Stereotactic Body Radiation Therapy, Tremelimumab and Durvalumab in Treating Participants With Recurrent or Metastatic Cervical, Vaginal, or Vulvar Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 18
Summary
- Conditions
- Metastatic Cervical Squamous Cell Carcinoma, Not Otherwise Specified
- Human Papillomavirus-Related Cervical Squamous Cell Carcinoma
- Advanced Cervical Adenocarcinoma
- Recurrent Cervical Squamous Cell Carcinoma, Not Otherwise Specified
- Stage IVA Vulvar Cancer AJCC v8
- Stage III Vaginal Cancer AJCC v8
- Stage IV Vaginal Cancer AJCC v8
- Advanced Vaginal Carcinoma
- Advanced Vulvar Carcinoma
- Recurrent Cervical Adenocarcinoma
- Human Papillomavirus-Related Vulvar Squamous Cell Carcinoma
- Recurrent Cervical Carcinoma
- Stage IV Cervical Cancer AJCC v8
- Vulvar Squamous Cell Carcinoma
- Recurrent Vulvar Carcinoma
- Stage IIIB Cervical Cancer AJCC v8
- Metastatic Cervical Adenocarcinoma
- Stage IIIB Vulvar Cancer AJCC v8
- Metastatic Cervical Carcinoma
- Stage IIIA Cervical Cancer AJCC v8
- Stage IVB Vulvar Cancer AJCC v8
- Stage IVA Cervical Cancer AJCC v8
- Metastatic Vaginal Adenocarcinoma
- Stage IIIA Vulvar Cancer AJCC v8
- Recurrent Vaginal Carcinoma
- Stage IVB Vaginal Cancer AJCC v8
- Vaginal Squamous Cell Carcinoma, Not Otherwise Specified
- Stage IVB Cervical Cancer AJCC v8
- Stage IIIC Vulvar Cancer AJCC v8
- Vulvar Adenocarcinoma
- Stage IVA Vaginal Cancer AJCC v8
- Stage III Cervical Cancer AJCC v8
- Metastatic Vaginal Carcinoma
- Stage III Vulvar Cancer AJCC v8
- Stage IV Vulvar Cancer AJCC v8
- Metastatic Vulvar Carcinoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
PRIMARY OBJECTIVE: I. To determine the safety, and tolerability of combined immune checkpoint blockade with 3 fractions of stereotactic body radiation therapy (stereotactic ablative radiotherapy [SABR]) of up to two metastatic lesions in patients with recurrent and or metastatic cervical, vaginal, o...
PRIMARY OBJECTIVE: I. To determine the safety, and tolerability of combined immune checkpoint blockade with 3 fractions of stereotactic body radiation therapy (stereotactic ablative radiotherapy [SABR]) of up to two metastatic lesions in patients with recurrent and or metastatic cervical, vaginal, or vulvar cancer. SECONDARY OBJECTIVES: I. To evaluate clinical response rates and assess toxicities of treatment to durvalumab combined with tremelimumab with 3 fractions of SABR of at least one and up to two metastatic lesions in patients with recurrent/metastatic cervical, vaginal, or vulvar cancer. II. To estimate progression-free survival, overall survival, and time to next treatment. EXPLORATORY OBJECTIVES: I. To evaluate potential biomarkers of immune response to combined immune-checkpoint inhibition with SABR and correlate this with clinical response to treatment. II. To evaluate potential biomarkers of immune response including cervical and rectal microbial diversity, cervical immune cell infiltration and peripheral immune cell activation as correlates of clinical response to treatment. OUTLINE: Participants receive tremelimumab intravenously (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. After completion of study treatment, participants are followed up at 30 days, at 2, 3, 4, 6, 8, 10, and 12 months, and then every 6 months thereafter.
Tracking Information
- NCT #
- NCT03452332
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Lilie L Lin M.D. Anderson Cancer Center
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