Cutaneous Squamous Cell CarcinomaPhase 2NCT06384820
Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)
A Phase 2 study testing cemiplimab and fianlimab in people with Cutaneous Squamous Cell Carcinoma, run by Regeneron Pharmaceuticals.
Trial summary
This study is researching an investigational drug called REGN2810, also known as cemiplimab, and when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma
- What is being tested?
- cemiplimab and fianlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Nov 2024to 6 May 2030
- Phase
- Phase 2
- 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
- Stage III/IV (M0) CSCC, for which surgery would be recommended in routine clinical practice
- Tumor biopsy is required during screening period as described in the protocol
- Participant is willing to undergo delayed surgery
- At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function as described in the protocol
Who cannot join
- Stage I or II CSCC
- Anogenital, penile, vermilion lip CSCC
- CSCC bone invasion
- Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy as described in the protocol
- Prior radiation therapy for CSCC
- Myocardial infarction within 6 months of enrollment, or history of myocarditis.
- Prior treatment with anti-cancer systemic therapy within the last 3 years prior to projected enrollment date as described in the protocol
- Note: Other protocol-defined Inclusion/Exclusion Criteria apply
About this study
Official title: A Phase 2 Peri-Operative Study of Treatment With Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Patients With Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)
This study is researching an investigational drug called REGN2810, also known as cemiplimab, and when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (CSCC).
The aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery.
Read more
The study is looking at several other research questions, including:
- Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery
- Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery
- What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab
- How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times
- Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Being tested
- cemiplimab, fianlimab
- Keywords
- Neoadjuvant, Adjuvant, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cemiplimabDrug
Also called REGN2810, Libtayo
Administered Intravenous (IV) infusion every three weeks (Q3W)
fianlimabDrug
Also called REGN3767
IV infusion Q3W
| Study group | Role | What they receive |
|---|---|---|
| cemiplimab | Experimental | Not described Receives: Drug: cemiplimab |
| fianlimab+cemiplimab | Experimental | Not described Receives: Drug: cemiplimab; Drug: fianlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate by blinded independent pathological review (BIPR)
Measured: Up to 100 days
Secondary outcomes (26)
pCR rate by local pathological review
Measured: Up to 100 days
Major pathological response (MPR)
Measured: Up to 100 days
Event-free survival (EFS)
Measured: Up to 3 years
Disease free survival (DFS)
Measured: Up to 3 years
Objective response rate (ORR) prior to surgery
Measured: Up to 100 days
Overall survival (OS)
Measured: Up to 3 years
Occurrence of treatment-emergent adverse events (TEAEs)
Measured: Up to 3 years
Occurrence of immune-mediated adverse events (imAEs)
Measured: Up to 3 years
Occurrence of treatment-related TEAEs
Measured: Up to 3 years
Occurrence of adverse event of special interest (AESI)
Measured: Up to 3 years
Occurrence of treatment-emergent serious adverse events (SAEs)
Measured: Up to 3 years
Occurrence of laboratory abnormalities
Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Measured: Up to 3 years
Occurrence of death due to TEAE
Measured: Up to 3 years
Occurrence of interruption of study drug(s) due to TEAEs
Measured: Up to 3 years
Occurrence of discontinuation of study drug(s) due to TEAEs
Measured: Up to 3 years
Occurrence of cancellation of surgery due to TEAE
Measured: Up to 100 days
Occurrence of delay to surgery due to TEAE
Measured: Up to 100 days
Concentrations of cemiplimab in serum
Measured: Up to 3 years
Concentrations of fianlimab in serum
Measured: Up to 3 years
Concentrations of other experimental agents (as applicable) in serum
Measured: Up to 3 years
Incidence of anti-drug antibodies (ADA) to cemiplimab
Measured: Up to 3 years
Incidence of ADA to fianlimab
Measured: Up to 3 years
Incidence of ADA to other experimental agents (as applicable)
Measured: Up to 3 years
Titer of ADA to cemiplimab
Measured: Up to 3 years
Titer of ADA to fianlimab
Measured: Up to 3 years
Titer of ADA to other experimental agents (as applicable)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start14 Nov 2024 (estimated)
- Primary completion8 Jun 2026 (estimated)
- Study completion6 May 2030 (estimated)
Why it stopped: Business Decision
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.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384820
- Sponsor's protocol ID
- R3767-ONC-2330
- Other IDs
- 2023-510514-38-00, 2023
- Status last verified
- Jul 2024
- First submitted
- 22 Apr 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Peri-Operative Study of Treatment With Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Patients With Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)
- ClinicalTrials.gov ID
- NCT06384820
- Acronym / sponsor ID
- R3767-ONC-2330
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Keywords
- Neoadjuvant, Adjuvant, Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2024 (estimated)
- Primary completion
- 8 Jun 2026 (estimated)
- Study completion
- 6 May 2030 (estimated)
- First posted
- 25 Apr 2024 (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.
This study is researching an investigational drug called REGN2810, also known as cemiplimab, and when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (CSCC).
The aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery.
The study is looking at several other research questions, including:
- Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery
- Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery
- What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab
- How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times
- Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cemiplimab | Experimental | Drug: cemiplimab |
| fianlimab+cemiplimab | Experimental | Drug: cemiplimab, Drug: fianlimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stage III/IV (M0) CSCC, for which surgery would be recommended in routine clinical practice
- Tumor biopsy is required during screening period as described in the protocol
- Participant is willing to undergo delayed surgery
- At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (8 listed)
- Stage I or II CSCC
- Anogenital, penile, vermilion lip CSCC
- CSCC bone invasion
- Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy as described in the protocol
- Prior radiation therapy for CSCC
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: REGN2810, LibtayoAdministered Intravenous (IV) infusion every three weeks (Q3W) | Drug | cemiplimab, fianlimab+cemiplimab |
| fianlimabAlso: REGN3767IV infusion Q3W | Drug | fianlimab+cemiplimab |
Primary outcome
Pathological complete response (pCR) rate by blinded independent pathological review (BIPR)
Time frame: Up to 100 days
26 secondary outcomes
pCR rate by local pathological review
Time frame: Up to 100 days
Major pathological response (MPR)
Time frame: Up to 100 days
Event-free survival (EFS)
Time frame: Up to 3 years
Disease free survival (DFS)
Time frame: Up to 3 years
Objective response rate (ORR) prior to surgery
Time frame: Up to 100 days
Overall survival (OS)
Time frame: Up to 3 years
Occurrence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 3 years
Occurrence of immune-mediated adverse events (imAEs)
Time frame: Up to 3 years
Occurrence of treatment-related TEAEs
Time frame: Up to 3 years
Occurrence of adverse event of special interest (AESI)
Time frame: Up to 3 years
Occurrence of treatment-emergent serious adverse events (SAEs)
Time frame: Up to 3 years
Occurrence of laboratory abnormalities
Time frame: Up to 3 years
Occurrence of death due to TEAE
Time frame: Up to 3 years
Occurrence of interruption of study drug(s) due to TEAEs
Time frame: Up to 3 years
Occurrence of discontinuation of study drug(s) due to TEAEs
Time frame: Up to 3 years
Occurrence of cancellation of surgery due to TEAE
Time frame: Up to 100 days
Occurrence of delay to surgery due to TEAE
Time frame: Up to 100 days
Concentrations of cemiplimab in serum
Time frame: Up to 3 years
Concentrations of fianlimab in serum
Time frame: Up to 3 years
Concentrations of other experimental agents (as applicable) in serum
Time frame: Up to 3 years
Incidence of anti-drug antibodies (ADA) to cemiplimab
Time frame: Up to 3 years
Incidence of ADA to fianlimab
Time frame: Up to 3 years
Incidence of ADA to other experimental agents (as applicable)
Time frame: Up to 3 years
Titer of ADA to cemiplimab
Time frame: Up to 3 years
Titer of ADA to fianlimab
Time frame: Up to 3 years
Titer of ADA to other experimental agents (as applicable)
Time frame: Up to 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cemiplimab and fianlimab in people with Cutaneous Squamous Cell Carcinoma, run by Regeneron Pharmaceuticals.
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 6 inclusion and 8 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 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Pathological complete response (pCR) rate by blinded independent pathological review (BIPR) (time frame: Up to 100 days). 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 26 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.