Brachytherapy With Durvalumab or Tremelimumab for the Treatment of Patients With Platinum-Resistant, Refractory, Recurrent, or Metastatic Gynecological Malignancies

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT04395079
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Malignant Female Reproductive System Neoplasm
  • Platinum-Resistant Malignant Female Reproductive System Neoplasm
  • Recurrent Malignant Female Reproductive System Neoplasm
  • Refractory Malignant Female Reproductive System Neoplasm

Eligibility Criteria

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

Interventions

  • Durvalumab — BIOLOGICAL
    Given IV
  • Internal Radiation Therapy — RADIATION
    Undergo brachytherapy
  • Tremelimumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial studies the side effects and how well brachytherapy with durvalumab or tremelimumab work for the treatment of gynecological malignancies that is resistant to platinum therapy (platinum-resistant), does not respond to treatment (refractory), has come back (recurrent), or has spread to other places in body (metastatic). Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see whether brachytherapy with durvalumab or tremelimumab works better in treating patients with gynecological malignancies.

Key Dates

Start date
Aug 7, 2020
Status verified
Jul 2025
Primary completion
Oct 11, 2024
Completion
Dec 1, 2026

Study Design

Enrollment
9 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (durvalumab, brachytherapy)
    Patients receive durvalumab IV on day 1. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo brachytherapy on day 8. Treatment repeats every 21 days for 3 fractions in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (tremelimumab, brachytherapy)
    Patients receive tremelimumab IV on day 1. Treatment repeats every 28 days for 2-4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo brachytherapy on day 8. Treatment repeats every 21 days for 3 fractions in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events (safety lead-in) [ Time Frame: Up to 90 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095-

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By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

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