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PD-L1 Inhibitor

NT-I7 + Atezolizumab for High-Risk Skin Cancer

Phase 1 & 2

Waitlist Available

Led By Brian Gastman, MD

Research Sponsored by NeoImmuneTech

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be ≥18 years of age on day of signing informed consent document

Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%)

Must not have

Patients with active tuberculosis (TB)

Patients who have a history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 56 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding NT-I7 to atezolizumab helps patients with high-risk melanoma, MCC, or cSCC who haven't responded to anti-PD-1/PD-L1 treatment or who have relapsed.

Who is the study for?

Adults with high-risk skin cancers like melanoma, Merkel Cell Carcinoma, or cutaneous Squamous Cell Carcinoma. Suitable for those who haven't tried anti-PD-1/PD-L1 drugs or whose cancer returned after such treatments. Must be in good health overall and have a decent performance status.

What is being tested?

The trial is testing if adding NT-I7 to atezolizumab improves outcomes for patients with certain types of skin cancer that are either new to treatment with anti-PD-1/PD-L1 drugs or have not responded well to them.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, fatigue, infusion-related symptoms, and increased risk of infections. The exact side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active tuberculosis.

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I have a history of lung conditions but not active lung inflammation.

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I have a serious heart condition.

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I haven't had major surgery in the last 28 days and don't expect to need one during the study.

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I haven't had signs of infection in the last 2 weeks.

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I have not had a severe infection in the last 4 weeks.

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I have cancer that has spread to the lining of my brain and spinal cord.

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My Type 2 diabetes is not well-managed.

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I haven't taken any immune-weakening drugs in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 56 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 56 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 56 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and Tolerability of NT-I7 in combination with atezolizumab to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of NT-I7

Secondary study objectives

Preliminary assessment of the Objective Response Rate (ORR) of NT-I7 in combination with atezolizumab

Preliminary assessment the Disease Control Rate (DCR) of NT-I7 in combination with atezolizumab

Preliminary assessment the Duration of Objective Response (DOR) of NT-I7 in combination with atezolizumab

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Checkpoint Inhibitor-Relapsed/Refractory cSCC MCC Melanoma PtsExperimental Treatment2 Interventions

Anti-PD-1/PD-L1 relapsed/refractory patients with cSCC, MCC and melanoma

Group II: Checkpoint Inhibitor-Naive cSCC, MCC PtsExperimental Treatment2 Interventions

Anti-PD-1/PD-L1 naïve patients with cSCC and MCC

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

FDA approved

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

NeoImmuneTechLead Sponsor

11 Previous Clinical Trials

532 Total Patients Enrolled

Immune Oncology NetworkUNKNOWN

1 Previous Clinical Trials

14 Total Patients Enrolled

Martin Cheever, MDStudy DirectorFred Hutchinson Cancer Center

NgocDiep Le, MD, PhDStudy ChairNeoImmuneTech, Inc.

Brian Gastman, MDPrincipal InvestigatorThe Cleveland Clinic

3 Previous Clinical Trials

321 Total Patients Enrolled

Media Library

Atezolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03901573 — Phase 1 & 2

$Neuroendocrine Carcinoma Research Study Groups: Checkpoint Inhibitor-Naive cSCC, MCC Pts, Checkpoint Inhibitor-Relapsed/Refractory cSCC MCC Melanoma Pts$