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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
Must not have
Clinically active bleeding, or active gastric or duodenal ulcer
A history of another primary malignancy that is currently clinically significant, requiring active intervention except for hormone therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have active bleeding or an active stomach ulcer.
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I have another cancer that needs treatment besides hormone therapy.
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I still have moderate side effects from previous treatments.
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I haven't had cancer treatment that affects my whole body within the last 3 weeks.
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I have not received a live vaccine in the last 30 days.
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I need steroids for uncontrolled brain symptoms despite epilepsy medication.
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My cancer has spread to the lining of my brain or spinal cord, or to my lymph system.
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I am currently taking immunosuppressants or steroids higher than 10 mg/day of prednisone.
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I have HIV and need HAART or have active hepatitis B or C.
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I do not have any severe ongoing illnesses or recent major heart issues.
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I haven't taken strong CYP3A4 drugs in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2021 Phase 1 & 2 trial • 407 Patients • NCT02052778
79%
Hyperphosphataemia
46%
Diarrhoea
38%
Constipation
33%
Fatigue
29%
Decreased appetite
29%
Nausea
25%
Alanine aminotransferase increased
25%
Aspartate aminotransferase increased
21%
Dyspnoea
21%
Vomiting
21%
Abdominal pain
21%
Alopecia
17%
Asthenia
17%
Stomatitis
17%
Anaemia
17%
Weight decreased
13%
Dry skin
13%
Dysgeusia
13%
Dry eye
13%
Gastrooesophageal reflux disease
13%
Dry mouth
13%
Blood creatinine increased
13%
Nail disorder
13%
Headache
13%
Onycholysis
8%
Pyrexia
8%
Urinary tract infection
8%
Musculoskeletal chest pain
8%
Cough
8%
Rash
8%
Arthralgia
8%
Oedema peripheral
8%
Intestinal obstruction
8%
Blood alkaline phosphatase increased
8%
Retinal detachment
8%
Blood bilirubin increased
8%
Back pain
8%
Cataract
8%
Musculoskeletal pain
8%
Thrombocytopenia
4%
Weight increased
4%
Dyspepsia
4%
Punctate keratitis
4%
Taste disorder
4%
Pruritus
4%
Hypercalcaemia
4%
Mouth ulceration
4%
Blood creatine phosphokinase increased
4%
Pain in extremity
4%
Lower respiratory tract infection
4%
Oropharyngeal pain
4%
Neutropenia
4%
Muscular weakness
4%
Palmar-plantar erythrodysaesthesia syndrome
4%
Ileus
4%
Paronychia
4%
Lung infection
4%
Hypophosphataemia
4%
Gastric haemorrhage
4%
Gamma-glutamyltransferase increased
4%
Muscle spasms
4%
Tendonitis
4%
Peripheral sensory neuropathy
4%
Hypotension
4%
Vulvovaginal dryness
4%
Abdominal pain upper
4%
Small intestinal haemorrhage
4%
Acute myocardial infarction
4%
Cholangitis
4%
Tooth infection
4%
Insomnia
4%
Dysuria
4%
Renal failure
4%
Dysphagia
4%
Lymphocyte count decreased
4%
Neuropathy peripheral
4%
Bronchitis
4%
Inguinal hernia
4%
Spinal cord compression
4%
Vision blurred
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Dose Expansion: Cohort 5
Phase 1: Dose Expansion: Sub-cohort 2
Phase 1: Dose Expansion: Cohort 2
Phase 1: Dose Escalation: QOD Dosing: 24 mg
Phase 1: Dose Escalation: QOD Dosing: 160 mg
Phase 1: Dose Escalation: QD Dosing: 4 mg
Phase 1: Dose Escalation: QD Dosing: 8 mg
Phase 1: Dose Escalation: QOD Dosing: 36 mg
Phase 1: Dose Escalation: QOD Dosing: 56 mg
Phase 1: Dose Expansion: Cohort 4
Phase 1: Dose Expansion: Cohort 6
Phase 1: Dose Escalation: QOD Dosing: 8 mg
Phase 1: Dose Escalation: QOD Dosing: 80 mg
Phase 1: Dose Escalation: QOD Dosing: 120 mg
Phase 1: Dose Escalation: QOD Dosing: 16 mg
Phase 1: Dose Escalation: QD Dosing: 24 mg
Phase 1: Dose Expansion Cohort 1
Phase 2
Phase 1: Dose Escalation: QOD Dosing: 200 mg
Phase 1: Dose Escalation: QD Dosing: 16 mg
Phase 1: Dose Escalation: QD Dosing: 20 mg
Phase 1: Dose Expansion: Cohort 3
Phase 1: Dose Expansion: Sub-cohort 1

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2810

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,194 Total Patients Enrolled
23 Trials studying Endometrial Cancer
6,094 Patients Enrolled for Endometrial Cancer
National Comprehensive Cancer NetworkNETWORK
119 Previous Clinical Trials
7,932 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
~1 spots leftby Dec 2024
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