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: 2025-09-17
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
2025-09-17
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=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=93 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
|
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 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Ascites
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
General disorders
Generalized weakness
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Vascular disorders
Thromboembolic event
|
11.1%
1/9 • Number of events 2 • Approximately 2 years 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
Other adverse events
| Measure |
Dose Level 1
n=9 participants at risk
Futibatinib 20 mg PO daily Pembrolizumab 200 mg IV on D1
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
55.6%
5/9 • Number of events 15 • Approximately 2 years 11 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
44.4%
4/9 • Number of events 12 • Approximately 2 years 11 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
77.8%
7/9 • Number of events 10 • Approximately 2 years 11 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
44.4%
4/9 • Number of events 5 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Mucositis oral
|
44.4%
4/9 • Number of events 5 • Approximately 2 years 11 months
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
22.2%
2/9 • Number of events 4 • Approximately 2 years 11 months
|
|
Investigations
Creatinine increased
|
33.3%
3/9 • Number of events 4 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Diarrhea
|
55.6%
5/9 • Number of events 5 • Approximately 2 years 11 months
|
|
General disorders
Fatigue
|
33.3%
3/9 • Number of events 4 • Approximately 2 years 11 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
44.4%
4/9 • Number of events 5 • Approximately 2 years 11 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.2%
2/9 • Number of events 4 • Approximately 2 years 11 months
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
11.1%
1/9 • Number of events 3 • Approximately 2 years 11 months
|
|
Investigations
White blood cell decreased
|
33.3%
3/9 • Number of events 3 • Approximately 2 years 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
2/9 • Number of events 2 • Approximately 2 years 11 months
|
|
General disorders
Edema limbs
|
22.2%
2/9 • Number of events 2 • Approximately 2 years 11 months
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
22.2%
2/9 • Number of events 2 • Approximately 2 years 11 months
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • Number of events 2 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
11.1%
1/9 • Number of events 2 • Approximately 2 years 11 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: Hand foot syndrome
|
22.2%
2/9 • Number of events 2 • Approximately 2 years 11 months
|
|
Eye disorders
Tumor pain
|
22.2%
2/9 • Number of events 2 • Approximately 2 years 11 months
|
|
Infections and infestations
Urinary tract infection
|
22.2%
2/9 • Number of events 2 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Abdominal distention
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Anal hemorrhage
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify: elevated prothrombin time
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Eye disorders
Cataract
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Eye disorders
Dry eye
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Metabolism and nutrition disorders
Hypoglycmeia
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Infections and infestations
Infections and infestations - Other, specify: COVID-19 infection
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Investigations
Investigations - Other, specify: decreased total protein
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Investigations
Investigations - Other, specify: increased TSH
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Eye disorders
Keratits
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Metabolism and nutrition disorders
Metabolism and nutritional disorders - Other, specify: elevated serum phosphorus
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Infections and infestations
Paronychia
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify: moderate right hydroureteronephrosis
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 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 • Approximately 2 years 11 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: finger rash
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: skin rash
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify: finger warts
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Skin and subcutaneous tissue disorders
Skin papilloma
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Investigations
Thyroid stimulating hormone increased
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Reproductive system and breast disorders
Vaginal pain
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Number of events 2 • Approximately 2 years 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Musculoskeletal and connective tissue disorders
Ankle frature - Right
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
1/9 • Number of events 1 • Approximately 2 years 11 months
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Number of events 2 • Approximately 2 years 11 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