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Combination of Pembrolizumab and Lenvatinib, in Pre-treated Thymic CArcinoma paTIents

NCT04710628 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-02-19

No results posted yet for this study

Summary

This is a multicentric, open-label, single arm phase II study to evaluate the efficacy and safety of the combination of pembrolizumab and lenvatinib in pre-treated thymic carcinoma patients who have progressed after at least one line of platinum-based chemotherapy for advanced disease without having received any previous immunotherapy (previous bevacizumab allowed, but not sunitinib), and not amenable to curative-intent radical surgery and/or radiotherapy, regardless of PD-L1 status.

Conditions

  • Metastatic Thymic Carcinoma
  • Thymoma Type B3

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg will be administered to patients as 30-minute intravenous infusion (a window of -5 minutes and +10 minutes is permitted) every 3 weeks.

DRUG

Lenvatinib 10 mg

Lenvatinib 20 mg (2 capsules of 10 mg) will be administered daily at the same time, with or without food. At the day 1 of each cycle, lenvatinib will be administered within 4 hours after finishing pembrolizumab (lenvatinib after pembrolizumab)

Sponsors & Collaborators

Principal Investigators

  • Jordi Remon, MD, PhD · HM-CIOCC, Hospital HM Delfos, HM Hospitales, Barcelona (Spain)

  • Benjamin Besse, MD, PhD · Medical Oncology Department Gustave Roussy, Villejuif (France)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-21
Primary Completion
2024-07-01
Completion
2026-02-16

Countries

  • France
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT04710628 on ClinicalTrials.gov