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A Study of Durvalumab With or Without Tremelimumab in Endometrial Cancer

NCT03015129 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-02-06

Study results available
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Summary

This study will test the safety and efficacy of the experimental drug called durvalumab with or without another experimental drug called tremelimumab in endometrial cancer.

Radiologic tumor assessment will be repeated every 8 weeks +/- 7 days for the first 48 weeks and then every 12 weeks +/- 7 days until PD. For patients who remain progression free 2 years post completion of protocol directed treatment, every 6 months +/- 1 month. irRECIST assessments will only be completed for patients continuing treatment beyond PD.

Conditions

  • Endometrial Cancer
  • Endometrial Carcinosarcoma
  • Endometrial Carcinoma
  • Endometrial Cancer Recurrent
  • Endometrial Carcinoma, Recurrent

Interventions

DRUG

Durvalumab

DRUG

Tremelimumab

Sponsors & Collaborators

Principal Investigators

  • Vicky Makker, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03015129 on ClinicalTrials.gov