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NCT02586207 · OUTCOME

Adverse Events Will be Assessed and Graded Using CTCAE 4.0. Occurrences With Max Grade and Percentage/Number of Participants Affected by AEs Will be Provided.

Pembrolizumab in Combination With CRT for LA-SCCHN · Source last updated 2025-10-07

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
through day 240 (this time frame allows capturing of AEs that occurred up to 90 days after completion of treatment)

What was measured

To determine the safety and tolerability of pembrolizumab given in combination with cisplatin-based chemoradiotherapy (CRT) in subjects with treatment naive Stage III-IVB squamous cell carcinoma of the head and neck (SCCHN). Number of participants affected by AEs will be reported by grade and percentage of participants affected. Safety and tolerability will be assessed by clinical review of all relevant parameters including adverse events (AEs), laboratory tests, and vital signs. Count and percentage of AE will be provided.

Analysis population: Number of participants who experience an Adverse Event.

Groups in this outcome

Single Arm

Pembrolizumab + Cisplatin + Radiation pembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141. Cisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36 Radiation: 70 Gy fractionated over 35 days

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

Analysis denominator · Participants

GroupSource count
Single Arm57

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Single Arm57Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        57
denoms
  1. counts
    1. group Id
      OG000
      value
      57
    units
    Participants
description
To determine the safety and tolerability of pembrolizumab given in combination with cisplatin-based chemoradiotherapy (CRT) in subjects with treatment naive Stage III-IVB squamous cell carcinoma of the head and neck (SCCHN). Number of participants affected by AEs will be reported by grade and percentage of participants affected. Safety and tolerability will be assessed by clinical review of all relevant parameters including adverse events (AEs), laboratory tests, and vital signs. Count and percentage of AE will be provided.
groups
  1. description
    Pembrolizumab + Cisplatin + Radiation pembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141. Cisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36 Radiation: 70 Gy fractionated over 35 days
    id
    OG000
    title
    Single Arm
param Type
COUNT_OF_PARTICIPANTS
population Description
Number of participants who experience an Adverse Event.
reporting Status
POSTED
time Frame
through day 240 (this time frame allows capturing of AEs that occurred up to 90 days after completion of treatment)
title
Adverse Events Will be Assessed and Graded Using CTCAE 4.0. Occurrences With Max Grade and Percentage/Number of Participants Affected by AEs Will be Provided.
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice