Advanced Melanoma MedDRA version: 19.0 Level: LLT Classification code 10025667 Term: Malignant melanoma site/stage unspecified System Organ Class: 100000004864
Conditions
Interventions
Product Code: IMCgp100
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: IMCgp100
Other descriptive name: IMCGP100
Sponsors
Immunocore Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study must meet all of the following criteria: 1. Patient is currently participating in an Immunocore-sponsored study of IMCgp100 and is actively receiving IMCgp100. Patient must have fulfilled all required assessments in the parent study (unless the study is being terminated) 2. Patient is currently receiving clinical benefit from the treatment with IMCgp100, as determined by the principal investigator from the parent study 3. Patient has demonstrated compliance with the parent study requirements, as assessed by the principal investigator and patient is able to comply with the necessary visits and assessments as part of the rollover study 4. Written informed consent must be obtained prior to enrolling in the rollover study and receiving the study treatment. If consent cannot be expressed in writing, then the consent must be formally documented and witnessed, ideally via an independent trusted witness Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 31
Exclusion criteria
Exclusion criteria: Patients eligible for this study must not meet any of the following criteria: 1. Patient has been permanently discontinued from any IMCgp100 study or from IMCgp100 treatment in the parent study due to unequivocal progressive disease, unacceptable toxicity, noncompliance to study procedures, withdrawal of consent, or any other reason 2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test 3. Women of child-bearing potential who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using 2 methods of highly effective contraception from Screening, and must agree to continue using such precautions for 6 months after the final dose of investigational product; cessation of birth control after this point should be discussed with a responsible physician. Highly effective methods include barrier methods, intrauterine devices or hormonal methods. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Women of child-bearing potential must have a negative serum pregnancy test at Screening. Otherwise, female patients must be post-menopausal (no menstrual period for at least 12 months prior to Screening), or surgically sterile 4. Male patients who are not surgically sterile unless they are using a double barrier contraception method from enrollment through treatment and for 6 months following administration of the last dose of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the number of patients with AEs associated with IMCgp100 treatment.;Primary end point(s): The primary endpoint is incidence of AEs associated with IMCgp100.;Timepoint(s) of evaluation of this end point: This will be measured continuously throughout the study; Secondary Objective: - To characterize the long-term safety (> 1 year dosing) and tolerability profile associated with treatment with IMCgp100 - To evaluate the incidence of anti-IMCgp100 antibody formation following multiple infusions of IMCgp100 - To estimate the OS of patients treated with IMCgp100 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Tolerability: Dose interruptions, reductions, and dose intensity of IMCgp100 - Assessments of anti-IMCgp100 antibody formation - Date of death in all patients treated with IMCgp100 ; Timepoint(s) of evaluation of this end point: tolerability: From baseline at each study visit until follow-up. Immunogenicity samples are to be taken at Day 1 of all odd-numbered cycles and at End of Treatment. Patients will be contacted every 3 months during the survival follow-up period. | — |
Countries
Australia, Canada, France, Germany, Italy, United Kingdom, United States
Contacts
Public ContactChristina M. Coughlin
Immunocore, Ltd.
Outcome results
None listed