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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 tests if adding a new drug to chemo helps fight metastatic pancreatic cancer better than chemo 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival
Secondary outcome measures
Change From Baseline In Carbohydrate Antigen 19-9
Complete Response
Duration Of Response
+4 more

Trial 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
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030

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.

Find a Location

Who is running the clinical trial?

Agenus Inc.Lead Sponsor
52 Previous Clinical Trials
4,711 Total Patients Enrolled
Medical DirectorStudy DirectorAgenus Inc.
2,801 Previous Clinical Trials
8,070,252 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05630183 — Phase 2
Pancreatic Cancer Research Study Groups: Part 1: Combination (Safety Lead-in Phase), Part 2: Combination, Part 2: Standard of Care
Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT05630183 — Phase 2
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630183 — Phase 2
~16 spots leftby Dec 2024