Table 1

Key patient eligibility criteria

Key inclusion criteriaKey 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.