Trial · NCT05903833
Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy
NCT05903833, Phase 2, Recruiting, AGO Research GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy. Trials, record NCT05903833. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05903833
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab Combination With Lenvatinib in Pts With Recurrent,Persistent,Metastatic or Locally Advanced Vulvar Cancer Not Amenable to Curative Surgery or Radiotherapy
- NCT number
- NCT05903833
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 42 participants, estimated
- Lead sponsor
- AGO Research GmbH
- Conditions
- Recurrent Vulvar Cancer, Persistent Vulvar Cancer, Metastatic Vulva Cancer, Locally Advanced Vulvar Cancer
- Interventions
- Pembrolizumab, Lenvatinib
- First posted
- 2023-06-15
- Last updated
- 2026-05-11
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ORR within 24 weeks | 24 weeks | ORR will be defined as the proportion of patients with PR or CR within 24 weeks starting with the first study treatment. Tumor responses will be assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) |
| Secondary | Evaluate the efficacy of lenvatinib + pembrolizumab in terms of overall ORR | From date of starting study treatment until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months | Overall ORR |
| Secondary | Evaluate the efficacy of lenvatinib + pembrolizumab in terms of disease control rate (DCR) | For 8 weeks | DCR will be defined as the proportion of patients with PR, CR or stable disease (SD) |
| Secondary | Evaluate the efficacy of lenvatinib + pembrolizumab in terms of duration of response (DOR) | Time from response until first progression or death, whichever occurs first, assessed up to 40 months | DOR will be defined as time from response until first progression or death, whichever occurs first |
| Secondary | Evaluate the efficacy of lenvatinib + pembrolizumab in terms of overall survival (OS) | Time from date of starting study treatment to death, assessed up to 40 months | OS will be defined as the time from date of starting study treatment to death. |
| Secondary | Evaluate the efficacy of lenvatinib + pembrolizumab in terms of progression free survival (PFS) | Time from starting study treatment to progressive disease or death, whichever occurs first, assessed up to 40 months | PFS will be defined as the time from starting study treatment to progressive disease (PD) or death, whichever occurs first |
| Secondary | Evaluate the efficacy of lenvatinib + pembrolizumab in terms of time to first subsequent therapy (TFST) | The time from date of starting study treatment until the start of the first subsequent therapy or death whichever occurs first, assessed up to 40 months | • TFST will be defined as the time from date of starting study treatment until the start of the first subsequent therapy or death whichever occurs first. |
| Secondary | Evaluate the efficacy of lenvatinib + pembrolizumab in terms of time to second subsequent therapy (TSST) | Time from date of starting study treatment until the start of second subsequent treatment or death whichever occurs first, assessed up to 40 motnhs | • TSST will be defined as the time from date of starting study treatment until the start of second subsequent treatment or death whichever occurs first. |
| Secondary | Patient reported outcomes (QLQ) | Assessed frequently during the trial up to 40 months | Quality of life is measured by patient reported outcome instruments EORTC QLQ C-30 to evaluate the efficacy of combination of lenvatinib and pembrolizumab |
| Secondary | Patient reported outcomes (QLQ) | Assessed frequently during the trial up to 40 months | Quality of life is measured by patient reported outcome instruments EORTC QLQ VU34 to evaluate the efficacy of combination of lenvatinib and pembrolizumab |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT05903833
GET https://conductscience.org/api/trials/v1/NCT05903833/registered