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Durvalumab and Lenvatinib in Participants With Advanced and Recurrent Endometrial Carcinoma

NCT04444193 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-06-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Durvalumab

Anti-PD-L1 Monoclonal Antibody

DRUG

Lenvatinib Oral Product

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

Sponsors & Collaborators

  • Shanghai First Maternity and Infant Hospital

    lead OTHER

Principal Investigators

  • Xiaoping Wan, MD.,Ph.D · Shanghai First Maternity and Infant Hospital

  • Huan Tong · Shanghai First Maternity and Infant Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2021-05-31
Completion
2021-05-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04444193 on ClinicalTrials.gov