Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
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
Participants
Interval / dispersion
Not reported
Time frame
Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization.
What was measured
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Analysis population: Eligible participants that received protocol treatment
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
Group
Source count
Arm I (Adjuvant Pembrolizumab)
141
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
152
Reported measurements
Adrenal insufficiency
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Alanine aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
3
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
5
Not reported
Not reported
Not reported
Not reported
Alkaline phosphatase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Anemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arthralgia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arthritis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Aspartate aminotransferase increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
2
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
4
Not reported
Not reported
Not reported
Not reported
Blood and lymphatic system disorders - Other, spec
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Cardiac disorders - Other, specify
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Cardiac troponin I increased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Chest wall pain
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Cognitive disturbance
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Colitis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Dehydration
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Diarrhea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
2
Not reported
Not reported
Not reported
Not reported
Electrocardiogram QT corrected interval prolonged
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Fall
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
2
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Febrile neutropenia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Fever
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
2
Not reported
Not reported
Not reported
Not reported
Gallbladder infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Headache
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Hematoma
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Hepatobiliary disorders - Other, specify
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Hyperglycemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
3
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
2
Not reported
Not reported
Not reported
Not reported
Hypertension
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
2
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
3
Not reported
Not reported
Not reported
Not reported
Hypokalemia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
2
Not reported
Not reported
Not reported
Not reported
Hyponatremia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Hypothyroidism
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Infections and infestations - Other, specify
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Lung infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
2
Not reported
Not reported
Not reported
Not reported
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
3
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Metabolism and nutrition disorders - Other, specif
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Myalgia
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Myocarditis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
2
Not reported
Not reported
Not reported
Not reported
Myositis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Nausea
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
2
Not reported
Not reported
Not reported
Not reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Platelet count decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Pneumonitis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
2
Not reported
Not reported
Not reported
Not reported
Pruritus
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
2
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Rash maculo-papular
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
4
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
2
Not reported
Not reported
Not reported
Not reported
Respiratory failure
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Sepsis
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Seroma
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Skin and subcutaneous tissue disorders - Other, sp
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Skin infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Small intestinal obstruction
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Soft tissue infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Stroke
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Surgical and medical procedures - Other, specify
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Syncope
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
2
Not reported
Not reported
Not reported
Not reported
Thromboembolic event
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Urinary tract infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Vomiting
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
White blood cell decreased
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Wound dehiscence
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
1
Not reported
Not reported
Not reported
Not reported
Wound infection
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Arm I (Adjuvant Pembrolizumab)
0
Not reported
Not reported
Not reported
Not reported
Arm II (Adjuvant and Neoadjuvant Pembrolizumab)
2
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Adrenal insufficiency
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
5
title
Alanine aminotransferase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Alkaline phosphatase increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Anemia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Arthralgia
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Arthritis
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
4
title
Aspartate aminotransferase increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Blood and lymphatic system disorders - Other, spec
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Cardiac disorders - Other, specify
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Cardiac troponin I increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Chest wall pain
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Cognitive disturbance
denoms
counts
group Id
OG000
value
141
group Id
OG001
value
152
units
Participants
description
Only adverse events that are possibly, probably or definitely related to study drug are reported.
groups
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)
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
population Description
Eligible participants that received protocol treatment
reporting Status
POSTED
time Frame
Duration of treatment and follow-up until relapse, death, or 3.5 years post randomization.
title
Number of Participants With Grade 3 Through 5 Adverse Events That Are Related to Study Drug