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

Sponsor
Samsung Medical Center
Study ID
NCT04800978
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BAVC-C+Durvalumab — BIOLOGICAL
    * 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

Study Details

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

Key Dates

Start date
Jun 14, 2021
Status verified
Jan 2021
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BVAC-C+Durvalumab
    • Part A: The primary objective of the part A is to assess the maximum tolerable dose of BVAC-C combined with durvalumab 1500 mg as defined by dose-limiting toxicities (DLTs), and to find the maximum tolerated dose (MTD) that can be safely used for Part B (single arm phase II). • Part B: The primary objective of the part B is to evaluate the safety and clinical efficacy, as measured by 6-month PFS rate, of the combination therapy of durvalumab and BVAC-C in patients with HPV 16 or 18 positive cervical cancer recurrent after or refractory to first-line platinum-based chemotherapy +/-bevacizumab.

Primary Outcome Measure

Part A : Dose-limiting toxicities(DLTs) [ Time Frame: up to 11 weeks ]

Central Contacts

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