Description:
The primary objective of the study is to compare disease-free survival (DFS) of patients with
high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus
those treated with placebo, after surgery and radiation therapy (RT).
The secondary objectives of the study are:
- To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant
cemiplimab, versus those treated with placebo, after surgery and RT
- To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom
from locoregional recurrence (FFLRR) after surgery and RT
- To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom
from distant recurrence (FFDR) after surgery and RT
- To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative
incidence of second primary CSCC tumors (SPTs) after surgery and RT
- To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC
patients after surgery and RT
Title
- Brief Title: Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
R2810-ONC-1788
- SECONDARY ID:
2019-000566-38
- NCT ID:
NCT03969004
Conditions
- Cutaneous Squamous Cell Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Cemiplimab | REGN2810, Libtayo | Cemiplimab |
Placebo | | Placebo |
Purpose
The primary objective of the study is to compare disease-free survival (DFS) of patients with
high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus
those treated with placebo, after surgery and radiation therapy (RT).
The secondary objectives of the study are:
- To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant
cemiplimab, versus those treated with placebo, after surgery and RT
- To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom
from locoregional recurrence (FFLRR) after surgery and RT
- To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom
from distant recurrence (FFDR) after surgery and RT
- To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative
incidence of second primary CSCC tumors (SPTs) after surgery and RT
- To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC
patients after surgery and RT
Trial Arms
Name | Type | Description | Interventions |
---|
Cemiplimab | Experimental | | |
Placebo | Placebo Comparator | | |
Eligibility Criteria
Key Inclusion Criteria:
- For Japan only, men and women ≥21 years old
- Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or
primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC
lesion previously treated within the draining lymph node echelon), with macroscopic
gross resection of all disease
- High risk CSCC, as defined in the protocol
- Completion of curative intent post-operative radiation therapy (RT) within 2 to 6
weeks of randomization
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1
- Adequate hepatic, renal, and bone marrow function as defined in the protocol
Key Exclusion Criteria:
- Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the
protocol
- Concurrent malignancy other than localized CSCC and/or history of malignancy other
than localized CSCC within 3 years of date of randomization as defined in the protocol
- Patients with hematologic malignancies (eg, chronic lymphocytic leukemia (CLL))
- Patients with history of distantly metastatic CSCC (visceral or distant nodal), unless
the disease-free interval is at least 3 years (regional nodal involvement of disease
in draining lymph node basin that was resected and radiated prior to enrollment will
not be exclusionary)
- Ongoing or recent (within 5 years of randomization date) evidence of significant
autoimmune disease that required treatment with systemic immunosuppressive treatments,
which may suggest risk for immune-related adverse events (irAEs). The following are
not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes,
residual hypothyroidism that required only hormone replacement, or psoriasis that does
not require systemic treatment.
- Has had prior systemic anti-cancer immunotherapy for CSCC
Note: Other protocol defined Inclusion/Exclusion criteria apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause. |
Time Frame: | Up to 54 months |
Safety Issue: | |
Description: | For patients who do not have a tumor recurrence or death, DFS will be censored on the date of last disease assessment. |
Secondary Outcome Measures
Measure: | Overall survival (OS), defined as time from randomization to the date of death. A patient who has not died will be censored on the last known date as alive. |
Time Frame: | Up to 78 months |
Safety Issue: | |
Description: | |
Measure: | FFLRR defined as time from randomization to the date of first locoregional recurrence (LRR). Patients who died without a preceding LRR will be censored on the date of death. |
Time Frame: | Up to 54 months |
Safety Issue: | |
Description: | For patients who do not have a LRR or death, FFLRR will be censored on the date of last disease assessment. |
Measure: | 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. |
Time Frame: | Up to 54 months |
Safety Issue: | |
Description: | For patients who do not have a DR or death, FFDR will be censored on the date of last disease assessment. |
Measure: | 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. |
Time Frame: | Up to 54 months |
Safety Issue: | |
Description: | |
Measure: | Incidence and severity of treatment-emergent adverse events (TEAE) |
Time Frame: | Up to 78 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of deaths |
Time Frame: | Up to 78 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of laboratory abnormalities |
Time Frame: | Up to 78 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Regeneron Pharmaceuticals |
Trial Keywords
Last Updated
May 21, 2021