Basal Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, Non-Small Cell Lung Cancer, Oropharynx Squamous Cell Carcinoma, Triple Negative Breast Cancer
Conditions
Keywords
vidutolimod, Metastatic Cancer, Advanced Cancer, MCC, CSCC, BCC, TNBC, NSCLC, OPSCC
Brief summary
The goal of this study is to learn if giving cemiplimab and vidutolimod together could be effective in treating advanced cancer. The main questions it aims to answer are: * How many participants' cancers respond to vidutolimod together with cemiplimab? * Is vidutolimod together with cemiplimab safe and well-tolerated? * How well does vidutolimod together with cemiplimab treat participants' cancer? Participants will receive trial treatment for up to 2 years. 30 days after stopping treatment, participants will have a follow-up visit. After that visit, the trial staff will continue to follow up with participants about every 3 months, until the trial ends.
Detailed description
Former Sponsor Checkmate Pharmaceuticals Note: Early termination planned on 31Oct2024 due to study drug supply
Interventions
DRUGvidutolimod
Participants will receive vidutolimod for up to 2 years as follows: 10 mg IT weekly for 7 doses after which vidutolimod will be administered every 3 weeks (Q3W). The first dose of vidutolimod may be administered subcutaneously (SC) or IT at the discretion of Investigator. All subsequent doses will be IT. The initial 7 doses of vidutolimod, delivered on a weekly dosing schedule, must be completed before starting the Q3W vidutolimod dosing schedule.
DRUGcemiplimab
Participants will receive cemiplimab for up to 2 years as follows: 350 mg IV infusion over 30 minutes at week 1 dose 1 (W1D1) and Q3W thereafter.
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Participants enrolled in the study must meet all of the following inclusion criteria to be eligible. 1. Histopathologically-confirmed diagnosis of cancer, as defined by the protocol. 2. Measurable disease, as defined by RECIST v1.1 and as defined in the protocol. Note: CSCC, MCC and BCC subjects without radiographically measurable disease are not excluded if there is at least 1 lesion ≥ 10 mm in at east 1 dimension documented by color photography. 3. Adequate organ function based on most recent laboratory values within 3 weeks before first dose of study treatment on Week 1 Day 1 (W1D1), as defined in the protocol. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening. Key
Exclusion criteria
Participants presenting with any of the following will not qualify for entry into the study: 1. Received radiation therapy (or other non-systemic therapy) within 2 weeks before first dose of study treatment on W1D1. Participants should have recovered (i.e. Grade ≤ 1 or at baseline) from radiation-related toxicities. 2. Had major surgeries (including complete oncologic resection) within last 4 weeks prior to enrollment, and/or have not recovered adequately from the toxicities and/or complications from the intervention. Minor surgeries (including routine resections of early stage CSCCs and BCCs that may be due to field cancerization) require a 7-day washout. 3. Received systemic pharmacologic doses of corticosteroids \> 10 mg/day prednisone within 15 days before first dose of study treatment on W1D1, as defined in the protocol. 4. History of immune-mediated AE leading to permanent discontinuation due to prior PD-1-blocking antibody. 5. Not fully recovered from AEs due to prior treatment (to Grade 1 or less, per Common Terminology Criteria for Adverse Events (CTCAE), with the exception of persistent vitiligo, alopecia, hypothyroidism, diabetes mellitus, and adrenal and/or pituitary insufficiency. 6. Active pneumonitis or history of noninfectious pneumonitis that required steroids. 7. Severe uncontrolled medical disease within 12 months of screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis, cerebrovascular accident, or implanted or continuous use of a pacemaker or defibrillator, or emphysema with FEV1 ≤ 50% predicted. 8. Known history of immunodeficiency. 9. Known additional malignancy that is progressing or required active treatment within the past 3 years, as defined in the protocol. 10. Active autoimmune disease that required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment. 11. Untreated, symptomatic, or enlarging central nervous system metastases or carcinomatous meningitis (including leptomeningeal metastases from solid tumors). NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 31.5 Months | ORR is defined as the Percent of participants with a confirmed objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Up to 31.5 months | Number of participants with any treatment-emergent adverse event (TEAE), any serious TEAE, and any TEAE leading to discontinuation or death reported. |
| Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Up to 31.5 months | Number of participants per NCI CTCAE version 5.0 Adverse Event Grade reported: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care activities of daily living Grade 4 Life-threatening consequences: urgent intervention indicated Grade 5 Death related to adverse event |
| Duration of Response (DOR) | Up to 31.5 months | DOR is defined as the time from date of first documented response (CR or PR) to date of documented progressive disease (PD), based on RECIST v1.1, per investigator |
| Progression Free Survival (PFS) | Up to 31.5 months | PFS is defined as the time from date of first dose of study treatment to date of documented PD based on RECIST v1.1 or death, whichever occurs first |
| Overall Survival (OS) | Up to 31.5 months | OS is defined as the time from date of first dose of study treatment to date of death |
Countries
Australia, United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort A1: CMP-001+Cemiplimab for CSCC Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule | 25 |
| Cohort A2: CMP-001+Cemiplimab for CSCC Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule | 19 |
| Cohort B1: CMP-001+Cemiplimab for MCC Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule | 13 |
| Cohort B2: CMP-001+Cemiplimab for MCC Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule | 16 |
| Cohort D: CMP-001+Cemiplimab for BCC Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \[PD-L1\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule | 4 |
| Total | 77 |
Baseline characteristics
| Characteristic | Cohort A1: CMP-001+Cemiplimab for CSCC | Total | Cohort D: CMP-001+Cemiplimab for BCC | Cohort B2: CMP-001+Cemiplimab for MCC | Cohort B1: CMP-001+Cemiplimab for MCC | Cohort A2: CMP-001+Cemiplimab for CSCC |
|---|---|---|---|---|---|---|
| Age, Continuous | 70.5 Years STANDARD_DEVIATION 14.09 | 68.8 Years STANDARD_DEVIATION 12.46 | 54.5 Years STANDARD_DEVIATION 9.4 | 69.2 Years STANDARD_DEVIATION 13.2 | 71.0 Years STANDARD_DEVIATION 11.55 | 67.9 Years STANDARD_DEVIATION 9.42 |
| Race/Ethnicity, Customized American Indian / Alaskan Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Participants | 6 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 21 Participants | 70 Participants | 4 Participants | 15 Participants | 12 Participants | 18 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 5 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 22 Participants | 68 Participants | 4 Participants | 15 Participants | 12 Participants | 15 Participants |
| Sex: Female, Male Female | 6 Participants | 23 Participants | 0 Participants | 5 Participants | 5 Participants | 7 Participants |
| Sex: Female, Male Male | 19 Participants | 54 Participants | 4 Participants | 11 Participants | 8 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 8 / 25 | 8 / 19 | 4 / 13 | 9 / 16 | 0 / 4 |
| other Total, other adverse events | 24 / 25 | 19 / 19 | 13 / 13 | 15 / 16 | 4 / 4 |
| serious Total, serious adverse events | 14 / 25 | 11 / 19 | 6 / 13 | 11 / 16 | 2 / 4 |
Outcome results
Primary
Objective Response Rate (ORR)
ORR is defined as the Percent of participants with a confirmed objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment
Time frame: Up to 31.5 Months
Population: Full Analysis Set (FAS) includes all enrolled participants who received any study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A1: CMP-001+Cemiplimab for CSCC | Objective Response Rate (ORR) | 44.0 Percentage of participants |
| Cohort A2: CMP-001+Cemiplimab for CSCC | Objective Response Rate (ORR) | 5.3 Percentage of participants |
| Cohort B1: CMP-001+Cemiplimab for MCC | Objective Response Rate (ORR) | 46.2 Percentage of participants |
| Cohort B2: CMP-001+Cemiplimab for MCC | Objective Response Rate (ORR) | 6.3 Percentage of participants |
| Cohort D: CMP-001+Cemiplimab for BCC | Objective Response Rate (ORR) | 25.0 Percentage of participants |
Secondary
Duration of Response (DOR)
DOR is defined as the time from date of first documented response (CR or PR) to date of documented progressive disease (PD), based on RECIST v1.1, per investigator
Time frame: Up to 31.5 months
Population: Number of participants analyzed for DOR included only participants with confirmed complete response (CR) or partial response (PR)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A1: CMP-001+Cemiplimab for CSCC | Duration of Response (DOR) | 11.3 Months |
| Cohort A2: CMP-001+Cemiplimab for CSCC | Duration of Response (DOR) | NA Months |
| Cohort B1: CMP-001+Cemiplimab for MCC | Duration of Response (DOR) | NA Months |
| Cohort B2: CMP-001+Cemiplimab for MCC | Duration of Response (DOR) | NA Months |
| Cohort D: CMP-001+Cemiplimab for BCC | Duration of Response (DOR) | NA Months |
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death
Number of participants with any treatment-emergent adverse event (TEAE), any serious TEAE, and any TEAE leading to discontinuation or death reported.
Time frame: Up to 31.5 months
Population: Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1: CMP-001+Cemiplimab for CSCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE | 25 Participants |
| Cohort A1: CMP-001+Cemiplimab for CSCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any serious TEAE | 14 Participants |
| Cohort A1: CMP-001+Cemiplimab for CSCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE leading to discontinuation | 5 Participants |
| Cohort A1: CMP-001+Cemiplimab for CSCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE leading to death | 4 Participants |
| Cohort A2: CMP-001+Cemiplimab for CSCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE | 19 Participants |
| Cohort A2: CMP-001+Cemiplimab for CSCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE leading to death | 0 Participants |
| Cohort A2: CMP-001+Cemiplimab for CSCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any serious TEAE | 10 Participants |
| Cohort A2: CMP-001+Cemiplimab for CSCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE leading to discontinuation | 4 Participants |
| Cohort B1: CMP-001+Cemiplimab for MCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE leading to death | 0 Participants |
| Cohort B1: CMP-001+Cemiplimab for MCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any serious TEAE | 6 Participants |
| Cohort B1: CMP-001+Cemiplimab for MCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE leading to discontinuation | 3 Participants |
| Cohort B1: CMP-001+Cemiplimab for MCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE | 13 Participants |
| Cohort B2: CMP-001+Cemiplimab for MCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE | 16 Participants |
| Cohort B2: CMP-001+Cemiplimab for MCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any serious TEAE | 11 Participants |
| Cohort B2: CMP-001+Cemiplimab for MCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE leading to death | 1 Participants |
| Cohort B2: CMP-001+Cemiplimab for MCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE leading to discontinuation | 4 Participants |
| Cohort D: CMP-001+Cemiplimab for BCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE leading to death | 0 Participants |
| Cohort D: CMP-001+Cemiplimab for BCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE leading to discontinuation | 0 Participants |
| Cohort D: CMP-001+Cemiplimab for BCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any serious TEAE | 2 Participants |
| Cohort D: CMP-001+Cemiplimab for BCC | Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death | Any TEAE | 4 Participants |
Secondary
Overall Survival (OS)
OS is defined as the time from date of first dose of study treatment to date of death
Time frame: Up to 31.5 months
Population: Full Analysis Set (FAS) includes all enrolled participants who received any study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A1: CMP-001+Cemiplimab for CSCC | Overall Survival (OS) | 15.6 Months |
| Cohort A2: CMP-001+Cemiplimab for CSCC | Overall Survival (OS) | 12.7 Months |
| Cohort B1: CMP-001+Cemiplimab for MCC | Overall Survival (OS) | NA Months |
| Cohort B2: CMP-001+Cemiplimab for MCC | Overall Survival (OS) | 9.9 Months |
| Cohort D: CMP-001+Cemiplimab for BCC | Overall Survival (OS) | NA Months |
Secondary
Progression Free Survival (PFS)
PFS is defined as the time from date of first dose of study treatment to date of documented PD based on RECIST v1.1 or death, whichever occurs first
Time frame: Up to 31.5 months
Population: Full Analysis Set (FAS) includes all enrolled participants who received any study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort A1: CMP-001+Cemiplimab for CSCC | Progression Free Survival (PFS) | 10.3 Months |
| Cohort A2: CMP-001+Cemiplimab for CSCC | Progression Free Survival (PFS) | 2.0 Months |
| Cohort B1: CMP-001+Cemiplimab for MCC | Progression Free Survival (PFS) | 10.4 Months |
| Cohort B2: CMP-001+Cemiplimab for MCC | Progression Free Survival (PFS) | 3.7 Months |
| Cohort D: CMP-001+Cemiplimab for BCC | Progression Free Survival (PFS) | NA Months |
Secondary
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Number of participants per NCI CTCAE version 5.0 Adverse Event Grade reported: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care activities of daily living Grade 4 Life-threatening consequences: urgent intervention indicated Grade 5 Death related to adverse event
Time frame: Up to 31.5 months
Population: Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1: CMP-001+Cemiplimab for CSCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 1 Mild | 2 Participants |
| Cohort A1: CMP-001+Cemiplimab for CSCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 2 Moderate | 6 Participants |
| Cohort A1: CMP-001+Cemiplimab for CSCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 3 Severe | 11 Participants |
| Cohort A1: CMP-001+Cemiplimab for CSCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 4 Life-threatening | 1 Participants |
| Cohort A1: CMP-001+Cemiplimab for CSCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 5 Death | 4 Participants |
| Cohort A1: CMP-001+Cemiplimab for CSCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Missing | 1 Participants |
| Cohort A2: CMP-001+Cemiplimab for CSCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 5 Death | 0 Participants |
| Cohort A2: CMP-001+Cemiplimab for CSCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Missing | 0 Participants |
| Cohort A2: CMP-001+Cemiplimab for CSCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 1 Mild | 2 Participants |
| Cohort A2: CMP-001+Cemiplimab for CSCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 3 Severe | 10 Participants |
| Cohort A2: CMP-001+Cemiplimab for CSCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 4 Life-threatening | 1 Participants |
| Cohort A2: CMP-001+Cemiplimab for CSCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 2 Moderate | 6 Participants |
| Cohort B1: CMP-001+Cemiplimab for MCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 4 Life-threatening | 3 Participants |
| Cohort B1: CMP-001+Cemiplimab for MCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 5 Death | 0 Participants |
| Cohort B1: CMP-001+Cemiplimab for MCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 1 Mild | 2 Participants |
| Cohort B1: CMP-001+Cemiplimab for MCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 3 Severe | 2 Participants |
| Cohort B1: CMP-001+Cemiplimab for MCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 2 Moderate | 6 Participants |
| Cohort B1: CMP-001+Cemiplimab for MCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Missing | 0 Participants |
| Cohort B2: CMP-001+Cemiplimab for MCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 4 Life-threatening | 1 Participants |
| Cohort B2: CMP-001+Cemiplimab for MCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 2 Moderate | 4 Participants |
| Cohort B2: CMP-001+Cemiplimab for MCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 3 Severe | 8 Participants |
| Cohort B2: CMP-001+Cemiplimab for MCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Missing | 0 Participants |
| Cohort B2: CMP-001+Cemiplimab for MCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 5 Death | 1 Participants |
| Cohort B2: CMP-001+Cemiplimab for MCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 1 Mild | 2 Participants |
| Cohort D: CMP-001+Cemiplimab for BCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 5 Death | 0 Participants |
| Cohort D: CMP-001+Cemiplimab for BCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 3 Severe | 3 Participants |
| Cohort D: CMP-001+Cemiplimab for BCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 2 Moderate | 1 Participants |
| Cohort D: CMP-001+Cemiplimab for BCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Missing | 0 Participants |
| Cohort D: CMP-001+Cemiplimab for BCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 4 Life-threatening | 0 Participants |
| Cohort D: CMP-001+Cemiplimab for BCC | Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 1 Mild | 0 Participants |