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DRUG:

BVAC-C

i
Other names: BVAC-C
Associations
Company:
Cellid
Drug class:
Immunostimulant
Related drugs:
Associations
7ms
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, Front Immunol)
Patients were allocated to 3 arms; Arm 1, BVAC-C injection at 0, 4, 8 weeks; Arm 2, BVAC-C injection at 0, 4, 8, 12 weeks; Arm 3, BVAC-C injection at 0, 4, 8, 12 weeks with topotecan at 2, 6, 10, 14 weeks. Further studies are needed to identify potential biomarkers of response. ClinicalTrials.gov, identifier NCT02866006.
P1/2 data • Clinical Trial,Phase I • Clinical Trial,Phase II • Journal • IO biomarker
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IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha)
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topotecan • BVAC-C
1year
AN OPEN LABEL, SINGLE ARM, MULTICENTER TRIAL OF DURVALUMAB AND BVAC-C, IN PATIENTS WITH HPV 16 OR 18 POSITIVE CERVICAL CANCER (DURBAC) (IGCS 2023)
The trial focuses on patients with HPV 16 or 18 positive cervical cancer that is recurrent after or refractory to first-line platinum-based chemotherapy +/- bevacizumab. Part A, encompassing 9 patients, concluded in June 2022. Currently, Part B is actively enrolling patients with 15 participants enrolled so far.
Clinical • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden)
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PD-L1 expression
|
Avastin (bevacizumab) • Imfinzi (durvalumab) • BVAC-C
2years
BVAC-C-P1: Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer (clinicaltrials.gov)
P1/2, N=32, Completed, Cellid Co., Ltd. | Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Jun 2022
Trial completion • Trial completion date • Metastases
|
CD4 (CD4 Molecule)
|
topotecan • BVAC-C
over2years
BVAC-C-P1: Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer (clinicaltrials.gov)
P1/2, N=32, Active, not recruiting, Cellid Co., Ltd. | Trial completion date: Mar 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Dec 2021
Trial completion date • Trial primary completion date
|
CD4 (CD4 Molecule)
|
topotecan • BVAC-C
over3years
BVAC-C-P1: Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer (clinicaltrials.gov)
P1/2, N=32, Active, not recruiting, Cellid Co., Ltd. | Trial completion date: Dec 2021 --> Mar 2022 | Trial primary completion date: Apr 2021 --> Mar 2022
Clinical • Trial completion date • Trial primary completion date
|
CD4 (CD4 Molecule)
|
topotecan • BVAC-C