Ignite Creation Date:
2024-05-06 @ 2:42 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04394624
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2020-05-14
Brief Title:
Tusamitamab Ravtansine SAR408701 in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Pretreated Patients With NSQ NSCLC CARMEN-LC04
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Open-label Single-arm Trial to Evaluate Antitumor Activity Safety and Pharmacokinetics of Tusamitamab Ravtansine SAR408701 Used in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Metastatic Non-squamous Non Small-cell Lung Cancer NSQ NSCLC Patients With CEACAM5-positive Tumors Previously Treated With Platinum-based Chemotherapy and an Immune Checkpoint Inhibitor
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
CARMEN-LC04
Brief Summary:
Primary Objectives
Doublet Cohort
Part 1 safety run-in
To assess the tolerability and to confirm the recommended dose of tusamitamab ravtansine in combination with ramucirumab in the NSQ NSCLC population
Part 2
To assess the antitumor activity of tusamitamab ravtansine in combination with ramucirumab in the NSQ NSCLC population
Triplet cohort
To assess the tolerability and to confirm the recommended dose of tusamitamab ravtansine in combination with ramucirumab and pembrolizumab in the NSQ NSCLC population
Secondary Objectives
Doublet Cohort
To assess the safety and tolerability of tusamitamab ravtansine in combination with ramucirumab
To assess the durability of the response to treatment with tusamitamab ravtansine in combination with ramucirumab
To assess anti-tumor activity of tusamitamab ravtansine in combination with ramucirumab on progression free survival PFS and disease control rate DCR
To assess the pharmacokinetic PK profiles of tusamitamab ravtansine SAR408701 and ramucirumab when given in combination
To assess the immunogenicity of tusamitamab ravtansine SAR408701 when given in combination with ramucirumab
Triplet cohort
To assess the safety and tolerability of tusamitamab ravtansine in combination with ramucirumab and pembrolizumab
To assess the antitumor activity of tusamitamab ravtansine in combination with ramucirumab and pembrolizumab in the NSQ NSCLC population
To assess the immunogenicity of tusamitamab ravtansine when given in combination with ramucirumab and pembrolizumab
Doublet Cohort
Part 1 safety run-in
To assess the tolerability and to confirm the recommended dose of tusamitamab ravtansine in combination with ramucirumab in the NSQ NSCLC population
Part 2
To assess the antitumor activity of tusamitamab ravtansine in combination with ramucirumab in the NSQ NSCLC population
Triplet cohort
To assess the tolerability and to confirm the recommended dose of tusamitamab ravtansine in combination with ramucirumab and pembrolizumab in the NSQ NSCLC population
Secondary Objectives
Doublet Cohort
To assess the safety and tolerability of tusamitamab ravtansine in combination with ramucirumab
To assess the durability of the response to treatment with tusamitamab ravtansine in combination with ramucirumab
To assess anti-tumor activity of tusamitamab ravtansine in combination with ramucirumab on progression free survival PFS and disease control rate DCR
To assess the pharmacokinetic PK profiles of tusamitamab ravtansine SAR408701 and ramucirumab when given in combination
To assess the immunogenicity of tusamitamab ravtansine SAR408701 when given in combination with ramucirumab
Triplet cohort
To assess the safety and tolerability of tusamitamab ravtansine in combination with ramucirumab and pembrolizumab
To assess the antitumor activity of tusamitamab ravtansine in combination with ramucirumab and pembrolizumab in the NSQ NSCLC population
To assess the immunogenicity of tusamitamab ravtansine when given in combination with ramucirumab and pembrolizumab
Detailed Description:
The expected duration of the study intervention for participants may vary based on progression date median expected duration of study per participant is estimated 11 months up to 1 month for screening a median of 6 months for treatment and a median of 4 months for end-of-treatment assessments and safety follow-up visit
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 |
|---|---|---|---|
| 2019-003914-15 | EUDRACT_NUMBER | ICTRP | None |
| U1111-1244-1585 | REGISTRY | None | None |