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Tyrosine Kinase Inhibitor
Futibatinib + PD-1 Antibody for Esophageal Cancer
Phase 2
Recruiting
Research Sponsored by Taiho Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial studies a new cancer treatment to see if it's safe & effective.
Who is the study for?
Adults over 18 with advanced esophageal cancer that can't be removed by surgery or has spread, and who haven't had previous systemic treatments for it. Participants must have a certain PD-L1 score, good performance status, proper organ function, ability to take oral meds, and no other active cancers or significant health issues like HIV/Hepatitis B/C.Check my eligibility
What is being tested?
The trial is testing the combination of Futibatinib with standard-of-care immunotherapy (PD-1 antibody) and chemotherapy drugs in patients with solid tumors. It's an open-label study where everyone gets the treatment to see how effective and safe it is.See study design
What are the potential side effects?
Possible side effects include immune-related reactions due to Pembrolizumab (PD-1 antibody), such as inflammation in organs; typical chemo side effects like nausea, fatigue, hair loss; plus specific risks from Futibatinib related to liver function changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ORR by investigator assessment
Secondary outcome measures
6-month PFS rate
DCR per investigator assessment
DoR per investigator assessment
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment7 Interventions
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) .
Group II: Cohort AExperimental Treatment7 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
2017
Completed Phase 4
~2680
Futibatinib
2014
Completed Phase 2
~410
Pembrolizumab
2017
Completed Phase 2
~2010
Cisplatin
2013
Completed Phase 3
~1940
5-FU
2014
Completed Phase 3
~3420
Oxaliplatin
2011
Completed Phase 4
~2560
Leucovorin
2005
Completed Phase 4
~5730
Levoleucovorin
2019
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Taiho Oncology, Inc.Lead Sponsor
66 Previous Clinical Trials
11,478 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is advanced but can be removed or treated with radiation.I have an autoimmune disease treated with medication in the last 2 years.I have been treated with drugs targeting PD-1/PD-L1, FGF/FGFR, or T-cell receptors before.My organs are working well.I have been diagnosed with an immune system disorder.I have received an organ or tissue transplant from another person.I am fully active or can carry out light work.I can take pills by mouth.My pancreatic cancer is advanced and cannot be removed by surgery.I have another cancer that is getting worse or needs treatment.I have a serious eye condition affecting my retina.I have had pneumonitis treated with steroids or have it now.My cancer is a specific type of esophagus or esophagogastric junction cancer and cannot be surgically removed.My cancer is adenocarcinoma and can be treated with targeted therapy.I have HIV or a history of Hepatitis B or C.I am 18 years old or older.I haven't had any drug treatments for my advanced cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A
- Group 2: Cohort B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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