Botensilimab + Chemotherapy for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+36 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Agenus Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing whether adding a new drug, botensilimab, to standard chemotherapy can better treat patients with advanced pancreatic cancer. The study will ensure the new drug is safe and determine the right dose. It will also compare the effectiveness of the new combination treatment to chemotherapy alone.

Eligibility Criteria

This trial is for adults with metastatic pancreatic cancer who have already tried FOLFIRINOX treatment. They should be relatively healthy otherwise, with a life expectancy of at least 3 months and able to perform daily activities (ECOG status 0 or 1). Participants must not have other active cancers or serious illnesses, no history of severe allergies to study drugs, and agree to use effective contraception.

Inclusion Criteria

My diagnosis is pancreatic cancer confirmed by tissue analysis.

My organs are working well.

I am a woman who can have children and have a negative pregnancy test.

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Exclusion Criteria

I have not received a COVID-19 vaccine in the week before starting the study drugs.

I have had more than one treatment for my metastatic disease.

I have been treated with drugs that boost the immune system.

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Treatment Details

Interventions

Botensilimab (Monoclonal Antibodies)
Gemcitabine (Anti-metabolites)
Nab-paclitaxel (Anti-tumor antibiotic)

Trial OverviewThe study is testing the effectiveness of Botensilimab when added to standard chemotherapy (Gemcitabine and Nab-paclitaxel) versus chemotherapy alone in treating metastatic pancreatic cancer. Patients are divided into two groups: one receiving only chemotherapy and the other receiving both Botensilimab and chemotherapy.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Part 2: CombinationExperimental Treatment3 Interventions

Participants will receive botensilimab in combination standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).

Group II: Part 1: Combination (Safety Lead-in Phase)Experimental Treatment3 Interventions

Participants will receive botensilimab in combination with standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).

Group III: Part 2: Standard of CareActive Control2 Interventions

Participants will receive standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Gemzar for: