Trial Outcomes & Findings for A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma (NCT NCT05036681)
NCT ID: NCT05036681
Last Updated: 2026-03-27
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
through study completion, an average of 1 year
Results posted on
2026-03-27
Participant Flow
Only one dose level was administered. The trial was terminated due to low enrollment. Enrollment was affected by changes to SOC during the period of trial enrollment
Participant milestones
| Measure |
Dose Level 1
Futibatinib 20 mg PO daily Pembrolizumab 200 mg IV on D1
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=9 Participants
Futibatinib 20 mg PO daily Pembrolizumab 200 mg IV on D1
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=56 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=56 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=56 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=56 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=56 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=56 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=56 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=56 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=56 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=56 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=56 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 1 yearPopulation: Participants were all female, between 50 and 73 of age, all with endometrial cancer
Outcome measures
| Measure |
Dose Level 1
n=9 Participants
Futibatinib 20 mg PO daily Pembrolizumab 200 mg IV on D1
|
|---|---|
|
To Evaluate the Objective Response Rate (ORR) of Futibatinib and Pembrolizumab in Patients With Metastatic Microsatellite Stable (MSS) Endometrial Carcinoma.
|
1 number of participants with PR/CR
|
SECONDARY outcome
Timeframe: From treatment initiation until disease progression, death or last adequate disease assessment up to study termination.Time from initiation of treatment to the occurrence of disease progression or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Dose Level 1
n=9 Participants
Futibatinib 20 mg PO daily Pembrolizumab 200 mg IV on D1
|
|---|---|
|
Progression Free Survival
|
87 days
Interval 17.0 to 420.0
|
SECONDARY outcome
Timeframe: From treatment initiation until death from any cause up to study termination.Time from the initiation of the treatment to death from any cause
Outcome measures
| Measure |
Dose Level 1
n=9 Participants
Futibatinib 20 mg PO daily Pembrolizumab 200 mg IV on D1
|
|---|---|
|
Overall Survival
|
157 days
Interval 17.0 to 1176.0
|
Adverse Events
Dose Level 1
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1
n=9 participants at risk
Futibatinib 20 mg PO daily Pembrolizumab 200 mg IV on D1
|
|---|---|
|
Nervous system disorders
Transient ischemic attacl
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Ascites
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
General disorders
Generalized weakness
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Vascular disorders
Thromboembolic event
|
11.1%
1/9 • Number of events 2 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
Other adverse events
| Measure |
Dose Level 1
n=9 participants at risk
Futibatinib 20 mg PO daily Pembrolizumab 200 mg IV on D1
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Eye disorders
Dry eye
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Metabolism and nutrition disorders
Hypoglycmeia
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Infections and infestations
Infections and infestations - Other, specify: COVID-19 infection
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Investigations
Investigations - Other, specify: decreased total protein
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Investigations
Investigations - Other, specify: increased TSH
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Eye disorders
Keratits
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Metabolism and nutrition disorders
Metabolism and nutritional disorders - Other, specify: elevated serum phosphorus
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Infections and infestations
Paronychia
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: moderate right hydroureteronephrosis
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Investigations
Thyroid stimulating hormone increased
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: hard nodules on fingers
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: finger rash
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: skin rash
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: finger warts
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Skin and subcutaneous tissue disorders
Skin papilloma
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Investigations
Creatinine increased
|
33.3%
3/9 • Number of events 4 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Diarrhea
|
55.6%
5/9 • Number of events 5 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
General disorders
Fatigue
|
33.3%
3/9 • Number of events 4 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
44.4%
4/9 • Number of events 5 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.2%
2/9 • Number of events 4 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
11.1%
1/9 • Number of events 3 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Investigations
White blood cell decreased
|
33.3%
3/9 • Number of events 3 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
2/9 • Number of events 2 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
General disorders
Edema limbs
|
22.2%
2/9 • Number of events 2 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
22.2%
2/9 • Number of events 2 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • Number of events 2 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
11.1%
1/9 • Number of events 2 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Hand foot syndrome
|
22.2%
2/9 • Number of events 2 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Eye disorders
Tumor pain
|
22.2%
2/9 • Number of events 2 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Infections and infestations
Urinary tract infection
|
22.2%
2/9 • Number of events 2 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Abdominal distention
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Anal hemorrhage
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify: elevated prothrombin time
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Eye disorders
Cataract
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Blood and lymphatic system disorders
Anemia
|
55.6%
5/9 • Number of events 15 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
44.4%
4/9 • Number of events 12 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
77.8%
7/9 • Number of events 10 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
44.4%
4/9 • Number of events 5 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Mucositis oral
|
44.4%
4/9 • Number of events 5 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
22.2%
2/9 • Number of events 4 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Reproductive system and breast disorders
Vaginal pain
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Number of events 2 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Musculoskeletal and connective tissue disorders
Ankle frature - Right
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
1/9 • Number of events 1 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Number of events 2 • Adverse Events: Approximately 2 years 11 months All-Cause Mortality: Approximately 3 years 2 months
|
Additional Information
Dr. Siqing Fu
The University of Texas MD Anderson Cancer Center
Phone: (713) 792-4318
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place