Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099418
Status:
WITHDRAWN
Last Update Posted:
2024-06-28
First Post:
2023-10-19
Brief Title:
Efficacy and Safety of VB1016 Alone or in Combination With Atezolizumab in Patients With Advanced Cervical Cancer
Sponsor:
Nykode Therapeutics ASA
Organization:
Nykode Therapeutics ASA
Study Overview
Official Title:
A Two-Arm Randomized Double-Blind Placebo-Controlled Phase 2 Selection Trial to Evaluate the Efficacy and Safety of VB1016 Alone or in Combination With Atezolizumab in Patients With HPV16-Positive PD-L1-positive Recurrent or Metastatic Cervical Cancer Who Are Refractory to Pembrolizumab With Chemotherapy WithWithout Bevacizumab
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial VB-C-04 was stopped due to company strategic reasons and recent changes in standard of care in the recurrent and metastatic cervical cancer setting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center study in patients with recurrent or metastatic HPV16-positive PD-L1 positive cervical cancer who has progressed during or after treatment with the first-line standard of care pembrolizumab with chemotherapy withwithout bevacizumab
The trial is designed to investigate VB1016 alone or in combination with the immune checkpoint inhibitor atezolizumab
The trial consist of 2 parts the first part which investigates VB1016 placebo versus VB1016 atezolizumab Approximately 30 patients will be included in each group The goal of this part is to evaluate which of the two treatments is the best
The second part of the study will select the best treatment from part 1 and investigate the safety and efficacy of additional 70 patients
The trial is designed to investigate VB1016 alone or in combination with the immune checkpoint inhibitor atezolizumab
The trial consist of 2 parts the first part which investigates VB1016 placebo versus VB1016 atezolizumab Approximately 30 patients will be included in each group The goal of this part is to evaluate which of the two treatments is the best
The second part of the study will select the best treatment from part 1 and investigate the safety and efficacy of additional 70 patients
Detailed Description:
This is a two-arm randomized double-blind placebo-controlled phase 2 selection trial to evaluate the efficacy and safety of VB1016 alone or in combination with atezolizumab in patients with HPV16-positive PD-L1-positive recurrent or metastatic cervical cancer who are refractory to pembrolizumab with chemotherapy withwithout bevacizumab A selection design with a margin of practical equivalence will be implemented to monitor efficacy of the two experimental arms VB1016 atezolizumab vs VB1016 placebo
The trial consist of 2 parts the first part which investigates VB1016 placebo versus VB1016 atezolizumab Approximately 30 patients will be included in each group The goal of this part is to evaluate which of the two treatments is the superior
The second part of the study will select the superior treatment from part 1 and investigate the safety and efficacy of additional 70 patients
The trial consist of 2 parts the first part which investigates VB1016 placebo versus VB1016 atezolizumab Approximately 30 patients will be included in each group The goal of this part is to evaluate which of the two treatments is the superior
The second part of the study will select the superior treatment from part 1 and investigate the safety and efficacy of additional 70 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-3091 | OTHER | GOG Foundation | None |