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Antineoplastic Agents

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Pembrolizumab

Immunomodulating Agents

Ipilimumab

Dacarbazine

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Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Enzyme Inhibitors

Biologic:IMCgp100 (Soluble gp 100-specific T cell receptor with anti - CD3 scFV: IMCgp100)

1 of 3 Investigator's Choice options: Systemic Dacarbazine

1 of 3 Investigator's Choice options: Systemic Ipilimumab

1 of 3 Investigator's Choice options: Systemic Pembrolizumab

IMCgp100 is to be administered at 20 mcg cycle 1 day1, then 30 mcg cycle 1 day 8, then 68 mcg cycle 1 day 15 and weekly thereafter by IV infusion over 15 minutes until confirmed disease progression or unacceptable toxicity

IMCgp100

Dacarbazine is to be administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity

Ipilimumab is to be administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments

Pembrolizumab is to be administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity

Immunocore Medical Information

To evaluate the overall survival of HLA-A\*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.

This Phase II study is designed to evaluate the safety and efficacy of IMCgp100 compared with Investigator's Choice (dacarbazine, ipilimumab or pembrolizumab) in HLA-A\*0201 positive adult patients with advanced UM treated in the first line setting with no prior systemic or liver-directed chemo-, radio- or immune-therapy administered in the advanced setting (prior surgical resection of liver metastases and adjuvant systemic therapy are acceptable). Comparison of the IMCgp100 efficacy results in this Phase II study will be made with the concurrently randomized arm (Investigator's Choice) with a primary endpoint of overall survival (OS) and secondary efficacy endpoints of progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and disease control rate (DCR).

Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma

A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced Uveal Melanoma

Overall survival is defined as the time from randomization to date of death due to any cause.

Safety was defined as the number of participants with treatment emergent adverse events, including laboratory abnormalities, ECG changes, and/or physical examination findings.

Progression free survival (PFS) is defined as the time from randomization to the date of progression (RECIST v1.1) or death due to any cause.

General health status was assessed using the EQ-5D,5L questionnaire, which includes five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 scoring levels, where 1 indicates a better health state (no problems) and 3 indicates a worse health state. A positive change indicates improvement.

The EQ-5D VAS score records the participant's self-rated health on a vertical visual analogue scale, with 0 being the worst imaginable health state and 100 being the best imaginable health state. A positive change indicates improvement.

Global health status and quality of life was assessed using the EORTC QLQ-C30 questionnaire. The score range for the EORTC QLQ-C30 is from 0 to 100, with higher scores indicating better functioning and better global health status and health-related quality of life. A positive change indicates improvement.

Serum PK concentrations of tebentafusp were collected over time.

Objective response rate (ORR) is defined as the proportion of patients achieving an objective response (RECIST v1.1).

Duration of response (DOR) is defined as the time from first documented objective response (RECIST v1.1) until the date of documented disease progression.

Disease control rate (DCR) is defined as the proportion of patients with either an objective response or stable disease (RECIST v1.1)

Immunocore Ltd

The Safety Analysis Set included all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group (Investigator's Choice) was pre-specified as part of the study design and data for each treatment in that arm were not analyzed separately. Adverse events were defined as events that were new or worsened during the on-treatment period.

Tebentafusp administered at 20 mcg at Cycle 1 Day 1, 30 mcg at Cycle 1 Day 8, and 68 mcg at Cycle 1 Day 15 by IV infusion and weekly thereafter.

Tebentafusp

1 of 3 Investigator's Choice options: Systemic Dacarbazine, Ipilimumab or Pembrolizumab. Dacarbazine: administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity; Ipilimumab: administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments; Pembrolizumab: administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity.

Investigator's Choice

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

The Intent-to-treat (ITT) Analysis Set comprises all participants assigned to treatment analyzed by the treatment assignment whether or not the participant received the assigned treatment. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design.

Study Director

The Intent-to-treat (ITT) Analysis Set comprises all participants assigned to treatment analyzed by the treatment assignment whether or not the participant received the assigned treatment. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed.

Efficacy: Overall Survival

The Safety Analysis Set includes all randomized participants who received at least 1 full or partial dose of tebentafusp or investigator's choice. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design; therefore, data per different treatments were not analyzed.

Safety: Number of Participants With Treatment Emergent Adverse Events

Efficacy: Progression Free Survival (PFS)

Mobility - Baseline Cycle 1

Mobility - Change at Cycle 3

Mobility - Change at Cycle 5

Mobility - Change at Cycle 9

Mobility - Change at Cycle 13

Mobility - Change at Cycle 17

Mobility - Change at Cycle 21

Mobility - Change at Cycle 25

Mobility - Change at Cycle 29

Mobility - Change at EOT

Self-care - Baseline Cycle 1

Self-care - Change at Cycle 3

Self-care - Change at Cycle 5

Self-care - Change at Cycle 9

Self-care - Change at Cycle 13

Self-care - Change at Cycle 17

Self-care - Change at Cycle 21

Self-care - Change at Cycle 25

Self-care - Change at Cycle 29

Self-care - Change at EOT

Usual activities - Baseline Cycle 1

Usual activities - Change at Cycle 3

Usual activities - Change at Cycle 5

Usual activities - Change at Cycle 9

Usual activities - Change at Cycle 13

Usual activities - Change at Cycle 17

Usual activities - Change at Cycle 21

Usual activities - Change at Cycle 25

Usual activities - Change at Cycle 29

Usual activities - Change at EOT

Pain/Discomfort - Baseline Cycle 1

Pain/Discomfort - Change at Cycle 3

Pain/Discomfort - Change at Cycle 5

Pain/Discomfort - Change at Cycle 9

Pain/Discomfort - Change at Cycle 13

Pain/Discomfort - Change at Cycle 17

Pain/Discomfort - Change at Cycle 21

Pain/Discomfort - Change at Cycle 25

Pain/Discomfort - Change at Cycle 29

Pain/Discomfort - Change at EOT

Anxiety/Depression - Baseline Cycle 1

Anxiety/Depression - Change at Cycle 3

Anxiety/Depression - Change at Cycle 5

Anxiety/Depression - Change at Cycle 9

Anxiety/Depression - Change at Cycle 13

Anxiety/Depression - Change at Cycle 17

Anxiety/Depression - Change at Cycle 21

Anxiety/Depression - Change at Cycle 25

Anxiety/Depression - Change at Cycle 29

Anxiety/Depression - Change at EOT

Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores

Baseline Cycle 1

Change at Cycle 3

Change at Cycle 5

Change at Cycle 9

Change at Cycle 13

Change at Cycle 17

Change at Cycle 21

Change at Cycle 25

Change at Cycle 29

Change at EOT

Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS)

Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status

Cycle 1 Day 1 - End of Infusion

Cycle 1 Day 1 - 12 to 24 hours post-infusion

Cycle 1 Day 8 - End of Infusion

Cycle 1 Day 8 - 12 to 24 hours post-infusion

Cycle 1 Day 15 - End of Infusion

Cycle 1 Day 15 - 12 to 24 hours post-infusion

The PK Analysis Set included participants in the Safety Analysis Set who had at least 1 measurable PK concentration and who had relevant date, time, and dosing data for the sample.

Pharmacokinetics (PK): Tebentafusp Concentration

Efficacy: Objective Response Rate (ORR)

Efficacy: Duration of Response (DOR)

Efficacy: Disease Control Rate (DCR)

Pharmacokinetics: Frequency of Anti-IMCgp100 Antibody Formation

Dacarbazine administered at 1,000 mg/m\^2 of body surface area IV infusion every 3 weeks until confirmed disease progression or unacceptable toxicity.

Investigator's Choice: Dacarbazine

Ipilimumab administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments.

Investigator's Choice: Ipilimumab

Pembrolizumab administered at 2 mg/kg IV infusion over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity.

Investigator's Choice: Pembrolizumab

Overall Study

Pharmaceutical Solutions

Concentrate solution for intravenous infusion

Medical Information

This Expanded Access Program aims to:

1. Provide access to tebentafusp for mUM patients.
2. Provide access to tebentafusp for patients, who were on the control arm of the randomized controlled Phase II trial (IMCgp100-202) and were unable to crossover during the specified window.
3. Ensure that patients, who are benefiting from tebentafusp treatment while participating in an ongoing Immunocore sponsored clinical study (e.g., IMCgp100-102 or IMCgp100-201), may continue tebentafusp treatment on this Programme once the ongoing trial has met all of its key primary and secondary objectives.

A Cohort IND Expanded Access Program for Supporting Patient Access to Tebentafusp

A Cohort IND Expanded Access Program (EAP) for Tebentafusp for Treatment of HLA-A*02:01 Positive Patients With Metastatic Uveal Melanoma

Clinigen, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma	NCT03070392	Uveal Melanoma	IMCgp100 Dacarbazine Ipilimumab Pembrolizumab	18 Years - 99 Years	Immunocore Ltd
Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma	NCT03070392	Uveal Melanoma	IMCgp100 Dacarbazine Ipilimumab Pembrolizumab	18 Years - 99 Years	Immunocore Ltd
A Cohort IND Expanded Access Program for Supporting Patient Access to Tebentafusp	NCT04960891	Uveal Melanoma	Tebentafusp	18 Years -	Immunocore Ltd

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