Combination of Pembrolizumab and Lenvatinib, in Pre-treated Thymic CArcinoma paTIents (NCT04710628) | Clinical Trial Compass
CompletedPhase 2
Combination of Pembrolizumab and Lenvatinib, in Pre-treated Thymic CArcinoma paTIents
France43 participantsStarted 2021-09-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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.
Exclusion criteria
✕. 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.