Trial · NCT02570308
A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma
NCT02570308, Phase 1, Phase 2, Completed, Immunocore Ltd; results first posted 2021-09-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma. Trials, record NCT02570308. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02570308
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma
- NCT number
- NCT02570308
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 146 participants, actual
- Lead sponsor
- Immunocore Ltd
- Conditions
- Uveal Melanoma
- Interventions
- IMCgp100
- First posted
- 2015-10-07
- Last updated
- 2023-03-21
- Results first posted
- 2021-09-01
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Dose Limiting Toxicity (DLT) in Phase 1 | Up to 49 months | Number of participants with a dose limiting toxicity, defined as an adverse event (AE) or abnormal laboratory value assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment and meets any of the pre-specified criteria. |
| Primary | Objective Response Rate in Phase 2 | Up to 38 months | Objective response rate (ORR) is defined as the percentage of participants with measurable disease with at least 1 visit response of complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later, as defined in RECIST v.1.1 and assessed by an independent central review (ICR). The denominator in the calculation of the ORR is the number of participants in the full analysis set with measurable disease at baseline. |
| Secondary | Objective Response Rate in Phase 1 | Up to 49 months | ORR is defined as the percentage of participants with measurable disease with at least 1 visit response of CR or PR that is confirmed at least 4 weeks later, as defined in RECIST v.1.1 and assessed by an investigator. The denominator in the calculation of the ORR is the number of participants in the full analysis set with measurable disease at baseline. |
| Secondary | Progression-free Survival | Up to 49 months | Progression-free survival is defined as the time in months from first dose of study drug until the date of disease progression or death (by any cause in the absence of disease progression) as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2. |
| Secondary | Disease Control Rate | 24 weeks | Disease control rate (DCR) is defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD) recorded at least 24 weeks (± 1 week) after commencement of study drug and prior to any progressive disease (PD) event, as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2. |
| Secondary | Duration of Response | Up to 49 months | Duration of response (DOR) is defined as the time in months from the date of first documented objective response (CR or PR) until the date of documented disease progression or death by any cause in the absence of disease progression as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2. |
| Secondary | Time to Response | Up to 49 months | Time to response (TTR) is defined as the time in months from the date of first dose of study drug until the date of first documented objective response as assessed by RECIST v1.1 by the investigator for Phase 1 and ICR for Phase 2. |
| Secondary | Overall Survival | Up to 49 months | Overall survival (OS) is defined as the time in months from the date of first dose of study drug until death due to any cause in general. |
| Secondary | Minor Response Rate | Up to 49 months | Rate of minor response (or better) is defined as the proportion of participants with a confirmed CR, PR, or minor response (MinR) as assessed by RECIST v1.1 by the investigator for Phase 1 or ICR for Phase 2, where MinR is a reduction from baseline in sum of diameters between 10%-29%. The sum of diameters is defined as per RECIST v1.1 as the sum of longest diameters or short axis of target lesions (mm). |
| Secondary | Number of Participants With Treatment Dose Interruptions or Reductions | Up to 49 months | Tolerability of study treatment was assessed by summarizing the number of participants with dose interruptions or reductions that occurred during the treatment period. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Dose Limiting Toxicity (DLT) in Phase 1 | Up to 49 months | The Safety Analysis Set (SAS) included all participants who received at least 1 full or partial dose of tebentafusp. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Objective Response Rate in Phase 2 | Up to 38 months | The Full Analysis Set (FAS) included all participants who received at least 1 full or partial dose of tebentafusp. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate in Phase 1 | Up to 49 months | The Full Analysis Set (FAS) included all participants who received at least 1 full or partial dose of tebentafusp. The analysis was pre-specified to be a pooled analysis of all Phase 1 cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival | Up to 49 months | The Full Analysis Set (FAS) included all participants who received at least 1 full or partial dose of tebentafusp. The analysis was pre-specified to be a pooled analysis of all Phase 1 cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Months | MEDIAN |
| SECONDARY | Disease Control Rate | 24 weeks | The Full Analysis Set (FAS) included all participants who received at least 1 full or partial dose of tebentafusp. The analysis was pre-specified to be a pooled analysis of all Phase 1 cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response | Up to 49 months | The analysis population included all participants who received at least 1 full or partial dose of tebentafusp and who achieved a response. The analysis was pre-specified to be a pooled analysis of all Phase 1 cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Months | MEDIAN |
| SECONDARY | Time to Response | Up to 49 months | The analysis population included all participants who received at least 1 full or partial dose of tebentafusp and who achieved a response. The analysis was pre-specified to be a pooled analysis of all Phase 1 cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Months | MEAN |
| SECONDARY | Overall Survival | Up to 49 months | The Full Analysis Set (FAS) included all participants who received at least 1 full or partial dose of tebentafusp. The analysis was pre-specified to be a pooled analysis of all Phase 1 cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Months | MEDIAN |
| SECONDARY | Minor Response Rate | Up to 49 months | The Full Analysis Set (FAS) included all participants who received at least 1 full or partial dose of tebentafusp. The analysis was pre-specified to be a pooled analysis of all Phase 1 cohort participants (irrespective of dose); therefore, data by individual dose were not analyzed. | Percentage of participants | MEDIAN |
| SECONDARY | Number of Participants With Treatment Dose Interruptions or Reductions | Up to 49 months | The Safety Analysis Set (SAS) included all participants who received at least 1 full or partial dose of tebentafusp. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Dose Limiting Toxicity (DLT) in Phase 1 | Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp | 0 | Participants | ||
| Number of Participants With a Dose Limiting Toxicity (DLT) in Phase 1 | Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp | 1 | Participants | ||
| Number of Participants With a Dose Limiting Toxicity (DLT) in Phase 1 | Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp | 2 | Participants | ||
| Number of Participants With a Dose Limiting Toxicity (DLT) in Phase 1 | Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp | 0 | Participants | ||
| Objective Response Rate in Phase 2 | Phase 2 Dose Expansion: 68 mcg Tebentafusp | 4.7 | 95% Confidence Interval 1.8 to 10.0 | Percentage of participants | |
| Objective Response Rate in Phase 1 | Phase 1 Dose Escalation | 15.8 | 95% Confidence Interval 3.4 to 39.6 | Percentage of participants | |
| Progression-free Survival | Phase 1 Dose Escalation | 7.4 | 95% Confidence Interval 1.2 to 14.8 | Months | |
| Progression-free Survival | Phase 2 Dose Expansion | 2.8 | 95% Confidence Interval 2.0 to 3.7 | Months | |
| Disease Control Rate | Phase 1 Dose Escalation | 47.4 | 95% Confidence Interval 24.4 to 71.1 | Percentage of participants | |
| Disease Control Rate | Phase 2 Dose Expansion | 22.8 | 95% Confidence Interval 15.9 to 31.1 | Percentage of participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp | 3 | |
| Overall Study | STARTED | Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp | 6 | |
| Overall Study | STARTED | Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp | 4 | |
| Overall Study | STARTED | Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp | 6 | |
| Overall Study | STARTED | Phase 2 Dose Expansion: 68 mcg Tebentafusp | 127 | |
| Overall Study | COMPLETED | Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp | 2 | |
| Overall Study | COMPLETED | Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp | 1 | |
| Overall Study | COMPLETED | Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp | 0 | |
| Overall Study | COMPLETED | Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp | 2 | |
| Overall Study | COMPLETED | Phase 2 Dose Expansion: 68 mcg Tebentafusp | 53 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,345
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 | Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp | 1 | 3 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp | 2 | 6 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp | 1 | 4 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp | 2 | 6 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Phase 2 Dose Expansion: 68 mcg Tebentafusp | 17 | 127 | 21 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp | 0 | 3 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp | 0 | 6 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp | 1 | 4 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp | 0 | 6 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Phase 2 Dose Expansion: 68 mcg Tebentafusp | 1 | 127 | 1 |
1 to 10 of 1,345Source ClinicalTrials.gov
See all 1,345 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp | 1 | 3 |
| Total, all-cause mortality | Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp | 5 | 6 |
| Total, all-cause mortality | Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp | 4 | 4 |
| Total, all-cause mortality | Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp | 4 | 6 |
| Total, all-cause mortality | Phase 2 Dose Expansion: 68 mcg Tebentafusp | 69 | 127 |
| Total, other adverse events | Phase 1 Dose Escalation Cohort 1: 54 mcg Tebentafusp | 3 | 3 |
| Total, other adverse events | Phase 1 Dose Escalation Cohort 2: 64 mcg Tebentafusp | 6 | 6 |
| Total, other adverse events | Phase 1 Dose Escalation Cohort 3: 73 mcg Tebentafusp | 4 | 4 |
| Total, other adverse events | Phase 1 Dose Escalation Cohort 4: 68 mcg Tebentafusp | 6 | 6 |
| Total, other adverse events | Phase 2 Dose Expansion: 68 mcg Tebentafusp | 127 | 127 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02570308
GET https://conductscience.org/api/trials/v1/NCT02570308/results?page=2