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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242173
Recruitment Status : Terminated (Lack of Interest)
First Posted : January 27, 2020
Results First Posted : July 14, 2022
Last Update Posted : November 4, 2022
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cutaneous Squamous Cell Carcinoma
Cutaneous Squamous Cell Carcinoma of the Head and Neck
Intervention Drug: Cemiplimab-Rwlc
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cemiplimab-rwlc Treatment
Hide Arm/Group Description

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)

Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Cemiplimab-rwlc Treatment
Hide Arm/Group Description

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 Number of Baseline Participants 3
Hide Baseline Analysis Population Description
Study terminated early due to lack of interest
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  33.3%
>=65 years
2
  66.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
0
   0.0%
Male
3
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
3
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  33.3%
White
2
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Overall Response Rate
Hide Description

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.

Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected due to low number of patients accrued to study
Arm/Group Title Cemiplimab-rwlc Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Progression Free Survival
Hide Description Progression Free Survival (PFS), defined as time from on study date to disease progression
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected due to low number of patients accrued to study
Arm/Group Title Cemiplimab-rwlc Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival (OS), defined as time from on study date to death from any cause
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected due to low number of patients accrued to study
Arm/Group Title Cemiplimab-rwlc Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected from start of treatment to 30 days after end of treatment, approximately 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cemiplimab-rwlc Treatment
Hide Arm/Group Description

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)

All-Cause Mortality
Cemiplimab-rwlc Treatment
Affected / at Risk (%)
Total   0/3 (0.00%)    
Hide Serious Adverse Events
Cemiplimab-rwlc Treatment
Affected / at Risk (%) # Events
Total   0/3 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cemiplimab-rwlc Treatment
Affected / at Risk (%) # Events
Total   1/3 (33.33%)    
Blood and lymphatic system disorders   
Leukocytosis *  1/3 (33.33%)  1
Metabolism and nutrition disorders   
Hyperkalemia *  1/3 (33.33%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christine Chung
Organization: Moffitt Cancer Center
Phone: 1-813-745-5061
EMail: Christine.Chung@moffitt.org
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT04242173    
Other Study ID Numbers: MCC-20114
First Submitted: January 23, 2020
First Posted: January 27, 2020
Results First Submitted: May 27, 2022
Results First Posted: July 14, 2022
Last Update Posted: November 4, 2022