A Multicentric, Open-Label, Single Arm Phase II Study To Evaluate The Efficacy AndSafety Of The Combination Of PEmbrolizumab And Lenvatinib In Pre-Treated Thymic CArcinomaPaTIents. PECATI”.
- Conditions
- Metastatic Thymic Carcinoma & B3-thymoma.Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-508001-25-00
- Lead Sponsor
- Medica Scientia Innovation Research S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 43
Relapsed / Recurrent histologically confirmed B3-Thymoma or TC patients not amenable to curative-intent radical surgery and/or radiotherapy, regardless of PD-L1 expression., A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies: a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 6 months after the last dose of study treatment., Adequate bone marrow and organ function according to Table 1 (section 3.1.1)., Written informed consent prior to beginning specific protocol procedures., Patients progress after at least one previous line of platinumbased chemotherapy for advanced disease: a. Patients treated with neo-adjuvant or adjuvant platinum-based chemotherapy combined with radical surgery or as part of radical chemoradiotherapy are eligible if chemotherapy was completed within 6 months before enrolment., 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 1.1 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 enrolment. 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
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)., 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: a. 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, nonmelanomatous skin cancer or carcinoma in situ of the cervix are allowed., Has received prior therapy with sunitinib., 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 len
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method