Trial · NCT02723006
Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma
NCT02723006, Phase 1, Terminated, Millennium Pharmaceuticals, Inc.; results first posted 2021-04-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma. Trials, record NCT02723006. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02723006
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma
- NCT number
- NCT02723006
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 22 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Melanoma
- Interventions
- TAK-580, TAK-202, vedolizumab, nivolumab, ipilimumab
- First posted
- 2016-03-30
- Last updated
- 2024-03-05
- Other registries' IDs
- eudract:2015-005554-35
- Results first posted
- 2021-04-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Dose Limiting Toxicities (DLTs) During the Dose-escalation Safety Lead-in Phase | TAK-580 + Nivolumab and TAK-202 + Nivolumab: Baseline up to Week 9; Vedolizumab + Nivolumab + Ipilimumab: Baseline up to Week 7 | DLTs was evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. |
| Secondary | Overall Response Rate (ORR) During the Dose-escalation Safety Lead-in Phase | Baseline up to Week 50 | ORR based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. was the percentage of participants with complete response (CR) or partial response (PR). CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR: was at least a 30 percent (%) decrease in sum of diameter (SOD) of target lesions, taking as reference the baseline SOD. |
| Secondary | Duration of Response (DOR) During the Dose-escalation Safety Lead-in Phase | From date of first documented confirmed CR/PR until date of first documentation of PD or death (up to Week 50) | DOR based on RECIST version 1.1 was the time from the date of first documented confirmed CR/PR until the first documentation of confirmed progressive disease (PD) or death, whichever occurred first. CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD persistence of one or more non- target lesions and/or maintenance of tumor marker level above the normal limits. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. |
| Secondary | Progression-free Survival (PFS) During the Dose-escalation Safety Lead-in Phase | From first dose date to the date of the first documentation of confirmed PD or death (up to Week 50) | PFS was the time from first dose date to date of the first documentation of confirmed PD or death, whichever occurred first. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions. |
| Secondary | Overall Survival (OS) During the Dose-escalation Safety Lead-in Phase | From first dose of study drug until date of death from any cause (up to Week 50) | OS was the time from date of first dose of study drug until date of death from any cause. |
| Secondary | Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the first dose of study drug up to 30 days after the last dose of study drug (up to Week 50) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Dose Limiting Toxicities (DLTs) During the Dose-escalation Safety Lead-in Phase | TAK-580 + Nivolumab and TAK-202 + Nivolumab: Baseline up to Week 9; Vedolizumab + Nivolumab + Ipilimumab: Baseline up to Week 7 | The safety analysis set included all participants who received at least 1 dose, even if incomplete, of study treatment (TAK-580, TAK-202, or vedolizumab). | DLTs | NUMBER |
| SECONDARY | Overall Response Rate (ORR) During the Dose-escalation Safety Lead-in Phase | Baseline up to Week 50 | Planned efficacy analyses was not performed as the study was terminated due to lack of enrollment, lack of clinical benefit and after the pre-specified stopping rule was met for diarrhea. | ||
| SECONDARY | Duration of Response (DOR) During the Dose-escalation Safety Lead-in Phase | From date of first documented confirmed CR/PR until date of first documentation of PD or death (up to Week 50) | Planned efficacy analyses was not performed as the study was terminated due to lack of enrollment, lack of clinical benefit and after the pre-specified stopping rule was met for diarrhea. | ||
| SECONDARY | Progression-free Survival (PFS) During the Dose-escalation Safety Lead-in Phase | From first dose date to the date of the first documentation of confirmed PD or death (up to Week 50) | Planned efficacy analyses was not performed as the study was terminated due to lack of enrollment, lack of clinical benefit and after the pre-specified stopping rule was met for diarrhea. | ||
| SECONDARY | Overall Survival (OS) During the Dose-escalation Safety Lead-in Phase | From first dose of study drug until date of death from any cause (up to Week 50) | Planned efficacy analyses was not performed as the study was terminated due to lack of enrollment, lack of clinical benefit and after the pre-specified stopping rule was met for diarrhea. | ||
| SECONDARY | Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the first dose of study drug up to 30 days after the last dose of study drug (up to Week 50) | The safety analysis set included all participants who received at least 1 dose, even if incomplete, of study treatment (TAK-580, TAK-202, or vedolizumab). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Dose Limiting Toxicities (DLTs) During the Dose-escalation Safety Lead-in Phase | Arm 1: TAK-580 + Nivolumab | 0 | DLTs | ||
| Number of Dose Limiting Toxicities (DLTs) During the Dose-escalation Safety Lead-in Phase | Arm 2: TAK-202 + Nivolumab | 3 | DLTs | ||
| Number of Dose Limiting Toxicities (DLTs) During the Dose-escalation Safety Lead-in Phase | Arm 3: Vedolizumab + Ipilimumab + Nivolumab | 0 | DLTs | ||
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Arm 1: TAK-580 + Nivolumab | TEAEs | 1 | participants | |
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Arm 2: TAK-202 + Nivolumab | TEAEs | 9 | participants | |
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Arm 3: Vedolizumab + Ipilimumab + Nivolumab | TEAEs | 12 | participants | |
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Arm 1: TAK-580 + Nivolumab | SAEs | 1 | participants | |
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Arm 2: TAK-202 + Nivolumab | SAEs | 2 | participants | |
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Arm 3: Vedolizumab + Ipilimumab + Nivolumab | SAEs | 7 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: TAK-580 + Nivolumab | 1 | |
| Overall Study | STARTED | Arm 2: TAK-202 + Nivolumab | 9 | |
| Overall Study | STARTED | Arm 3: Vedolizumab + Ipilimumab + Nivolumab | 12 | |
| Overall Study | COMPLETED | Arm 1: TAK-580 + Nivolumab | 0 | |
| Overall Study | COMPLETED | Arm 2: TAK-202 + Nivolumab | 2 | |
| Overall Study | COMPLETED | Arm 3: Vedolizumab + Ipilimumab + Nivolumab | 5 | |
| Overall Study | NOT COMPLETED | Arm 1: TAK-580 + Nivolumab | 1 | |
| Overall Study | NOT COMPLETED | Arm 2: TAK-202 + Nivolumab | 7 | |
| Overall Study | NOT COMPLETED | Arm 3: Vedolizumab + Ipilimumab + Nivolumab | 7 |
Source ClinicalTrials.gov
Adverse events438
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 | Nausea | Gastrointestinal disorders | Arm 1: TAK-580 + Nivolumab | 1 | 1 | 3 |
| other | Nausea | Gastrointestinal disorders | Arm 2: TAK-202 + Nivolumab | 6 | 9 | 7 |
| other | Nausea | Gastrointestinal disorders | Arm 3: Vedolizumab + Ipilimumab + Nivolumab | 8 | 12 | 10 |
| other | Fatigue | General disorders | Arm 1: TAK-580 + Nivolumab | 1 | 1 | 2 |
| other | Fatigue | General disorders | Arm 2: TAK-202 + Nivolumab | 4 | 9 | 8 |
| other | Fatigue | General disorders | Arm 3: Vedolizumab + Ipilimumab + Nivolumab | 9 | 12 | 12 |
| other | Headache | Nervous system disorders | Arm 1: TAK-580 + Nivolumab | 1 | 1 | 1 |
| other | Headache | Nervous system disorders | Arm 2: TAK-202 + Nivolumab | 3 | 9 | 4 |
| other | Headache | Nervous system disorders | Arm 3: Vedolizumab + Ipilimumab + Nivolumab | 5 | 12 | 10 |
| other | Pyrexia | General disorders | Arm 1: TAK-580 + Nivolumab | 1 | 1 | 1 |
1 to 10 of 438Source ClinicalTrials.gov
See all 438 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: TAK-580 + Nivolumab | 0 | 1 |
| Total, all-cause mortality | Arm 2: TAK-202 + Nivolumab | 0 | 9 |
| Total, all-cause mortality | Arm 3: Vedolizumab + Ipilimumab + Nivolumab | 2 | 12 |
| Total, other adverse events | Arm 1: TAK-580 + Nivolumab | 1 | 1 |
| Total, other adverse events | Arm 2: TAK-202 + Nivolumab | 9 | 9 |
| Total, other adverse events | Arm 3: Vedolizumab + Ipilimumab + Nivolumab | 12 | 12 |
| Total, serious adverse events | Arm 1: TAK-580 + Nivolumab | 1 | 1 |
| Total, serious adverse events | Arm 2: TAK-202 + Nivolumab | 2 | 9 |
| Total, serious adverse events | Arm 3: Vedolizumab + Ipilimumab + Nivolumab | 7 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02723006
GET https://conductscience.org/api/trials/v1/NCT02723006/events?page=2