NCT03808168

Nivolumab Based Immunotherapy for Treatment of High Grade Cervical Dysplasia

Phase II Trial of Nivolumab Based Immunotherapy for the Treatment of High-Grade Cervical Dysplasia

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

High-grade cervical dysplasia (cervical intraepithelial neoplasia (CIN) II/III), is both detectable and quantifiable, which presents many opportunities for evaluation or early treatment, intervention and eventually, for cancer prevention. High-grade dysplasia is typically detected during cervical cancer screening with a pap smear. To determine the pathologic response rate of high grade cervical dysplasia with PD-1 checkpoint modulation with Nivolumab.This is a randomized phase II trial with two experimental arms (1 dose of nivolumab and 3 doses of nivolumab).

Conditions

• Cervix Uteri--Diseases

Interventions

Type	Name	Description
DRUG	Nivolumab	Protocol dose: 3mg/kg mg as a 30-minute IV infusion on Day 1 (Arm I) or Days 1, 15, 29 (Arm II).

Timeline

• Start date: 2019-01-15
• Primary completion: 2019-06-01
• Completion: 2020-06-01
• First posted: 2019-01-17
• Last updated: 2019-01-18