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Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer

NCT03277482 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-05-31

No results posted yet for this study

Summary

This research study is evaluating the safety and effectiveness of 2 immunotherapy drugs in combination with radiation therapy as a possible treatment for recurrent or metastatic gynecologic cancer.

The names of the immunotherapy drugs involved in this study are:

* Durvalumab
* Tremelimumab

Conditions

  • Recurrent Gynecological Cancer
  • Metastatic Cervical Cancer
  • Metastatic Ovarian Cancer
  • Metastatic Vaginal Cancer
  • Metastatic Vulvar Cancer
  • Metastatic Endometrial Cancer
  • Recurrent Cervical Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Vaginal Cancer
  • Recurrent Vulvar Cancer
  • Recurrent Endometrial Cancer

Interventions

DRUG

Durvalumab

Durvalumab is given by intravenous infusion every 4 weeks for a maximum of 13 doses over 52 weeks. One cycle is defined as every 4 weeks. Each infusion will take approximately 1 hour.

DRUG

Tremelimumab

Tremelimumab is given by intravenous infusion every 4 weeks for a maximum of 4 doses over 16 weeks. One cycle is defined as every 4 weeks. If receiving both durvalumab and tremelimumab for the first 4 cycles, they will be given on the same day. Each infusion will take approximately 1 hour

RADIATION

Radiation Therapy

Radiation treatment will begin on the same day as the first immunotherapy infusion or on the following day. The radiation treatment course is either 1 day or 5 days.

Sponsors & Collaborators

Principal Investigators

  • Martin King, MD, PhD · Brigham and Women's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2022-07-15
Completion
2022-07-15
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Drugs
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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 NCT03277482 on ClinicalTrials.gov