Durvalumab and Lenvatinib in Participants With Advanced and Recurrent Endometrial Carcinoma

Sponsor
Shanghai First Maternity and Infant Hospital
Study ID
NCT04444193
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Anti-PD-L1 Monoclonal Antibody
  • Lenvatinib Oral Product — DRUG
    Lenvatinib (Lenvima, Eisai China) is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT

Study Details

This study will evaluate the safety and efficacy of durvalumab in combination with lenvatinib in participants with advanced and recurrent endometrial carcinoma.The primary hypothesis of this study are that patients with advanced and recurrent endometrial carcinoma could benefit from durvalumab plus lenvatinib with respect to: 1)Progression Free Survival (PFS) ; 2) Objective Response Rate (ORR); and Overall survival (OS). The investigators design a clinical study to explore whether the combination above as a treatment in patients with advanced and recurrent endometrial carcinoma could prolong PFS and to analyze potential immune biomarker of therapeutic response.

Key Dates

Start date
Aug 31, 2020
Status verified
Jun 2020
Primary completion
May 31, 2021
Completion
May 31, 2021

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab and Lenvatinib
    Combination therapy of Lenvatinib 80-120mg daily orally and durvalumab 1500mg by IV infusion every 4 weeks

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 3 years ]

Central Contacts

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