Trial Outcomes & Findings for Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer (NCT NCT05263492)
NCT ID: NCT05263492
Last Updated: 2025-10-02
Results Overview
Number of patients evaluable for measurement of tumor response evaluated and recorded according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
24 Weeks
Results posted on
2025-10-02
Participant Flow
Participant milestones
| Measure |
Pembrolizumab & Lenvatinib
Lenvatinib, 20 mg administered orally (PO) once daily (QD) during each 21-day cycle, and Pembrolizumab, 200 mg administered by intravenous (IV) infusion on day 1 of each 21-day cycle.
Lenvatinib: Lenvatinib once a day by mouth every day
Pembrolizumab: Pembrolizumab through a needle or tube in a vein (intravenously, IV) every 3 weeks.
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|---|---|
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Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Pembrolizumab & Lenvatinib
Lenvatinib, 20 mg administered orally (PO) once daily (QD) during each 21-day cycle, and Pembrolizumab, 200 mg administered by intravenous (IV) infusion on day 1 of each 21-day cycle.
Lenvatinib: Lenvatinib once a day by mouth every day
Pembrolizumab: Pembrolizumab through a needle or tube in a vein (intravenously, IV) every 3 weeks.
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|---|---|
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Overall Study
Adverse Event
|
1
|
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Overall Study
Disease progression during active treatment
|
3
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Baseline Characteristics
Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab & Lenvatinib
n=4 Participants
Lenvatinib, 20 mg administered orally (PO) once daily (QD) during each 21-day cycle, and Pembrolizumab, 200 mg administered by intravenous (IV) infusion on day 1 of each 21-day cycle.
Lenvatinib: Lenvatinib once a day by mouth every day
Pembrolizumab: Pembrolizumab through a needle or tube in a vein (intravenously, IV) every 3 weeks.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: This trial only recruited 4 participants, data were not collected due to study termination prior to participants' assessment at the pre-specified time points
Number of patients evaluable for measurement of tumor response evaluated and recorded according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 90 days following the last dose of study treatmentPopulation: Only 4 participants were enrolled on this protocol, data were not collected due to study termination prior to participants' assessment at the pre-specified time points
Number of patients who are alive following last dose of study treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 90 days following the last dose of study treatmentPopulation: The trial was terminated. Only 4 participants were enrolled in this trial, data were not collected due to study termination prior to participants' assessment at the pre-specified time points
Number of patients who have not had disease progression following last dose of study treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 90 days following the last dose of study treatmentPopulation: The trial was terminated. Only 4 participants were enrolled, data were not collected due to study termination prior to participants' assessment at the pre-specified time points
Number of patients who have not relapsed following last dose of study treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days following the last dose of study treatmentPopulation: The trial was terminated. Only 4 participants were enrolled in this trial.
Using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0), all AEs captured
Outcome measures
| Measure |
Pembrolizumab & Lenvatinib
n=4 Participants
Lenvatinib, 20 mg administered orally (PO) once daily (QD) during each 21-day cycle, and Pembrolizumab, 200 mg administered by intravenous (IV) infusion on day 1 of each 21-day cycle.
Lenvatinib: Lenvatinib once a day by mouth every day
Pembrolizumab: Pembrolizumab through a needle or tube in a vein (intravenously, IV) every 3 weeks.
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|---|---|
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Determine the Number of Patients With Treatment-related Adverse Events (AEs) in the Study Population
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4 Participants
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SECONDARY outcome
Timeframe: up to 30 days (plus or minus 15 days) following last dose of study treatment, average of 4.75 months.Number of patients who discontinue treatment due to treatment-related AEs.
Outcome measures
| Measure |
Pembrolizumab & Lenvatinib
n=4 Participants
Lenvatinib, 20 mg administered orally (PO) once daily (QD) during each 21-day cycle, and Pembrolizumab, 200 mg administered by intravenous (IV) infusion on day 1 of each 21-day cycle.
Lenvatinib: Lenvatinib once a day by mouth every day
Pembrolizumab: Pembrolizumab through a needle or tube in a vein (intravenously, IV) every 3 weeks.
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|---|---|
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Determine the Number of Patients Who Discontinue Treatment Due to Treatment-related Adverse Events (AEs)
|
4 Participants
|
Adverse Events
Pembrolizumab & Lenvatinib
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pembrolizumab & Lenvatinib
n=4 participants at risk
Lenvatinib, 20 mg administered orally (PO) once daily (QD) during each 21-day cycle, and Pembrolizumab, 200 mg administered by intravenous (IV) infusion on day 1 of each 21-day cycle.
Lenvatinib: Lenvatinib once a day by mouth every day
Pembrolizumab: Pembrolizumab through a needle or tube in a vein (intravenously, IV) every 3 weeks.
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|---|---|
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Blood and lymphatic system disorders
Anemia
|
75.0%
3/4 • Number of events 9 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Endocrine disorders
Hyperthyroidism
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 5 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Gastrointestinal disorders
Gingival pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
1/4 • Number of events 2 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
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Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 5 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Gastrointestinal disorders
Vomiting
|
75.0%
3/4 • Number of events 5 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
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General disorders
Fatigue
|
100.0%
4/4 • Number of events 11 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
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General disorders
Fever
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
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|
Infections and infestations
Vaginal infection
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Infections and infestations
Wound infection
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Investigations
Alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
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|
Investigations
Blood lactate dehydrogenase increased
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Investigations
Creatinine increased
|
75.0%
3/4 • Number of events 8 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
4/4 • Number of events 17 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • Number of events 2 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Investigations
Platelet count decreased
|
75.0%
3/4 • Number of events 3 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Investigations
Thyroid stimulating hormone increased
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Investigations
White blood cell decreased
|
50.0%
2/4 • Number of events 4 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Metabolism and nutrition disorders
Anorexia
|
75.0%
3/4 • Number of events 3 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
4/4 • Number of events 8 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
2/4 • Number of events 5 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
2/4 • Number of events 4 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Psychiatric disorders
Insomnia
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Renal and urinary disorders
Bladder spasm
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
2/4 • Number of events 4 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
|
|
Vascular disorders
Hypertension
|
50.0%
2/4 • Number of events 3 • Adverse events were collected from the time the informed consent form was signed, through end of treatment visit, +/- 15 days after the last administered component of study regimen, and every three months during survival status until patient disease progression, relapse, or death, average of 4.75 months.
The trial was terminated. Only 4 participants were enrolled in this trial.
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Additional Information
Massey IIT Research Operations
Virginia Commonwealth University Massey Cancer Center
Phone: 804-628-6430
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place