Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650709
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
NEoadjuvant Olaparib Combination OvArian Cancer Targeted Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Proof of Concept Trial Investigating the Safety and Efficacy of the Neoadjuvant Triplet Olaparib Durvalumab and Bevacizumab in Advanced FIGO Stage IV High Grade Serous Ovarian Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEOCATS
Brief Summary:
The goal of this phase 2 clinical trial is to learn if the three treatments olaparib durvalumab and bevacizumab can treat participants with a diagnosis of stage 4 high grade serous ovarian cancer that is too advanced to undergo upfront surgery
The main questions it aims to answer are
Is the treatment able to shrink the cancer sufficiently for participants to undergo surgery Is the combination of treatments safe in this neoadjuvant before surgery setting This is a single arm study with no comparator arm
Participants will receive the treatment up to 3 cycles with each drug given as follows in a 28-day cycle
Olaparib orally on a twice daily continuous dosing schedule Durvalumab given intravenously on day 1 Bevacizumab given intravenously on day 1 and 15 Day 15 omitted in C3
Participants will be assessed throughout the study for safety and efficacy endpoints
The main questions it aims to answer are
Is the treatment able to shrink the cancer sufficiently for participants to undergo surgery Is the combination of treatments safe in this neoadjuvant before surgery setting This is a single arm study with no comparator arm
Participants will receive the treatment up to 3 cycles with each drug given as follows in a 28-day cycle
Olaparib orally on a twice daily continuous dosing schedule Durvalumab given intravenously on day 1 Bevacizumab given intravenously on day 1 and 15 Day 15 omitted in C3
Participants will be assessed throughout the study for safety and efficacy endpoints
Detailed Description:
This is a single arm proof of concept phase 2 study Subjects with a suspected or confirmed diagnosis of high grade serous ovarian cancer who are not thought to be candidates for primary debulking surgery and are considered candidates for neoadjuvant chemotherapy and are not known to have BRCA mutation associated HGSOC will be considered for the trial
Patients will be given the following triplet therapy for 2 cycles Olaparib 300mg PO BID continuous dosing Durvalumab 1500mg IV day 1 Bevacizumab 10mgkg IV on day 1 and 15 of a 28-day cycle
Patients that respond to the therapy following 2 cycles will receive 1 further cycle followed by interval cytoreductive surgery planned 3-4 weeks after completion of cycle 3 and at least 28 days from the last dose of Bevacizumab
Following surgery patients will revert back to standard of care SOC treatment and receive up to 6 cycles of chemotherapy followed by SOC recommended maintenance treatments as determined by the local treating oncology teams
All subsequent treatments received and their response will be recorded as part of the study data collection up to and including first documented progression
Patients that do not respond to the therapy after 2 cycles will discontinue the triplet therapy and switch to salvage standard of care treatment
Patients will be given the following triplet therapy for 2 cycles Olaparib 300mg PO BID continuous dosing Durvalumab 1500mg IV day 1 Bevacizumab 10mgkg IV on day 1 and 15 of a 28-day cycle
Patients that respond to the therapy following 2 cycles will receive 1 further cycle followed by interval cytoreductive surgery planned 3-4 weeks after completion of cycle 3 and at least 28 days from the last dose of Bevacizumab
Following surgery patients will revert back to standard of care SOC treatment and receive up to 6 cycles of chemotherapy followed by SOC recommended maintenance treatments as determined by the local treating oncology teams
All subsequent treatments received and their response will be recorded as part of the study data collection up to and including first documented progression
Patients that do not respond to the therapy after 2 cycles will discontinue the triplet therapy and switch to salvage standard of care treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None