Ignite Creation Date:
2024-05-06 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05104567
Status:
TERMINATED
Last Update Posted:
2024-03-28
First Post:
2021-10-21
Brief Title:
A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer Master Protocol Pegathor Gastrointestinal 203
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Phase 2 Non-randomized Open-label Multi-cohort Multi-center Study Assessing the Clinical Benefit of SAR444245 THOR-707 Combined With Other Anticancer Therapies for the Treatment of Participants With Advanced and Metastatic Gastrointestinal Cancer
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early discontinuation based on strategic sponsor decision not driven by any safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a phase 2 non-randomized open-label multi-cohort multi-center study assessing the clinical benefit of SAR444245 THOR-707 combined with other anticancer therapies for the treatment of participants aged 18 years and older with advanced and metastatic gastrointestinal cancer This study is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies
Sub study 01 - Cohort A aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic esophageal squamous cell carcinoma ESCC
Sub study 02 - Cohort B1 B2 and B3 would focus on non MSI-H tumors with a large unmet need to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma GCGEJ especially with low PD-L1 expression or after progression on prior PD1PD-L1-based regimens
Sub study 03 - Cohort C aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in participants with advanced unresectable or metastatic HCC who relapsed on prior PD1PD-L1-based regimens
Sub study 04 - Cohort D1 and D2 aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with either the anti-PD1 antibody pembrolizumab or with the anti-EGFR IgG1 antibody cetuximab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic colorectal cancer mCRC
Sub study 01 - Cohort A aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic esophageal squamous cell carcinoma ESCC
Sub study 02 - Cohort B1 B2 and B3 would focus on non MSI-H tumors with a large unmet need to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma GCGEJ especially with low PD-L1 expression or after progression on prior PD1PD-L1-based regimens
Sub study 03 - Cohort C aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in participants with advanced unresectable or metastatic HCC who relapsed on prior PD1PD-L1-based regimens
Sub study 04 - Cohort D1 and D2 aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with either the anti-PD1 antibody pembrolizumab or with the anti-EGFR IgG1 antibody cetuximab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic colorectal cancer mCRC
Detailed Description:
The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 28 days a treatment period max 35 cycles cohort A B1B2 B3 C and D1 735 days or until PD cohort D2 an end-of-treatment visit at least 30 days following the last administration of study drug or until the patient receives another anticancer therapy whichever is earlier and a follow-up visit 3 months after treatment discontinuation and every 3 months following until disease progression or initiation of another antitumor treatment or death whichever is earlier
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-002181-41 | EUDRACT_NUMBER | Merck Sharp Dohme LLC | None |
| U1111-1251-4981 | REGISTRY | None | None |
| MK-3475-B78 | OTHER | None | None |
| KEYNOTE-B78 | OTHER | None | None |