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Soo Park, MD
Soo Park, MD
Posted: Tuesday, December 10, 2024
A phase II/III trial is underway to investigate a novel neoantigen therapy in combination with the PD-L1 inhibitor pembrolizumab for treatment of resectable locally advanced cutaneous squamous cell carcinoma (SCC). Recruiting for this study is currently ongoing across 21 countries and will be conducted by Ann W. Silk, MD, MS, of Dana-Farber Cancer Institute, Boston, and colleagues. The design of this open-label, randomized, adaptive study (INTerpath-007) was presented at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting (Abstract 652).
“V940 (mRNA-4157) is a novel individualized neoantigen therapy that encodes up to 34 neoantigens specifically tailored for each patient, derived from their tumor-specific mutational profile. V940 plus pembrolizumab significantly improved recurrence-free survival over pembrolizumab alone for completely resected, high-risk, stage IIIB/C/D and IV cutaneous melanoma,” stated the study investigators.
Patients with histologically confirmed resectable stage II to IV cutaneous SCC with no metastases who had not received prior systemic therapy will be enrolled in phase II (n = 600). Patients will be randomly assigned (5:5:2) to receive surgery plus intravenous pembrolizumab (600 mg every 6 weeks) plus intramuscular (IM) V940 (1 mg every 3 weeks) plus surgery, pembrolizumab plus surgery, or surgery alone. Radiation will be allowed in all arms, according to physician’s choice.
If the study progresses into phase III, additional patients will be assigned to receive surgery plus pembrolizumab plus IM V940 (1 mg every 3 weeks) plus surgery or pembrolizumab plus surgery (n = 412 and 1,012, respectively). Imaging will be performed at screening and at regular intervals for each group. The primary endpoint is to determine event-free survival in patients treated with pembrolizumab and V940 in comparison to surgery with or without pembrolizumab. Additional endpoints include pathologic complete response and overall survival.
Disclosure: No disclosure information was provided.
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