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Pembrolizumab plus Lenvatinib in vulvar cancer patients: The prospective, multi-cohorts and multicentre, phase 2 MITO VULVA-01 study.

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509180-24-00
Acronym
MITO VULVA-01
Enrollment
80
Registered
2025-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vulvar cancer

Brief summary

Objective response rate (ORR) defined as a complete response (CR) or partial response (PR) by the Investigator using RECIST 1.1 criteria, in each single cohort (ORR will be evaluated after 4 cycles in Cohort A patients and on the whole treatment period in Cohort B and C patients), Safety profile of Pembrolizumab plus Lenvatinib according to CTCAE (version 5.0) and PRO-CTCAE questionnaire in the overall study population

Interventions

DRUGLenvatinib
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.

Sponsors

IRCCS Istituto Nazionale Tumori Fondazione Pascale
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Objective response rate (ORR) defined as a complete response (CR) or partial response (PR) by the Investigator using RECIST 1.1 criteria, in each single cohort (ORR will be evaluated after 4 cycles in Cohort A patients and on the whole treatment period in Cohort B and C patients), Safety profile of Pembrolizumab plus Lenvatinib according to CTCAE (version 5.0) and PRO-CTCAE questionnaire in the overall study population—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026