Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
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ClinicalTrials.gov Identifier: NCT03070392 |
Recruitment Status :
Active, not recruiting
First Posted : March 3, 2017
Results First Posted : September 14, 2021
Last Update Posted : March 21, 2022
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Sponsor:
Immunocore Ltd
Information provided by (Responsible Party):
Immunocore Ltd
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Uveal Melanoma |
Interventions |
Biological: IMCgp100 Drug: Dacarbazine Biological: Ipilimumab Biological: Pembrolizumab |
Enrollment | 378 |
Participant Flow
Recruitment Details | A total of 378 patients were randomly assigned (2:1) to Tebentafusp (n=252) or Investigator's Choice (n=126) at 58 sites in 14 countries. |
Pre-assignment Details | The data cut-off date for this analysis was 13 October 2020. Combining participants into a single group as part of the Investigator's Choice arm was pre-specified as part of the study design. |
Arm/Group Title | Tebentafusp | Investigator's Choice: Dacarbazine | Investigator's Choice: Ipilimumab | Investigator's Choice: Pembrolizumab |
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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. | Dacarbazine administered at 1,000 mg/m^2 of body surface area IV infusion every 3 weeks until confirmed 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 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. |
Period Title: Overall Study | ||||
Started | 252 | 7 | 16 | 103 |
Completed | 0 | 0 | 10 | 0 |
Not Completed | 252 | 7 | 6 | 103 |
Reason Not Completed | ||||
Not Treated | 7 | 0 | 3 | 12 |
Death | 3 | 0 | 0 | 1 |
Withdrawal by Subject | 7 | 0 | 0 | 3 |
Physician Decision | 1 | 0 | 0 | 2 |
Progressive Disease | 154 | 6 | 2 | 70 |
Adverse Event | 6 | 1 | 1 | 3 |
Alternate anticancer treatment | 1 | 0 | 0 | 1 |
Ongoing | 73 | 0 | 0 | 11 |
Baseline Characteristics
Arm/Group Title | Tebentafusp | Investigator's Choice | Total | |
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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. | 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. | Total of all reporting groups | |
Overall Number of Baseline Participants | 252 | 126 | 378 | |
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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.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 252 participants | 126 participants | 378 participants | |
61.3 (11.9) | 63.6 (10.7) | 62.1 (11.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 252 participants | 126 participants | 378 participants | |
Female |
124 49.2%
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64 50.8%
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188 49.7%
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Male |
128 50.8%
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62 49.2%
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190 50.3%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 252 participants | 126 participants | 378 participants | |
American Indian or Alaska Native |
0 0.0%
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1 0.8%
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1 0.3%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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White |
222 88.1%
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107 84.9%
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329 87.0%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
30 11.9%
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18 14.3%
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48 12.7%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Study Director |
Organization: | Immunocore, Ltd |
Phone: | 1-844-IMMUNO-1 |
EMail: | clinicaltrials@immunocore.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Immunocore Ltd |
ClinicalTrials.gov Identifier: | NCT03070392 |
Other Study ID Numbers: |
IMCgp100-202 |
First Submitted: | February 14, 2017 |
First Posted: | March 3, 2017 |
Results First Submitted: | August 17, 2021 |
Results First Posted: | September 14, 2021 |
Last Update Posted: | March 21, 2022 |