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NCT03698019 · OUTCOME

Two-Year Event-Free Survival Rate

A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma · Source last updated 2026-08-04

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
2 years

What was measured

Event-free survival (EFS) is measured from date of randomization to date of first: documentation of progression that render participant unable to receive planned protocol surgery, off protocol therapy for any reason without subsequent protocol surgery, failure to begin adjuvant therapy within 84 days after surgery, relapse after surgery or death due to any cause. Participants last known to be alive and event-free are censored at date of last contact. All events that occurred before the start of adjuvant therapy were assigned an event date of 84 days.

Groups in this outcome

Arm I (Adjuvant Pembrolizumab)

Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery

Arm II (Adjuvant and Neoadjuvant Pembrolizumab)

Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery

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 I (Adjuvant Pembrolizumab)159
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)154

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Adjuvant Pembrolizumab)49Not reported4159Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)72Not reported6480Not reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.004
    param Type
    Hazard Ratio (HR)
    param Value
    0.64
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.004
    param Type
    Hazard Ratio (HR)
    param Value
    0.64
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        41
        upper Limit
        59
        value
        49
      2. group Id
        OG001
        lower Limit
        64
        upper Limit
        80
        value
        72
denoms
  1. counts
    1. group Id
      OG000
      value
      159
    2. group Id
      OG001
      value
      154
    units
    Participants
description
Event-free survival (EFS) is measured from date of randomization to date of first: documentation of progression that render participant unable to receive planned protocol surgery, off protocol therapy for any reason without subsequent protocol surgery, failure to begin adjuvant therapy within 84 days after surgery, relapse after surgery or death due to any cause. Participants last known to be alive and event-free are censored at date of last contact. All events that occurred before the start of adjuvant therapy were assigned an event date of 84 days.
dispersion Type
95% Confidence Interval
groups
  1. description
    Within 17 days (preferably within 14 days) days after IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    id
    OG000
    title
    Arm I (Adjuvant Pembrolizumab)
  2. description
    Patients receive pembrolizumab IV over 30 minutes on day 1 every 3 weeks for 3 cycles, then undergo surgery within 3 weeks. Within 84 days, patients receive pembrolizumab IV over 30 minutes every 3 weeks for 15 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood throughout the study and MRI or CT on study. Biospecimen Collection: Undergo collection of blood Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Pembrolizumab: Given IV Therapeutic Conventional Surgery: Undergo surgery
    id
    OG001
    title
    Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
param Type
NUMBER
reporting Status
POSTED
time Frame
2 years
title
Two-Year Event-Free Survival Rate
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice