Advanced Melanoma
Conditions
Brief summary
ORR, defined as the proportion of patients who achieved PR and/or CR per local Investigator assessment using RECIST version 1.1, CBR, defined as the proportion of patients who respond to treatment, estimated as the proportion of patients who achieve SD, PR, or CR per local Investigator assessment using iRECIST., OS, evaluated as time from baseline until death.
Detailed description
incidence and severity of AEs (including physical examination findings) related to LTX 315 or to the combination of LTX-315 and pembrolizumab from baseline to end of treatment, incidence of clinical laboratory abnormalities based on clinical chemistry, hematology, urinalysis, and coagulation test results, change from baseline in vital signs measurements (pulse rate, body temperature, respiration rate), change from baseline in blood pressure measurements, change from baseline in 12-lead ECG parameters, including QT interval corrected for heart rate using Fridericia’s formula (QTcF), incidence of LTX-315 injection site assessment findings (injection site pain, swelling, and redness).
Interventions
DRUGCIMETIDINE
DRUGCHLORPHENAMINE
DRUGMONTELUKAST
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Lytix Biopharma AS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR, defined as the proportion of patients who achieved PR and/or CR per local Investigator assessment using RECIST version 1.1, CBR, defined as the proportion of patients who respond to treatment, estimated as the proportion of patients who achieve SD, PR, or CR per local Investigator assessment using iRECIST., OS, evaluated as time from baseline until death. | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence and severity of AEs (including physical examination findings) related to LTX 315 or to the combination of LTX-315 and pembrolizumab from baseline to end of treatment, incidence of clinical laboratory abnormalities based on clinical chemistry, hematology, urinalysis, and coagulation test results, change from baseline in vital signs measurements (pulse rate, body temperature, respiration rate), change from baseline in blood pressure measurements, change from baseline in 12-lead ECG parameters, including QT interval corrected for heart rate using Fridericia’s formula (QTcF), incidence of LTX-315 injection site assessment findings (injection site pain, swelling, and redness). | — |
Countries
France, Norway, Spain
Outcome results
None listed