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New treatment option for Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
Official title Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06580054
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced cutaneous squamous cell carcinoma of the head and neck.
Also referred to as BCD-201, GME 751.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to enrollment. Participants must have recovered...
- Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related...
- 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...
See the full eligibility criteria
Who can 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.
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- Is currently participating in or has participated in a study of an investigational agent or has used an treatment investigational device within 4 weeks prior to the first dose of study intervention. Participants who...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.