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- BVAC-C / Cellid, Imfinzi (durvalumab) / AstraZeneca
An open label, single arm phase II, multicenter trial of durvalumab and BVAC-C, in patients with HPV 16- or 18-positive cervical cancer and failure of first-line platinum-based chemotherapy (DURBAC). (E451) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1815;
P2
The essential eligibility criteria comprise histologically confirmed cervical carcinoma with HPV 16/18 positivity, recurrence following or resistance to a solitary prior first-line platinum-based chemotherapy
- || BVAC-C / Cellid
P1/2 data, Clinical Trial,Phase I, Clinical Trial,Phase II, Journal, IO biomarker: Efficacy and safety of BVAC-C in HPV type 16- or 18-positive cervical carcinoma who failed 1st platinum-based chemotherapy: a phase I/IIa study. (Pubmed Central) - Apr 16, 2024
P1/2
Further studies are needed to identify potential biomarkers of response. ClinicalTrials.gov, identifier NCT02866006.
- || BVAC-C / Cellid
Trial completion, Trial completion date, Metastases: BVAC-C-P1: Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer (clinicaltrials.gov) - Oct 12, 2022
P1/2, N=32, Completed, Sponsor: Cellid Co., Ltd.
ClinicalTrials.gov, identifier NCT02866006. Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Jun 2022
- BVAC-C / Cellid, Imfinzi (durvalumab) / AstraZeneca
AN OPEN LABEL, SINGLE ARM, MULTICENTER TRIAL OF DURVALUMAB AND BVAC-C, IN PATIENTS WITH HPV 16 OR 18 POSITIVE RECURRENT CERVICAL CANCER () - Sep 9, 2022 - Abstract #IGCS2022IGCS_1037;
Key eligibility criteria include 1) histologically confirmed HPV 16/18-positive cervical carcinoma, 2) only 1 prior first-line platinum-based chemotherapy +/- bevacizumab not amenable to local therapy, and 3) measurable disease per RECIST v1.1. Trial in progress: there are no available conclusions at the time of submission.
- | BVAC-C / Cellid
Trial completion date, Trial primary completion date, Metastases: BVAC-C-P1: Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer (clinicaltrials.gov) - Aug 12, 2022
P1/2, N=32, Active, not recruiting, Sponsor: Cellid Co., Ltd.
Trial in progress: there are no available conclusions at the time of submission. Trial completion date: Mar 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Dec 2021
- | BVAC-C / Cellid
Trial completion date, Trial primary completion date, Metastases: BVAC-C-P1: Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer (clinicaltrials.gov) - Aug 18, 2021
P1/2, N=32, Active, not recruiting, Sponsor: Cellid Co., Ltd.
Trial completion date: Mar 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Dec 2021 Trial completion date: Dec 2021 --> Mar 2022 | Trial primary completion date: Apr 2021 --> Mar 2022
- BVAC-C / Cellid
[VIRTUAL] Phase IIa study of BVAC-C in HPV type 16 or 18 positive recurrent cervical carcinoma. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_3480;
P1/2
They were allocated to 3 arms; Arm 1, BVAC-C injection at 0, 4, 8 weeks (1x108 cells/dose); Arm 2, BVAC-C injection at 0, 4, 8, 12 weeks (5x107 cells/dose); Arm 3, BVAC-C injection at 0, 4, 8, 12 weeks (5x107 cells/dose) with topotecan at 2, 6, 10, 14 weeks (0.75 mg/m2 for 3 days) . BVAC-C demonstrated a durable antitumor activity with an immune response in HPV 16- or 18-positive recurrent cervical carcinoma patients who failed 1st line platinum based chemotherapy.
- | BVAC-C / Cellid, Imfinzi (durvalumab) / AstraZeneca
New P2 trial, Checkpoint inhibition: DURBAC: Combination of Durvalumab and BVAC-C in Patients With HPV 16 or 18 Positive Cervical Cancer Failure to First-Line Platinum-based Chemotherapy (clinicaltrials.gov) - Mar 15, 2021
P2, N=37, Not yet recruiting, Sponsor: Samsung Medical Center
- | BVAC-C / Cellid
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: BVAC-C-P1: Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer (clinicaltrials.gov) - Dec 10, 2020
P1/2, N=32, Active, not recruiting, Sponsor: Cellid Co., Ltd.
BVAC-C demonstrated a durable antitumor activity with an immune response in HPV 16- or 18-positive recurrent cervical carcinoma patients who failed 1st line platinum based chemotherapy. Recruiting --> Active, not recruiting | Trial completion date: Aug 2020 --> Dec 2021 | Trial primary completion date: Apr 2020 --> Apr 2021
- BVAC-C / Cellid
[VIRTUAL] Phase I study of a B cell-based and monocyte-based immunotherapeutic vaccine, BVAC-C, in human papillomavirus type 16- or 18-positive recurrent cervical cancer (Virtual Meeting: All Session Times Are U.S. EDT) - Apr 13, 2020 - Abstract #AACRI2020AACR-I_123;
BVAC-C was well tolerated and demonstrated a durable anti-tumor activity with an immune response in HPV 16-positive or 18-positive recurrent cervical carcinoma patients. A Phase 2 efficacy trial is currently underway.
- || BVAC-C / Cellid
P1 data, Journal: Phase I Study of a B Cell-Based and Monocyte-Based Immunotherapeutic Vaccine, BVAC-C in Human Papillomavirus Type 16- or 18-Positive Recurrent Cervical Cancer. (Pubmed Central) - Jan 18, 2020
BVAC-C was well tolerated and demonstrated a durable anti-tumor activity with an immune response in HPV 16-positive or 18-positive recurrent cervical carcinoma patients. A Phase 2 efficacy trial is currently underway.
- | BVAC-C / Cellid
Phase classification, Trial primary completion date, Metastases: BVAC-C-P1: Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer (clinicaltrials.gov) - Jul 18, 2018
P1/2, N=30, Recruiting, Sponsor: Cellid Co., Ltd.
A Phase 2 efficacy trial is currently underway. Trial primary completion date: Apr 2018 --> Apr 2020 | Phase classification: P1 --> P1/2
- BVAC-C / Cellid
Trial primary completion date, Metastases: BVAC-C-P1: Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer (clinicaltrials.gov) - Jan 30, 2018
P1, N=9, Recruiting, Sponsor: Cellid Co., Ltd.
Trial primary completion date: Apr 2018 --> Apr 2020 | Phase classification: P1 --> P1/2 Trial primary completion date: Aug 2017 --> Apr 2018
- BVAC-C / Cellid
Enrollment open, Metastases: BVAC-C-P1: Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer (clinicaltrials.gov) - Oct 26, 2016
P1, N=9, Recruiting, Sponsor: Cellid Co., Ltd.
Trial primary completion date: Aug 2017 --> Apr 2018 Not yet recruiting --> Recruiting
- BVAC-C / Cellid
New P1 trial, Metastases: BVAC-C-P1: Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer (clinicaltrials.gov) - Aug 15, 2016
P1, N=9, Not yet recruiting, Sponsor: Cellid Co., Ltd.