What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as chemotherapy with drugs like gemcitabine and nab-paclitaxel, often cause side effects including nausea, vomiting, fatigue, neutropenia, and peripheral neuropathy. When combined with immune checkpoint inhibitors like CTLA-4 inhibitors (e.g., ipilimumab), additional immune-related adverse events can occur, such as colitis, dermatitis, hepatitis, endocrinopathies, and pneumonitis. The combination of these treatments can increase the risk of severe and serious side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, primarily focusing on chemotherapy regimens such as gemcitabine and nab-paclitaxel, as well as FOLFIRINOX (a combination of fluorouracil, leucovorin, irinotecan, and oxaliplatin). While CTLA-4 inhibitors like ipilimumab have been approved for other cancers such as melanoma, their use in pancreatic cancer is still under investigation. The clinical trial involving Botensilimab aims to explore the potential benefits of adding a CTLA-4 inhibitor to standard chemotherapy for metastatic pancreatic cancer, which could represent a new therapeutic approach if proven effective.

What other types of research exist?

Promising novel alternatives to Botensilimab for pancreatic cancer patients in 2024 include: 1) Pembrolizumab (PD-1 inhibitor) in combination with chemotherapy, 2) Nivolumab (PD-1 inhibitor) combined with Ipilimumab (CTLA-4 inhibitor), 3) Targeted therapies such as PARP inhibitors for patients with BRCA mutations, and 4) CAR-T cell therapies targeting specific antigens expressed in pancreatic cancer. These alternatives are based on recent clinical trials and ongoing research in the field.

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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

No Placebo-Only Group

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Nab-paclitaxel

2014

Completed Phase 3

~1950

Gemcitabine

2017

Completed Phase 3

~1920

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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.