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Cutaneous Squamous Cell CarcinomaPhase 1NCT05729139

Cemiplimab/Peg-Interferon-α in Advanced CSCC

A Phase 1 study testing Cemiplimab-Rwlc and PEG-IFN alfa-2a in people with Cutaneous Squamous Cell Carcinoma and Squamous Cell Carcinoma, run by Baptist Health South Florida at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The primary purpose of this research study is to test the safety and possible harms of cemiplimab/peg-interferon-alpha, when it is given to participants at different dose levels. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cemiplimab-Rwlc and PEG-IFN alfa-2a
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jul 2023to Jul 2028
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • 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
  • 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
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  • Male or female ≥ 18 years old
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  • 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
  • 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
  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Who cannot join

  • Participants who have had chemotherapy, immunotherapy or targeted therapy within 21 days of protocol treatment initiation, or those who have not recovered to grade 1 CTCAE adverse events due to agents administered ≥ 3 weeks earlier
  • Participants may not be receiving any other investigational agents
  • Pregnancy or lactation
  • Known allergic reactions to components of similar chemical or biologic composition to either cemiplimab or interferon
  • 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
  • Any organ transplant participants on immunosuppressive agents
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  • Participants with chronic lymphocytic leukemia (CLL) or other hematologic malignancies are allowed as long as they meet all other criteria listed above
  • 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
  • Participants with autoimmune disease on immunosuppressive therapy
  • Participants with a history of non-infectious pneumonitis

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

Other trials in United States

About this study

Official title: Cemiplimab/PEG-Interferon-α Combination for Advanced Cutaneous Squamous Cell Carcinoma (aCSCC)

The primary purpose of this research study is to test the safety and possible harms of cemiplimab/peg-interferon-alpha, when it is given to participants at different dose levels. The researchers want to find out what effects (good and bad) cemiplimab/Peg-Interferon has on participants with advanced cutaneous squamous cell carcinoma (aCSCC) so that they can find the best dose to treat aCSCC and reduce side effects as much as possible.

Being tested
Cemiplimab-Rwlc, PEG-IFN alfa-2a
Keywords
cemiplimab, peg-interferon-alpha
Medical subject headings
Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cemiplimab-RwlcDrug

    Also called Libtayo

    350 mg via IV infusion over 30 minutes every 3 weeks for up to two years

  • PEG-IFN alfa-2aDrug

    Also called PEGASYS

    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.

Study groups in NCT05729139
Study groupRoleWhat they receive
Cemiplimab and Pegylated Interferon-alpha (PEG-IFN-alpha)ExperimentalCemiplimab 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.
Receives: Drug: Cemiplimab-Rwlc; Drug: PEG-IFN alfa-2a

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Incidence of Dose Limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs) Leading to Discontinuation or Death

    DLT rate by dose level, frequency distribution of treated participants with AE using the worst common terminology criteria grade. Participants will be counted only (1) once at the preferred term level, (2) once at the system organ class level, and (3) once in the "total participant" row at their worst common terminology criteria grade, regardless of system organ class or preferred term.

    The DLT window of observation will be during treatment cycle 1 only (i.e., during the first 21-day cycle; adverse events (AEs) meeting the definition of a DLT but occurring after this period will not be considered DLTs). The occurrence of certain toxicities during treatment cycle 1 will be considered a DLT, if assessed by the investigator to be possibly related or related to PEG-IFN-α and/or cemiplimab.

    Measured: 2 years

Secondary outcomes (4)

  1. Response Rate (RR)

    RR is defined as the proportion of participants whose best overall response is complete (CR) or partial (PR).

    Measured: 2 years

  2. Duration of Response (DOR)

    DOR is defined as the amount of time from the initiation of study therapy to the first documented disease progression or death due to any cause, whichever occurs first in participants who had achieved CR or PR.

    Measured: 2 years

  3. Progression-free Survival (PFS)

    PFS is defined as the time from the initiation of study therapy to the first documented disease progression or death due to any cause, whichever occurs first

    Measured: 2 years

  4. Overall Survival (OS)

    OS is defined as the time from the initiation of study therapy to death due to any cause or date of last follow-up, whichever occurs first.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2023
  2. Study startJul 2023 (estimated)
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2028 (estimated)

Why it stopped: PI is leaving institution prior to study opening for accrual.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05729139
Sponsor's protocol ID
2021-RAB-001
Status last verified
Aug 2023
First submitted
6 Feb 2023
Last updated
9 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29863979

  • 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.

    PubMed 2229497

  • 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.

    PubMed 1444502

  • 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.

    PubMed 14692941

  • 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.

    PubMed 16713458

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cemiplimab-Rwlc and PEG-IFN alfa-2a in people with Cutaneous Squamous Cell Carcinoma and Squamous Cell Carcinoma, run by Baptist Health South Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Incidence of Dose Limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs) Leading to Discontinuation or Death (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05729139, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.

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