A Randomized Placebo-Controlled Double-Blind Study of Adjuvant Cemiplimab Versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma (CSCC); R2810-ONC-1788

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Men and women =18 years old (for Japan only, men and women =21 years old). 2. Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC lesion previously treated within the draining lymph node echelon), with macroscopic gross resection of all disease. 3. High risk CSCC, as defined by at least 1 of the following: a. Nodal disease with extracapsular extension (ECE)* and at least 1 node >20 mm on the surgical pathology report.*ECE is defined as extension through the lymph node capsule into the surrounding connective tissue, with or without associated stromal reaction. Unambiguous evidence of gross ECE (defined as invasion of skin, infiltration of musculature/fixation to adjacent structures on clinical examination) is a sufficiently high threshold to classify these as ECE positive. b. In-transit metastases (ITM), defined as skin or subcutaneous metastases that are > 2 cm from the primary lesion but are not beyond the regional nodal basin. c. T4 lesion, including HN lesions and non-HN lesions. d. Perineural invasion (PNI), defined as clinical and/or radiologic involvement of named nerves. e. Recurrent CSCC, defined as CSCC that arises within the area of the previously resected tumor, plus at least 1 of the following additional features: • =N2b disease associated with the recurrent lesion • Nominal =T3 (recurrent lesion =4 cm in diameter or minor bone erosion or deep invasion >6 mm measured from the granular layer of normal adjacent epithelium). • Poorly differentiated histology and =20 mm diameter of recurrent lesion. The recurrent tumor must be documented to be within the area of the previously resected CSCC by radial measurement of the greatest radius of the final defect, measured from the estimated center of the original surgical wound

You may not be eligible for this study if the following are true:

  • 1. Squamous cell carcinomas (SCCs) arising in non-cutaneous sites (eg, dry red lip [vermillion], oral cavity, oropharynx, paranasal sinus, larynx, hypopharynx, nasopharynx, salivary gland, nasal mucosa, anogenital area, or SCC nodal metastasis with unknown primary). 2. Concurrent malignancy other than localized CSCC and/or history of malignancy other than localized CSCC within 3 years of date of randomization, except for tumors with negligible risk of metastasis or death, such as adequately treated (BCC) of the skin, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast, or low-risk early stage prostate adenocarcinoma (T1-T2aN0M0 and Gleason score =6 and prostate-specific antigen (PSA) =10 ng/mL) for which the management plan is active surveillance, or prostate adenocarcinoma with biochemical-only recurrence with documented PSA doubling time of >12 months for which the management plan is active surveillance. 3. Patients with hematologic malignancies (eg, chronic lymphocytic leukemia [CLL]).

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