Trial Outcomes & Findings for Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (NCT NCT03691714)

Last Updated: 2026-06-01

Results Overview

Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

RECIST 1.1 was assessed for each participant every 8 weeks from study initiation until the end of study treatment. The time from first RECIST 1.1 assessment to the final at the end of study was 8.5 months.

Results posted on

2026-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	Durvalumab and Cetuximab Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance Durvalumab: Two hour infusion Cetuximab: Two hour infusion for loading dose followed by weekly one hour infusion
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Durvalumab (MEDI4736) With Cetuximab in Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Durvalumab and Cetuximab n=35 Participants Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance Durvalumab: Two hour infusion Cetuximab: Two hour infusion for loading dose followed by weekly one hour infusion
Age, Continuous	64 years n=24 Participants
Sex: Female, Male Female	24 Participants n=24 Participants
Sex: Female, Male Male	11 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	35 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	2 Participants n=24 Participants
Race (NIH/OMB) White	33 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants
Region of Enrollment United States	35 participants n=24 Participants
ECOG Status 0 = Fully active; no restrictions	6 Participants n=24 Participants
ECOG Status 1 = Restricted in strenuous activity but ambulatory	22 Participants n=24 Participants
ECOG Status 2 = Ambulatory, capable of self-care, unable to work	7 Participants n=24 Participants

PRIMARY outcome

Timeframe: RECIST 1.1 was assessed for each participant every 8 weeks from study initiation until the end of study treatment. The time from first RECIST 1.1 assessment to the final at the end of study was 8.5 months.

Population: Population included participants that had at least one dose of durvalumab.

Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Durvalumab and Cetuximab n=33 Participants Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance Durvalumab: Two hour infusion Cetuximab: Two hour infusion for loading dose followed by weekly one hour infusion
Objective Response Rate	13 Participants

SECONDARY outcome

Timeframe: From informed consent through study treatment and the 90-day safety follow-up period after the last dose of durvalumab and cetuximab, up to 24 months

Percentage of adverse events that were treatment related and greater than or equal to Grade 3 using CTCAE v 5.0. Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).

Outcome measures

Outcome measures
Measure	Durvalumab and Cetuximab n=873 Number of adverse events Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance Durvalumab: Two hour infusion Cetuximab: Two hour infusion for loading dose followed by weekly one hour infusion
Treatment Related Adverse Events	9 percentage of all adverse events

SECONDARY outcome

Timeframe: 6 months

Population: Subjects received at least one dose of Durvalumab.

Combined complete response, partial response, and stable disease

Outcome measures

Outcome measures
Measure	Durvalumab and Cetuximab n=33 Participants Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance Durvalumab: Two hour infusion Cetuximab: Two hour infusion for loading dose followed by weekly one hour infusion
Disease Control Rate	20 Participants

SECONDARY outcome

Timeframe: 24 months

Imaging review using RECIST 1.1 Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	Durvalumab and Cetuximab n=35 Participants Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance Durvalumab: Two hour infusion Cetuximab: Two hour infusion for loading dose followed by weekly one hour infusion
Progression-free Survival	5.8 months Interval 3.7 to 14.1

SECONDARY outcome

Timeframe: 24 months

Date of on treatment to date of death

Outcome measures

Outcome measures
Measure	Durvalumab and Cetuximab n=35 Participants Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance Durvalumab: Two hour infusion Cetuximab: Two hour infusion for loading dose followed by weekly one hour infusion
Overall Survival	9.6 months Interval 4.8 to 16.3

Adverse Events

Durvalumab and Cetuximab

Serious events: 24 serious events

Other events: 35 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Durvalumab and Cetuximab n=35 participants at risk Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance Durvalumab: Two hour infusion Cetuximab: Two hour infusion for loading dose followed by weekly one hour infusion
Blood and lymphatic system disorders Leukocytosis	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Cardiac disorders Sinus tachycardia	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Endocrine disorders Diabetes mellitus type 1	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Endocrine disorders Diabetic ketoacidosis	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Eye disorders Eye chemosis/inflammation	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Colonic hemorrhage	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Diarrhea	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Hematemesis	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Oral cavity fistula	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Vomiting	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Death NOS	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Edema face	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Fever	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Device related infection	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Lung infection	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Sepsis	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Surgical site infection	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Fall	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Fracture	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Tracheal obstruction	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Tracheostomy site bleeding	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Metabolism and nutrition disorders Anorexia	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Metabolism and nutrition disorders Dehydration	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Metabolism and nutrition disorders Failure to thrive	5.7% 2/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Nervous system disorders Encephalopathy	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Nervous system disorders Spinal cord compression	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Psychiatric disorders Confusion	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Renal and urinary disorders Acute kidney injury	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Reproductive system and breast disorders Aspiration	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders HCAP/aspiration pneumonia with acute hypoxic respiratory failure	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Hemoptysis	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Lung Infection/Pneumonia	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Vascular disorders Hypotension	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Vascular disorders Thromboembolic event	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.

Other adverse events

Other adverse events
Measure	Durvalumab and Cetuximab n=35 participants at risk Durvalumab 500mg as a 120-minute intravenous infusion every two weeks. Cetuximab 400mg/m2 IV loading dose followed by weekly Cetuximab 250mg/m2 IV Treatment with Durvalumab continues until progression and Cetuximab may continue as maintenance Durvalumab: Two hour infusion Cetuximab: Two hour infusion for loading dose followed by weekly one hour infusion
Eye disorders Eye Etropian	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Eye disorders Eye inflammation	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Diarrhea	31.4% 11/35 • Number of events 18 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Drooling	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Psychiatric disorders Depression	14.3% 5/35 • Number of events 5 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Psychiatric disorders Insomnia	17.1% 6/35 • Number of events 6 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Psychiatric disorders Panic attacks	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Vascular disorders Hypotension	11.4% 4/35 • Number of events 6 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Vascular disorders Lymphedema	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Blood and lymphatic system disorders Anemia	8.6% 3/35 • Number of events 15 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Blood and lymphatic system disorders Cervical adenopathy	8.6% 3/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Blood and lymphatic system disorders Leukocytosis	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Blood and lymphatic system disorders Macrocytic Anemia	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Cardiac disorders Atrial fibrillation	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Cardiac disorders Atrial flutter	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Cardiac disorders Chest pain - cardiac	8.6% 3/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Cardiac disorders Cyanosis	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Cardiac disorders Palpitations	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Cardiac disorders Pericardial effusion	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Cardiac disorders Sinus tachycardia	2.9% 1/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Ear and labyrinth disorders Ear drainage	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Ear and labyrinth disorders Ear fullness	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Ear and labyrinth disorders Ear inflammation	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Ear and labyrinth disorders Ear pain	14.3% 5/35 • Number of events 5 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Ear and labyrinth disorders Hearing impaired	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Ear and labyrinth disorders Vertigo	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Ear and labyrinth disorders Vestibular disorder	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Endocrine disorders Diabetes mellitus type 1	2.9% 1/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Endocrine disorders Diabetic ketoacidosis	2.9% 1/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Endocrine disorders Hypothyroidism	2.9% 1/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Eye disorders Blurred vision	8.6% 3/35 • Number of events 4 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Eye disorders Dry eye	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Eye disorders Eye chemosis, orbital apex inflammation extending into Cavernous sinus	2.9% 1/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Eye disorders Eye discharge	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Eye disorders Eyelid function disorder	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Eye disorders Fuzzy vision	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Eye disorders Itchy eyes	5.7% 2/35 • Number of events 4 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Eye disorders Periorbital dermatitis	2.9% 1/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Eye disorders Periorbital edema	5.7% 2/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Eye disorders Scleral disorder	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Eye disorders Uveitis	2.9% 1/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Eye disorders Vision decreased	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Abdominal distension	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Abdominal pain	5.7% 2/35 • Number of events 4 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Bloating	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Chipped tooth	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Colitis	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Colonic hemorrhage	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Constipation	17.1% 6/35 • Number of events 8 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Dental caries	2.9% 1/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Dry mouth	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Dyspepsia	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Dysphagia	22.9% 8/35 • Number of events 12 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Esophageal stenosis	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Esophagitis	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Flatulence	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Halitosis	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Hematemesis	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Lip pain	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Melena	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Mucositis oral	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Nausea	42.9% 15/35 • Number of events 23 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Oral cavity fistula	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Oral dysesthesia	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Oral hemorrhage	11.4% 4/35 • Number of events 5 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Oral pain	14.3% 5/35 • Number of events 6 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders PEG tub dislodge	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Rectal hemorrhage	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Stomach pain	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Throat closing	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Throat tightness	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Toothache	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Gastrointestinal disorders Vomiting	45.7% 16/35 • Number of events 31 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Chills	8.6% 3/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Death NOS	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Disease progression	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Edema face	25.7% 9/35 • Number of events 18 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Facial inflammation	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Fatigue	51.4% 18/35 • Number of events 31 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Fever	14.3% 5/35 • Number of events 7 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Generalized edema	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Lips, tongue, gums inflammation	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Localized edema	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Neck edema	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Non-cardiac chest pain	14.3% 5/35 • Number of events 5 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
General disorders Pain	20.0% 7/35 • Number of events 8 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Immune system disorders Allergic reaction	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Bladder infection	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Cheek abscess	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Cold sore	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Conjunctivitis	8.6% 3/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Conjunctivitis infective	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations COVID-19	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Device related infection	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Enterocolitis infectious	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations G tube infection	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Lung infection	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Mouth sore	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations MRSA	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Paronychia	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Pneumonia	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Redness at trach site	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Sepsis	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Skin infection	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Stoma site infection	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Surgical site infection	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Thrush	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Toe infection	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Infections and infestations Urinary tract infection	2.9% 1/35 • Number of events 4 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Abdomen tube leaking	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Arm wound	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Arterial injury	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Bruising	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Chin bleeding	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Discomfort at G-tube site	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Dislodged feeding tube	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Ear Wound	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Fall	22.9% 8/35 • Number of events 11 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Fracture	8.6% 3/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications G tube erythema and drainage	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Gastrostomy tube leaking	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Infusion related reaction	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Irritation at G-tube site	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Leg wound	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Lip swelling from botox	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders Arthritis	5.7% 2/35 • Number of events 5 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders Back pain	11.4% 4/35 • Number of events 6 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders Bilateral shoulder bone spurs	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Injury, poisoning and procedural complications Buttocks wound	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders CVA tenderness	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders Flank pain	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	8.6% 3/35 • Number of events 4 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders Leg Cramps	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders Myalgia	11.4% 4/35 • Number of events 4 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders Neck pain	14.3% 5/35 • Number of events 7 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders Neck stiffness	11.4% 4/35 • Number of events 4 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 2/35 • Number of events 4 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Musculoskeletal and connective tissue disorders Trismus	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor drainage	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor hemorrhage	8.6% 3/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Nervous system disorders Dizziness	37.1% 13/35 • Number of events 18 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Nervous system disorders Cranial nerve deficit	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Nervous system disorders Encephalopathy	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Nervous system disorders Headache	31.4% 11/35 • Number of events 17 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Nervous system disorders Lightheadedness	8.6% 3/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Nervous system disorders Memory impairment	8.6% 3/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Nervous system disorders Paresthesia	8.6% 3/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Nervous system disorders Peripheral sensory neuropathy	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Nervous system disorders Presyncope	8.6% 3/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Nervous system disorders Spinal cord compression	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Nervous system disorders Stroke	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Nervous system disorders Syncope	11.4% 4/35 • Number of events 5 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Nervous system disorders Tremor	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Psychiatric disorders Anxiety	8.6% 3/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Psychiatric disorders Confusion	8.6% 3/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Renal and urinary disorders Acute kidney injury	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Renal and urinary disorders Hematuria	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Renal and urinary disorders Urinary frequency	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Renal and urinary disorders Urinary incontinence	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Renal and urinary disorders Urinary retention	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Aspiration	14.3% 5/35 • Number of events 5 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Bronchial stricture	2.9% 1/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Chest congestion	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Cough	17.1% 6/35 • Number of events 6 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.7% 9/35 • Number of events 10 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Epistaxis	11.4% 4/35 • Number of events 10 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders HCAP/aspiration pneumonia with acute hypoxic respiratory failure	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Hemoptysis	11.4% 4/35 • Number of events 4 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Hiccups	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Hoarseness	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Mucous plug	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Pharyngeal hemorrhage	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Postnasal drip	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Productive cough	17.1% 6/35 • Number of events 7 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Sinus pain	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Sore throat	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Thick secretions	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Tracheal mucositis	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Voice alteration	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Respiratory, thoracic and mediastinal disorders Wheezing	8.6% 3/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Alopecia	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Brittle nails	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Dry skin	37.1% 13/35 • Number of events 23 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Erythema around PEG tube site	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Erythema-face	2.9% 1/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Eyelash crusty	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Eyelashes falling out	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Fingertips cracking/splitting/peeling	8.6% 3/35 • Number of events 6 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Fissues	5.7% 2/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Nail changes	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Nail loss	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Nail ridging	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Neck edema	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Necrotic lesion	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	5.7% 2/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Pressure sore	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Pruritus	25.7% 9/35 • Number of events 16 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Purpura	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Rash acneiform	77.1% 27/35 • Number of events 60 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Rash maculo-papular	14.3% 5/35 • Number of events 9 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Skin breakdown	11.4% 4/35 • Number of events 4 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Skin irritation around g-tube	5.7% 2/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Skin ulceration	11.4% 4/35 • Number of events 5 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Mouth irritation	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Toenail pain	2.9% 1/35 • Number of events 2 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Skin and Other Subcutaneous Tissue Disorders (Unknown)	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Skin and subcutaneous tissue disorders Urticaria	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Surgical and medical procedures Esophagram	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Surgical and medical procedures Feed tube replacement	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Surgical and medical procedures PEG place	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Vascular disorders Flushing	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Vascular disorders Hypertension	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Vascular disorders Pulmonary embolism	2.9% 1/35 • Number of events 1 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.
Vascular disorders Thromboembolic event	5.7% 2/35 • Number of events 3 • Adverse events were recorded from time of signature of informed consent, throughout the treatment period and including the follow-up period (90 days after the last dose of durvalumab + cetuximab).The median length of collection was 4.2 months (0.46 months - 24.50 months). Our system does not differ from ct.gov.

Additional Information

Trisha Wise-Draper M.D., Ph.D.

University of Cincinnati Cancer Center

Phone: (513) 558-2826

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place