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

Summary

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.

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

Interventions

BIOLOGICAL

Durvalumab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

RADIATION

Stereotactic Radiosurgery

Undergo SABR

BIOLOGICAL

Tremelimumab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Lilie L Lin · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-18

Primary Completion

2023-08-11

Completion

2023-08-11

FDA Drug

Yes

Countries

• United States

Study Locations