Trial · NCT02506153
Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery
NCT02506153, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2024-08-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery. Trials, record NCT02506153. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02506153
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery
- NCT number
- NCT02506153
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,301 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Mucosal Melanoma, Metastatic Non-Cutaneous Melanoma, Non-Cutaneous Melanoma, Recurrent Cutaneous Melanoma, Recurrent Mucosal Melanoma, Recurrent Non-Cutaneous Melanoma
- Interventions
- Biospecimen Collection, Computed Tomography, Ipilimumab, Magnetic Resonance Imaging, Pembrolizumab, Positron Emission Tomography, Quality-of-Life Assessment, Recombinant Interferon Alfa-2b
- First posted
- 2015-07-23
- Last updated
- 2026-10-01
- Results first posted
- 2024-08-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | 5 years after last randomization | Time from date of randomization to date of death due to any cause. Patients known to be alive are censored at date of last contact. The results were presented as 5-year OS estimate. |
| Secondary | Relapse-free Survival (RFS) | 5 years after last randomization | Time from date of randomization to date of first documentation of relapse or death due to any cause. Patients last known to be alive and relapse-free are censored at date of last contact. |
| Secondary | Overall Survival (OS) in Participants Who Are PD-L1 Positive | 94 months; from study start November 10, 2015 to September 15, 2023 | Time from date of randomization to date of death due to any cause. Patients known to be alive are censored at date of last contact. |
| Secondary | Relapse-free Survival (RFS) in Participants Who Are PD-L1 Positive | 5 years after last randomization | Time from date of randomization to date of first documentation of relapse or death due to any cause. Patients last known to be alive and relapse-free are censored at date of last contact. |
| Secondary | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first. | Only adverse events that are possibly, probably or definitely related to study drug are reported. CTCAE Version 5.0 was used for all AE reporting. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | 5 years after last randomization | The analysis population includes the 1301 participants who were eligible and evaluable (654 in the SOC arm and 647 in the MK-3475 arm). | percentage of participants | NUMBER |
| SECONDARY | Relapse-free Survival (RFS) | 5 years after last randomization | The analysis population includes the 1301 participants who were eligible and evaluable (654 in the SOC arm and 647 in the MK-3475 arm). | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) in Participants Who Are PD-L1 Positive | 94 months; from study start November 10, 2015 to September 15, 2023 | The analysis population includes the 1070 participants who were eligible and evaluable with a PDL-1 positive status (536 in the SOC arm and 534 in the MK-3475 arm). | percentage of participants | NUMBER |
| SECONDARY | Relapse-free Survival (RFS) in Participants Who Are PD-L1 Positive | 5 years after last randomization | The analysis population includes the 1070 participants who were eligible and evaluable with a PDL-1 positive status (536 in the SOC arm and 534 in the MK-3475 arm). | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first. | Participants who were eligible and received at least one dose of protocol treatment. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group276
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | FDA Approved Regimen (SOC) | 76 | 95% Confidence Interval 73 to 80 | percentage of participants | |
| Overall Survival (OS) | MK-3475 (Pembrolizumab) | 82 | 95% Confidence Interval 78 to 84 | percentage of participants | |
| Relapse-free Survival (RFS) | FDA Approved Regimen (SOC) | 49 | 95% Confidence Interval 45 to 53 | percentage of participants | |
| Relapse-free Survival (RFS) | MK-3475 (Pembrolizumab) | 58 | 95% Confidence Interval 54 to 62 | percentage of participants | |
| Overall Survival (OS) in Participants Who Are PD-L1 Positive | FDA Approved Regimen (SOC) | 79 | 95% Confidence Interval 74 to 82 | percentage of participants | |
| Overall Survival (OS) in Participants Who Are PD-L1 Positive | MK-3475 (Pembrolizumab) | 83 | 95% Confidence Interval 80 to 86 | percentage of participants | |
| Relapse-free Survival (RFS) in Participants Who Are PD-L1 Positive | FDA Approved Regimen (SOC) | 51 | 95% Confidence Interval 46 to 55 | percentage of participants | |
| Relapse-free Survival (RFS) in Participants Who Are PD-L1 Positive | MK-3475 (Pembrolizumab) | 60 | 95% Confidence Interval 56 to 64 | percentage of participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | FDA Approved Regimen | Abdominal pain | 6 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | MK-3475 (Pembrolizumab) | Abdominal pain | 2 | Participants |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FDA Approved Regimen (SOC) | 654 | |
| Overall Study | STARTED | MK-3475 (Pembrolizumab) | 647 | |
| Overall Study | COMPLETED | FDA Approved Regimen (SOC) | 52 | |
| Overall Study | COMPLETED | MK-3475 (Pembrolizumab) | 366 | |
| Overall Study | NOT COMPLETED | FDA Approved Regimen (SOC) | 602 | |
| Overall Study | NOT COMPLETED | MK-3475 (Pembrolizumab) | 281 |
Source ClinicalTrials.gov
Adverse events382
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 | FDA Approved Regimen | 129 | 565 | |
| other | Anemia | Blood and lymphatic system disorders | MK-3475 (Pembrolizumab) | 115 | 639 | |
| other | Adrenal insufficiency | Endocrine disorders | FDA Approved Regimen | 29 | 565 | |
| other | Adrenal insufficiency | Endocrine disorders | MK-3475 (Pembrolizumab) | 22 | 639 | |
| other | Endocrine disorders-Other | Endocrine disorders | FDA Approved Regimen | 52 | 565 | |
| other | Endocrine disorders-Other | Endocrine disorders | MK-3475 (Pembrolizumab) | 28 | 639 | |
| other | Hyperthyroidism | Endocrine disorders | FDA Approved Regimen | 19 | 565 | |
| other | Hyperthyroidism | Endocrine disorders | MK-3475 (Pembrolizumab) | 54 | 639 | |
| other | Hypothyroidism | Endocrine disorders | FDA Approved Regimen | 69 | 565 | |
| other | Hypothyroidism | Endocrine disorders | MK-3475 (Pembrolizumab) | 143 | 639 |
1 to 10 of 382Source ClinicalTrials.gov
See all 382 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FDA Approved Regimen | 130 | 654 |
| Total, all-cause mortality | MK-3475 (Pembrolizumab) | 131 | 647 |
| Total, other adverse events | FDA Approved Regimen | 557 | 565 |
| Total, other adverse events | MK-3475 (Pembrolizumab) | 622 | 639 |
| Total, serious adverse events | FDA Approved Regimen | 23 | 565 |
| Total, serious adverse events | MK-3475 (Pembrolizumab) | 125 | 639 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36416836 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FDA Approved Regimen vs MK-3475 (Pembrolizumab): deaths from any cause | Trial comparisons |
| FDA Approved Regimen vs MK-3475 (Pembrolizumab): 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02506153
GET https://conductscience.org/api/trials/v1/NCT02506153/results?page=2