High-Risk Skin Cancers With Atezolizumab Plus NT-I7

Part of paid clinical trials in Duarte, California.

Sponsor
NeoImmuneTech
Study ID
NCT03901573
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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)

Key Dates

Start date
Dec 26, 2019
Status verified
Oct 2025
Primary completion
Aug 15, 2023
Completion
Aug 15, 2023

Study Design

Enrollment
31 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Checkpoint Inhibitor-Naive cSCC, MCC Pts
    Anti-PD-1/PD-L1 naïve patients with cSCC and MCC
  • Experimental: Checkpoint Inhibitor-Relapsed/Refractory cSCC MCC Melanoma Pts
    Anti-PD-1/PD-L1 relapsed/refractory patients with cSCC, MCC and melanoma

Primary Outcome Measure

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 [ Time Frame: 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) ]

Locations (8)

FacilityCityStateZIP
City of HopeDuarteCalifornia91010
Northwestern UniversityChicagoIllinois60208
Dana FarberBostonMassachusetts02215
MGHBostonMassachusetts02215
Washington UniversitySt LouisMissouri63110
Mt SinaiNew YorkNew York10029
Cleveland ClinicClevelandOhio44106
Providence Portland Medical CenterPortlandOregon97213

Related coverage on Hipa.ai

Find similar trials in Duarte, CA

By condition
Skin cancerMelanoma
By specialty
OncologySkin cancerDermatology
By research site
City of Hope· Duarte, CANorthwestern University· Chicago, ILDana Farber· Boston, MAMGH· Boston, MAWashington University· St Louis, MOMt Sinai· New York, NY

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