Switch Maintenance in Pancreatic

Pancreatic Cancer Clinical Trial

Official title: Phase Ib/II Open-Label, Multicenter, Randomized Study Evaluating the Safety and Efficacy of 'Switch Maintenance' Combination Immunotherapy Using AB154, AB122, and APX005M in Patients With Metastatic Pancreatic Cancer

Status Recruiting

Clinical Trial Summary

This study is being done to test the safety and effectiveness of combining domvanalimab (AB154), zimberelimab (AB122), and APX005M with pancreatic cancer that has spread to other parts of body.

This research study involves immunotherapy. Immunotherapy triggers the body's immune system to fight cancer cells.

The names of the study drugs involved in this study are:

• Domvanalimab (also known as AB154)

• Zimberelimab (also known as AB122)

• APX005M

Clinical Trial Description

This is an open-label, Phase 1b/2, multicenter, randomized study evaluating the safety and efficacy of 'switch maintenance' combination immunotherapy (domvanalimab) zimberelimab and APX005M versus 'continuous maintenance' in patients with metastatic pancreatic cancer following 4-6 months of FOLFIRINOX

The names of the study drugs involved in this study are:

• Domvanalimab (also known as AB154)

• Zimberelimab (also known as AB122)

• APX005M

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

Participants will be randomized into one of two groups:

• Arm A will receive domvanalimab, zimberelimab, and APX005M every two weeks through an infusion.

• Arm B will receive leucovorin, fluorouracil, and irinotecan every two weeks through an infusion

If you are in Arm B and the drugs stop working, participants may receive the drugs given in Arm A.

Participants will receive study treatment as long the disease does not worsen or there are no serious side effects for a maximum of 26 cycles (2 years) and will be followed for 12 months after the discontinue the study drugs.

It is expected that about 46 people will take part in this research study.

This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational drug or drugs and also tries to define the appropriate dose of the investigational drug(s) to use for further studies. Phase II clinical trials test the safety and effectiveness of an investigational drug or drugs to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

The U.S. Food and Drug Administration (FDA) has not approved domvanalimab, zimberelimab, or APX005M as a treatment for any disease.

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Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Pancreas
• Carcinoma
• Carcinoma, Adenosquamous
• Carcinoma, Squamous Cell
• Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT05419479
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Contact: James Cleary, MD, PhD
• Phone: 617-632-6073
• Email: James_Cleary@DFCI.HARVARD.EDU
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 30, 2022
• Completion date: September 30, 2028