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

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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