Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors
- Conditions
- Interventions
- Registration Number
- NCT05945823
- Lead Sponsor
- Taiho Oncology, Inc.
- Brief Summary
This is a nonrandomized, uncontrolled, open-label, multicenter Phase 2 study to evaluate the efficacy, safety, and tolerability of futibatinib in combination with PD-1 antibody-based SoC therapy in adult patients with solid tumors.
- Detailed Description
Patients with locally advanced, unresectable or metastatic esophageal cancer (EC) or pancreatic ductal adenocarcinoma (PDAC) will receive futibatinib in combination with pembrolizumab plus standard of care (SOC) chemotherapy. Patients with EC will receive Investigator choice of chemotherapy (FP or mFOLFOX6), patients with PDAC will receive mFOLFIRINOX. Subje...
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 66
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort B Irinotecan Patients with PDAC will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus mFOLFIRINOX for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase) . Cohort A Futibatinib Patients with Esophageal cancer (Adenocarcinoma or Squamous cell cancer) will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy (FP or mFOLFOX6) for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase). Cohort A Pembrolizumab Patients with Esophageal cancer (Adenocarcinoma or Squamous cell cancer) will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy (FP or mFOLFOX6) for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase). Cohort A Cisplatin Patients with Esophageal cancer (Adenocarcinoma or Squamous cell cancer) will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy (FP or mFOLFOX6) for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase). Cohort A 5-FU Patients with Esophageal cancer (Adenocarcinoma or Squamous cell cancer) will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy (FP or mFOLFOX6) for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase). Cohort A Oxaliplatin Patients with Esophageal cancer (Adenocarcinoma or Squamous cell cancer) will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy (FP or mFOLFOX6) for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase). Cohort A Leucovorin Patients with Esophageal cancer (Adenocarcinoma or Squamous cell cancer) will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy (FP or mFOLFOX6) for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase). Cohort A Levoleucovorin Patients with Esophageal cancer (Adenocarcinoma or Squamous cell cancer) will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy (FP or mFOLFOX6) for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase). Cohort B Futibatinib Patients with PDAC will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus mFOLFIRINOX for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase) . Cohort B 5-FU Patients with PDAC will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus mFOLFIRINOX for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase) . Cohort B Pembrolizumab Patients with PDAC will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus mFOLFIRINOX for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase) . Cohort B Oxaliplatin Patients with PDAC will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus mFOLFIRINOX for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase) . Cohort B Leucovorin Patients with PDAC will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus mFOLFIRINOX for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase) . Cohort B Levoleucovorin Patients with PDAC will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus mFOLFIRINOX for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase) .
- Primary Outcome Measures
Name Time Method ORR by investigator assessment 12 months Defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on investigator assessment
- Secondary Outcome Measures
Name Time Method Treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 12 months Safety will be assessed based on reported AEs (including SAEs), graded by CTCAE V5.0., and dose modifications.
DoR per investigator assessment 12 months defined as time from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first
DCR per investigator assessment 12 months defined as percentage of patients who achieve complete response, partial response or stable disease per RECIST 1.1 by investigator assessment
PFS per investigator assessment 12 months defined as the time from date of enrollment to the date of disease progression based on Investigator assessment of radiographic images or death, whichever occurs first
6-month PFS rate 12 months defined as percentage of patients without disease progression within 6 months of enrollment
Trial Locations
- Locations (22)
University of California Los Angeles UCLA - Cancer Care - Santa Monica
🇺🇸Santa Monica, California, United States
Rocky Mountain Cancer Centers Midtown
🇺🇸Denver, Colorado, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
The Minniti Center - Medical Oncology and Hematology
🇺🇸Mickleton, New Jersey, United States
Roswell Park Comprehensive Cancer Center (RPCCC) (Roswell Park Cancer Institute (RPCI))
🇺🇸Buffalo, New York, United States
NYU Langone
🇺🇸New York, New York, United States
Gabrail Cancer Center Research LLC
🇺🇸Canton, Ohio, United States
Alliance Cancer Specialists
🇺🇸Horsham, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States
Inova Schar Cancer Institute
🇺🇸Fairfax, Virginia, United States
Blue Ridge Cancer Care
🇺🇸Roanoke, Virginia, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Gundersen Lutheran Health System
🇺🇸La Crosse, Wisconsin, United States
Centre Hospitalier Regional Universitaire de Lille
🇫🇷Lille Cedex, France
Centre Hospitalier Regional Universitaire Poitiers
🇫🇷Poitiers, France
Krankenhaus Nordwest gGmbH
🇩🇪Frankfurt, Germany
Universitaetsmedizin Mainz
🇩🇪Mainz, Germany
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain