NCT03901573

High-Risk Skin Cancers With Atezolizumab Plus NT-I7

A Phase 1b/2a, 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-1/PD-L1 naïve or Relapsed/Refractory High-risk Skin Cancers

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: NeoImmuneTech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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-1/PD-L1 naive or relapsed/refractory high-risk melanoma, Merkel Cell Carcinoma (MCC) and cutaneous Squamous Cell Carcinoma (cSCC)

Detailed 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 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).

Conditions

• Melanoma
• Merkel Cell Carcinoma
• Cutaneous Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	NT-I7	Dose Escalation (Phase 1b) - NT-I7 IM (intramuscular) on Day 1 of each Cycle until MTD or RP2D is achieved. Dose Expansion - NT-I7 IM (intramuscular) on Day 1 of each Cycle, at Maximum Tolerated Dose (MTD) or RP2D defined in escalation phase
DRUG	atezolizumab	Dose Escalation - atezolizumab IV (intravenous) on Day 1 of each Cycle Dose Expansion - atezolizumab IV (intravenous) on Day 1 of each Cycle

Timeline

• Start date: 2019-12-26
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2019-04-03
• Last updated: 2025-10-22
• Results posted: 2025-10-22

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study