Study on Switch Maintenance Therapy for Pancreatic Cancer
Sponsor: James Cleary, MD, PhD
ClinicalTrials ID:NCT05419479
This clinical trial is testing a new combination of immunotherapy drugs to see if they are safe and effective for treating pancreatic cancer that has spread to other parts of the body. The study involves the drugs domvanalimab, zimberelimab, and APX005M.
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new combination of immunotherapy drugs—domvanalimab, zimberelimab, and APX005M—for treating pancreatic cancer that has spread. Immunotherapy helps the body's immune system fight cancer cells. Participants will be randomly assigned to receive either the new combination of drugs or a standard chemotherapy treatment. The study will monitor how well the treatments work and any side effects over a period of up to two years, with follow-up for an additional year.
Description
This study is a Phase 1b/2 trial, which means it is testing both the safety and effectiveness of the new treatment. Participants will be divided into two groups: one group will receive the new combination of immunotherapy drugs (domvanalimab, zimberelimab, and APX005M) every two weeks, while the other group will receive standard chemotherapy drugs (leucovorin, fluorouracil, and irinotecan) every two weeks. If the standard treatment stops working, participants may switch to the new combination therapy.
The study will last for up to 26 cycles (about two years), and participants will be followed for 12 months after stopping the study drugs. About 46 people are expected to participate.
This is an investigational study, meaning the drugs are not yet approved by the FDA for treating any disease. The study aims to find out if these drugs can be a safe and effective treatment option for pancreatic cancer.
Eligibility Criteria
Inclusion Criteria
- Must have confirmed pancreatic cancer that has spread and cannot be treated with standard methods.
- Must have measurable cancer that can be tracked by scans or exams.
- Must have received 4-6 months of a specific chemotherapy regimen (FOLFIRINOX) with stable disease or better.
- Must be 18 years or older.
- Must have good overall health with an ECOG performance status of 0 or 1.
- Must have adequate blood counts and organ function.
- Must be willing to undergo tumor biopsies before and during treatment.
- Women of childbearing potential must use effective contraception and have a negative pregnancy test before starting treatment.
- Men must agree to use contraception and not donate sperm during and after treatment.
- Must be able to understand and sign a consent form.
- Must be willing to comply with study requirements.
Exclusion Criteria
- Cannot have cancer that has progressed on FOLFIRINOX.
- Cannot have had recent chemotherapy or radiation therapy within two weeks before starting the study.
- Cannot have severe allergies to similar drugs.
- Cannot have received certain immune therapies before.
- Cannot have certain types of pancreatic cancer.
- Cannot have certain genetic mutations or deficiencies.
- Cannot have had major surgery recently.
- Cannot have certain infections or immune deficiencies.
- Cannot have active autoimmune diseases or be on immune-suppressing medications.
- Cannot have received a live vaccine recently.
- Cannot have uncontrolled illnesses or other cancers within the past two years.
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