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NCT02224781 · OUTCOME

2-year Overall Survival (OS)

Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma · Source last updated 2026-08-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry

What was measured

Overall Survival (OS) was defined as the time from randomization to death from any cause. Patients who have not died would be censored at the date of last known alive. 2-year OS rate was defined as a proportion of patients who are alive after two years of follow-up time among all cases who have died within 2 years or alive after 2-year follow-up time. Kaplan-Meier method was used to estimate 2-year OS.

Analysis population: All randomized patients (ie, intent-to-treat population)

Groups in this outcome

Arm A (Immunotherapy)

IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Echocardiography Test: Undergo ECHO Ipilimumab: Given IV Multigated Acquisition Scan: Undergo MUGA scan Nivolumab: Given IV Quality-of-Life Assessment: Ancillary studies

Arm B (BRAF Inhibitor Therapy)

Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Dabrafenib Mesylate: Given PO Echocardiography Test: Undergo ECHO Multigated Acquisition Scan: Undergo MUGA scan Quality-of-Life Assessment: Ancillary studies Trametinib Dimethyl Sulfoxide: Given PO

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A (Immunotherapy)135
Arm B (BRAF Inhibitor Therapy)132

Reported measurements

Source class 1
Values in Proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Immunotherapy)0.683Not reported0.6030.764Not reported
Arm B (BRAF Inhibitor Therapy)0.541Not reported0.4530.629Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.002
    statistical Comment
    Stratified log rank test was conducted, stratifying on the randomization factors
    statistical Method
    Log Rank
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.002
    statistical Comment
    Stratified log rank test was conducted, stratifying on the randomization factors
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.603
        upper Limit
        0.764
        value
        0.683
      2. group Id
        OG001
        lower Limit
        0.453
        upper Limit
        0.629
        value
        0.541
denoms
  1. counts
    1. group Id
      OG000
      value
      135
    2. group Id
      OG001
      value
      132
    units
    Participants
description
Overall Survival (OS) was defined as the time from randomization to death from any cause. Patients who have not died would be censored at the date of last known alive. 2-year OS rate was defined as a proportion of patients who are alive after two years of follow-up time among all cases who have died within 2 years or alive after 2-year follow-up time. Kaplan-Meier method was used to estimate 2-year OS.
dispersion Type
95% Confidence Interval
groups
  1. description
    IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Echocardiography Test: Undergo ECHO Ipilimumab: Given IV Multigated Acquisition Scan: Undergo MUGA scan Nivolumab: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    OG000
    title
    Arm A (Immunotherapy)
  2. description
    Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Dabrafenib Mesylate: Given PO Echocardiography Test: Undergo ECHO Multigated Acquisition Scan: Undergo MUGA scan Quality-of-Life Assessment: Ancillary studies Trametinib Dimethyl Sulfoxide: Given PO
    id
    OG001
    title
    Arm B (BRAF Inhibitor Therapy)
param Type
NUMBER
population Description
All randomized patients (ie, intent-to-treat population)
reporting Status
POSTED
time Frame
assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry
title
2-year Overall Survival (OS)
type
PRIMARY
unit Of Measure
Proportion of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice