Table 1.

Key patient eligibility criteria

Key inclusion criteria

Key exclusion criteria

Stage III, IV, or recurrent, histologically confirmed endometrial carcinoma with measurable or radiographically apparent disease* Prior therapies may include chemotherapy (only if administered as neoadjuvant or adjuvant therapy and/or concurrently with radiation), radiation, or hormonal therapy (only if discontinued ≥1 week before randomization) Provided archival tumor tissue or newly obtained biopsy of tumor for determination of mismatch repair status Eastern Cooperative Oncology Group performance status of 0/1

Carcinosarcoma, endometrial leiomyosarcoma, or other high grade sarcomas, or endometrial stromal sarcomas Additional malignancies that have progressed or required active treatment in the last 3 years† Gastrointestinal conditions that might affect absorption of lenvatinib Active infection requiring systemic treatment Previous therapy with any treatment targeting vascular endothelial growth factor-directed angiogenesis; anti-PD-1, anti-PD-L1, or anti-PD-L2 agents; or any agent directed at another stimulatory or co-inhibitory T cell receptor Inadequate organ function

*Disease may be either measurable or non-measurable per Response Evaluation Criteria in Solid Tumors v1.1 but must be radiographically apparent by blinded independent central review.

†Not including basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy.

PD-1, programmed death 1; PD-L1, programmed death ligand 1; PD-L2, programmed death ligand 2.