A Study Evaluating Efficacy and Safety of Multiple Treatment Combinations in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (Morpheus-Head and Neck Cancer)
Head and Neck Cancer
Skin Cancer (Non-Melanoma)
Unknown Primary
18 Years and older, Male and Female
CO43613 (primary)
NCI-2022-06114
Summary
This is a Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants
with locally advanced squamous cell carcinoma of the head and neck (SCCHN). The study will
enroll treatment-naive participants with resectable Stage III-IVA human papillomavirus
(HPV)-negative, programmed death-ligand 1 (PD-L1)-positive SCCHN with measurable disease, as
assessed by the investigator according to Response Evaluation Criteria in Solid Tumors,
Version 1.1 (RECIST v1.1) who have not received systemic treatment for their disease.
Eligibility
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Histologically confirmed, resectable Stage III-IVA SCCHN
- Eligible candidate for R0 resection with curative intent at the time of screening
- HPV-negative test for oropharyngeal carcinoma, as determined locally by p16 immunohistochemistry (IHC), in situ hybridization, or polymerase chain reaction-based assay
- Measurable disease (at least one target lesion), as assessed according to RECIST v1.1
- PD-L1 expression, defined as a combined positive score (CPS) >= 1
- Adequate hematologic and end-organ function
- Negative HIV test with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count >= 200/µL, and have an undetectable viral load.
- Negative hepatitis B surface antigen (HBsAg) test at screening
- Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), Positive total hepatitis B core antibody (HBcAb) followed by a negative quantitative hepatitis B virus (HBV) DNA.
Treatment Sites in Georgia
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