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Pembrolizumab Plus Lenvatinib in Previously Treated Classic Kaposi Sarcoma

NCT05846724 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-01-22

No results posted yet for this study

Summary

Phase II study of Pembrolizumab plus Lenvatinib in relapsed/refractory Classic Kaposi Sarcoma (CKS). After a screening phase of up to 28 days, each participant will receive study intervention of pembrolizumab plus lenvatinib until reaching a discontinuation criterion: disease progression; unacceptable adverse event(s) (AEs); intercurrent illness that prevents further administration of treatment; participant withdraws consent; pregnancy of participant; non-compliance with study intervention or procedure requirements; or administrative reasons requiring cessation of treatment.

After the end of treatment, each participant will be followed for the occurrence of AEs and spontaneously reported pregnancy.

Participants who discontinue for reasons other than PD will have post-treatment follow-up for disease status until PD is documented clinically by a team of committed dermatologists, and/or radiographically per RECIST 1.1, a non-study anticancer treatment is initiated, consent is withdrawn, or the participant becomes lost to follow-up.

All participants will be followed for overall survival (OS) until death, withdrawal of consent,lost to follow-up, or the end of the study. The end of the study will be when the last participant completes the last study-related telephone call or visit,withdraws from the study, or is lost to follow-up.

Conditions

  • Kaposi Sarcoma
  • Classic Kaposi Sarcoma
  • Refractory Kaposi Sarcoma

Interventions

DRUG

Pembrolizumab + Lenvatinib

single-arm study of pembrolizumab plus lenvatinib

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2029-02-01
Completion
2030-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05846724 on ClinicalTrials.gov