A Phase 2 Study of Fc Enhanced checKpoint bLockade With CTLA4 Antibody Vilastobart in Combination With PD-1 antibodY RetifAnlimab in BRCA or PALB2 Deficient Pancreatic Adenocarcinoma (EKLAVYA-HRD)
Massachusetts General Hospital
Summary
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).
Description
This is a single arm open label phase 2 clinical trial of a novel immunotherapy combination with Fc enhanced CTLA4 inhibitor, Vilastobart, in combination with PD-1 inhibitor, retifanlimab, in patients with metastatic pancreatic cancer who harbor a germline or somatic pathogenic alterations in BRCA1, BRCA2 or PALB2. The primary obejctive is to determine the efficacy of vilastobart in combination with retifanlimab in patients with BRCA1, BRCA2 or PALB2 altered pancreatic cancer as measured by objective response rate (ORR).This research study involves screening, study treatment with the study dru…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must have histologically proven metastatic pancreatic cancer. Histologies including acinar cell carcinoma, carcinoma, ductal carcinoma, ductal adenocarcinoma, poorly differentiated or adenosquamous carcinoma are allowed. * Participant must have a germline or somatic pathogenic alteration in BRCA1, BRCA2, or PALB2 on tumor next generation sequencing (NGS) performed using a CLIA certified assay. Somatic pathogenic alterations detected on circulating tumor DNA need confirmation on tumor tissue NGS. Germline pathogenic alterations in BRCA1, BRCA2 or PALB2 do not…
Interventions
- Drugvilastobart (XTX101)
100mg administered once every 6 weeks (Day 1 of every 6-week cycle) by intravenous infusion (IV) over about 90-140 minutes. This will continue for up to 4 6-week cycles (4 doses).
- DrugRetifanlimab
375 mg administered once every 3 weeks (Days 2 and 23 of every 6-week cycle) by intravenous infusion over about 30 minutes. This will continue for up to 12 months.
Location
- Massachusetts General HospitalBoston, Massachusetts