A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)

Conditions

Stage II to IV cutaneous squamous cell carcinoma

Brief summary

The primary endpoint is pathologic complete response (pCR) rate assessed by independent central pathology review

Detailed description

Major pathologic response (mPR) rate assessed by independent central pathology review, pCR rate assessed by local pathology review, mPR rate assessed by local pathology review, Objective response rate (ORR) prior to surgery, according to investigator assessment using RECIST 1.1, Event free survival (EFS), Disease free survival (DFS), Overall survival (OS), Incidence of adverse events (AEs), Incidence of serious adverse events (SAEs), Incidence of deaths, Incidence of laboratory abnormalities, Change in surgical plan in the screening period versus actual surgery after neoadjuvant cemiplimab, Change in post-surgical management plan in the screening period versus actual post-surgical management

Related papers

No related papers found yet.

Interventions

DRUGLIBTAYO 350 mg concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is pathologic complete response (pCR) rate assessed by independent central pathology review	—

Secondary

Measure	Time frame
Major pathologic response (mPR) rate assessed by independent central pathology review, pCR rate assessed by local pathology review, mPR rate assessed by local pathology review, Objective response rate (ORR) prior to surgery, according to investigator assessment using RECIST 1.1, Event free survival (EFS), Disease free survival (DFS), Overall survival (OS), Incidence of adverse events (AEs), Incidence of serious adverse events (SAEs), Incidence of deaths, Incidence of laboratory abnormalities, Change in surgical plan in the screening period versus actual surgery after neoadjuvant cemiplimab, Change in post-surgical management plan in the screening period versus actual post-surgical management	—

Measure

Time frame

Major pathologic response (mPR) rate assessed by independent central pathology review, pCR rate assessed by local pathology review, mPR rate assessed by local pathology review, Objective response rate (ORR) prior to surgery, according to investigator assessment using RECIST 1.1, Event free survival (EFS), Disease free survival (DFS), Overall survival (OS), Incidence of adverse events (AEs), Incidence of serious adverse events (SAEs), Incidence of deaths, Incidence of laboratory abnormalities, Change in surgical plan in the screening period versus actual surgery after neoadjuvant cemiplimab, Change in post-surgical management plan in the screening period versus actual post-surgical management

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Countries

Germany

Outcome results

None listed