Medical College of Wisconsin
The investigators propose a phase II signal-finding study, TRIFECTA-SCC, to determine whether four 100 mg IV every 6 week doses of vilastobart plus six every 4 week doses of Opdualag with induction radiotherapy can lead to ≥50% 6-month progression-free survival for patients with recurrent and/or metastatic squamous cell carcinoma. Patients with pathology-confirmed squamous cell carcinoma, previously untreated in the recurrent and/or metastatic setting, and adequate organ function will be included.
Inclusion Criteria: * Patients 18 years or older with pathology-confirmed recurrent and/or metastatic (R/M) squamous cell carcinoma (SCC) who have not received systemic therapy specifically for R/M SCC. Tumors reported as mixed histology are ineligible. Patients must have 1-5 R/M lesions. Contiguous matted nodal conglomerates will be counted as a single lesion. * Initial primary site of disease is not restricted and may include the head and neck, lung, skin, urogenital, gynecological, anal canal, gastrointestinal, or squamous cell carcinoma of an unknown primary site. * Patients must have mea…
35 Gy in five fractions to all eligible lesions.
four vilastobart 100 mg IV doses every 6 weeks at Weeks 0, 6, 12, and 18
six Opdualag doses every 4 weeks at Weeks 0, 4, 8, 12, 16, and 20
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