Stereotactic Body Radiation Therapy, Tremelimumab and Durvalumab in Treating Participants With Recurrent or Metastatic Cervical, Vaginal, or Vulvar Cancers

Conditions

• Advanced Cervical Adenocarcinoma
• Advanced Vaginal Carcinoma
• Advanced Vulvar Carcinoma
• Human Papillomavirus-Related Cervical Squamous Cell Carcinoma
• Human Papillomavirus-Related Vulvar Squamous Cell Carcinoma
• Metastatic Cervical Adenocarcinoma
• Metastatic Cervical Carcinoma
• Metastatic Cervical Squamous Cell Carcinoma, Not Otherwise Specified
• Metastatic Vaginal Adenocarcinoma
• Metastatic Vaginal Carcinoma
• Metastatic Vulvar Carcinoma
• Recurrent Cervical Adenocarcinoma
• Recurrent Cervical Carcinoma
• Recurrent Cervical Squamous Cell Carcinoma, Not Otherwise Specified
• Recurrent Vaginal Carcinoma
• Recurrent Vulvar Carcinoma
• Stage III Cervical Cancer AJCC v8
• Stage III Vaginal Cancer AJCC v8
• Stage III Vulvar Cancer AJCC v8
• Stage IIIA Cervical Cancer AJCC v8
• Stage IIIA Vulvar Cancer AJCC v8
• Stage IIIB Cervical Cancer AJCC v8
• Stage IIIB Vulvar Cancer AJCC v8
• Stage IIIC Vulvar Cancer AJCC v8
• Stage IV Cervical Cancer AJCC v8
• Stage IV Vaginal Cancer AJCC v8
• Stage IV Vulvar Cancer AJCC v8
• Stage IVA Cervical Cancer AJCC v8
• Stage IVA Vaginal Cancer AJCC v8
• Stage IVA Vulvar Cancer AJCC v8
• Stage IVB Cervical Cancer AJCC v8
• Stage IVB Vaginal Cancer AJCC v8
• Stage IVB Vulvar Cancer AJCC v8
• Vaginal Squamous Cell Carcinoma, Not Otherwise Specified
• Vulvar Adenocarcinoma
• Vulvar Squamous Cell Carcinoma

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — BIOLOGICAL
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Stereotactic Radiosurgery — RADIATION
  Undergo SABR
• Tremelimumab — BIOLOGICAL
  Given IV

Study Details

This phase I trial studies how well stereotactic body radiation therapy works in combination with tremelimumab and durvalumab in treating participants with cervical, vaginal, or vulvar cancers that have come back (recurrent) or spread to other areas of the body (metastatic). Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving stereotactic body radiation therapy, tremelimumab, and durvalumab may work better in treating participants with cervical, vaginal, or vulvar cancers.

Key Dates

Start date

Jul 18, 2018

Status verified

Sep 2023

Primary completion

Aug 11, 2023

Completion

Aug 11, 2023

Study Design

Enrollment

20 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (tremelimumab, durvalumab, SABR)
  Participants receive tremelimumab IV over 1 hour followed by durvalumab IV over 1 hour on day 1 of each cycle. Participants also undergo SABR over 30-45 minutes on days 8, 10, and 12 of cycle 1. Treatment with tremelimumab repeats every 4 weeks for up to 4 cycles, and treatment with durvalumab repeats every 4 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03 [ Time Frame: Up to 3 months after last dose of durvalumab ]

Locations (2)

Find similar trials in Dallas, TX

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