BALSTILIMAB for Basal cell carcinoma | Squamous cell carcinoma of the skin | Non-melanoma skin cancer

Inclusion criteria

• {"criterion_text":"- signed written informed consent\n- adequate hematological and organ function defined by the following parameters: - White blood count (WBC) > 3000/μl - Absolute Neutrophil Count (ANC) > 1500/μl -Hemoglobin (Hb) > 8 g/dl (or > 5.6 mmol/L), may have been transfused to 7 days before C1D1 - Platelet count > 100.000/μl - Adequate hepatic function defined by serum total bilirubin < 2 x ULN, ALT and/or AST < 3 x ULN (or <5xULN with liver metastases) - Adequate renal function defined by serum creatinine < 1.5 x ULN or eGFR > 40 mL/min (as per Cockroft-Gault formula)\n- Highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female patients if the risk of conception exists.\n- male or female subjects aged > 18 years\n- histologically proven all types of non-melanoma skin cancers, excluding cutaneous lymphomas\n- patients must have metastatic or locally recurrent disease with measurable or targetable at least one lesion on skin/subcutaneous tissue, which can be measured\n- due to progression or tumor extent are disqualified from surgical excision, radiotherapy or other local treatment (systemic naïve population) and/or patient who progressed on systemic treatment.\n- assess to fresh tumor biopsy\n- ECOG PS of 0-2\n- estimated life expectancy of more than 12 weeks\n- disease must be measurable with at least one unidimensional measurable lesion by RECIST v1.1 (including skin lesions)."}

Exclusion criteria

• {"criterion_text":"- Participation in another interventional treatment at the time of within the past 30 days before C1D1.\n- Known severe hypersensitivity reactions to monoclonal antibodies (Grade > 3 NCI-CTCAE v 5.0), history or current evidence of clinically relevant allergies or hypersensitivity, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially uncontrolled asthma).\n- Persisting toxicity related to prior therapy Grade > 1 NCI-CTCAE v5.0; however, sensory neuropathy Grade <= 2 will be acceptable.\n- Pregnancy or lactation.\n- Known alcohol or drug abuse.\n- Clinically significant (i.e., active) cardiovascular and/or thromboembolic diseases: a. Cerebral vascular accident or stroke < 6 months prior to enrolment b. Uncontrolled hypertension c. Congestive heart failure (New York Heart Association (NYHA Class III or IV d. Cardiac arrhythmia requiring medication - patient will be included after discussion with Cardiologist. e. Symptomatic ischemic or severe valvular heart disease f. Unstable angina pectoris or a myocardial infarction within 6 months prior to screening, i.e. signing ICF\n- Administration of a life vaccine within 4 weeks prior to study drug administration. Life vaccines are also prohibited during study treatment\n- All other significant diseases (for example, inflammatory bowel disease, secondary cancers), which, in the opinion of the Investigator, might impair the patient´s tolerance of the study treatment.\n- Legal incapacity or limited legal capacity or any psychiatric condition that would prohibit the understanding or rendering of informed consent.\n- Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints) such as antiprogrammed death 1 (PD-1), anti-PD-L1 antibody;\n- Concurrent anticancer treatment (for example, cytoreductive therapy, radiotherapy [except for palliative bone directed radiotherapy, or radiotherapy administered on non-target superficial lesions], immune therapy, or cytokine therapy except for erythropoietin). Radiotherapy administered to superficial lesions is not allowed if such lesions are considered target lesions in the efficacy evaluation or may influence the efficacy evaluation of the study treatment.\n- Major surgery for any reason, except diagnostic biopsy, within 4 weeks and/or if the subject has not fully recovered from surgery within 4 weeks.\n- Concurrent systemic therapy with steroids or other immunosuppressive agents (e.g. methotrexate, azathioprine, interferons, mycophenolate, anti-TNF agents and other), or the use of any investigational drug within 28 days before the start of study treatment. Short-term administration of systemic steroids e.g. for allergic reactions or the management of immune-related adverse events [irAE] while on study is allowed. Also, patients requiring hormone replacement with corticosteroids for adrenal insufficiency are eligible if the steroids are administered only for purpose of hormonal replacement and at doses < 10 mg or equivalent prednisone per day. [Note: Patients receiving bisphosphonate or denosumab are eligible.]Conditions requiring systemic anti-arrhythmic therapy known to prolong QT/QTc interval, patients with QTcF interval >480 msec on at least 2 separate and consecutive ECGs at screening or a medical history of long-QT-Syndrome.\n- Patients with active central nervous system (CNS) metastases are excluded. Subjects with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 1 month in MRI, and do not require continued steroid therapy.\n- Prior organ transplantation (including allogeneic stem-cell transplantation).\n- Known history of testing positive HBV or HCV infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening is positive). HIV positive patients are not excluded.\n- Active or history of any autoimmune disease (except for patients with vitiligo) or immune deficiencies that required treatment with systemic immunosuppressive drugs."}

Primary endpoints

• {"endpoint_text":"- Clinical benefit rate (CBR), defined as a stable disease (SD; partial response (PR) or complete response (CR) as determined by the investigator according to criteria –RECIST 1.1","definition_or_measurement_approach":"CBR defined as stable disease (SD), partial response (PR) or complete response (CR) as determined by the investigator per RECIST v1.1 (translation notes assessment at ~12 weeks)."}

Secondary endpoints

• {"endpoint_text":"- Clinical benefit rate (CBR), defined as a stable disease (SD; partial response (PR) or complete response (CR) on two consecutive examinations >= 4 weeks apart, as determined by the investigator according to criteria ir - RECIST","definition_or_measurement_approach":"CBR defined as SD/PR/CR on two consecutive assessments ≥4 weeks apart as per investigator assessments using RECIST."}
• {"endpoint_text":"- Duration of Response (DoR), Progression free/Overall survival rate at 12 and 24 month","definition_or_measurement_approach":"Duration of Response and PFS/OS rates assessed at 12 and 24 months."}
• {"endpoint_text":"- Incidence of and severity of AEs according to scale NCI CTCAE v 5.0. Changes in vital signs, physical findings, ECG/ECHO parameters, and clinical laboratory results","definition_or_measurement_approach":"Safety assessed by incidence and severity of AEs per NCI CTCAE v5.0 and changes in vitals, physical exam, ECG/ECHO and laboratory tests."}
• {"endpoint_text":"- Change from day 1 in patient-reported outcomes (QLQ): : QLQ-C30, EQ-5D-3L, FACT-ICM, In patients +65 year old, Comprehensive Geriatric Assessment (CGA) will be performed at screening (SCR) and end of treatment (EOT)","definition_or_measurement_approach":"Patient-reported outcomes measured by QLQ-C30, EQ-5D-3L, FACT-ICM; patients ≥65 will have CGA at screening and end of treatment."}

Poland

Earliest CTIS Part Ii Submission Date

19-08-2024

Latest Decision Or Authorization Date

13-04-2026

Processing Time Days

602

Number Of Sites

1

Number Of Participants

39

Primary sponsor

Full Name

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland