Spots Global Cancer Trial Database for Combination of Durvalumab and BVAC-C in Patients With HPV 16 or 18 Positive Cervical Cancer Failure to First-Line Platinum-based Chemotherapy

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Combination of Durvalumab and BVAC-C in Patients With HPV 16 or 18 Positive Cervical Cancer Failure to First-Line Platinum-based Chemotherapy

Official Title: An Open Label, Single Arm, Safety Lead-in, Multicenter, Investigator Initiated Trial of Combination of Durvalumab , An Immune Checkpoint Inhibitor, and BVAC-C, A Cell-based Immunotherapeutic Vaccine, in Patients With HPV 16 or 18 Positive Cervical Cancer Failure to First-Line Platinum-based Chemotherapy

Study ID: NCT04800978

Conditions

Cervical Cancer

Interventions

BAVC-C+Durvalumab

Study Description

Brief Summary: This is an exploratory, open label, multi-center trial to evaluate the safety and efficacy of combination of durvalumab with BVAC-C in patients with cervical cancer refractory to or relapse after platinum-based first-line chemotherapy with safety lead-in phase. The study consists of 2 parts: part A, a safety lead-in phase, and part B, an exploratory safety and efficacy evaluation phase. Part A will be conducted as a 3+3 dose escalation manner, and part B will be conducted as a non-randomized single arm study. •Part A: Open-labeled; 3+3 dose-escalation; Multi-center; safety lead-in phase •Part B: Open-labeled; Non-randomized, Single arm; Multi-center, efficacy evaluation phase

Detailed Description: