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

NCT04710628 | Completed Phase 2

• 1 other identifier: MedOPP341
• Study Type: interventional
• Target: 43
• Locations: 3 countries
• Sites: 13

Brief 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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS rate at 5 months, defined as the percentage of patients with B3-Thymoma and Thymic Carcinoma without disease progression at 5 months after starting the treatment combination.

  5 months

Secondary Outcomes (6)

• Response rate (RR)

  5 months

• Maximum tumor shrinkage (MTS)

  5 months

• Disease control rate (DCR)

  5 months

• Duration of response (DoR)

  5 months

• Overall survival (OS)

  2 years

Study Arms (1)

PEMBROLIZUMAB + LENVATINIB

EXPERIMENTAL

Pembrolizumab 200 mg will be administered to patients as 30-minute IV infusion every 3 weeks (a window of -5 minutes and +10 minutes is permitted). 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). Lenvatinib cannot be chewed

Drug: Pembrolizumab; Drug: Lenvatinib 10 mg

Interventions

Pembrolizumab DRUG

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.

Also known as: MK-3475, lambrolizumab

PEMBROLIZUMAB + LENVATINIB

Lenvatinib 10 mg DRUG

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)

Also known as: E7080

PEMBROLIZUMAB + LENVATINIB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Relapsed / Recurrent histologically confirmed B3-Thymoma or TC patients not amenable to curative-intent radical surgery and/or radiotherapy, regardless of PD-L1 expression.
• Patients progress after at least one previous line of platinum-based chemotherapy for advanced disease:
• a. Patients treated with neo-adjuvant or adjuvant platinum-based chemotherapy combined with radical surgery or as part of radical chemo-radiotherapy are eligible if chemotherapy was completed within 6 months before enrollment.
• 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.
• Male/female who are at least 18 years of age on the day of signing informed consent.
• ECOG performance status 0-1
• Life expectancy ≥ 3 months
• Radiological progression documented per RECIST 1.1 during or after completion of previous line therapy, per investigator's criteria.
• 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;
• Provides historical (obtained archived FFPE) or fresh tumor biopsy specimen for biomarker studies, if feasible. Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated is acceptable. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archival tissue. Note: If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut.
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) OR
• A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after the last dose of study treatment.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• 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).
• Has received prior therapy with sunitinib.
• 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.
• Uncontrolled blood pressure (Systolic BP\>140 mmHg or diastolic BP \>90 mmHg) in spite of an optimized regimen of antihypertensive medication.
• 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.
• Intratumor cavitation, direct invasion of main mediastinal blood vessels by the tumor or exist previous bleeding.
• 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.
• Has received prior investigational agents within 4 weeks prior to allocation.
• Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy may be eligible.
• If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment. If surgery is needed during treatment, lenvatinib will be withheld for at least 1 week prior to elective surgery and until at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of lenvatinib after resolution of wound healing has not been established.
• Fraction ejection \< 50%.
• Known history or current evidence of active Hepatitis B (e.g., HBsAg reactive) or C (e.g., HCV RNA \[qualitative\] is detected) or Human Immunodeficiency Virus (HIV) (HIV-1/2 antibodies).
• If CT has to be used, known contra-indications for CT with IV contrast.
• Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the last 15 days prior to enrolment:

Sponsors & Collaborators

• MedSIR: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (13)

Institut Bergonié

Bordeaux, France

Location

Centre Oscar Lambert

Lille, France

Location

Hôpitaux Universitaires de Marseille - Hôpital Nord

Marseille, France

Location

Institut Curie

Paris, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Location

IGR Gustave Roussy

Villejuif, France

Location

A.O.U. San Luigi Gonzaga

Orbassano, Italy

Location

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Sant Creu i Sant Pau

Barcelona, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, Spain

Location

Related Publications (1)

• Remon J, Bironzo P, Girard N, Bigay-Game L, Juan-Vidal O, de Castro J, Reguart N, Greillier L, Cousin S, Dansin E, Majem M, Bernabe R, Mosquera Martinez J, Diaz M, Meya A, Alcala-Lopez D, Garcia-Sanz A, Righi L, Novello S, Besse B. Lenvatinib plus pembrolizumab in pretreated metastatic B3 thymoma and thymic carcinoma (PECATI): a single-arm, phase 2 trial. Lancet Oncol. 2025 Sep;26(9):1215-1226. doi: 10.1016/S1470-2045(25)00300-6.

  PMID: 40907517 DERIVED

MeSH Terms

Conditions

Thymoma

Interventions

pembrolizumab; lenvatinib

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jordi Remon, MD, PhD

  HM-CIOCC, Hospital HM Delfos, HM Hospitales, Barcelona (Spain)

  PRINCIPAL INVESTIGATOR

• Benjamin Besse, MD, PhD

  Medical Oncology Department Gustave Roussy, Villejuif (France)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: January 15, 2021
• Study Start: September 21, 2021
• Primary Completion: July 1, 2024
• Study Completion: February 16, 2026
• Last Updated: February 19, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); ES (6); FR (6)