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

NCT04800978 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-03-16

No results posted yet for this study

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

Conditions

Interventions

BIOLOGICAL

BAVC-C+Durvalumab

* Durvalumab Durvalumab will be supplied in glass vials containing 500 mg of liquid solution at a concentration of 50 mg/mL for infusion after dilution. * BVAC-C BVAC-C will be supplied in cyclic olefin co-polymer vials containing 1x10⁸ cells of suspension at a concentration of 5x10⁷ cells/mL infusion

Sponsors & Collaborators

  • Asan Medical Center

    collaborator OTHER

  • Seoul National University Hospital

    collaborator OTHER

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • Severance Hospital

    collaborator OTHER

  • National Cancer Center, Korea

    collaborator OTHER_GOV

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-14
Primary Completion
2024-08-31
Completion
2024-08-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04800978 on ClinicalTrials.gov