Stereotactic Ablative Radiotherapy (SABR) in Combination With Durvalumab and Tremelimumab in Patients With Cervical, Vaginal, or Vulvar Cancer
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|ClinicalTrials.gov Identifier: NCT03452332|
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : September 12, 2018
The goal of this clinical research study is to learn if it is safe to give a special type of radiation called stereotactic ablative radiotherapy (SABR) in combination with durvalumab and tremelimumab to patients with advanced forms of cervical, vaginal, or vulvar cancer that is recurrent (has returned after treatment) and/or metastatic (has spread). Researchers also want to learn if this combination can help to control the disease.
SABR is a type of radiation commonly used to treat various types of cancer with larger doses of radiation focused precisely at the tumor.
This is an investigational study. Durvalumab is FDA approved for the treatment of urothelial cancer. Tremelimumab is not FDA approved or commercially available. The use of these drugs in combination with SABR is investigational. SABR is delivered using FDA-approved and commercially available methods.
The study doctor can describe how the study drugs and radiation are designed to work.
Up to 18 patients will enroll in this multi-center study. Up to 9 will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasms of Female Genital Organs Cervical Cancer Vaginal Cancer Vulvar Cancer||Drug: Durvalumab Drug: Tremelimumab Radiation: Stereotactic Ablative Radiotherapy (SABR)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Multi-Center Study of Stereotactic Ablative Radiotherapy (SABR) in Combination With Durvalumab and Tremelimumab in Patients With Recurrent/Metastatic Advanced Cervical, Vaginal, or Vulvar Cancer|
|Actual Study Start Date :||July 18, 2018|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2020|
Experimental: Durvalumab + Tremelimumab + SABR
Participants receive Tremelimumab by vein over about 1 hour on Day 1 of Cycles 1-4. Participants receive Durvalumab by vein over about 1 hour on Day 1 of every cycle (about 1 hour after the end of the Tremelimumab dose during Cycles 1-4).
On Days 8, 10, and 12 of Cycle 1, participants also receive SABR over about 30-45 minutes each time.
Participants only receive SABR during cycle 1 and Tremelimumab over 4 cycles. Participants may continue to receive Durvalumab for up to 8 cycles.
Study conducted in 4 week cycles.
Durvalumab 1500 mg by vein over about 1 hour on Day 1 of every cycle (about 1 hour after the end of the Tremelimumab dose during Cycles 1-4).
Other Name: MEDI4736
Tremelimumab 75 mg by vein given 1 week (+/- 3 days) prior to SABR then every 4 weeks for 4 cycles.
Radiation: Stereotactic Ablative Radiotherapy (SABR)
SABR administered during cycle 1, day 7 +/- 3 days. SABR given in 3 fractions, every other day, to a total dose of 24 Gy (8 Gy per fraction x 3 fractions) completed within one week and targeted to the largest easily accessible metastases.
Other Name: Radiation therapy
- Safety Assessed Based on Dose Limiting Toxicities (DLTs) Based on Adverse Events (AEs) Assessed by NCI CTCAE v 4.03.) [ Time Frame: Baseline up to 8 months ]
- Clinical Response Rate Measured by Tumor Response Based on RECIST Criteria v 1.1 [ Time Frame: Baseline up to 1 year ]
- Objective Response Defined as Complete Response (CR) or Partial Response (PR) by RECIST v1.1. [ Time Frame: Baseline up to 1 year ]
- Progression-Free Survival Defined as the Time From the Start of Therapy to First Documented Disease Progression or Death From Any Cause [ Time Frame: Baseline up to 1 year ]
- Overall Survival Defined as the Time From Start of Therapy to Death From any Cause. [ Time Frame: Baseline up to 1 year ]
- Time to Next Treatment (TTNT) Defined as the Time From the End of Immune-Checkpoint Inhibition Treatment on this Study to Institution of Next Therapy. [ Time Frame: Baseline up to 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452332
|Contact: Lilie L. Lin, MDfirstname.lastname@example.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Lilie L. Lin, MD||M.D. Anderson Cancer Center|