Cutaneous Squamous Cell CarcinomaPhase 2DISCERNNCT05878288
Deep sequencIng in Cutaneous Squamous CEll caRciNomas
A Phase 2 study testing Cemiplimab in people with Cutaneous Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma of the Head and Neck, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma of the Head and Neck, Neoplasms
- What is being tested?
- Cemiplimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteAustralia
- Study dates
- 26 May 2023to May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 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).
- At least one measurable lesion per RECIST 1.1.
- Age ≥18 years.
- Histologically confirmed diagnosis of invasive CSCC.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Anticipated life expectancy >12 weeks.
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- Adequate organ function defined as:
- Hepatic function:
- Total bilirubin ≤1.5× upper limit of normal (ULN).
- Patients with Gilbert's Disease and total bilirubin up to 3× ULN are eligible.
- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤3× ULN.
- 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:
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- Haemoglobin ≥9.0 g/dL.
- Absolute neutrophil count (ANC) ≥1.5 x 109/L.
- Platelet count ≥75 x 109/L.
Who cannot join
- 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.
- Metastatic disease.
- Steroid use >10mg prednisone per day within 14 days of study drug (except if physiologic replacement).
- Active autoimmune disease requiring active systemic therapy within the last 5 years.
- Interstitial lung disease or pneumonitis requiring systemic therapy in the last 5 years.
- 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.
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- Breast-feeding or positive serum pregnancy test consistent with pregnancy (excluding false positives defined as a failure of βHCG doubling in 48 hours) or inability to comply with recommended contraception.
- Receipt of live vaccine (including attenuated) within 30 days of first study treatment.
- Prior transplant recipient (corneal transplant patients are eligible).
- Prior PD-L1/PD-1 inhibitor exposure for the same lesion as enrolment.
- Squamous cell carcinoma of unknown primary (those with presumed clinical assessment of CSCC are eligible).
- 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.
- History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments.
- Patients with allergy or hypersensitivity to cemiplimab or to any of the excipients must be excluded.
- Institutionalised patients by order of judicial or administrative authority.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive and Deep Profiling in Cutaneous Squamous Cell Carcinomas to Unravel Treatment Efficacy in Immunotherapy Treated Patients
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.
Read the detailed description
The purpose of this study is to comprehensively assess the molecular profile of the tumour ecosystem of CSCC patients who receive immunotherapy in the neoadjuvant curative setting, in order to identify molecular mechanisms facilitating treatment response and resistance and to identify molecular markers for disease monitoring. Patients who receive immunotherapy for the neoadjuvant management of CSCC will be invited to participate in this translational research study during their treatment journey to provide tumour tissue (fresh and formal-fixed paraffin-embedded, FFPE) and blood samples before and after exposure to immunotherapy.
This study has primarily a translational research objective with the clinical component conducted as a prospective, single-centre, single-arm, open label study.
- Conditions
- Cutaneous Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma of the Head and Neck, Neoplasms, Non-melanoma Skin Cancer
- Being tested
- Cemiplimab
- Keywords
- single-cell sequencing, molecular profiling, neoadjuvant, immunotherapy, cemiplimab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CemiplimabDrug
Also called Libtayo, REGN-2810, REGN2810, cemiplimab-rwlc
Cemiplimab 50 mg/mL supplied as a sterile liquid in single-use glass vials.
| Study group | Role | What they receive |
|---|---|---|
| Cemiplimab | Other | 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. Receives: Drug: Cemiplimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Generation of analyzable data from single-cell RNA sequencing and genomic profiling
Measured: At 72 months
Secondary outcomes (6)
To evaluate pathological response rates (cPR, mPR defined as <10% viable tumour, and other).
Measured: Estimated 48 months
To evaluate ORR using computed tomography (CT) scan imaging assessed by RECIST 1.1
Measured: Estimated 48 months
To evaluate ORR using computed tomography (CT) scan imaging assessed by imRECIST
Measured: Estimated 48 months
To summarise immune-related adverse events (AE) > grade 2, AESI, AEs > grade 3 and SAEs, according to CTCAE v5.0.
Measured: At 72 months
To evaluate DFS rates.
Measured: Estimated 48 months
To evaluate OS rates.
Measured: Estimated 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start26 May 2023
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne, University of Adelaide, Monash University, Regeneron Pharmaceuticals, Sanofi
- Responsible party
- Sponsor
- Investigators
- Annette M Lim, MBBS, FRACP, PhD, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878288
- Sponsor's protocol ID
- HREC/88736/PMCC-2022-326880
- Acronym
- DISCERN
- Status last verified
- Sep 2026
- First submitted
- 17 Apr 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive and Deep Profiling in Cutaneous Squamous Cell Carcinomas to Unravel Treatment Efficacy in Immunotherapy Treated Patients
- ClinicalTrials.gov ID
- NCT05878288
- Acronym / sponsor ID
- DISCERN / HREC/88736/PMCC-2022-326880
- Conditions
- Cutaneous Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma of the Head and Neck, Neoplasms, Non-melanoma Skin Cancer
- Keywords
- single-cell sequencing, molecular profiling, neoadjuvant, immunotherapy, cemiplimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Collaborators
- University of Melbourne, University of Adelaide, Monash University, Regeneron Pharmaceuticals, Sanofi
- Study start
- 26 May 2023 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to comprehensively assess the molecular profile of the tumour ecosystem of CSCC patients who receive immunotherapy in the neoadjuvant curative setting, in order to identify molecular mechanisms facilitating treatment response and resistance and to identify molecular markers for disease monitoring. Patients who receive immunotherapy for the neoadjuvant management of CSCC will be invited to participate in this translational research study during their treatment journey to provide tumour tissue (fresh and formal-fixed paraffin-embedded, FFPE) and blood samples before and after exposure to immunotherapy.
This study has primarily a translational research objective with the clinical component conducted as a prospective, single-centre, single-arm, open label study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cemiplimab | Other | Drug: CemiplimabCemiplimab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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).
- At least one measurable lesion per RECIST 1.1.
- Age ≥18 years.
- Histologically confirmed diagnosis of invasive CSCC.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Key exclusion criteria (16 listed)
- 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.
- Metastatic disease.
- Steroid use >10mg prednisone per day within 14 days of study drug (except if physiologic replacement).
- Active autoimmune disease requiring active systemic therapy within the last 5 years.
- Interstitial lung disease or pneumonitis requiring systemic therapy in the last 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CemiplimabAlso: Libtayo, REGN-2810, REGN2810, cemiplimab-rwlcCemiplimab 50 mg/mL supplied as a sterile liquid in single-use glass vials. | Drug | Cemiplimab |
Primary outcome
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
Time frame: At 72 months
Generation of analyzable data from single-cell RNA sequencing and genomic profiling
6 secondary outcomes
To evaluate pathological response rates (cPR, mPR defined as <10% viable tumour, and other).
Time frame: Estimated 48 months
To evaluate ORR using computed tomography (CT) scan imaging assessed by RECIST 1.1
Time frame: Estimated 48 months
To evaluate ORR using computed tomography (CT) scan imaging assessed by imRECIST
Time frame: Estimated 48 months
To summarise immune-related adverse events (AE) > grade 2, AESI, AEs > grade 3 and SAEs, according to CTCAE v5.0.
Time frame: At 72 months
To evaluate DFS rates.
Time frame: Estimated 48 months
To evaluate OS rates.
Time frame: Estimated 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette M Lim, MBBS, FRACP, PhD principal investigator
Peter MacCallum Cancer Centre, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cemiplimab in people with Cutaneous Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma of the Head and Neck, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
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 16 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. 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 Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
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 (time frame: At 72 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.