Vilastobart + Retifanlimab for Pancreatic Cancer
(EKLAVYA-HRD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a single arm, open-label, non-randomized multi-institution phase II trial of a Fc enhanced CTLA4 antibody, vilastobart, in combination with PD-1 antibody, retifanlimab, in patients with BRCA1, BRCA2 or PALB2 deficient pancreatic cancer (PC).
Who Is on the Research Team?
Harshabad Singh, MBBS MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for people with pancreatic cancer who have changes in the BRCA1, BRCA2, or PALB2 genes. Participants must meet certain health requirements and cannot join if they have conditions that would interfere with the study.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Retifanlimab
- Vilastobart
Trial Overview
The study tests a combination of two immune-based drugs—vilastobart (an enhanced CTLA4 antibody) and retifanlimab (a PD-1 antibody)—in patients with specific genetic forms of pancreatic cancer. All participants receive both drugs.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
This arm involves screening, study treatment with the study drugs, study visits, and follow-up visits for up to 3 years from time of joining study. Participants will receive up to 4 doses of Vilastobart, and Retifanlimab every three weeks until disease progression, intolerable side effects, or for a total of one year. Premedication for all vilastobart doses is required. For participants who experience disease progression on retifanlimab monotherapy or after completion of therapy on trial may be considered for re-induction with vilastobart and retifanlimab. Treatment beyond disease progression will be permitted for first instance of progressive disease by RECIST only if patients remain clinically stable from their disease and ongoing treatment is considered appropriate by patient, treating physician, and Sponsor Investigator.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Xilio Development, Inc.
Industry Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
Lustgarten Foundation
Collaborator
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