Innovacionnie Tehnologii V Medicine Prezentaciya

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This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice. Condition or disease Intervention/treatment Phase Endometrial Neoplasms Drug: Pembrolizumab Drug: Lenvatinib Drug: Paclitaxel Drug: Doxorubicin Phase 3. ORR is defined as the percentage of participants who have best overall response of either complete response (CR) or partial response (PR), as determined by BICR per RECIST 1.1.

• Health-Related Quality of Life (HRQoL) Score Using the European Organization for Research and Treatment (EORTC) Quality of Life (QoL) Questionnaire (QLQ-C30) Version 3.0 [ Time Frame: Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and at the end of follow-up (up to approximately 27 months) ]. Change from baseline in HRQoL using the global score of EORTC QLQ-C30 will be determined.

EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, which contains 30 items and measures 5 functional dimensions (physical, role, emotional, cognitive, and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. The score for each item and the overall score ranges from 0 to 100.

A high overall scale and subscale scores represent improved health status. However, in case of individual symptoms, higher scores suggest increased perception of these symptoms of life. • Number of Participants With Adverse Events (AE) [ Time Frame: Up to approximately 27 months ]. Time to treatment failure due to toxicity, defined as the time from the date of randomization to the date that a participant discontinues study treatment due to AEs. Inclusion Criteria: • Has a histologically confirmed diagnosis of endometrial carcinoma (EC) • Documented evidence of advanced, recurrent or metastatic EC.

• Has radiographic evidence of disease progression after 1 prior systemic, platinum-based chemotherapy regimen for EC. Participants may have received up to 1 additional line of platinum-based chemotherapy if given in the neoadjuvant or adjuvant treatment setting. Note: There is no restriction regarding prior hormonal therapy. • Has historical or fresh tumor biopsy specimen for determination of mismatch repair (MMR) status.

• Has at least 1 measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and confirmed by Blinded Independent Central Review BICR. • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment. • Is not pregnant, breastfeeding, and agrees to use a highly effective method of contraception during the treatment period and for at least 120 days (for participants treated with lenvatinib plus pembrolizumab) or at least 180 days (for participants treated with treatment of physician's choice [TPC]) after the last dose of study treatment.

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Exclusion Criteria: • Has carcinosarcoma (malignant mixed mullerian tumor), endometrial leiomyosarcoma and endometrial stromal sarcomas. • Has unstable central nervous system (CNS) metastases.

• Has active malignancy (except for endometrial cancer, definitively treated in-situ carcinomas [e.g. Breast, cervix, bladder], or basal or squamous cell carcinoma of the skin) within 24 months of study start. • Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.

• Has a pre-existing greater than or equal (>=) Grade 3 gastrointestinal or non-gastrointestinal fistula. • Has radiographic evidence of major blood vessel invasion/infiltration. • Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment. • Has a history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, cerebrovascular accident (CVA) stroke, or cardiac arrhythmia associated with hemodynamic instability within 12 months of the first dose of study treatment. • Has an active infection requiring systemic treatment. • Has not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy.