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

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)

Brief summary

DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause.

Detailed description

Overall survival (OS), defined as time from randomization to the date of death., FFLRR defined as time from randomization to the date of first locoregional recurrence (LRR)., Freedom from distant recurrence (FFDR), defined as time from randomization to the date of first distant recurrence (DR). Patients who died without a preceding DR will be censored on the date of death., Cumulative occurrence of second primary cutaneous squamous cell carcinoma tumor (SPTs) for each patient from randomization to occurrence of first primary endpoint event or end of study., Safety, as measured by the incidence and severity of treatment-emergent adverse events (TEAE), deaths, and laboratory abnormalities., Cemiplimab concentrations in serum and immunogenicity as measured in ADA in serum

Related papers

No related papers found yet.

Interventions

DRUGLIBTAYO 350 mg concentrate for solution for infusion.

DRUGmatching Placebo with R2810

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause.	—

Secondary

Measure	Time frame
Overall survival (OS), defined as time from randomization to the date of death., FFLRR defined as time from randomization to the date of first locoregional recurrence (LRR)., Freedom from distant recurrence (FFDR), defined as time from randomization to the date of first distant recurrence (DR). Patients who died without a preceding DR will be censored on the date of death., Cumulative occurrence of second primary cutaneous squamous cell carcinoma tumor (SPTs) for each patient from randomization to occurrence of first primary endpoint event or end of study., Safety, as measured by the incidence and severity of treatment-emergent adverse events (TEAE), deaths, and laboratory abnormalities., Cemiplimab concentrations in serum and immunogenicity as measured in ADA in serum	—

Measure

Time frame

Overall survival (OS), defined as time from randomization to the date of death., FFLRR defined as time from randomization to the date of first locoregional recurrence (LRR)., Freedom from distant recurrence (FFDR), defined as time from randomization to the date of first distant recurrence (DR). Patients who died without a preceding DR will be censored on the date of death., Cumulative occurrence of second primary cutaneous squamous cell carcinoma tumor (SPTs) for each patient from randomization to occurrence of first primary endpoint event or end of study., Safety, as measured by the incidence and severity of treatment-emergent adverse events (TEAE), deaths, and laboratory abnormalities., Cemiplimab concentrations in serum and immunogenicity as measured in ADA in serum

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Countries

Belgium, France, Germany, Greece, Ireland, Italy, Poland, Spain

Outcome results

None listed