Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424717
Status:
WITHDRAWN
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Brief Title:
Study of Avelumab and Tuvusertib in Participants With Advanced Urothelial Cancer That Has Progressed on Prior Anti-PD-L1 Therapy JAVELIN DDRiver Bladder
Sponsor:
EMD Serono Research Development Institute Inc
Organization:
EMD Serono
Study Overview
Official Title:
A Single Arm Open-label Multicenter Phase 2 Study to Evaluate the Efficacy Safety and Tolerability of Avelumab in Combination With the ATR Inhibitor Tuvusertib in Participants With Advanced Urothelial Carcinoma That Has Progressed on Prior Anti-PD-L1 Therapy JAVELIN DDRiver Bladder
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial withdrawn based on re-prioritization of the clinical development path for tuvusertib No subjects were enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the antitumor activity of avelumab in combination with tuvusertib in terms of objective response in participants with advanced urothelial carcinoma Study details include
ConditionDisease Participants with urothelial carcinoma locally advanced and unresectable or metastatic that has progressed on prior anti-PD-L1 therapy Treatment Duration Participants will be treated until progressive disease death or discontinuation due to eg withdrawal of consent or lost to follow-up Visit Frequency While receiving study intervention participants will visit the site twice per every 21-day study intervention period 1 week after end of study intervention participants will visit the site for an End of Study Intervention Visit followed by 2 Safety Follow-Up visits at 1 and 3 months after last dose and thereafter have remote Long-Term Follow-up every 3 months
Study Duration The overall study is planned to close after the last participant has been followed up for at least 12 months
ConditionDisease Participants with urothelial carcinoma locally advanced and unresectable or metastatic that has progressed on prior anti-PD-L1 therapy Treatment Duration Participants will be treated until progressive disease death or discontinuation due to eg withdrawal of consent or lost to follow-up Visit Frequency While receiving study intervention participants will visit the site twice per every 21-day study intervention period 1 week after end of study intervention participants will visit the site for an End of Study Intervention Visit followed by 2 Safety Follow-Up visits at 1 and 3 months after last dose and thereafter have remote Long-Term Follow-up every 3 months
Study Duration The overall study is planned to close after the last participant has been followed up for at least 12 months
Detailed Description:
None
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 |
|---|---|---|---|
| 2024-511203-42-00 | OTHER | EU CT Number | None |