Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2023-07-31
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cemiplimab and Pegylated Interferon-alpha (PEG-IFN-alpha)
Cemiplimab administered at 350 mg intravenous (IV) every three weeks for up to 2 years. PEG-IFN-alpha administered subcutaneously weekly at doses of 45 mcg to 135 mcg for up to 1 year. Exact dosing will depend on when the participant is enrolled in the study and the number of serious adverse effects that have been encountered by previous participants, if any.
Cemiplimab-Rwlc
350 mg via IV infusion over 30 minutes every 3 weeks for up to two years
PEG-IFN alfa-2a
Self-administered by the participant via subcutaneous injection in the abdomen or thigh weekly for up to one year. Participants will receive one of three doses:
Dose level 0: 45 mcg
Dose level 1: 90 mcg
Dose level 2: 135 mcg
Dose level 0 is considered the starting dose and sequential cohorts of three participants will be treated with escalated doses until the maximum tolerated dose is established.
Interventions
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Cemiplimab-Rwlc
350 mg via IV infusion over 30 minutes every 3 weeks for up to two years
PEG-IFN alfa-2a
Self-administered by the participant via subcutaneous injection in the abdomen or thigh weekly for up to one year. Participants will receive one of three doses:
Dose level 0: 45 mcg
Dose level 1: 90 mcg
Dose level 2: 135 mcg
Dose level 0 is considered the starting dose and sequential cohorts of three participants will be treated with escalated doses until the maximum tolerated dose is established.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Participants must have histologically or cytologically confirmed aCSCC
* Participants who present with unknown primary SCC at the time of diagnosis will be eligible if participants have a plausible primary skin site removed in the past
* Similarly, participants with neck, parotid or facial lymph nodes biopsy proven SCC with no identifiable mucosal primary would also be eligible
4. Participants must have measurable disease, defined by RECIST v1.1 as at least one lesion that can be accurately measured in at least one dimension of ≥ or equal than 10mm by CT, MRI, positron emission tomography/computed tomography (PET/CT) or ruler/caliper
5. Male or female ≥ 18 years old
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
7. Participants must have normal organ function as defined below:
* Absolute neutrophil count ≥ 1,500/mcl
* Platelets ≥ 75,000
* Aspartate transaminase (AST) or alanine aminotransferase (ALT) \< 2.5 x upper limit of normal or up to 5x Upper Limit of Normal (ULN) if known to be secondary to liver metastasis
* Serum creatinine \< 1.5 or creatinine clearance ≥ 30 ml/min by either Cockcroft-Gault formula or 24-hour urine collection analysis
8. For females of reproductive potential: pregnancy test must be negative (urine or serum), and use of highly effective contraception (like birth control pills and condoms) prior to screening and agreement to use such a method during study participation
9. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
Exclusion Criteria
2. Participants may not be receiving any other investigational agents
3. Pregnancy or lactation
4. Known allergic reactions to components of similar chemical or biologic composition to either cemiplimab or interferon
5. Uncontrolled ongoing illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction \< 30 days, cerebrovascular accident/transient ischemic attack (CVA/TIA) \< 30 days, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
6. Any organ transplant participants on immunosuppressive agents
* Participants with chronic lymphocytic leukemia (CLL) or other hematologic malignancies are allowed as long as they meet all other criteria listed above
7. Patient must not be candidates for curative locoregional treatments
* Participants with recurrent locoregional disease for who a resection is unacceptably morbid and unlikely to be curative are eligible
8. Participants with autoimmune disease on immunosuppressive therapy
9. Participants with a history of non-infectious pneumonitis
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Baptist Health South Florida
OTHER
Responsible Party
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Principal Investigators
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Guilherme Rabinowits, M.D.
Role: PRINCIPAL_INVESTIGATOR
Miami Cancer Institute at Baptist Health, Inc.
Locations
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Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States
Countries
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References
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Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, Lewis KD, Chung CH, Hernandez-Aya L, Lim AM, Chang ALS, Rabinowits G, Thai AA, Dunn LA, Hughes BGM, Khushalani NI, Modi B, Schadendorf D, Gao B, Seebach F, Li S, Li J, Mathias M, Booth J, Mohan K, Stankevich E, Babiker HM, Brana I, Gil-Martin M, Homsi J, Johnson ML, Moreno V, Niu J, Owonikoko TK, Papadopoulos KP, Yancopoulos GD, Lowy I, Fury MG. PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351. doi: 10.1056/NEJMoa1805131. Epub 2018 Jun 4.
Regeneron Pharmaceuticals. LIBTAYO® (cemiplimab-rwlc) [Package Insert] Tarrytown. NY: Regeneron Pharmaceuticals; 2018.
Cornell RC, Greenway HT, Tucker SB, Edwards L, Ashworth S, Vance JC, Tanner DJ, Taylor EL, Smiles KA, Peets EA. Intralesional interferon therapy for basal cell carcinoma. J Am Acad Dermatol. 1990 Oct;23(4 Pt 1):694-700. doi: 10.1016/0190-9622(90)70276-n.
Edwards L, Berman B, Rapini RP, Whiting DA, Tyring S, Greenway HT Jr, Eyre SP, Tanner DJ, Taylor EL, Peets E, et al. Treatment of cutaneous squamous cell carcinomas by intralesional interferon alfa-2b therapy. Arch Dermatol. 1992 Nov;128(11):1486-9.
Kim KH, Yavel RM, Gross VL, Brody N. Intralesional interferon alpha-2b in the treatment of basal cell carcinoma and squamous cell carcinoma: revisited. Dermatol Surg. 2004 Jan;30(1):116-20. doi: 10.1111/j.1524-4725.2004.30020.x.
Tucker SB, Polasek JW, Perri AJ, Goldsmith EA. Long-term follow-up of basal cell carcinomas treated with perilesional interferon alfa 2b as monotherapy. J Am Acad Dermatol. 2006 Jun;54(6):1033-8. doi: 10.1016/j.jaad.2006.02.035.
Related Links
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Miami Cancer Institute
Other Identifiers
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2021-RAB-001
Identifier Type: -
Identifier Source: org_study_id
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