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Tyrosine Kinase Inhibitor

Futibatinib + Pembrolizumab for Endometrial Cancer

Phase 2
Recruiting
Led By Siqing fu
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is testing a new combination therapy for endometrial cancer that is metastatic and microsatellite stable. The goal is to find a regimen that is well tolerated and leads to durable responses.

Who is the study for?
This trial is for adults with advanced or metastatic endometrial carcinoma that's microsatellite stable (MSS) and can't be cured by surgery or radiation. They should have tried or declined chemotherapy, have good organ function, no prior anti-PD-(L)1 therapy or FGFR inhibitors, measurable disease per RECIST 1.1 criteria, and not be pregnant while on the trial.Check my eligibility
What is being tested?
The study tests a combination of futibatinib and pembrolizumab in patients with MSS endometrial carcinoma to find a treatment that's well-tolerated and provides lasting responses. It's a phase II pilot study designed to assess this new regimen.See study design
What are the potential side effects?
Potential side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions like fever or chills, fatigue, digestive issues such as nausea or diarrhea, blood disorders like anemia or clotting problems, increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I am not pregnant, can use birth control, and will do so for 180 days after my last dose.
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I finished any radiation therapy at least 14 days ago and have recovered from its side effects.
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My advanced endometrial cancer cannot be cured with surgery or radiation, and I have had or declined chemotherapy.
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My cancer is microsatellite stable, confirmed by a certified lab.
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I have never been treated with anti-PD-(L)1 or FGFR inhibitor therapies.
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I can provide recent tissue samples or agree to a biopsy for the study.
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I can take pills and do not have issues with absorbing medication.
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My organs are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the objective response rate (ORR) of futibatinib and pembrolizumab in patients with metastatic microsatellite stable (MSS) endometrial carcinoma.

Side effects data

From 2021 Phase 1 & 2 trial • 407 Patients • NCT02052778
86%
Hyperphosphataemia
43%
Diarrhoea
43%
Alanine aminotransferase increased
43%
Nausea
29%
Vomiting
29%
Dry skin
29%
Abdominal pain
29%
Paraesthesia
29%
Aspartate aminotransferase increased
29%
Decreased appetite
29%
Dry mouth
29%
Onycholysis
14%
Asthenia
14%
Xerosis
14%
Headache
14%
Intestinal obstruction
14%
Oesophagitis
14%
Disease progression
14%
Failure to thrive
14%
Dry eye
14%
Vision blurred
14%
Alopecia
14%
Constipation
14%
Stomatitis
14%
Fatigue
14%
Dysgeusia
14%
Dysphagia
14%
Haematemesis
14%
Gamma-glutamyltransferase increased
14%
Altered state of consciousness
14%
Anaemia
14%
Mouth ulceration
14%
Pyrexia
14%
Paronychia
14%
Blood alkaline phosphatase increased
14%
Hyponatraemia
14%
Aphasia
14%
Partial seizures
14%
Musculoskeletal pain
14%
Epigastric discomfort
14%
Hiccups
14%
Nail discolouration
14%
Cheilitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Dose Escalation: QOD Dosing: 200 mg
Phase 1: Dose Escalation: QOD Dosing: 24 mg
Phase 2
Phase 1: Dose Escalation: QD Dosing: 8 mg
Phase 1: Dose Escalation: QOD Dosing: 8 mg
Phase 1: Dose Expansion Cohort 1
Phase 1: Dose Escalation: QOD Dosing: 36 mg
Phase 1: Dose Escalation: QOD Dosing: 80 mg
Phase 1: Dose Escalation: QD Dosing: 20 mg
Phase 1: Dose Escalation: QOD Dosing: 120 mg
Phase 1: Dose Expansion: Cohort 3
Phase 1: Dose Escalation: QD Dosing: 16 mg
Phase 1: Dose Escalation: QOD Dosing: 160 mg
Phase 1: Dose Expansion: Sub-cohort 1
Phase 1: Dose Escalation: QOD Dosing: 16 mg
Phase 1: Dose Escalation: QD Dosing: 4 mg
Phase 1: Dose Escalation: QD Dosing: 24 mg
Phase 1: Dose Expansion: Cohort 2
Phase 1: Dose Expansion: Cohort 4
Phase 1: Dose Expansion: Cohort 5
Phase 1: Dose Expansion: Sub-cohort 2
Phase 1: Dose Escalation: QOD Dosing: 56 mg
Phase 1: Dose Expansion: Cohort 6

Trial Design

2Treatment groups
Experimental Treatment
Group I: pembrolizumabExperimental Treatment1 Intervention
Group II: futibatiniExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Futibatinib
2014
Completed Phase 2
~410
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,335 Total Patients Enrolled
21 Trials studying Endometrial Cancer
5,424 Patients Enrolled for Endometrial Cancer
National Comprehensive Cancer NetworkNETWORK
115 Previous Clinical Trials
7,605 Total Patients Enrolled
1 Trials studying Endometrial Cancer
11 Patients Enrolled for Endometrial Cancer
Siqing fuPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Futibatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05036681 — Phase 2
Endometrial Cancer Research Study Groups: pembrolizumab, futibatini
Endometrial Cancer Clinical Trial 2023: Futibatinib Highlights & Side Effects. Trial Name: NCT05036681 — Phase 2
Futibatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05036681 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are included in this experiment at most?

"That is correct. The online information on clinicaltrials.gov demonstrates that the study is still looking for 30 individuals at 1 centre."

Answered by AI

What are the most common indications for Futibatinib?

"Futibatinib is typically used to treat malignant neoplasms, but it can also help patients with conditions like microsatellite instability high and disease progression after chemotherapy."

Answered by AI

Are there any positions still available for those interested in participating in this research?

"The trial, which was initially posted on September 30th 2021, is currently looking for willing participants. The listing was most recently edited on July 31st 2022."

Answered by AI

What are the possible dangers associated with Futibatinib?

"Futibatinib's safety is not as well known because it is only in Phase 2 trials. There is some data supporting its safety, but no information on whether or not the drug actually works."

Answered by AI

Are there other instances in which Futibatinib has been trialed?

"Presently, 1005 clinical trials are underway that focus on Futibatinib. Out of those ongoing studies, 124 have reached Phase 3. The majority of these research projects are situated in Houston, Texas; though, there are 36268 total locations running trials for this medication globally."

Answered by AI
~6 spots leftby Dec 2024