Recruiting NCT06947928
Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IFx-Hu2.0, Placebo, Pembrolizumab.
- Who it may be relevant to
- Registry conditions: Advanced Or Metastatic Merkel Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug IFx-Hu2.0
Therapeutic Classification: • Innate immune agonist Route of Administration: • Intralesional - Drug Placebo
Route of Administration: • Intralesional - Drug Pembrolizumab
Therapeutic Classification: • Immunotherapy (Immune checkpoint inhibitor) Route of administration: • Intravenous (IV) infusion
Primary outcome measures
- Objective response rate (ORR) [Time frame: 12 weeks post-treatment initiation and confirmed on a second response assessment at least 28 days after the initial response assessment]
Secondary outcome measures (1)
- Progression free survival (PFS) [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- 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.
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.
- 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.
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 18 centers
- USC Norris Comprehensive Cancer Center — Los Angeles
- University of California San Francisco - Helen Diller Family Comprehensive Cancer Center — San Francisco
- Stanford Health Care - Skin Cancer Program — Stanford
- University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora
- Mayo Clinic Comprehensive Cancer Center — Jacksonville
- Sylvester Comprehensive Cancer Center — Miami
- Moffitt Cancer Center — Tampa
- Dana-Farber Cancer Institute — Boston
- … and 10 more centers
Identifiers
NCT: NCT06947928 · MCC 2021-01