Trial · NCT05263492
Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer
NCT05263492, Phase 2, Terminated, Virginia Commonwealth University; results first posted 2025-10-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer. Trials, record NCT05263492. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05263492
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer
- NCT number
- NCT05263492
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Endometrial Cancer, Mismatch Repair-Proficient, Recurrent Endometrial Cancer
- Interventions
- Lenvatinib, Pembrolizumab
- First posted
- 2022-03-02
- Last updated
- 2025-10-02
- Results first posted
- 2025-10-02
- Limitations and caveats
- This trial was terminated early for low accrual.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine the Objective Response Rate (ORR) at 24 Weeks in Black Patients With Recurrent Endometrial Cancer Treated With Lenvatinib 20 mg Orally Daily in Combination With Pembrolizumab 200 mg IV Every 3 Weeks | 24 Weeks | Number of patients evaluable for measurement of tumor response evaluated and recorded according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) |
| Secondary | Determine the Median Progression Free Survival (PFS) | Up to 90 days following the last dose of study treatment | Number of patients who are alive following last dose of study treatment |
| Secondary | Determine the Median Progression Free Survival (PFS) | Up to 90 days following the last dose of study treatment | Number of patients who have not had disease progression following last dose of study treatment |
| Secondary | Determine the Median Progression Free Survival (PFS) | Up to 90 days following the last dose of study treatment | Number of patients who have not relapsed following last dose of study treatment |
| Secondary | Determine the Number of Patients With Treatment-related Adverse Events (AEs) in the Study Population | Up to 30 days following the last dose of study treatment | Using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0), all AEs captured |
| Secondary | Determine the Number of Patients Who Discontinue Treatment Due to Treatment-related Adverse Events (AEs) | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Determine the Objective Response Rate (ORR) at 24 Weeks in Black Patients With Recurrent Endometrial Cancer Treated With Lenvatinib 20 mg Orally Daily in Combination With Pembrolizumab 200 mg IV Every 3 Weeks | 24 Weeks | This trial only recruited 4 participants, data were not collected due to study termination prior to participants' assessment at the pre-specified time points | ||
| SECONDARY | Determine the Median Progression Free Survival (PFS) | Up to 90 days following the last dose of study treatment | 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 | ||
| SECONDARY | Determine the Median Progression Free Survival (PFS) | Up to 90 days following the last dose of study treatment | 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 | ||
| SECONDARY | Determine the Median Progression Free Survival (PFS) | Up to 90 days following the last dose of study treatment | 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 | ||
| SECONDARY | Determine the Number of Patients With Treatment-related Adverse Events (AEs) in the Study Population | Up to 30 days following the last dose of study treatment | The trial was terminated. Only 4 participants were enrolled in this trial. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Determine the Number of Patients Who Discontinue Treatment Due to Treatment-related Adverse Events (AEs) | up to 30 days (plus or minus 15 days) following last dose of study treatment, average of 4.75 months. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Determine the Number of Patients With Treatment-related Adverse Events (AEs) in the Study Population | Pembrolizumab & Lenvatinib | 4 | Participants | ||
| Determine the Number of Patients Who Discontinue Treatment Due to Treatment-related Adverse Events (AEs) | Pembrolizumab & Lenvatinib | 4 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab & Lenvatinib | 4 | |
| Overall Study | COMPLETED | Pembrolizumab & Lenvatinib | 0 | |
| Overall Study | NOT COMPLETED | Pembrolizumab & Lenvatinib | 4 |
Source ClinicalTrials.gov
Adverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Pembrolizumab & Lenvatinib | 3 | 4 | 9 |
| other | Eosinophilia | Blood and lymphatic system disorders | Pembrolizumab & Lenvatinib | 1 | 4 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Pembrolizumab & Lenvatinib | 1 | 4 | 1 |
| other | Hyperthyroidism | Endocrine disorders | Pembrolizumab & Lenvatinib | 2 | 4 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Pembrolizumab & Lenvatinib | 1 | 4 | 1 |
| other | Constipation | Gastrointestinal disorders | Pembrolizumab & Lenvatinib | 1 | 4 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Pembrolizumab & Lenvatinib | 1 | 4 | 5 |
| other | Gastroesophageal reflux disease | Gastrointestinal disorders | Pembrolizumab & Lenvatinib | 1 | 4 | 1 |
| other | Gingival pain | Gastrointestinal disorders | Pembrolizumab & Lenvatinib | 1 | 4 | 1 |
| other | Mucositis oral | Gastrointestinal disorders | Pembrolizumab & Lenvatinib | 1 | 4 | 2 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab & Lenvatinib | 2 | 4 |
| Total, other adverse events | Pembrolizumab & Lenvatinib | 4 | 4 |
| Total, serious adverse events | Pembrolizumab & Lenvatinib | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05263492
GET https://conductscience.org/api/trials/v1/NCT05263492/events?page=2