IMCgp100-401 is a rollover study that is designed to provide continued access to IMCgp100 for eligible participants with advanced melanoma who have previously participated in an IMCgp100 study (parent study).
IMCgp100-401 is a rollover study that is designed to provide continued access to IMCgp100 for eligible participants with advanced melanoma who have previously participated in an IMCgp100 study (parent study). Parent studies that are eligible for participants to continue to receive IMCgp100 in this rollover study must have completed and satisfied its primary endpoints or have been terminated by the Sponsor for reasons other than safety. Eligible participants will have tolerated IMCgp100 for a minimum of 4 weeks of dosing without significant toxicities that would preclude further dosing in the opinion of the principal investigator or Sponsor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Bispecific soluble human leukocyte antigen-A2 (HLA-A2) restricted gp100-specific TCR fused to anti-CD3
Memorial Slone Kettering Cancer Center
New York, New York, United States
Dept of Oncology & Haematology, Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Dept of Medical Oncology, Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events
Incidence of adverse events was presented as the number of participants with treatment-emergent adverse events (TEAEs). TEAEs were defined as adverse events (AEs) that started or worsened in severity from the date of first dose of the rollover study (regardless of time) up until 90 days after the last dose of study drug of this rollover study. Participants with multiple events in the same category were counted only once in that category. Participants with events in more than 1 category were counted once in each of those categories. TEAEs indicated considered related to IMCgp100 were determined by the investigator to be possibly related or related to study drug.
Time frame: Up to 2 years and 4 months
Tolerability: Dose Interruptions by Participant - Number of Cycles
Tolerability of study treatment was assessed by summarizing the number of treatment dose interruptions, characterized in part by number of cycles started and completed in the rollover study (22 days per cycle).
Time frame: Up to 2 years and 4 months
Tolerability: Dose Interruptions by Participant - Duration
Tolerability of study treatment was assessed by summarizing the number of treatment dose interruptions, characterized in part by duration of interruption and treatment.
Time frame: Up to 2 years and 4 months
Tolerability: Dose Reductions by Participant - Actual Total Dose Received
Tolerability of study treatment was assessed by summarizing actual total dose received in micrograms in the rollover study.
Time frame: Up to 2 years and 4 months
Tolerability: Dose Reductions by Participant - Dose Intensity
Tolerability of study treatment was assessed by summarizing dose intensity, described as actual dose received/actual duration (micrograms per week) in the rollover study.
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Time frame: Up to 2 years and 4 months
Tolerability: Dose Reductions by Participant - Relative Dose Intensity
Tolerability of study treatment was assessed by summarizing the relative dose intensity, described as the ratio of dose intensity to planned dose/planned duration in the rollover study.
Time frame: Up to 2 years and 4 months
Overall Survival Status of All Participants Treated With IMCgp100: Number of Months
This endpoint was used to estimate the overall survival (OS) in participants treated with IMCgp100. OS is defined as the time from the date of first dose of study drug in the parent study until death due to any cause. Any participant not known to have died at the time of analysis was right-censored based on the last recorded date on which the participant was known to be alive, i.e. the latest of (i) the "Date of death or Last contact" (for those participants still alive) on the End of Study electronic case report form page and (ii) "Date patient last known to be alive" on the Survival Follow Up eCRF page. Number of days was then converted to months.
Time frame: Up to 2 years and 4 months
Assessments of Anti-IMCgp100 Antibody Formation: Number of Participants With Anti-IMCgp100 Antibody Formation
The concentration/AE - immunogenicity relationship was explored graphically, and tabulated to characterize a relationship between the changes from screening immunogenicity presence and serum concentration of IMCgp100.
Time frame: Up to 2 years and 4 months