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COMPLETEDPHASE2

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

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. PECATI.

NCT04710628•MedSIR

View on ClinicalTrials.gov

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.

Detailed Description

Men and women aged ≥ 18 years old diagnosed with B3-thymoma or metastatic thymic carcinoma 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. Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1 criteria. Patients are not eligible if they are candidates for a local treatment with a curative intention. Patients must present Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 and with adequate organ function.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants are eligible to be included in the study only if all of the following criteria apply:
•1. Relapsed / Recurrent histologically confirmed B3-Thymoma or TC patients not amenable to curative-intent radical surgery and/or radiotherapy, regardless of PD-L1 expression.
•2. Patients progress after at least one previous line of platinum-based chemotherapy for advanced disease:
•3. Negative result for Myasthenia Gravis (MG) by acetylcholine receptor antibodies test. Note: Acetylcholine receptor antibodies test should be performed within 6 months prior to screening visit.
•4. Male/female who are at least 18 years of age on the day of signing informed consent.
•5. ECOG performance status 0-1
•6. Life expectancy ≥ 3 months
•7. Radiological progression documented per RECIST 1.1 during or after completion of previous line therapy, per investigator's criteria.
•8. Presence of measurable disease according to RECIST criteria. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
•a. Disease status must be documented by full chest and upper abdomen (including adrenal glands) CT and/or MRI within 28 days prior study enrollment. If clinically indicated, brain imaging must be performed;
+6 more criteria

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
•2. Has received prior therapy with sunitinib.
•3. Any evidence of active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable (i.e. without evidence of progression by imaging for at least four weeks prior to enrollment and any neurologic symptoms have returned to baseline), and have not received steroids (for a total equivalent dose of more than 10 mg of prednisone per day) for at least 7 days prior to enrollment.
•4. Uncontrolled blood pressure (Systolic BP\>140 mmHg or diastolic BP \>90 mmHg) in spite of an optimized regimen of antihypertensive medication.
•5. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at Screening.
•6. Intratumor cavitation, direct invasion of main mediastinal blood vessels by the tumor or exist previous bleeding.
•7. Subjects having \> 1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \<1 g/24 hours.
•8. Has received prior investigational agents within 4 weeks prior to allocation.
•9. Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy may be eligible.
+21 more criteria

Locations (13)

Institut Bergonié

Bordeaux, France

Centre Oscar Lambert

Lille, France

Hôpitaux Universitaires de Marseille - Hôpital Nord

Marseille, France

Institut Curie

Paris, France

Centre Hospitalier Universitaire de Toulouse

Toulouse, France

IGR Gustave Roussy

Villejuif, France

A.O.U. San Luigi Gonzaga

Orbassano, Italy

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Hospital Sant Creu i Sant Pau

Barcelona, Spain

Key Dates

Start Date

September 21, 2021

Primary Completion Date

July 1, 2024

Completion Date

February 16, 2026

Last Updated

February 19, 2026

Enrollment

ACTUAL participants

Conditions

Metastatic Thymic CarcinomaThymoma Type B3

Interventions

Pembrolizumab

DRUG

Lenvatinib 10 mg

DRUG

Carboplatin and Paclitaxel With or Without Ramucirumab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Thymic Cancer That Cannot Be Removed by Surgery

NCT03694002

Locally Advanced Thymic CarcinomaMetastatic Thymic Carcinoma+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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