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History of Changes for Study: NCT03969004
Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
Latest version (submitted July 20, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 28, 2019 None (earliest Version on record)
2 June 24, 2019 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 October 3, 2019 Study Status and Contacts/Locations
4 November 13, 2019 Study Status and Contacts/Locations
5 January 14, 2020 Study Status and Contacts/Locations
6 March 18, 2020 Contacts/Locations and Study Status
7 April 21, 2020 Study Status, IPDSharing and Contacts/Locations
8 July 7, 2020 Contacts/Locations and Study Status
9 August 7, 2020 Contacts/Locations and Study Status
10 November 2, 2020 Contacts/Locations and Study Status
11 November 20, 2020 Contacts/Locations and Study Status
12 December 16, 2020 Contacts/Locations and Study Status
13 February 5, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
14 April 20, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
15 May 20, 2021 Study Status and Contacts/Locations
16 January 27, 2022 Contacts/Locations, Study Status, Eligibility, Outcome Measures and Study Description
17 July 20, 2022 Contacts/Locations, Study Status and Study Description
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Study NCT03969004
Submitted Date:  May 28, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: R2810-ONC-1788
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
Secondary IDs: 2019-000566-38 [EudraCT Number]
Open or close this module Study Status
Record Verification: May 2019
Overall Status: Not yet recruiting
Study Start: June 5, 2019
Primary Completion: June 10, 2025 [Anticipated]
Study Completion: March 6, 2026 [Anticipated]
First Submitted: May 6, 2019
First Submitted that
Met QC Criteria:
May 28, 2019
First Posted: May 31, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
May 28, 2019
Last Update Posted: May 31, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Regeneron Pharmaceuticals
Responsible Party: Sponsor
Collaborators: Sanofi
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

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
Detailed Description:
Open or close this module Conditions
Conditions: Cutaneous Squamous Cell Carcinoma
Keywords: High risk
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 412 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Cemiplimab Drug: Cemiplimab
Intravenous (IV) infusion over 30 minutes
Other Names:
  • REGN2810
  • Libtayo
Placebo Comparator: Placebo Drug: Placebo
Intravenous (IV) infusion over 30 minutes
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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 ]

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:
1. 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 ]

2. 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 ]

For patients who do not have a LRR or death, FFLRR will be censored on the date of last disease assessment.
3. 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 ]

For patients who do not have a DR or death, FFDR will be censored on the date of last disease assessment.
4. 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 ]

5. Incidence and severity of treatment-emergent adverse events (TEAE)
[ Time Frame: Up to 78 months ]

6. Incidence of deaths
[ Time Frame: Up to 78 months ]

7. Incidence of laboratory abnormalities
[ Time Frame: Up to 78 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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

Open or close this module Contacts/Locations
Central Contact Person: Clinical Trials Administrator
Telephone: 844-734-6643
Email: clinicaltrials@regeneron.com
Study Officials: Clinical Trial Management
Study Director
Regeneron Pharmaceuticals
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame:
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Access Criteria:
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://errs.regeneron.com/external
Open or close this module References
Citations:
Links:
Available IPD/Information:

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