Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
Purpose
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.
Condition
- Advanced Or Metastatic Merkel Cell Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- At least 18 years of age. 2. Life expectancy equal to or greater than six months. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status < 2. 4. 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 1. Must have at least one injectable lesion equal to or greater than 3 mm. 2. Must have measurable disease as defined by RECIST v1.1. 5. Participants should be CPI naïve i.e., no prior therapy with CPI including but not limited to Pembrolizumab, avelumab, ipilimumab, nivolumab. 6. 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. 7. Adequate hematological, hepatic, and renal function according to laboratory ranges and medical criteria defined within the study protocol.
Exclusion Criteria
- 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. 2. 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. 3. Participants with recurrent resectable MCC 4. Participants with prior systemic chemotherapy 5. Pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study. 6. Active, known, or suspected autoimmune disease. Potential Participants with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. Low-grade autoimmune toxicity is NOT an exclusion under this criterion. 7. 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.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
Los Angeles, California 90033
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94143
San Francisco, California 94143
Stanford Health Care - Skin Cancer Program
Stanford, California 94304
Stanford, California 94304
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado 80045
Aurora, Colorado 80045
Mayo Clinic Comprehensive Cancer Center
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Contact:
904-953-2000
904-953-2000
Sylvester Comprehensive Cancer Center
Miami, Florida 33136
Miami, Florida 33136
Moffitt Cancer Center
Tampa, Florida 33612
Tampa, Florida 33612
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Mayo Clinic Comprehensive Cancer Center
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Hackensack University Medical Center
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Atlantic Health System
Morristown, New Jersey 07960
Morristown, New Jersey 07960
East Carolina University
Greenville, North Carolina 27834
Greenville, North Carolina 27834
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
The University of Texas MD Anderson Cancer Center
Houston, Texas 77384
Houston, Texas 77384
Inova Schar Cancer
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Virginia Commonwealth University
Richmond, Virginia 23298
Richmond, Virginia 23298
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
Seattle, Washington 98109
West Virginia University
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
More Details
- Status
- Recruiting
- Sponsor
- TuHURA Biosciences, Inc.