Ignite Creation Date:
2024-05-06 @ 12:59 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03901573
Status:
TERMINATED
Last Update Posted:
2024-02-22
First Post:
2019-03-26
Brief Title:
High-Risk Skin Cancers With Atezolizumab Plus NT-I7
Sponsor:
NeoImmuneTech
Organization:
NeoImmuneTech
Study Overview
Official Title:
A Phase 1b2a Open Label Study to Evaluate Anti-tumor Efficacy and Safety of rhIL-7-hyFc NT-I7 in Combination With Anti-PD-L1 Atezolizumab in Patients With Anti-PD-1PD-L1 naïve or RelapsedRefractory High-risk Skin Cancers
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Strategic decision by sponsor
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 test whether the addition of NT-I7 to atezolizumab provides clinically meaningful outcomes for patients with anti-PD-1PD-L1 naive or relapsedrefractory high-risk melanoma Merkel Cell Carcinoma MCC and cutaneous Squamous Cell Carcinoma cSCC
Detailed Description:
This is a Phase 1b2a open-label multicenter study to evaluate the safety tolerability and anti-tumor effect of NT-I7 rhIL-7-hyFc in combination with atezolizumab MPDL3280A anti-PD-L1 in patients with anti-PD-1PD-L1 naïve or relapsedrefractory high-risk skin cancers including cutaneous Squamous Cell Carcinoma cSCC Merkel Cell Carcinoma MCC and melanoma
This study has been designed to evaluate the safety and tolerability including the Maximum Tolerated Dose MTD or recommended Phase 2 dose RP2D of NT-I7 in combination with atezolizumab
There are two phases to this study
Phase 1b a NT-I7 dose-escalation phase to determine the MTD or RP2D
Phase 2a a non-randomized parallel dose expansion phase to confirm the MTD or RP2D in both arms
Arm I Anti-PD-1PD-L1 checkpoint inhibitors CPI naïve patients with cSCC and MCC
Arm II Anti-PD-1PD-L1 relapsedrefractory patients with cSCC MCC and melanoma
Number of Patients A total of up to 84 patients will be enrolled Up to 24 patients will be enrolled in the Phase 1b up to 6 patients per dose level using 3 3 design and 60 patients will be enrolled in the Phase 2a 24 patients in Arm I ie 12 patients for each indication and 36 in Arm II ie 12 patients for each indication
This study has been designed to evaluate the safety and tolerability including the Maximum Tolerated Dose MTD or recommended Phase 2 dose RP2D of NT-I7 in combination with atezolizumab
There are two phases to this study
Phase 1b a NT-I7 dose-escalation phase to determine the MTD or RP2D
Phase 2a a non-randomized parallel dose expansion phase to confirm the MTD or RP2D in both arms
Arm I Anti-PD-1PD-L1 checkpoint inhibitors CPI naïve patients with cSCC and MCC
Arm II Anti-PD-1PD-L1 relapsedrefractory patients with cSCC MCC and melanoma
Number of Patients A total of up to 84 patients will be enrolled Up to 24 patients will be enrolled in the Phase 1b up to 6 patients per dose level using 3 3 design and 60 patients will be enrolled in the Phase 2a 24 patients in Arm I ie 12 patients for each indication and 36 in Arm II ie 12 patients for each indication
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 |
|---|---|---|---|
| ION-02 | OTHER | Immune Oncology Network | None |