AzTrials
AzTrials

Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and NeckPhase 2NCT06580054

Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma

A Phase 2 study testing Computed Tomography, Digital Photography and Magnetic Resonance Imaging in people with Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck and Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase II trial studies how well pembrolizumab works in treating patients with orbital (eye socket) and/or periorbital (surrounding the eye socket) cutaneous squamous cell cancer (cSCC) that has spread to nearby tissue or lymph nodes (locally advanced) or has come back after a period of improvement (recurrent). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Computed Tomography, Digital Photography and Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
5 Mar 2025to Dec 2026
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

  • Male/female participants who are at least 18 years of age on the day of signing informed consent.
  • Histologically confirmed diagnosis of locally advanced or diffuse or recurrent orbital or periorbital cutaneous squamous cell carcinoma.
  • Female participants:
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) as defined.
  • A WOCBP who agrees to follow the contraception guidance during the treatment period and for at least 120 days after the last dose of study treatment.
Show all 22Show fewer
  • The participant provides written informed consent for the trial.
  • Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Absolute neutrophil count (ANC) ≥ 1500/uL.
  • Platelets ≥ 100000/uL.
  • Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L.
  • Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
  • Creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) ≥ 30 mL/min for participant with creatinine levels > 1.5 x institutional ULN.
  • Creatinine clearance (CrCl) should be calculated per institutional standard.
  • Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 x ULN.
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x ULN (≤ 5 x ULN for participants with liver metastases).
  • International normalized ratio (INR) OR prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
  • Have recovered from toxicities and/or complications from any prior major surgery before starting study treatment.
  • Have a life expectancy of at least 12 weeks.
  • Patients with human immunodeficiency virus (HIV) adequately controlled on antiretroviral therapy.
  • Patients with known hepatitis B infection (defined as hepatitis B surface antigen [HbsAg] reactive) should be on suppressive anti hepatitis B virus (HBV) therapy, and patients with history of hepatitis C infection (defined as hepatitis C virus [HCV] ribonucleic acid [RNA] detected) must complete curative antiviral treatment with HCV viral load below limit of quantification. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.

Who cannot join

  • Has any other histologic type of skin cancer other than invasive squamous cell carcinoma as the primary disease under study.
  • A WOCBP who has a positive pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a negative serum pregnancy test will be required.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to enrollment. Participants must have recovered from all adverse events (AEs) due to previous therapies to ≤ grade 1 or baseline. Participants with ≤ grade 2 neuropathy may be eligible.
  • Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
  • Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist [registered trademark]) are live attenuated vaccines and are not allowed.
Show all 25Show fewer
  • Is currently participating in or has participated in a study of an investigational agent or has used an interventional investigational device within 4 weeks prior to the first dose of study intervention. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers like ocular surface squamous cell neoplasia.
  • Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
  • Has severe hypersensitivity (≥ grade 3) to pembrolizumab and/or any of its excipients.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a known history of active tuberculosis (TB) (bacillus tuberculosis).
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
  • Has had an allogenic tissue (e.g., hematopoietic stem cell transplant [HSCT])/solid organ transplant.
  • Has a history of any of the following cardiovascular conditions:
  • Myocardial infarction within 6 months of enrollment.
  • Active unstable angina.
  • Congestive heart failure (≥ New York Heart Association Classification Class II)
  • Cerebral vascular accident/stroke within 6 months of enrollment.
  • Serious cardiac arrhythmia requiring medication. The classification of "serious" is at the discretion of the investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Pembrolizumab for Orbital and Periocular Cutaneous Squamous Cell Carcinoma (cSCC)

This phase II trial studies how well pembrolizumab works in treating patients with orbital (eye socket) and/or periorbital (surrounding the eye socket) cutaneous squamous cell cancer (cSCC) that has spread to nearby tissue or lymph nodes (locally advanced) or has come back after a period of improvement (recurrent). Skin cancers that are close to the eye or on the eyelid often have more genetic (heredity) changes than other types of cancers. This means that the deoxyribonucleic acid (DNA) (the building blocks of the body that determine such things as the color of the hair) in tumor tissue has been altered compared to normal tissue. It is thought cancer cells with these DNA changes are more likely to respond to a type of drug called immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for patients with recurrent or metastatic cSCC not amenable (responsive) to cure by surgery or radiation. Giving pembrolizumab may work better in treating patients with locally advanced or recurrent orbital and/or periorbital cSCC.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine whether treatment of patients with locally advanced or recurrent orbital and/or periocular cSCC with pembrolizumab will be associated with tumor response.

SECONDARY OBJECTIVES:

  1. To assess the globe preservation rate among patients with locally advanced or recurrent orbital and/or periocular cSCC treated with pembrolizumab.

II. To determine whether treatment with pembrolizumab of patients with locally advanced or recurrent orbital and/or periocular cSCC will prevent progression of disease.

EXPLORATORY OBJECTIVES:

  1. To evaluate next generation sequencing (NGS) and correlate with response to therapy for patients with available tissue.

II. Correlate visual function to location and size of tumor over the course of treatment.

III. To identify if the presence of human papillomavirus (HPV) in the cSCC affects the tumor response.

IV. To determine the duration of response (DOR) at 2 years.

OUTLINE:

Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo magnetic resonance imaging (MRI) or computed tomography (CT) and photographs of tumor throughout the study.

After completion of study treatment, patients are followed up at 30 days and then every 9 weeks for 52 weeks and then every 12 weeks for up to 2 years.

Being tested
Computed Tomography, Digital Photography, Magnetic Resonance Imaging, Pembrolizumab

What participants receive

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

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Digital PhotographyOther

    Undergo photographs of tumor

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • PembrolizumabBiological

    Also called BCD-201, GME 751, GME751, Keytruda

    Given IV

Study groups in NCT06580054
Study groupRoleWhat they receive
Treatment (pembrolizumab)ExperimentalPatients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and photographs of tumor throughout the study.
Receives: Procedure: Computed Tomography; Other: Digital Photography; Procedure: Magnetic Resonance Imaging; Biological: Pembrolizumab

What is being measured

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

  1. Objective response rate

    Will be calculated from the tumor partial and complete responses based on immune-related Response Evaluation Criteria In Solid Tumors. Will be reported with exact 95% binomial confidence intervals.

    Measured: Up to 2 years

Secondary outcomes (2)

  1. Globe preservation

    To assess the globe preservation rate among patients. External and slit lamp photography will be obtained during the Ophthalmic exams

    Measured: Up to 2 years

  2. Time to progression

    Measured: Up to 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 posted30 Aug 2024
  2. Study start5 Mar 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06580054
Sponsor's protocol ID
UMCC 2021.025
Other IDs
NCI-2024-06539, HUM00229341, UMCC 2021.025
Status last verified
Jul 2026
First submitted
18 Aug 2024
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Computed Tomography, Digital Photography and Magnetic Resonance Imaging in people with Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck and Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck, run by University of Michigan Rogel Cancer Center 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 22 inclusion and 25 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 29 Jul 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 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 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?

Objective response rate (time frame: Up to 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 NCT06580054.

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 29 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in