Nivolumab Based Immunotherapy for Treatment of High Grade Cervical Dysplasia
- Sponsor
- University of Texas Southwestern Medical Center
- Study ID
- NCT03808168
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
- Cervix Uteri--Diseases
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUGProtocol dose: 3mg/kg mg as a 30-minute IV infusion on Day 1 (Arm I) or Days 1, 15, 29 (Arm II).
Study Details
The study design is a phase II interventional trial for women with biopsy proven high-grade cervical dysplasia. The study is an open label study and randomized. The study will have two arms. Patients will be randomized to both arms.
Key Dates
- Start date
- Jan 15, 2019
- Status verified
- Jan 2019
- Primary completion
- Jun 1, 2019
- Completion
- Jun 1, 2020
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Arm 1Nivolumab, 3 mg/kg Iv, day 1
- Active Comparator: Arm 2Nivolumab, 3 mg/kg IV, days 1, 15, 29
Primary Outcome Measure
Rate of regression on high grade dysplasia lesions [ Time Frame: 15 weeks after the beginning of immunotherapy ]