IMCgp100-401 Rollover Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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An Open-label, Multi-center, Rollover Study in Patients With Advanced Melanoma After Completing an IMCgp100 Clinical Study

Conditions
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Malignant Melanoma

Intervention / Treatment
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* Drug: IMCgp100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is currently participating in an Immunocore-sponsored study of IMCgp100 and is actively receiving IMCgp100. Participant must have fulfilled all required assessments in the parent study (unless the study is being terminated) Participant is currently receiving clinical benefit from the treatment with IMCgp100, as determined by the principal investigator from the parent study Participant has demonstrated compliance with the parent study requirements, as assessed by the principal investigator and participant is able to comply with the necessary visits and assessments as part of the rollover study 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 Exclusion Criteria: Participant has been permanently discontinued from any IMCgp100 study or from IMCgp100 treatment in the parent study due to unequivocal progressive disease, unacceptable toxicity, non-compliance to study procedures, withdrawal of consent, or any other reason 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 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 participants must be post-menopausal (no menstrual period for at least 12 months prior to Screening), or surgically sterile Male participants 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regimen 1<br>IMCgp100 (77 kDa bi-specific protein) weekly dosing regimen (QW) | Drug: IMCgp100<br>* Bispecific soluble human leukocyte antigen-A2 (HLA-A2) restricted gp100-specific TCR fused to anti-CD3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 2 years and 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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. | 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. | 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. | 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. | Up to 2 years and 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uveal melanoma, Cutaneous melanoma