AzTrials
AzTrials

Metastatic Thymic CarcinomaPhase 2PECATINCT04710628

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

A Phase 2 study testing Pembrolizumab and Lenvatinib 10 mg in people with Metastatic Thymic Carcinoma and Thymoma Type B3, run by MedSIR at 13 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Thymic Carcinoma, Thymoma Type B3
What is being tested?
Pembrolizumab and Lenvatinib 10 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
13 sitesin 3 countries
Study dates
21 Sep 2021to 16 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.
Show all 17Show fewer
  • 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.
  • 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.
  • Has adequate bone marrow and organ function. Specimens must be collected within 10 days prior to the start of study treatment.
  • Written informed consent prior to beginning specific protocol procedures.

Who cannot join

  • 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.
Show all 31Show fewer
  • 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:
  • Daily prednisone at doses up to 10 mg or equivalent doses of any other corticosteroid is allowed for example as replacement therapy.
  • History of interstitial lung disease (ILD) OR pneumonitis (other than COPD exacerbation) that has required oral or IV steroids.
  • Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
  • Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
  • Autoimmune disorders requiring immunosuppressive or dedicated treatment.
  • History of any other hematologic or primary solid tumor malignancy, unless in remission for at least 5 years and without specific treatment (as example, not allowed hormonal therapy to replace for breast cancer or hormonal therapy substitution in prostate cancer). pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non-melanomatous skin cancer or carcinoma in situ of the cervix are allowed.
  • Previous allogenic tissue/solid organ transplantation
  • Active infection requiring systemic therapy
  • A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Note: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication.
  • Has received prior radiotherapy within 2 weeks of start of study treatment.
  • Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients; known sensitivity or intolerance to lenvatinib and/or any of its excipients; severe hypersensitivity to monoclonal antibody-containing regimen.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Has an intestinal disease not allowing swallowing pills.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through the 6 months after the last dose of trial treatment.

Trial locations and contacts

13 sites in 3 countries.

13 sites in 3 countries

France6 sites

  • Institut Bergonié

    Bordeaux

  • Centre Oscar Lambert

    Lille

  • Hôpitaux Universitaires de Marseille - Hôpital Nord

    Marseille

  • Institut Curie

    Paris

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse

  • IGR Gustave Roussy

    Villejuif

Other trials in France

Spain6 sites

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Sant Creu i Sant Pau

    Barcelona

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Universitari i Politècnic La Fe

    Valencia

Other trials in Spain

Italy1 site

  • A.O.U. San Luigi Gonzaga

    Orbassano

Other trials in Italy

About this study

Official title: 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.

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.

Read the 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.

Being tested
Pembrolizumab, Lenvatinib 10 mg
Medical subject headings
Thymoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called MK-3475, lambrolizumab

    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.

  • Lenvatinib 10 mgDrug

    Also called E7080

    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)

Study groups in NCT04710628
Study groupRoleWhat they receive
PEMBROLIZUMAB + LENVATINIBExperimentalPembrolizumab 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
Receives: Drug: Pembrolizumab; Drug: Lenvatinib 10 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 months

Secondary outcomes (6)

  1. Response rate (RR)

    RR with the treatment combination

    Measured: 5 months

  2. Maximum tumor shrinkage (MTS)

    MTS with the treatment combination

    Measured: 5 months

  3. Disease control rate (DCR)

    DCR with the treatment combination

    Measured: 5 months

  4. Duration of response (DoR)

    DoR with the treatment combination

    Measured: 5 months

  5. Overall survival (OS)

    OS

    Measured: 2 years

  6. Incidence of Grade 3 and 4 AEs and SAEs

    Grade 3 and 4 AEs and serious adverse events (SAEs) will be assessed, according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v.5.0), to determine the safety and tolerability of the combination.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2021
  2. Study start21 Sep 2021
  3. Primary completion1 Jul 2024
  4. Study completion16 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04710628
Sponsor's protocol ID
MedOPP341
Acronym
PECATI
Status last verified
Apr 2025
First submitted
3 Dec 2020
Last updated
19 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40907517

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and Lenvatinib 10 mg in people with Metastatic Thymic Carcinoma and Thymoma Type B3, run by MedSIR at 13 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France, Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04710628, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in