A Phase II Randomized Trial of Neoadjuvant Chemotherapy or Chemo-Immunotherapy in Patients with Recurrent/Persistent PD-L1 Enriched Squamous Cell Carcinoma of the Head and Neck Undergoing Salvage Surgery (NEOPOLIS)

Sponsor:

NRG

Sponsor Study ID:

NRG-HN015

CTO #:

104333

NCT Number:

NCT07195734

Phase:

III

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Larynx; Lip, Oral Cavity and Pharynx

Study Objectives:

Event free survival (EFS) [Time Frame: From randomization to disease progression or treatment-related toxicities that precludes surgery, disease progression in the absence of surgery, disease recurrence after surgery, or death due to any cause, up to 7 years] Will be summarized by treatment arm using standard Kaplan-Meier methods, reporting the estimated 2-year EFS rate with corresponding 95% confidence intervals.

eConsent:

Not available

Study Documents:

Open Study Documents
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