NT-I7 + Atezolizumab for High-Risk Skin Cancer

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen byBrian Gastman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: NeoImmuneTech

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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)

Research Team

NgocDiep Le, MD, PhD

Principal Investigator

NeoImmuneTech

Martin Cheever, MD

Principal Investigator

Fred Hutchinson Cancer Center

Brian Gastman, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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.

Inclusion Criteria

I have MCC, cSCC, or melanoma that didn't respond well to anti-PD-1/L1 treatment.

My organs and bone marrow are working well.

I am 18 years old or older.

See 3 more

Exclusion Criteria

I have active tuberculosis.

You have a history of autoimmune disease.

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

See 16 more

Treatment Details

Interventions

Atezolizumab (PD-L1 Inhibitor)
NT-I7 (Immunostimulant)

Trial OverviewThe 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.

Participant Groups

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