Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

JRCT ID: jRCT2080224968

Registered date:29/11/2019

Basic Information

• Recruitment status: recruiting
• Health condition(s) or Problem(s) studied: Cutaneous Squamous Cell Carcinoma
• Date of first enrollment: 08/06/2020
• Target sample size: 412
• Countries of recruitment: Australia,Belgium,Brazil,Canada,France,Germany,Greece,Ireland,Italy,New Zealand,Poland,Russian Federation,Spain,United Kingdom,United States,Japan
• Study type: Interventional

Intervention(s)

Cemiplimab arm:
Drug: Cemiplimab (REGN2810)
Intravenous (IV) infusion over 30 minutes

Placebo arm:
Drug: Placebo
Intravenous (IV) infusion over 30 minutes

Outcome(s)

Primary Outcome

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

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 ]
8. Cemiplimab concentrations in serum [ Time Frame: Up to 78 months ]
9. Anti-drug antibodies (ADA) in serum [ Time Frame: Up to 78 months ]

Key inclusion & exclusion criteria

• Age minimum: >= 21age old
• Age maximum: Not applicable
• Gender: Both

Include 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 10 weeks of randomization
- Eastern Cooperative Oncology Group performance status (ECOG PS) <=1
- Adequate hepatic, renal, and bone marrow function as defined in the protocol

Exclude 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 (note: patients with chronic lymphocytic leukemia (CLL) are not excluded if they have not required systemic therapy for CLL within 6 months of enrollment)
- 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

Related Information

• Primary Sponsor: Regeneron Pharmaceuticals, Inc.
• Source(s) of Monetary Support: -
• Secondary ID(s): NCT03969004,2019-000566-38,JapicCTI-195056