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High-Risk Skin Cancers With Atezolizumab Plus NT-I7

NCT03901573 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-10-22

Study results available
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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)

Conditions

Interventions

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

Sponsors & Collaborators

  • Immune Oncology Network

    collaborator UNKNOWN

  • NeoImmuneTech

    lead INDUSTRY

Principal Investigators

  • NgocDiep Le, MD, PhD · NeoImmuneTech

  • Martin Cheever, MD · Fred Hutchinson Cancer Center

  • Brian Gastman, MD · The Cleveland Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-26
Primary Completion
2023-08-15
Completion
2023-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03901573 on ClinicalTrials.gov