere with the participant's participation in the study or in the evaluation of the study results. * Unwillingness or inability to comply with procedures required in this protocol.

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Conditions

The condition(s) this trial relates to.

pancreatic ductal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic pancreatic ductal adenocarcinoma

Contacts and locations

Locations

Atlantic Health Systems, Morristown

Morristown, New Jersey, 07960, United States
Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75247, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Cancer Care Centers of Brevard

Palm Bay, Florida, 32909, United States
Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II*

Las Vegas, Nevada, 89144, United States
Florida Cancer Specialist North

St. Petersburg, Florida, 22705, United States
Florida Cancer Specialist South

Fort Myers, Florida, 33901, United States
HonorHealth

Scottsdale, Arizona, 85258, United States
Icahn School of Medicine at Mount Sinai Tisch Cancer Institute

New York, New York, 10128, United States
Illinois Cancer Specialists

Arlington Heights, Illinois, 60005, United States
John Theurer Cancer Center at Hackensack

Hackensack, New Jersey, 07601, United States
Lifespan

Providence, Rhode Island, 02903, United States
Maryland Oncology Hematology

Columbia, Maryland, 21044, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Medical Oncology Hematology Consultants (MOHC) - Helen F. Graham Cancer Center

Newark, Delaware, 19713, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Minnesota Oncology

Minneapolis, Minnesota, 55404, United States
Nebraska Medicine-Nebraska Medical Center

Omaha, Nebraska, 68198, United States
Northeast Texas Cancer & Research Institute

Tyler, Texas, 75702, United States
Oncology Hematology Care - Eastgate

Cincinnati, Ohio, 45245, United States
Overlook Medical Center

Summit, New Jersey, 07901, United States
Rogel Cancer Center, University of Michigan Medicine

Ann Arbor, Michigan, 48109, United States
Sarah Cannon Research Institute at Tennessee Oncology

Cincinnati, Ohio, 45245, United States
Sarah Cannon Research Institute at Tennessee Oncology

Nashville, Tennessee, 37203, United States
Shenandoah Oncology

Winchester, Virginia, 22601, United States
Swedish Cancer Institute

Seattle, Washington, 98104, United States
Texas Oncology

Carrollton, Texas, 75010, United States
The Center for Cancer & Blood Disorders: Fort Worth

Fort Worth, Texas, 76104, United States
TxO - Denison Cancer Center

Denison, Texas, 75020, United States
UCLA Health - Santa Monica Cancer Care

Santa Monica, California, 90404, United States
USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States
USC Norris Oncology

Newport Beach, California, 92663, United States
Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States
Virginia Oncology Associates - Brock Cancer Center

Norfolk, Virginia, 23502, United States
Weill Cornell Medicine Sandra and Edward Meyer Cancer Center

New York, New York, 10065, United States
Weill Cornell Medicine-New York Presbyterian Hospital

New York, New York, 10021, United States

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