Ignite Creation Date:
2024-05-06 @ 1:46 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04123470
Status:
COMPLETED
Last Update Posted:
2023-08-29
First Post:
2019-10-09
Brief Title:
A Phase III Trial Investigating LOAd703 in Combination With Atezolizumab in Malignant Melanoma
Sponsor:
Lokon Pharma AB
Organization:
Lokon Pharma AB
Study Overview
Official Title:
A Phase III Trial Investigating LOAd703 in Combination With Atezolizumab in Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate safety and effect of combining an oncolytic adenovirus delolimogene mupadenorepvec LOAd703 with atezolizumab in patients with melanoma LOAd703 will be administered intratumorally for up to 12 injections while atezolizumab will be administered intravenously for the duration of the active study visits up to 57 weeks The patients are then monitored for survival for maximum study participation of 48 months The treatments will be given every 3 weeks The patients will then be monitored for toxicity PK ADA immune responses virus shedding tumor response by RECIST 11 and survival
Detailed Description:
This is a single arm open-label multicenter trial This study aims to evaluate safety and effect of combining an oncolytic adenovirus delolimogene mupadenorepvec LOAd703 with atezolizumab in patients with melanoma Patients will receive up to 12 LOAd703 intratumoral treatments in combination with intravenous infusions of atezolizumab LOAd703 will be tested at two dose levels to determine the maximum tolerated dose MTD of LOAd703 evaluated in the study using a BOIN design The LOAd703 dose can be divided for intratumoral injection into as many as 3 tumor lesions Atezolizumab will be tested at a fixed dose At least 25 response evaluable patients will be enrolled at the MTD for evaluation of their response using binominal testing The maximum number of evaluable patients in the study is 35 The patients will then be monitored for toxicity PK ADA immune responses virus shedding tumor response by RECIST 11 and survival
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 |
|---|---|---|---|
| 2019-003300-12 | EUDRACT_NUMBER | None | None |