Trial · NCT03070392
Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
NCT03070392, Phase 2, Completed, Immunocore Ltd; results first posted 2021-09-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma. Trials, record NCT03070392. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03070392
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
- NCT number
- NCT03070392
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 378 participants, actual
- Lead sponsor
- Immunocore Ltd
- Conditions
- Uveal Melanoma
- Interventions
- IMCgp100, Dacarbazine, Ipilimumab, Pembrolizumab
- First posted
- 2017-03-03
- Last updated
- 2026-10-29
- Results first posted
- 2021-09-14
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization to the data cut off date of 13-Oct-2020; median follow-up duration was 14.1 months. | Overall survival is defined as the time from randomization to date of death due to any cause. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events | Safety was assessed from informed consent through 90 days after end of treatment, up to 36 months. | Safety was defined as the number of participants with treatment emergent adverse events, including laboratory abnormalities, ECG changes, and/or physical examination findings. |
| Secondary | Progression Free Survival (PFS) | PFS was assessed every 3 months from randomization until disease progression or death, up to 36 months. | 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. |
| Secondary | Change From Baseline in EQ-5D,5L Domain Scores | EQ-5D,5L was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days. | 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. |
| Secondary | Change From Baseline in EQ-5D Visual Analogue Score (VAS) | EQ-5D,5L VAS was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days. | 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. |
| Secondary | Change From Baseline in EORTC QLQ-C30 Global Health Status | EORTC QLQ-C30 was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days. | 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. |
| Secondary | Tebentafusp Concentration | PK concentrations were assessed at pre-dose, end of infusion and anytime in the 12 to 24 hour window after completion of the infusion in Cycle 1 on Days 1, 8 and 15. | Serum pharmacokinetics (PK) concentrations of tebentafusp were collected over time. |
| Secondary | Objective Response Rate (ORR) | DOR was assessed every 3 months from randomization until disease progression, assessed up to 5.5 years. | Objective response rate (ORR) is defined as the percentage of patients achieving an objective response (RECIST v1.1). |
| Secondary | Duration of Response (DOR) | DOR was assessed every 3 months from randomization until disease progression, assessed up to 5.5 years. | Duration of response (DOR) is defined as the time from first documented objective response (RECIST v1.1) until the date of documented disease progression. The Kaplan-Meier estimates for the percentage of participants' DOR over time is presented. |
| Secondary | Disease Control Rate (DCR) | DCR was assessed every 3 months from randomization until disease progression, up to 5.5 years. | Disease control rate (DCR) is defined as the percentage of participants with either an objective response or stable disease (RECIST v1.1) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy: Overall Survival | From randomization to the data cut off date of 13-Oct-2020; median follow-up duration was 14.1 months. | 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. | Months | MEDIAN |
| SECONDARY | Safety: Number of Participants With Treatment Emergent Adverse Events | Safety was assessed from informed consent through 90 days after end of treatment, up to 36 months. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy: Progression Free Survival (PFS) | PFS was assessed every 3 months from randomization until disease progression or death, up to 36 months. | 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. | Months | MEDIAN |
| SECONDARY | Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | EQ-5D,5L was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days. | 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. | Units on a scale | MEAN |
| SECONDARY | Quality-of-life: Change From Baseline in EQ-5D Visual Analogue Score (VAS) | EQ-5D,5L VAS was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days. | 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. | Units on a scale | MEAN |
| SECONDARY | Quality-of-Life: Change From Baseline in EORTC QLQ-C30 Global Health Status | EORTC QLQ-C30 was assessed at baseline (Cycle 1 Day 1) and on Day 1 of every other cycle to Cycle 5 Day 1, every fourth cycle thereafter, beginning with Cycle 9 Day 1 and End of Treatment (EOT), up to 36 months. Each cycle is 21 days. | 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. | Units on a scale | MEAN |
| SECONDARY | Pharmacokinetics (PK): Tebentafusp Concentration | PK concentrations were assessed at pre-dose, end of infusion and anytime in the 12 to 24 hour window after completion of the infusion in Cycle 1 on Days 1, 8 and 15. | 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. | pg/mL | GEOMETRIC_MEAN |
| SECONDARY | Efficacy: Objective Response Rate (ORR) | ORR will be assessed after every participant has had at least 3 assessments, conducted every 3 months, up to 5.5 years. | |||
| SECONDARY | Efficacy: Duration of Response (DOR) | DOR will be assessed every 3 months from randomization until disease progression, assessed up to 5.5 years. | |||
| SECONDARY | Efficacy: Disease Control Rate (DCR) | DCR will be assessed every 3 months from randomization until disease progression, up to 5.5 years. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group152
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy: Overall Survival | Tebentafusp | 21.7 | 95% Confidence Interval 18.6 to 28.6 | Months | |
| Efficacy: Overall Survival | Investigator's Choice | 16.0 | 95% Confidence Interval 9.7 to 18.4 | Months | |
| Safety: Number of Participants With Treatment Emergent Adverse Events | Tebentafusp | 245 | Participants | ||
| Safety: Number of Participants With Treatment Emergent Adverse Events | Investigator's Choice | 105 | Participants | ||
| Efficacy: Progression Free Survival (PFS) | Tebentafusp | 3.3 | 95% Confidence Interval 3.0 to 5.0 | Months | |
| Efficacy: Progression Free Survival (PFS) | Investigator's Choice | 2.9 | 95% Confidence Interval 2.8 to 3.0 | Months | |
| Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Tebentafusp | Mobility - Baseline Cycle 1 | 1.2 | Standard Deviation 0.62 | Units on a scale |
| Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Investigator's Choice | Mobility - Baseline Cycle 1 | 1.3 | Standard Deviation 0.55 | Units on a scale |
| Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Tebentafusp | Mobility - Change at Cycle 3 | -0.1 | Standard Deviation 0.66 | Units on a scale |
| Quality-of-Life: Change From Baseline in EQ-5D,5L Domain Scores | Investigator's Choice | Mobility - Change at Cycle 3 | 0.1 | Standard Deviation 0.47 | Units on a scale |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tebentafusp | 252 | |
| Overall Study | STARTED | Investigator's Choice: Dacarbazine | 7 | |
| Overall Study | STARTED | Investigator's Choice: Ipilimumab | 16 | |
| Overall Study | STARTED | Investigator's Choice: Pembrolizumab | 103 | |
| Overall Study | COMPLETED | Tebentafusp | 0 | |
| Overall Study | COMPLETED | Investigator's Choice: Dacarbazine | 0 | |
| Overall Study | COMPLETED | Investigator's Choice: Ipilimumab | 10 | |
| Overall Study | COMPLETED | Investigator's Choice: Pembrolizumab | 0 | |
| Overall Study | NOT COMPLETED | Tebentafusp | 252 | |
| Overall Study | NOT COMPLETED | Investigator's Choice: Dacarbazine | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events288
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Tebentafusp | 25 | 245 | 62 |
| other | Anemia | Blood and lymphatic system disorders | Investigator's Choice | 4 | 111 | 4 |
| other | Lymphopenia | Blood and lymphatic system disorders | Tebentafusp | 24 | 245 | 51 |
| other | Lymphopenia | Blood and lymphatic system disorders | Investigator's Choice | 3 | 111 | 4 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tebentafusp | 5 | 245 | 7 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Investigator's Choice | 6 | 111 | 10 |
| other | Tachycardia | Cardiac disorders | Tebentafusp | 24 | 245 | 45 |
| other | Tachycardia | Cardiac disorders | Investigator's Choice | 3 | 111 | 3 |
| other | Hyperthyroidism | Endocrine disorders | Tebentafusp | 2 | 245 | 2 |
| other | Hyperthyroidism | Endocrine disorders | Investigator's Choice | 13 | 111 | 16 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tebentafusp | 84 | 245 |
| Total, all-cause mortality | Investigator's Choice | 57 | 111 |
| Total, other adverse events | Tebentafusp | 245 | 245 |
| Total, other adverse events | Investigator's Choice | 102 | 111 |
| Total, serious adverse events | Tebentafusp | 69 | 245 |
| Total, serious adverse events | Investigator's Choice | 26 | 111 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tebentafusp vs Investigator's Choice: Safety: Number of Participants With Treatment Emergent Adverse Events | Trial comparisons |
| Tebentafusp vs Investigator's Choice: deaths from any cause | Trial comparisons |
| Tebentafusp vs Investigator's Choice: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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