A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Of IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Checkpoint-Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
This Phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the Objective Response Rate (ORR) of IFx-Hu2.0 as an adjunctive therapy to pembrolizumab in adult participants (≥18 years) with advanced or metastatic Merkel Cell Carcinoma. A total of 118 participants will be randomized to receive either IFx-Hu2.0 or placebo via intralesional injection in a single lesion, followed by pembrolizumab.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• At least 18 years of age.
• Life expectancy equal to or greater than six months.
• Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2.
• Must be recurrent and/or unresectable Stage III or Stage IV American Joint Committee on Cancer (AJCC) (8th edition) and have histologically confirmed Merkel cell carcinoma
‣ Must have at least one injectable lesion equal to or greater than 3 mm.
⁃ Must have measurable disease as defined by RECIST v1.1.
• Participants should be CPI naïve i.e., no prior therapy with CPI including but not limited to Pembrolizumab, avelumab, ipilimumab, nivolumab.
• Tumor tissue from an archival core biopsy or resected site of disease must be provided for biomarker analyses. If archival tissue is not available, then a new biopsy should be performed.
• Adequate hematological, hepatic, and renal function according to laboratory ranges and medical criteria defined within the study protocol.
Locations
United States
California
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Stanford Health Care - Skin Cancer Program
RECRUITING
Palo Alto
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
RECRUITING
San Francisco
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
North Carolina
East Carolina University
RECRUITING
Greenville
New Jersey
Atlantic Health System
RECRUITING
Morristown
Virginia
Virginia Commonwealth University - Massey Cancer Center
RECRUITING
Richmond
Washington
Fred Hutchinson Cancer Research Center
RECRUITING
Seattle
Contact Information
Primary
James Bianco, MD
jbianco@tuhurabio.com
8138756600
Time Frame
Start Date:2025-10
Estimated Completion Date:2032-12-30
Participants
Target number of participants:118
Treatments
Experimental: Treatment Arm
Participants randomized to the treatment arm will receive IFx-Hu2.0 (0.1 mg) via intralesional injection in a single lesion once per week for 3 consecutive weeks. Pembrolizumab (200 mg) will be administered intravenously (IV) on Day 1, followed by administration every 3 weeks during the first year of treatment. In the second year, the pembrolizumab dose will be 400 mg every 6 weeks. Pembrolizumab treatment will continue until progressive disease (PD), unacceptable immune-related toxicities, or for a maximum duration of 2 years.
Placebo_comparator: Control Arm
Participants randomized to the control arm will receive placebo (0.9% Sodium Chloride Injection, USP) via intralesional injection in a single lesion once per week for 3 consecutive weeks. Pembrolizumab (200 mg) will be administered IV on Day 1, followed by administration every 3 weeks during the first year of treatment. In the second year, the dose will be 400 mg every 6 weeks. Pembrolizumab treatment will continue until PD, unacceptable immune-related toxicities, or for a maximum duration of 2 years.