OncoMatch/Clinical Trials/NCT06947928
Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
Is NCT06947928 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including IFx-Hu2.0 and Pembrolizumab for advanced or metastatic merkel cell carcinoma.
Treatment: IFx-Hu2.0 · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: checkpoint inhibitor (pembrolizumab, avelumab, ipilimumab, nivolumab)
no prior therapy with CPI including but not limited to Pembrolizumab, avelumab, ipilimumab, nivolumab
Cannot have received: systemic chemotherapy
Participants with prior systemic chemotherapy
Lab requirements
Blood counts
adequate hematological function according to laboratory ranges and medical criteria defined within the study protocol
Kidney function
adequate renal function according to laboratory ranges and medical criteria defined within the study protocol
Liver function
adequate hepatic function according to laboratory ranges and medical criteria defined within the study protocol
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford Health Care - Skin Cancer Program · Palo Alto, California
- University of California San Francisco - Helen Diller Family Comprehensive Cancer Center · San Francisco, California
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Atlantic Health System · Morristown, New Jersey
- East Carolina University · Greenville, North Carolina
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify