High-Risk Skin Cancers With Atezolizumab Plus NT-I7
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Melanoma
- Merkel Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a Phase 1b/2a, 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-1/PD-L1 naïve or relapsed/refractory high-risk skin cancers including cutaneous Squ...
This is a Phase 1b/2a, 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-1/PD-L1 naïve or relapsed/refractory 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-1/PD-L1 (checkpoint inhibitors, CPI) naïve patients with cSCC and MCC Arm II: Anti-PD-1/PD-L1 relapsed/refractory 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, i.e., 12 patients for each indication, and 36 in Arm II, i.e., 12 patients for each indication).
Tracking Information
- NCT #
- NCT03901573
- Collaborators
- Immune Oncology Network
- Investigators
- Study Chair: NgocDiep Le, MD, PhD NeoImmuneTech, Inc. Study Director: Martin Cheever, MD Fred Hutchinson Cancer Research Center Principal Investigator: Brian Gastman, MD The Cleveland Clinic