Advanced non-small cell lung cancer in second-line treatment and unresectable or metastatic melanoma
Conditions
Interventions
Anti-PD1 2C12 monoclonal antibody
200 mg every three weeks (intravenous infusion) until disease progression or unacceptable toxicity occurs
Antibodies, Monoclonal, Humanized
Antibodies, Monoclonal
Drug Therapy
Antineoplastic Agents
Administration, Intravenous
Anticuerpo monoclonal Anti-PD1 2C12
Sponsors
Center for Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients eligible for treatment with the monoclonal antibody Anti-PD1 2C12 who meet the diagnostic criteria described. • Patients =18 years of age and of any sex. • Patients with NSCLC who are progressing after receiving at least one platinum-doublet-based chemotherapy regimen. • Patients with NSCLC who are immunotherapy-naïve, using antibodies against immune checkpoints such as atezolizumab or other • Patients who provide informed consent to participate in the research. • Patients with measurable disease according to RECIST 1.1. • Patients with a life expectancy of at least three months. • Patients with an ECOG performance status = 2 according to the Eastern Cooperative Oncology Group (ECOG) scale. • Patients with no history of prior malignancy, with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the cervix. • Patients with adequate organ function as indicated by the following laboratory values: Parameter Value Absolute neutrophil count: = 1500/µL Platelets: = 100,000/µL Hemoglobin: = 9 g/dL Creatinine: = 1.5 times the upper limit of normal (ULN) according to the research site's reference parameters Total Bilirubin: = 1.5 times ULN AST (SGOT) and ALT (SGPT)*: = 3 times ULN* ALT and AST = 5 times ULN will be accepted in cases of liver metastases. *ALT = alanine aminotransferase, AST = aspartate aminotransferase. TSH: Within normal limits. Note: If TSH is not within normal limits at baseline, the participant may be eligible if free T3 and T4 are within normal limits. A TSH < 10 mIU/L will be accepted in patients with known, controlled hypothyroidism. • Patients of childbearing potential must have a negative pregnancy test at the time of screening. • Patients of childbearing potential must be willing to use adequate contraception throughout the study.
Exclusion criteria
Exclusion criteria: • Patients with NSCLC without PD-L1 expression or <1%. • Patients with NSCLC who have a documented EGFR sensitizing (activating) mutation or ALK rearrangement, documented in their medical record. • Pregnant or breastfeeding patients. • Patients receiving other investigational medications. • Patients receiving chronic steroid therapy or doses =10 mg/day of prednisone or equivalent within the 14 days prior to initiating treatment. • Patients with central nervous system metastases and/or carcinomatous meningitis. • Patients with active autoimmune disease requiring systemic treatment within the past two years (e.g., with disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants). Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. • Patients who have undergone an allogeneic solid organ/tissue transplant. • Patients with interstitial lung disease (ILD) or a history of pneumonitis requiring oral or intravenous steroids. • Patients with an active infection requiring intravenous systemic therapy. • In patients with symptoms and signs of hepatitis B, hepatitis C, or tuberculosis infection, active infection should be ruled out. • Patients with a history of psychiatric disorders or substance abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) (RECIST 1.1 criteria: complete or partial response). Measurement time: at enrollment, week 16, and subsequently every 12 weeks until 24 months or patient death. Grade 3-5 adverse events with a proven causal relationship (definite, highly probable, or probable) to product administration. Measurement time: up to 30 days after the last dose of treatment (maximum 24 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs). Measurement time: up to 30 days after the last dose of treatment received and up to a maximum of 24 months - Occurrence of any AE in the subject (yes/no). - Description of the AE (Name of the adverse event). - Duration of the AE (Difference in dates between the start and end of the event) - Intensity of the AE (Mild, Moderate, Severe, Life-threatening or disabling AE, Fatal AE) - Severity of the AE (Serious, Not serious) - Attitude towards the study treatment (no change in dose, temporary or permanent interruption of the study treatment) - Outcome of the AE (recovered/resolved, improving/in resolution, persistent/unresolved, with sequelae requiring treatment) -Causality (1.Definite, 2.Very Probable, 3.Probable, 4.Possible, 5.Not related, 6.Unknown) -Antibodies against the monoclonal antibody Anti-PD1 2C12 (yes/no). Measurement time: prior to the start of treatment and every six weeks while the treatment is maintained. Pharmacokinetic parameters (values ??estimated using the Monolix system, SAEM algorithm combined with Monte Carlo code with a sparse data design in blocks of 3, with 4 repetitions per block where each patient will have 4 extractions). Measurement time: baseline (first hour before infusion), end of infusion (at 60 minutes), after infusion at 6 hours, 24 hours, 48 ??hours, 168 hours (one week), 336 hours (two weeks), 504 hours (three weeks, coincides with the baseline sample of the next cycle): - Area under the curve (AUC) - Maximum concentration (Cmax) - Time to maximum concentration (Tmax) - Minimum concentration - Elimination half-life (t1/2) - Plasma clearance (CL) - Volume of distribution (Vd) Overall Survival (OS) (Time from the date of patient inclusion in the study until death, regardless of cause, or until the date of last news). Measurement time: 24 months. Progression-free survival (PFS) (Time from patient inclusion date to the date considered disease progression or death from any cause). Measurement time | — |
Countries
Cuba
Contacts
Public ContactYoanna Flores Vega
National Institute of Oncology and Radiobiology
Outcome results
None listed