Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03277482
Phase
PHASE1
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    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.
  • Tremelimumab — DRUG
    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 Therapy — RADIATION
    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.

Study Details

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

Key Dates

First listed
Sep 11, 2017
Start date
Jun 1, 2018
Status verified
May 2025
Primary completion
Jul 15, 2022
Completion
Jul 15, 2022

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Safety Lead-In
    A modified 3+3 design will be used in this trial Lead-in phase with Durvalumab\* and radiation therapy \*q4 weeks durvalumab for 13 cycles or until progression
  • Experimental: Phase I Radiation Dose Evaluation
    * Durvalumab * Tremelimumab\* -- Start radiation dose from safety lead-in (level 0 or level -1) \*q4 weeks durvalumab / tremelimumab for 4 cycles and continue durvalumab for 13 cycles or until disease progression

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Radiotherapy with durvalumab and tremelimumab [ Time Frame: 8 Weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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