Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
Sponsor3D Medicines (Sichuan) Co., Ltd.

About this trial

This is an open-label, multi-center, multi-corhort Phase II study of Envafolimab alone or with Lenvatinib in patients with advanced endometrial cancer.The primary objective is to evaluate objective response rate of envafolimab alone or with lenvatinib.

Eligibility criteria

Qualifiers

Volunteer to participate and sign the informed consent form.

Has a histologically confirmed diagnosis of endometrial carcinoma (EC). Has Documented evidence of advanced, recurrent or metastatic EC and are not candidates for curative surgery or radiation.

Failure or intolerance of standard first-line platinum-based chemotherapy regimen for EC.

Has at least 1 measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and confirmed by Blind Independent Imaging Review Committee (BIRC).

Disqualifiers

Previous lab results showed dMMR or MSI-H.

Participate in the clinical trials of other investigational drugs within 28 days before the first medication; or have received anti-tumor treatment within 2 weeks, including but not limited to chemotherapy and radiotherapy or targeted therapy.

The toxicity of previous anti-tumor treatments has not recovered to 0 or 1 level.

Recieved major surgery with 28 days before the first medication or has serious nonhealing wound, ulcer, or bone fracture at screening.

Trial design

Treatments tested in this trial

  • Envafolimab+Lenvatinib
  • Envafolimab

Treatment groups

108 Participants
are divided into 2 treatment groups