Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05878288




Registration number
NCT05878288
Ethics application status
Date submitted
17/04/2023
Date registered
26/05/2023
Date last updated
27/10/2023

Titles & IDs
Public title
Deep sequencIng in Cutaneous Squamous CEll caRciNomas
Scientific title
Comprehensive and Deep Profiling in Cutaneous Squamous Cell Carcinomas to Unravel Treatment Efficacy in Immunotherapy Treated Patients
Secondary ID [1] 0 0
HREC/88736/PMCC-2022-326880
Universal Trial Number (UTN)
Trial acronym
DISCERN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous Squamous Cell Carcinoma 0 0
Cutaneous Squamous Cell Carcinoma of the Head and Neck 0 0
Neoplasms 0 0
Non-melanoma Skin Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cemiplimab

Other: Cemiplimab - Cemiplimab 350 mg intravenously every 3 weeks for up to 12 weeks (up to 4 doses), or until unacceptable toxicity, disease progression, or withdrawal of consent.


Treatment: Drugs: Cemiplimab
Cemiplimab 50 mg/mL supplied as a sterile liquid in single-use glass vials.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of successful execution and generation of data from single-cell RNA sequencing and genomic profiling (including whole exome sequencing, RNA sequencing and immunohistochemistry) of CSCC from patients treated with immunotherapy
Timepoint [1] 0 0
At 72 months
Secondary outcome [1] 0 0
To evaluate pathological response rates (cPR, mPR defined as <10% viable tumour, and other).
Timepoint [1] 0 0
Estimated 48 months
Secondary outcome [2] 0 0
To evaluate ORR using computed tomography (CT) scan imaging assessed by RECIST 1.1
Timepoint [2] 0 0
Estimated 48 months
Secondary outcome [3] 0 0
To evaluate ORR using computed tomography (CT) scan imaging assessed by imRECIST
Timepoint [3] 0 0
Estimated 48 months
Secondary outcome [4] 0 0
To summarise immune-related adverse events (AE) > grade 2, AESI, AEs > grade 3 and SAEs, according to CTCAE v5.0.
Timepoint [4] 0 0
At 72 months
Secondary outcome [5] 0 0
To evaluate DFS rates.
Timepoint [5] 0 0
Estimated 48 months
Secondary outcome [6] 0 0
To evaluate OS rates.
Timepoint [6] 0 0
Estimated 48 months

Eligibility
Key inclusion criteria
1. Stage II to IV (M0) CSCC who are candidates for surgery, but who have an increased
risk of recurrence and/or risk of disfigurement or loss of function. Patients with
stage III or IV (M0) CSCC of the head/neck, extremity, or trunk are eligible, and
patients with stage II CSCC (=3 cm longest diameter in an aesthetically sensitive
region).

2. At least one measurable lesion per RECIST 1.1.

3. Age =18 years.

4. Histologically confirmed diagnosis of invasive CSCC.

5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

6. Anticipated life expectancy >12 weeks.

7. Adequate organ function defined as:

i) Hepatic function:

1. Total bilirubin =1.5× upper limit of normal (ULN).

2. Patients with Gilbert's Disease and total bilirubin up to 3× ULN are eligible.

3. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) =3× ULN.

4. Alkaline phosphatase (ALP) =2.5× ULN. ii) Renal function: Serum creatinine =2×
ULN or estimated creatinine clearance >35 mL/min (according the method of
Cockcroft and Gault). iii) Creatinine phosphokinase (CPK) (also known as CK
[creatinine kinase]) elevation = grade 2. iv) Bone marrow function:

1. Haemoglobin =9.0 g/dL.

2. Absolute neutrophil count (ANC) =1.5 x 109/L.

3. Platelet count =75 x 109/L.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active solid malignancy or haematological malignancies including chronic lymphocytic
leukaemia, (unless indolent or non-life-threatening) within the last 5 years. For
clarity, exceptions include other non-melanoma skin cancer that has undergone
potentially curative therapy, or in-situ cervical carcinoma or in-situ prostate cancer
with non-detectable prostate specific antigen or any other tumour that has been
treated, and the patient is deemed to be in complete remission for at least 2 years
prior to enrolment.

2. Metastatic disease.

3. Steroid use >10mg prednisone per day within 14 days of study drug (except if
physiologic replacement).

4. Active autoimmune disease requiring active systemic therapy within the last 5 years.

5. Interstitial lung disease or pneumonitis requiring systemic therapy in the last 5
years.

6. Active infection requiring therapy including human immunodeficiency virus (HIV)-1 or
HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV), or active
tuberculosis.

7. Breast-feeding or positive serum pregnancy test consistent with pregnancy (excluding
false positives defined as a failure of ßHCG doubling in 48 hours) or inability to
comply with recommended contraception.

8. Receipt of live vaccine (including attenuated) within 30 days of first study
treatment.

9. Prior transplant recipient (corneal transplant patients are eligible).

10. Prior PD-L1/PD-1 inhibitor exposure for the same lesion as enrolment.

11. Squamous cell carcinoma of unknown primary (those with presumed clinical assessment of
CSCC are eligible).

12. Any anticancer treatment other than radiation therapy (such as chemotherapy, targeted
systemic therapy, imiquimod, photodynamic therapy), either investigational or standard
of care, within 30 days of the initial administration of cemiplimab or planned to
occur during the study period.

13. History of documented allergic reactions or acute hypersensitivity reaction attributed
to antibody treatments.

14. Patients with allergy or hypersensitivity to cemiplimab or to any of the excipients
must be excluded.

15. Institutionalised patients by order of judicial or administrative authority.

16. Not willing to comply with all study related procedures, particularly consent for
collection of tumour and blood samples and imaging, at all protocol specified time
points.

Study design
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2029
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Adelaide
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Monash University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/Industry
Name [4] 0 0
Regeneron Pharmaceuticals
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Commercial sector/Industry
Name [5] 0 0
Sanofi
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To comprehensively describe the molecular profile of the tumour ecosystem of cutaneous
squamous cell carcinoma (CSCC) patients treated with neoadjuvant immunotherapy using
single-cell sequencing and bulk genomic profiling.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05878288
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Annette M Lim, MBBS, FRACP, PhD
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05878288