Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
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
1 other identifier
interventional
118
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2025
Longer than P75 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2025
CompletedFirst Posted
Study publicly available on registry
April 27, 2025
CompletedStudy Start
First participant enrolled
December 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2032
April 17, 2026
April 1, 2026
1.3 years
April 14, 2025
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR)
ORR defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) at 12 weeks and confirmed on a second response assessment at least 28 days after the initial response assessment, in the treatment arm based on BICR assessment according to RECIST v1.1. Confirmed response persisting at the time of response assessment, at approximately 24 weeks will constitute the data utilized for the endpoint analysis.
12 weeks post-treatment initiation and confirmed on a second response assessment at least 28 days after the initial response assessment
Secondary Outcomes (1)
Progression free survival (PFS)
Up to 5 years
Study Arms (2)
Treatment Arm
EXPERIMENTALParticipants 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.
Control Arm
PLACEBO COMPARATORParticipants 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.
Interventions
Therapeutic Classification: • Innate immune agonist Route of Administration: • Intralesional
Therapeutic Classification: • Immunotherapy (Immune checkpoint inhibitor) Route of administration: • Intravenous (IV) infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with protocol requirements.
- Participants with known active brain metastases with the exception of treated brain metastases that have imaging proving stability at least 4 weeks prior to the start of study treatment, no new metastases, and not requiring steroids.
- Participants with recurrent resectable MCC
- Participants with prior systemic chemotherapy
- Pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study.
- A condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143, United States
Stanford Health Care - Skin Cancer Program
Stanford, California, 94304, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Mayo Clinic Comprehensive Cancer Center
Jacksonville, Florida, 32224, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic Comprehensive Cancer Center
Rochester, Minnesota, 55905, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Atlantic Health System
Morristown, New Jersey, 07960, United States
East Carolina University
Greenville, North Carolina, 27834, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77384, United States
Inova Schar Cancer
Fairfax, Virginia, 22031, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew S Brohl, MD
Collaborator
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
April 14, 2025
First Posted
April 27, 2025
Study Start
December 11, 2025
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
December 30, 2032
Last Updated
April 17, 2026
Record last verified: 2026-04