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.
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
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
Parallel
IFx-Hu2.0
DrugTherapeutic Classification: • Innate immune agonist Route of Administration: • Intralesional
Placebo
DrugRoute of Administration: • Intralesional
Pembrolizumab
DrugTherapeutic Classification: • Immunotherapy (Immune checkpoint inhibitor) Route of administration: • Intravenous (IV) infusion
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.
Progression free survival (PFS)
PFS is defined as the time (months) from the date of randomization to the date of the documented PD based on BICR assessment according to RECIST v1.1, or death, whichever occurs first. Participants without progression or death will be censored on the date of last disease assessment.
Click on the lead sponsor to view all of their trials.
