Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Muromonab-CD3

IMCgp100 (77 kDa bi-specific protein) weekly dosing regimen (QW)

Bispecific soluble human leukocyte antigen-A2 (HLA-A2) restricted gp100-specific TCR fused to anti-CD3

IMCgp100

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.

IMCgp100-401 Rollover Study

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

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.

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).

Tolerability of study treatment was assessed by summarizing the number of treatment dose interruptions, characterized in part by duration of interruption and treatment.

Tolerability of study treatment was assessed by summarizing actual total dose received in micrograms in the rollover study.

Tolerability of study treatment was assessed by summarizing dose intensity, described as actual dose received/actual duration (micrograms per week) in the rollover study.

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.

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.

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.

Immunocore Ltd

All participants who received any treatment with IMCgp100 were considered evaluable for safety. All AEs, regardless of study drug relationship, were collected through the 30-day Safety Follow up Period.

Regimen 1

IMCgp100 weekly dosing regimen (QW)

IMCgp100: Bispecific soluble HLA-A2 restricted gp100-specific TCR fused to anti-CD3

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

All Patients Enrolled (ENR) set: all participants who provided informed consent for this study.

Chris Holland, Executive Director Head of Biometrics

Any TEAE

Any TEAE of CTCAE Grade ≥3

Any TEAE related to IMCgp100 by Investigator

Any TEAE of CTCAE Grade ≥3 and related to IMCgp100

Any serious TEAE

Any serious TEAE related to IMCgp100

Any TEAE leading to death

Any TEAE leading to discontinuation of study drug

Safety Analysis Set (SAF) includes all participants who have received at least 1 full or partial dose of IMCgp100.

Incidence of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events

Number of cycles started (rollover)

Number of cycles completed (rollover)

Participant 4001001 Regimen 1

Participant 4002001 Regimen 1

Participant 4003001 Regimen 1

Tolerability: Dose Interruptions by Participant - Number of Cycles

Duration of IMCgp100 treatment on rollover study

Duration of interruption on rollover study

Duration of IMCgp100 treatment from parent study

Tolerability: Dose Interruptions by Participant - Duration

Tolerability: Dose Reductions by Participant - Actual Total Dose Received

Tolerability: Dose Reductions by Participant - Dose Intensity

Tolerability: Dose Reductions by Participant - Relative Dose Intensity

Baseline to Death

Baseline to Study Terminated by Sponsor

Baseline to Alive

Full Analysis Set (FAS) comprises all participants assigned to treatment, who received at least 1 full or partial dose of IMCgp100.

Spots Global Cancer Trial Database for IMCgp100-401 Rollover Study

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial