Royal North Shore Hospital | Renal Medicine - Renal Research Unit
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About
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.
Enrollment
Sex
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Volunteers
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.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
827 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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