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New treatment option for Advanced Or Metastatic Merkel Cell Carcinoma
Official title Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
ClinicalTrials.gov ID: NCT06947928
What this study is testing
What is IFx-Hu2.0?
IFx-Hu2.0 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced or metastatic merkel cell carcinoma.
Also referred to as pAc/emm55.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Must have at least one injectable lesion equal to or greater than 3 mm.
You likely can't join if
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
- Participants with known active brain metastases with the exception of treated brain metastases that have imaging proving stability at least 4 weeks...
- 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...
See the full eligibility 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.
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Hackensack, New Jersey, United States
- Morristown, New Jersey, United States
- Greenville, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Richmond, Virginia, United States
- Seattle, Washington, United States
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Stanford, California, United States; Aurora, Colorado, United States; Jacksonville, Florida, United States; Miami, Florida, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.