Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04785820
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2021-03-04
Brief Title:
A Study of Lomvastomig RO7121661 and Tobemstomig RO7247669 Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A 3-Arm Randomized Blinded Active-Controlled Phase II Study of RO7121661 a PD1-TIM3 Bispecific Antibody and RO7247669 a PD1-LAG3 Bispecific Antibody Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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 is a Phase II randomized blinded active-controlled global multicenter study designed to evaluate the safety and efficacy of lomvastomig and tobemstomig compared with nivolumab in patients with advanced or metastatic esophageal squamous-cell carcinoma ESCC refractory or intolerant to fluoropyrimidine- or taxane- and platinum-based regimen
Following approval of the protocol amendment version 3 recruitment into the lomvastomig arm has been stopped The decision to stop recruitment for lomvastomig was based on strategic considerations and not based on emerging safety andor efficacy data The benefitrisk assessment for lomvastomig remains unchanged
The study was planned to enroll participants randomized in a 111 ratio to receive lomvastomig tobemstomig or nivolumab With version 3 of the protocol recruitment into the lomvastomig arm has stopped and moving forward participants will be randomized in a 11 ratio to receive either tobemstomig or nivolumab
Following approval of the protocol amendment version 3 recruitment into the lomvastomig arm has been stopped The decision to stop recruitment for lomvastomig was based on strategic considerations and not based on emerging safety andor efficacy data The benefitrisk assessment for lomvastomig remains unchanged
The study was planned to enroll participants randomized in a 111 ratio to receive lomvastomig tobemstomig or nivolumab With version 3 of the protocol recruitment into the lomvastomig arm has stopped and moving forward participants will be randomized in a 11 ratio to receive either tobemstomig or nivolumab
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 |
|---|---|---|---|
| 2020-004606-60 | EUDRACT_NUMBER | None | None |