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Anti-metabolites
Botensilimab + Chemotherapy for Pancreatic Cancer
Phase 2
Recruiting
Research Sponsored by Agenus Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Summary
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.
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Botensilimab may cause immune-related side effects such as inflammation in various organs, infusion reactions similar to allergic responses, fatigue, digestive issues like diarrhea or nausea, skin rash, hormonal gland problems which could affect hormone levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free Survival
Secondary study objectives
Change From Baseline In Carbohydrate Antigen 19-9
Complete Response
Duration Of Response
+3 moreTrial Design
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nab-paclitaxel
2014
Completed Phase 3
~1950
Gemcitabine
2017
Completed Phase 3
~1920
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for pancreatic cancer include chemotherapy and immunotherapy. Chemotherapy targets rapidly dividing cancer cells to disrupt their growth, while immunotherapy, such as CTLA-4 inhibitors like Botensilimab, enhances the immune system's ability to recognize and attack cancer cells.
This is crucial for pancreatic cancer patients, as the disease is often diagnosed at an advanced stage, making it challenging to treat with surgery alone. By boosting the immune response, these treatments aim to improve the effectiveness of cancer cell targeting and potentially enhance patient outcomes.
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Who is running the clinical trial?
Agenus Inc.Lead Sponsor
52 Previous Clinical Trials
4,738 Total Patients Enrolled
Medical DirectorStudy DirectorAgenus Inc.
2,834 Previous Clinical Trials
8,079,702 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.I have not had major surgery in the last 4 weeks.I have an uncontrolled HIV infection.I have had a bowel blockage or symptoms of one in the last 3 months.I do not have any uncontrolled illnesses like serious heart conditions.My cancer has spread to my brain or spinal cord.I have ongoing diarrhea worse than mild, despite treatment.My diagnosis is pancreatic cancer confirmed by tissue analysis.I have active or latent tuberculosis.My organs are working well.I do not have another cancer needing treatment or any cancer active in the last 2 years.I haven't needed treatment for an autoimmune disease in the last 2 years.I have active hepatitis C confirmed by tests.I rely on nutrition given through my veins.I am a woman who can have children and have a negative pregnancy test.My nerve damage symptoms are mild or non-existent.I agree to use effective birth control during the study.My cancer has worsened despite FOLFIRINOX treatment.I haven't taken any cancer drugs or participated in a drug study in the last month.I have a lung condition that could affect new lung toxicity detection.I had a mild or no symptom COVID-19 infection less than 10 days ago, or a severe one less than 20 days ago.My blood clotting levels are within a safe range.I have serious stomach or intestine problems.I haven't taken high-dose steroids or immunosuppressants recently.I haven't needed IV drugs for an infection in the last 2 weeks.My condition causes fluid buildup in my abdomen that treatments do not help.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Combination (Safety Lead-in Phase)
- Group 2: Part 2: Combination
- Group 3: Part 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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