High-Risk Skin Cancers With Atezolizumab Plus NT-I7

NCT03901573 | Terminated Phase 1 Results DMC FDA Drug

• 2 other identifiers: NIT-106ION-02
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 8

Brief 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

Melanoma; Merkel Cell Carcinoma; Cutaneous Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Phase 1b: To Evaluate the Safety and Tolerability of NT-I7 in Combination With Atezolizumab, Including Estimation of the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose

  1. Incidence, nature, and severity of adverse events graded according to NCI CTCAE 5.0 2. Incidence and nature of dose-limiting toxicities (DLTs) Note: ORR (Defined as the percentage of patients who have at least one confirmed partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1). ORR is included in Phase 2a Primary Outcome Measure.

  1. On or after administration of study treatment through 30 days after the last dose of study treatment (approximately 25 months after enrollment) 2.First 21 days (C1/D1 through Day 21)

• Phase 2a: To Evaluate the Objective Response Rate (ORR) According to RECIST 1.1 and iRECIST, as Determined by the Investigator

  Pooling of dose levels for this Outcome Measure was pre-specified in the Statistical Analysis Plan (SAP Section 4.2.1) and the study protocol. Phase 1b dose-escalation results are summarized by dose level (120, 360, 840, 1200 µg/kg), and Phase 2a results under 1200 µg/kg. Efficacy analyses pool Phase 1b doses (120-840 µg/kg) and the Phase 2a 1200 µg/kg dose to reflect the predefined analysis strategy and study objectives. This approach was chosen due to small sample sizes and early study termination, as documented in the Clinical Study Report (CSR).

  C1D1 until the start of a new anticancer treatment, disease progression, pregnancy, death, withdrawal of consent or end of study, whichever occurs first, up to 1 year

Secondary Outcomes (3)

• To Evaluate Immunogenicity of NT-I7 in Combination With Atezolizumab

  C1D1 through end of 90-day follow-up

• To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab

  C1D1 until the start of a new anticancer treatment, disease progression, pregnancy, death, withdrawal of consent or end of study, whichever occurs first, up to 1 year

• To Make a Preliminary Assessment of the Anti-tumor Activity of NT-I7 in Combination With Atezolizumab (DCR)

  C1D1 until the start of a new anticancer treatment, disease progression, pregnancy, death, withdrawal of consent or end of study, whichever occurs first, up to 1 year

Study Arms (2)

Checkpoint Inhibitor-Naive cSCC, MCC Pts

EXPERIMENTAL

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

Drug: NT-I7; Drug: atezolizumab

Checkpoint Inhibitor-Relapsed/Refractory cSCC MCC Melanoma Pts

EXPERIMENTAL

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

Drug: NT-I7; Drug: atezolizumab

Interventions

NT-I7 DRUG

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

Also known as: efineptakin alfa, rhIL-7-hyFc

Checkpoint Inhibitor-Naive cSCC, MCC Pts; Checkpoint Inhibitor-Relapsed/Refractory cSCC MCC Melanoma Pts

atezolizumab DRUG

Dose Escalation - atezolizumab IV (intravenous) on Day 1 of each Cycle Dose Expansion - atezolizumab IV (intravenous) on Day 1 of each Cycle

Also known as: Tecentriq

Checkpoint Inhibitor-Naive cSCC, MCC Pts; Checkpoint Inhibitor-Relapsed/Refractory cSCC MCC Melanoma Pts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be ≥18 years of age on day of signing informed consent document.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%).
• Patients must have adequate organ and marrow function.
• Patients positive for HIV can be considered.
• Arm I - cSCC: Patients must have biopsy-proven metastatic cSCC or locoregional cSCC that has recurred following standard locoregional therapy with surgery and/or radiation therapy; MCC: Patients must have biopsy-proven metastatic MCC or locoregional MCC in need of systemic therapy, including patients that have not had prior systemic therapy or have recurred following standard locoregional therapy with surgery and/or radiation therapy. Prior chemotherapy is allowed.
• Arm II - MCC: Patients must have biopsy-proven metastatic MCC or locoregional MCC that has recurred following anti-PD-1 or anti-PD-L1, or has SD following anti-PD-1 or anti-PD-L1, defined as 12 weeks of SD per RECIST 1.1; cSCC: Patients must have biopsy-proven metastatic cSCC or locoregional cSCC that has recurred following anti-PD-1 or anti-PD-L1, or has SD following anti-PD-1 or anti-PD-L1, defined as 12 weeks of SD per RECIST 1.1; Melanoma: Patients must have biopsy-proven metastatic melanoma or locoregional melanoma that has recurred following anti-PD-1, anti-PD-L1, or has SD following anti-PD-1 or anti-PD-L1, defined as 12 weeks of SD per RECIST 1.1.
• Note: Prior therapy with ipilimumab is allowed (subject to a 6-week washout period) but not required.
• Note: Progression following targeted therapies (e.g., BRAF inhibitor and/or MEK inhibitor) or other approved (e.g., talimogene laherparepvec \[T-VEC\]) or investigational therapies is allowed.

You may not qualify if:

• Pregnancy, lactation, or breastfeeding.
• Significant cardiovascular disease.
• Poorly controlled Type 2 diabetes mellitus.
• Major surgical procedure, other than for diagnosis, within 28 days prior to Cycle 1, Day 1, or anticipation of need for a major surgical procedure during the study.
• Patients who have had chemotherapy or radiotherapy within 2 weeks (4 weeks for nitrosoureas or systemic mitomycin C) prior to Cycle 1, Day 1.
• Patients who had prior treatment with immune CPIs, immunomodulatory monoclonal antibodies (mAbs), and/or mAb-derived therapies within 6 weeks before the initiation of study treatment, except for prior anti-PD-L1/anti-PD-1, which requires a 3-week washout period.
• Patients who have received treatment with any other investigational agent within 4 weeks prior to Cycle 1, Day 1.
• Patients who have received treatment and failed therapy with checkpoint inhibition plus a T-cell growth factor, e.g., IL-2 (NTKR-204), IL-15 (ALT-803) or IL-7 (CYT107).
• Patients with known primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control) are excluded, with some exceptions.
• Patients who have leptomeningeal disease.
• Patients with autoimmune disease history.
• Patients who have received treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1.
• 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.
• Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen \[HBsAg\] test at screening).
• Patients with active tuberculosis (TB).

Sponsors & Collaborators

• NeoImmuneTech: lead
• Immune Oncology Network: collaborator

Study Sites (8)

City of Hope

Duarte, California, 91010, United States

Location

Northwestern University

Chicago, Illinois, 60208, United States

Location

Dana Farber

Boston, Massachusetts, 02215, United States

Location

MGH

Boston, Massachusetts, 02215, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Mt Sinai

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44106, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Merkel Cell

Interventions

efineptakin alfa; atezolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Results Point of Contact

• Title: Alex Oh
• Organization: NeoImmuneTech,INC

aho@neoimmunetech.com

301-337-2283

Study Officials

• NgocDiep Le, MD, PhD

  NeoImmuneTech

  STUDY CHAIR

• Martin Cheever, MD

  Fred Hutchinson Cancer Center

  STUDY DIRECTOR

• Brian Gastman, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 3, 2019
• Study Start: December 26, 2019
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: October 22, 2025
• Results First Posted: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)