Trial Outcomes & Findings for Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC (NCT NCT04242173)

NCT ID: NCT04242173

Last Updated: 2022-11-04

Results Overview

Overall Response Rate (ORR) as indicated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 analysis of radiologic scans. In some patients, response assessments include photos and radiologic scans and will be evaluated by composite efficacy criteria. Clinical lesions will only be considered measurable when they are superficial (eg, skin nodules and palpable lymph nodes) and ≥10 mm (≥1 cm) diameter as assessed using calipers (e.g., skin nodules). Patients who are deemed as not evaluable according to RECIST 1.1 or inevaluable by the composite efficacy criteria will be considered as not reaching ORR.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: Up to 12 months
• Results posted on: 2022-11-04

Participant Flow

Participant milestones

Measure	Cemiplimab-rwlc Treatment Immunocompromised patients will be given Cemiplimab-rwlc every 3 weeks Cemiplimab-Rwlc: Cemiplimab-rwlc will be administered as a flat dose of 350 mg IV over approximately 30 minutes every 21 days (+/- 3 days)
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC

Baseline characteristics by cohort

Measure	Cemiplimab-rwlc Treatment n=3 Participants Immunocompromised patients will be given Cemiplimab-rwlc every 3 weeks Cemiplimab-Rwlc: Cemiplimab-rwlc will be administered as a flat dose of 350 mg IV over approximately 30 minutes every 21 days (+/- 3 days)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: Data was not collected due to low number of patients accrued to study

Overall Response Rate (ORR) as indicated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 analysis of radiologic scans. In some patients, response assessments include photos and radiologic scans and will be evaluated by composite efficacy criteria.

Clinical lesions will only be considered measurable when they are superficial (eg, skin nodules and palpable lymph nodes) and ≥10 mm (≥1 cm) diameter as assessed using calipers (e.g., skin nodules). Patients who are deemed as not evaluable according to RECIST 1.1 or inevaluable by the composite efficacy criteria will be considered as not reaching ORR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Population: Data was not collected due to low number of patients accrued to study

Progression Free Survival (PFS), defined as time from on study date to disease progression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Population: Data was not collected due to low number of patients accrued to study

Overall Survival (OS), defined as time from on study date to death from any cause

Outcome measures

Outcome data not reported

Adverse Events

Cemiplimab-rwlc Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cemiplimab-rwlc Treatment n=3 participants at risk Immunocompromised patients will be given Cemiplimab-rwlc every 3 weeks Cemiplimab-Rwlc: Cemiplimab-rwlc will be administered as a flat dose of 350 mg IV over approximately 30 minutes every 21 days (+/- 3 days)
Blood and lymphatic system disorders Leukocytosis	33.3% 1/3 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after end of treatment, approximately 7 months
Metabolism and nutrition disorders Hyperkalemia	33.3% 1/3 • Number of events 1 • Adverse events were collected from start of treatment to 30 days after end of treatment, approximately 7 months

Additional Information

Christine Chung

Moffitt Cancer Center

Phone: 1-813-745-5061

Email: Christine.Chung@moffitt.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place