BridgeMD
A Phase II, Open-Label, Single-Arm, Multicentre Study of Immunotherapy and non-invasive response evaluation in cutaneous squamous cell carcinoma as an organ preservation strategy: a proof of concept clinical study and translational correlates - INCEPT
EU CTIS ID: 2025-523633-25-00
What this study is testing
To evaluate the ability of upfront cemiplimab to spare the need for local therapies (e.g., surgery) in patients with difficult-to-treat locally advanced cutaneous squamous cell carcinoma (LA cSCC).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female ≥ 18 years of age (or based on the country legal age limit for adults) on day of signing the Informed Consent Form (ICF)
- Agreement upon the use of effective contraceptive methods (hormonal or barrier method of birth control, or abstinence) prior to study entry and for the duration of study participation, if men and women of child producing potential.
- Adequate organ function defined as: absolute neutrophil count (ANC) ≥1.5 X 109/L, Hemoglobin ≥9 g/dL, Platelets ≥100 x 109/L, Serum magnesium, sodium, corrected total calcium, phosphate, and potassium within normal ranges (or corrected with supplements or appropriate treatment). If these electrolyte ranges are not within normal range despite corrective treatment, then the Sponsor should be consulted to confirm eligibility. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN) and total bilirubin ≤1.5 x ULN (unless due to known Gilbert’s syndrome, who are excluded if total bilirubin >3.0 x ULN or direct bilirubin >1.5 x ULN); in cases of liver involvement, ALT/AST ≤5 x ULN and total bilirubin ≤2 x ULN will be allowed, unless due to known Gilbert’s syndrome when total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN will be allowed. Serum creatinine ≤1.5 x ULN or creatinine clearance ≥60 mL/min calculated according to the Cockroft and Gault formula or Modification of Diet in Renal Disease (MDRD) formula for patients aged >65 years. Serum albumin ≥3 g/dL. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 x ULN unless patient is receiving anticoagulant therapy and in therapeutic range of intended used anticoagulant. Activated partial thromboplastin time (APTT) or partial thromboplastin time (PTT)≤1.5 x ULN unless patient is receiving anticoagulant therapy and is in therapeutic range of intended used anticoagulant.
- Signed and dated IEC-approved Informed Consent.
- Histologic diagnosis of cutaneous squamous cell carcinoma.
- AJCC stage (8th edition) II (≥ 3 cm largest diameter) - III - IV (M0)
You likely can't join if
- Previous radiotherapy for cutaneous squamous cell carcinoma in the region affected by the current malignancy.
- Concomitant immunosuppressive treatment other than physiological steroid dose (i.e. prednisone 10 mg daily or equivalent).
- Autoimmune disease; cases with limited cutaneous psoriasis should be discussed by the multidisciplinary team to evaluate possible exemption.
- Has a known history of active TB (Bacillus Tuberculosis).
- Current or concomitant enrollment in another therapeutic clinical trial.
- Has previously received an organ transplant.
See the full eligibility criteria
Who can join
- Male or female ≥ 18 years of age (or based on the country legal age limit for adults) on day of signing the Informed Consent Form (ICF)
- Agreement upon the use of effective contraceptive methods (hormonal or barrier method of birth control, or abstinence) prior to study entry and for the duration of study participation, if men and women of child producing potential.
- Adequate organ function defined as: absolute neutrophil count (ANC) ≥1.5 X 109/L, Hemoglobin ≥9 g/dL, Platelets ≥100 x 109/L, Serum magnesium, sodium, corrected total calcium, phosphate, and potassium within normal ranges (or corrected with supplements or appropriate treatment). If these electrolyte ranges are not within normal range despite corrective treatment, then the Sponsor should be consulted to confirm eligibility. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN) and total bilirubin ≤1.5 x ULN (unless due to known Gilbert’s syndrome, who are excluded if total bilirubin >3.0 x ULN or direct bilirubin >1.5 x ULN); in cases of liver involvement, ALT/AST ≤5 x ULN and total bilirubin ≤2 x ULN will be allowed, unless due to known Gilbert’s syndrome when total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN will be allowed. Serum creatinine ≤1.5 x ULN or creatinine clearance ≥60 mL/min calculated according to the Cockroft and Gault formula or Modification of Diet in Renal Disease (MDRD) formula for patients aged >65 years. Serum albumin ≥3 g/dL. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 x ULN unless patient is receiving anticoagulant therapy and in therapeutic range of intended used anticoagulant. Activated partial thromboplastin time (APTT) or partial thromboplastin time (PTT)≤1.5 x ULN unless patient is receiving anticoagulant therapy and is in therapeutic range of intended used anticoagulant.
- Signed and dated IEC-approved Informed Consent.
- Histologic diagnosis of cutaneous squamous cell carcinoma.
- AJCC stage (8th edition) II (≥ 3 cm largest diameter) - III - IV (M0)
- Undergone multidisciplinary evaluation and discussion (attendance of ENT/general/plastic surgeon, radiation oncologist and medical oncologist is mandatory) to confirm the following criteria: deemed difficult to surgically treat due to high chances of micro and macroscopic residual disease (R1 & R2 resection) or disfiguring surgery; deemed difficult to treat with radical radiotherapy due to low chances of complete response (e.g. High GTV) or high risk of severe acute or late adverse events (e.g. chondronecrosis); eligible to cemiplimab monotherapy as per Summary of Product Characteristics (SmPC, annex A) for the treatment of adult patients with locally advanced cutaneous squamous cell carcinoma (LA cSCC) who are not candidates for curative surgery or curative radiotherapy.
- Patient’s refusal of surgical intervention and definitive radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Have measurable disease based on iPERCIST criteria.
- Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group) must have a negative serum pregnancy test at screening and must not be breastfeeding.
What rules you out
- Previous radiotherapy for cutaneous squamous cell carcinoma in the region affected by the current malignancy.
- Concomitant immunosuppressive treatment other than physiological steroid dose (i.e. prednisone 10 mg daily or equivalent).
- Autoimmune disease; cases with limited cutaneous psoriasis should be discussed by the multidisciplinary team to evaluate possible exemption.
- Has a known history of active TB (Bacillus Tuberculosis).
- Current or concomitant enrollment in another therapeutic clinical trial.
- Has previously received an organ transplant.
- Has previously received bone marrow transplantation.
- Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu Mist®) are live attenuated vaccines, and are not allowed.
- Metastatic disease (every T, every N, M1 according the AJCC 8th edition).
- Cardiac, pulmonary, infective, neurological disease or any other medical condition that could interfere with treatment according to the treating physician.
- Previous diagnosis of other malignant neoplasm in the last 3 years (in situ cervical cancer or completely excised basocellular/squamous cell skin cancer are always admitted).
- History of active primary immunodeficiency, known HIV, active HBV or HCV infection
- Psychiatric disorder or known substance abuse; person with limitation of freedom (i.e. jailed person).
The study team makes the final eligibility decision.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.