NCT03370276 · ADVERSE EVENTS

Adverse events

Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma · Source last updated 2026-04-02

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse events collected from on study date to 30 days after completion of study therapy, approximately 2 years. All participants were followed for events, whether or not evaluable.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I - Lead in Nivolumab and dose escalation of Cetuximab. Lead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 500 mg/m\^2; Nivolumab 240 mg. Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.	3 / 3	3 / 3	2 / 3
Phase II- Cohort A Patients who had progressed on at least one prior line of treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.	19 / 44	43 / 44	35 / 44
Phase II - Cohort B Patients who have not had any prior treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.	19 / 48	45 / 48	33 / 48

Group identifiers: EG000: Phase I - Lead in · EG001: Phase II- Cohort A · EG002: Phase II - Cohort B

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
2
group Id
EG002
num Affected
2
num At Risk
48
num Events
2
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
44
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Renal and urinary disorders -Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
5
num At Risk
44
num Events
5
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Respiratory failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
2
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Death, NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
PEG tube re-placement
organ System
Surgical and medical procedures
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
44
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Surgical and medical procedures - Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
44
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
2
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Pleural effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Disease progression
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
6
num At Risk
44
num Events
6
group Id
EG002
num Affected
3
num At Risk
48
num Events
3
term
Neoplasms benign, malignant and unspecified-Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
44
num Events
1
group Id
EG002
num Affected
1
num At Risk
48
num Events
2
term
Atrial fibrilation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
44
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Hypokalemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
44
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Flu like symptoms
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
44
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Skin infection

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
5
num At Risk
44
num Events
6
group Id
EG002
num Affected
4
num At Risk
48
num Events
5
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
44
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
2
group Id
EG002
num Affected
7
num At Risk
48
num Events
11
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
6
group Id
EG002
num Affected
7
num At Risk
48
num Events
13
term
Alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
44
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Alkalosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
2
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Allergic reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
44
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Allergic rhinitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
2
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
4
group Id
EG001
num Affected
5
num At Risk
44
num Events
6
group Id
EG002
num Affected
14
num At Risk
48
num Events
47
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
8
num At Risk
44
num Events
8
group Id
EG002
num Affected
9
num At Risk
48
num Events
10
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
44
num Events
0
group Id
EG002
num Affected
4
num At Risk
48
num Events
4
term
Anxiety
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
2
group Id
EG002
num Affected
3
num At Risk
48
num Events
4
term
Arthralgia

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
3
description
Nivolumab and dose escalation of Cetuximab. Lead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 500 mg/m\^2; Nivolumab 240 mg. Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Phase I - Lead in
deaths Num Affected
35
deaths Num At Risk
44
description
Patients who had progressed on at least one prior line of treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
id
EG001
other Num Affected
43
other Num At Risk
44
serious Num Affected
19
serious Num At Risk
44
title
Phase II- Cohort A
deaths Num Affected
33
deaths Num At Risk
48
description
Patients who have not had any prior treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
id
EG002
other Num Affected
45
other Num At Risk
48
serious Num Affected
19
serious Num At Risk
48
title
Phase II - Cohort B

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
5
num At Risk
44
num Events
6
group Id
EG002
num Affected
4
num At Risk
48
num Events
5
term
Abdominal Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
44
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Acute kidney injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
2
group Id
EG002
num Affected
7
num At Risk
48
num Events
11
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
6
group Id
EG002
num Affected
7
num At Risk
48
num Events
13
term
Alkaline phosphatase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
44
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Alkalosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
2
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Allergic reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
44
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Allergic rhinitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
2
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Alopecia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
4
group Id
EG001
num Affected
5
num At Risk
44
num Events
6
group Id
EG002
num Affected
14
num At Risk
48
num Events
47
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
8
num At Risk
44
num Events
8
group Id
EG002
num Affected
9
num At Risk
48
num Events
10
term
Anorexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
44
num Events
0
group Id
EG002
num Affected
4
num At Risk
48
num Events
4
term
Anxiety
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
2
group Id
EG002
num Affected
3
num At Risk
48
num Events
4
term
Arthralgia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
2
group Id
EG002
num Affected
2
num At Risk
48
num Events
2
term
Sepsis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
44
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Renal and urinary disorders -Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
5
num At Risk
44
num Events
5
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Respiratory failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
2
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Death, NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
PEG tube re-placement
organ System
Surgical and medical procedures
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
44
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Surgical and medical procedures - Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
44
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
2
num At Risk
44
num Events
2
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Pleural effusion
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Disease progression
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
6
num At Risk
44
num Events
6
group Id
EG002
num Affected
3
num At Risk
48
num Events
3
term
Neoplasms benign, malignant and unspecified-Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
44
num Events
1
group Id
EG002
num Affected
1
num At Risk
48
num Events
2
term
Atrial fibrilation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
44
num Events
0
group Id
EG002
num Affected
1
num At Risk
48
num Events
1
term
Hypokalemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
44
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Flu like symptoms
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.1)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
44
num Events
1
group Id
EG002
num Affected
0
num At Risk
48
num Events
0
term
Skin infection

time Frame

Adverse events collected from on study date to 30 days after completion of study therapy, approximately 2 years. All participants were followed for events, whether or not evaluable.

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

Preserved source evidence · Not medical advice