Who is sponsoring NCT02319044?

NCT02319044 is sponsored by AstraZeneca.

What drugs are being tested in NCT02319044?

Interventions in NCT02319044: MEDI4736, Tremelimumab, MEDI4736 + Tremelimumab.

What condition does NCT02319044 study?

NCT02319044 studies Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck.

Is NCT02319044 still recruiting?

NCT02319044 is currently completed. Last updated 29 September 2020.

Are results published for NCT02319044?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-09-29 · How we verify

NCT02319044

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase II Study of MEDI4736, Tremelimumab, and MEDI4736 in Combination w/ Tremelimumab Squamous Cell Carcinoma of the Head and Neck

Completed Phase 2 Results posted Last updated 29 September 2020

What this trial tests

Phase 2 trial testing MEDI4736 in Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck in 267 participants. Completed in 6 July 2020.

Timeline

15 April 2015

Primary endpoint
26 September 2016

6 July 2020

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	267
Start date	15 April 2015
Primary completion	26 September 2016
Estimated completion	6 July 2020
Sites	125 locations across Georgia, France, Malaysia, Belgium, Taiwan, United Kingdom, Germany, Hungary

Drugs / interventions tested

MEDI4736 — full drug profile →
Tremelimumab (TREMELIMUMAB) — full drug profile →
MEDI4736 + Tremelimumab — full drug profile →

Conditions studied

Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck — all drugs for Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 96, any sex, with Recurrent/Metastatic Squamous Cell Carcinoma of Head & Neck. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Objective Response Rate at 6 Months Primary · After 6 months

Objective response rate, primary analysis, based on BICR assessments according to RECIST v1.1. The number (%) of patients with a response excludes unconfirmed responses

Group	Value	95% CI
MEDI4736 + Tremelimumab	7.7	3.75 – 13.69
MEDI4736	9.2	3.46 – 19.02
Tremelimumab	1.6	0.04 – 8.53

Objective Response Rate at 12 Months Primary · After 12 months

Objective response rate (per RECIST 1.1 as assessed by blinded independent central review \[BICR\]) is defined as the number (%) of patients with a confirmed complete response or confirmed partial response and will be based on all treated patients who are PD-L1-positive with measurable disease at baseline per BICR. Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1. criteria are: Complete response \[CR\] = disappearance of all target lesions since baseline; and partial response \[PR\] = at least a 30% decrease in the sum of the diameters of target lesions.

Overall

Group	Value	95% CI
MEDI4736 + Tremelimumab	7.8	3.78 – 13.79
MEDI4736	9.2	3.46 – 19.02
Tremelimumab	1.6	0.04 – 8.53

Current smoking/nicotine status - Total

Group	Value	95% CI
MEDI4736 + Tremelimumab	13.6	2.91 – 34.91
MEDI4736	14.3	0.36 – 57.87
Tremelimumab	14.3	0.36 – 57.87

Current smoking/nicotine status - >10 pack years

Group	Value	95% CI
MEDI4736 + Tremelimumab	15.0	3.21 – 37.89
MEDI4736	14.3	0.36 – 57.87
Tremelimumab	16.7	0.42 – 64.12

Current smoking/nicotine status - ≤10 pack years

Group	Value	95% CI
MEDI4736 + Tremelimumab	0	0.00 – 84.19
Tremelimumab	0	0.00 – 97.50

Former smoking/nicotine status -Total

Group	Value	95% CI
MEDI4736 + Tremelimumab	6.8	2.54 – 14.25
MEDI4736	8.2	2.27 – 19.60
Tremelimumab	0	0.00 – 8.04

Former smoking/nicotine status - >10 pack years

Group	Value	95% CI
MEDI4736 + Tremelimumab	5.2	1.08 – 14.38
MEDI4736	9.1	1.92 – 24.33
Tremelimumab	0	0.00 – 10.89

Former smoking/nicotine status - ≤10 pack years

Group	Value	95% CI
MEDI4736 + Tremelimumab	10.0	2.11 – 26.53
MEDI4736	6.3	0.16 – 30.23
Tremelimumab	0	0.00 – 26.46

Smoking/nicotine status - Never

Group	Value	95% CI
MEDI4736 + Tremelimumab	5.3	0.13 – 26.03
MEDI4736	11.1	0.28 – 48.25
Tremelimumab	0	0.00 – 26.46

Best Objective Response Secondary · After 12 months

The best response a patient has had during their time in the study

Response - Total

Group	Value	95% CI
MEDI4736 + Tremelimumab	7.8
MEDI4736	9.2
Tremelimumab	1.6
Total	6.6

Response - Complete response (CR)

Group	Value	95% CI
MEDI4736 + Tremelimumab	0
MEDI4736	0
Tremelimumab	0
Total	0

Response - Partial response (PR)

Group	Value	95% CI
MEDI4736 + Tremelimumab	7.8
MEDI4736	9.2
Tremelimumab	1.6
Total	6.6

Non-response (NR) - Total

Group	Value	95% CI
MEDI4736 + Tremelimumab	92.2
MEDI4736	90.8
Tremelimumab	98.4
Total	93.4

NR - Stable disease (SD) >=6 months (24 weeks)

Group	Value	95% CI
MEDI4736 + Tremelimumab	5.4
MEDI4736	6.2
Tremelimumab	0
Total	4.3

NR - Unconfirmed complete or partial response (PR)

Group	Value	95% CI
MEDI4736 + Tremelimumab	1.6
MEDI4736	0
Tremelimumab	0
Total	0.8

NR - Stable disease

Group	Value	95% CI
MEDI4736 + Tremelimumab	3.9
MEDI4736	6.2
Tremelimumab	0
Total	3.5

NR - Progression

Group	Value	95% CI
MEDI4736 + Tremelimumab	64.3
MEDI4736	64.6
Tremelimumab	69.8
Total	65.8

Duration of Response - Participants Remaining in Response Secondary · After 12 months

Participants remaining in response - based on BICR assessments according to RECIST v1.1. An ongoing response was defined as a patient who had documented objective response and was still alive and progression-free at the time of the data cut-off.

Percentage remaining in response-3 months

Group	Value	95% CI
MEDI4736 + Tremelimumab	90.0
MEDI4736	100
Tremelimumab	100
Total	94.1

Percentage remaining in response-6 months

Group	Value	95% CI
MEDI4736 + Tremelimumab	70.0
MEDI4736	66.7
Tremelimumab	100
Total	70.6

Percentage remaining in response-9 months

Group	Value	95% CI
MEDI4736 + Tremelimumab	58.3
MEDI4736	66.7
Tremelimumab	NA
Total	64.2

Percentage remaining in response-12 months

Group	Value	95% CI
MEDI4736 + Tremelimumab	46.7
MEDI4736	NA
Tremelimumab	NA
Total	53.5

Percentage of ongoing response

Group	Value	95% CI
MEDI4736 + Tremelimumab	50.0
MEDI4736	66.7
Tremelimumab	100
Total	58.8

Time to Response Secondary · After 12 months

Time to response in patients with objective response based on BICR assessments according to RECIST 1.1

Number of responders

Group	Value	95% CI
MEDI4736 + Tremelimumab	100
MEDI4736	100
Tremelimumab	100
Total	100

Week 8, where response is first observed

Group	Value	95% CI
MEDI4736 + Tremelimumab	10.0
MEDI4736	0
Tremelimumab	0
Total	5.9

Week 9, where response is first observed

Group	Value	95% CI
MEDI4736 + Tremelimumab	50.0
MEDI4736	16.7
Tremelimumab	100
Total	41.2

Week 16, where response is first observed

Group	Value	95% CI
MEDI4736 + Tremelimumab	10.0
MEDI4736	16.7
Tremelimumab	0
Total	11.8

Week 17, where response is first observed

Group	Value	95% CI
MEDI4736 + Tremelimumab	10.0
MEDI4736	16.7
Tremelimumab	0
Total	11.8

Week 20, where response is first observed

Group	Value	95% CI
MEDI4736 + Tremelimumab	0
MEDI4736	16.7
Tremelimumab	0
Total	5.9

Week 24, where response is first observed

Group	Value	95% CI
MEDI4736 + Tremelimumab	10.0
MEDI4736	16.7
Tremelimumab	0
Total	11.8

Week 25, where response is first observed

Group	Value	95% CI
MEDI4736 + Tremelimumab	10.0
MEDI4736	16.7
Tremelimumab	0
Total	11.8

Time to Onset of Response From First Dose Secondary · After 12 months

Time to onset of response in patients with objective response based on BICR assessments according to RECIST 1.1

Group	Value	95% CI
MEDI4736 + Tremelimumab	2.0	2 – 6
MEDI4736	4.1	2 – 6
Tremelimumab	1.8	1.8 – 2
Total	3.5	2 – 6

Disease Control Rate (DCR) Secondary · After 6 months

Disease control rate (DCR) at 6 months based on BICR assessments according to RECIST v1.1. DCR at 6 months was evaluated using 2 different approaches to the length of stable disease (SD). -Method 1: Patients who had a best objective response of complete response (CR) or partial response (PR) within 24 weeks or had demonstrated SD for a minimum interval of 24 weeks following randomization. -Method 2: Patients who had a best objective response of CR or PR in the first 24 weeks or who had demonstrated SD for a minimum interval of 16 weeks following randomization.

METHOD 1: Disease control (DC) at 6 months

Group	Value	95% CI
MEDI4736 + Tremelimumab	13.2
MEDI4736	21.5
Tremelimumab	1.6
Total	12.5

METHOD 1: No DC at 6 months

Group	Value	95% CI
MEDI4736 + Tremelimumab	86.8
MEDI4736	78.5
Tremelimumab	98.4
Total	87.5

METHOD 1: No DC at 6 months-Not evaluable/missing

Group	Value	95% CI
MEDI4736 + Tremelimumab	20.2
MEDI4736	20.0
Tremelimumab	22.2
Total	20.6

METHOD 2: DC at 6 months

Group	Value	95% CI
MEDI4736 + Tremelimumab	20.2
MEDI4736	26.2
Tremelimumab	9.5
Total	19.1

METHOD 2: No DC at 6 months

Group	Value	95% CI
MEDI4736 + Tremelimumab	79.8
MEDI4736	73.8
Tremelimumab	90.5
Total	80.9

METHOD 2: No DC at 6 months-Not evaluable/missing

Group	Value	95% CI
MEDI4736 + Tremelimumab	20.2
MEDI4736	20.0
Tremelimumab	22.2
Total	20.6

Disease Control Rate (DCR) Secondary · After 12 months

Disease control rate (DCR) at 12 months based on BICR assessments according to RECIST v1.1. DCR at 6 months was evaluated using 2 different approaches to the length of stable disease (SD). -Method 1: Patients who had a best objective response of complete response (CR) or partial response (PR) within 24 weeks or had demonstrated SD for a minimum interval of 24 weeks following randomization. -Method 2: Patients who had a best objective response of CR or PR in the first 24 weeks or who had demonstrated SD for a minimum interval of 16 weeks following randomization.

DC at 12 months

Group	Value	95% CI
MEDI4736 + Tremelimumab	10.1
MEDI4736	12.3
Tremelimumab	1.6
Total	8.6

No DC at 12 months

Group	Value	95% CI
MEDI4736 + Tremelimumab	89.9
MEDI4736	87.7
Tremelimumab	98.4
Total	91.4

No DC at 12 months-Not evaluable/missing

Group	Value	95% CI
MEDI4736 + Tremelimumab	20.2
MEDI4736	20.0
Tremelimumab	22.2
Total	20.6

Progression-free Survival (PFS) Secondary · After 6 months

Progression status at 6 months based on BICR assessments according to RECIST v1.1 at time of Progression Free Survival (PFS) analysis. Progression was defined as the time from the data of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. -Target Lesions, Non Target Lesions and New Lesions are not necessarily mutually exclusive categories. -Progression death refers to death in the absence of RECIST 1.1 progression

Progression-Total

Group	Value	95% CI
MEDI4736 + Tremelimumab	82.0
MEDI4736	82.1
Tremelimumab	88.1
Total	83.5

Total-RECIST 1.1 Progression

Group	Value	95% CI
MEDI4736 + Tremelimumab	57.9
MEDI4736	59.7
Tremelimumab	67.2
Total	60.7

RECIST 1.1 progression-Target Lesions

Group	Value	95% CI
MEDI4736 + Tremelimumab	43.6
MEDI4736	43.3
Tremelimumab	55.2
Total	46.4

RECIST 1.1 progression-Non-target lesions

Group	Value	95% CI
MEDI4736 + Tremelimumab	21.1
MEDI4736	26.9
Tremelimumab	32.8
Total	25.5

RECIST 1.1 progression-New lesions

Group	Value	95% CI
MEDI4736 + Tremelimumab	26.3
MEDI4736	20.9
Tremelimumab	26.9
Total	25.1

Progression-Death

Group	Value	95% CI
MEDI4736 + Tremelimumab	24.1
MEDI4736	22.4
Tremelimumab	20.9
Total	22.8

No progression-Total

Group	Value	95% CI
MEDI4736 + Tremelimumab	18.0
MEDI4736	17.9
Tremelimumab	11.9
Total	16.5

No progression-PD free and still being followed

Group	Value	95% CI
MEDI4736 + Tremelimumab	14.3
MEDI4736	13.4
Tremelimumab	4.5
Total	11.6

Progression-free Survival (PFS) Secondary · After 12 months

Progression status at 12 months based on BICR assessments according to RECIST v1.1 at time of Progression Free Survival (PFS) analysis. Progression was defined as the time from the data of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. -Target Lesions, Non Target Lesions and New Lesions are not necessarily mutually exclusive categories. -Progression death refers to death in the absence of RECIST 1.1 progressio

Progression-Total

Group	Value	95% CI
MEDI4736 + Tremelimumab	88.7
MEDI4736	83.6
Tremelimumab	89.6
Total	87.6

Total-RECIST 1.1 Progression

Group	Value	95% CI
MEDI4736 + Tremelimumab	64.7
MEDI4736	59.7
Tremelimumab	68.7
Total	64.4

RECIST 1.1 progression-Target Lesions

Group	Value	95% CI
MEDI4736 + Tremelimumab	50.4
MEDI4736	47.8
Tremelimumab	56.7
Total	51.3

RECIST 1.1 progression-Non-target lesions

Group	Value	95% CI
MEDI4736 + Tremelimumab	23.3
MEDI4736	28.4
Tremelimumab	32.8
Total	27.0

RECIST 1.1 progression-New lesions

Group	Value	95% CI
MEDI4736 + Tremelimumab	27.1
MEDI4736	23.9
Tremelimumab	23.9
Total	25.5

Progression-Death

Group	Value	95% CI
MEDI4736 + Tremelimumab	24.1
MEDI4736	23.9
Tremelimumab	20.9
Total	23.2

No progression-Total

Group	Value	95% CI
MEDI4736 + Tremelimumab	11.3
MEDI4736	16.4
Tremelimumab	10.4
Total	12.4

No progression-PD free and still being followed

Group	Value	95% CI
MEDI4736 + Tremelimumab	6.8
MEDI4736	11.9
Tremelimumab	3.0
Total	7.1

Overall Survival Secondary · After 12 months

Survival status at time of overall survival analysis. 'Still in survival follow-up' includes patients known to be alive at data cut-off. 'Terminated prior to death' includes patients with unknown survival status or patients who were lost to follow-up.

Death

Group	Value	95% CI
MEDI4736 + Tremelimumab	64.7
MEDI4736	65.7
Tremelimumab	76.1
Total	67.8

Still in survival follow-up

Group	Value	95% CI
MEDI4736 + Tremelimumab	30.1
MEDI4736	28.4
Tremelimumab	16.4
Total	26.2

Terminated prior to death

Group	Value	95% CI
MEDI4736 + Tremelimumab	5.3
MEDI4736	6.0
Tremelimumab	7.5
Total	6.0

Terminated prior to death-Voluntary discon.

Group	Value	95% CI
MEDI4736 + Tremelimumab	5.3
MEDI4736	6.0
Tremelimumab	4.5
Total	5.2

Terminated prior to death-Other

Group	Value	95% CI
MEDI4736 + Tremelimumab	0
MEDI4736	0
Tremelimumab	3.0
Total	0.7

Quality of Life Secondary · After 12 months

Improvement in quality of life was assessed using European Organisation for Research and Treatment of Cancer (EORTC) questionnaires: -The impact of treatment on Health-Related Quality of Life, functioning, and symptoms was evaluated using the EORTC QLQ-C30 v3. -Head and neck cancer-specific symptoms were evaluated using the EORTC QLQ-H\&N35. The symptom and QoL/function improvement rate was defined as the number (%) of patients with 2 consecutive assessments at least 14 days apart that showed a clinically meaningful improvement (a decrease from baseline score ≥10 or EORTC QLQ-C30 scales) in th

EORTC QLQ-C30 Function-Physical

Group	Value	95% CI
MEDI4736 + Tremelimumab	12	6.7 – 20.8
MEDI4736	13.6	6.4 – 26.7
Tremelimumab	5.1	1.4 – 16.9

EORTC QLQ-C30 Function-Role

Group	Value	95% CI
MEDI4736 + Tremelimumab	16.3	10.0 – 25.5
MEDI4736	16.7	8.3 – 30.6
Tremelimumab	11.8	4.7 – 26.6

EORTC QLQ-C30 Function-Cognitive

Group	Value	95% CI
MEDI4736 + Tremelimumab	25	16.2 – 36.4
MEDI4736	29.4	16.8 – 46.2
Tremelimumab	10.7	3.7 – 27.2

EORTC QLQ-C30 Function-Emotional

Group	Value	95% CI
MEDI4736 + Tremelimumab	13.5	7.9 – 22.1
MEDI4736	13.6	6.4 – 26.7
Tremelimumab	2.6	0.5 – 13.2

EORTC QLQ-C30 Function-Social

Group	Value	95% CI
MEDI4736 + Tremelimumab	18.3	11.0 – 28.8
MEDI4736	15.2	6.7 – 30.9
Tremelimumab	16.1	7.1 – 32.6

EORTC QLQ-C30 Symptom-Fatigue

Group	Value	95% CI
MEDI4736 + Tremelimumab	16.8	10.9 – 25.0
MEDI4736	17.3	9.4 – 29.7
Tremelimumab	7.5	3.0 – 17.9

EORTC QLQ-C30 Symptom-Pain

Group	Value	95% CI
MEDI4736 + Tremelimumab	22.8	15.4 – 32.4
MEDI4736	20.8	11.7 – 34.3
Tremelimumab	6.7	2.3 – 17.9

EORTC QLQ-C30 Symptom-Nausea/vomiting

Group	Value	95% CI
MEDI4736 + Tremelimumab	22.2	12.5 – 36.3
MEDI4736	16.7	4.7 – 44.8
Tremelimumab	17.6	6.2 – 41.0

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs and SAEs were collected from time the informed consent was signed through 90 days after the last dose of the last study treatment or until another therapy was initiated.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MEDI4736 AND TREMELIMUMAB COMBINATION

Serious: 59/133 (44%)

Deaths: 86/133

MEDI4736

Serious: 18/65 (28%)

Deaths: 44/67

Tremelimumab

Serious: 25/65 (38%)

Deaths: 51/67

Serious adverse events (111 terms)

Reaction	System	MEDI4736 AND TREMELIMUMAB …	MEDI4736	Tremelimumab
Pneumonia	Infections and infestations	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Lung infection	Infections and infestations	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Pyrexia	General disorders	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Colitis	Gastrointestinal disorders	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Pneumonia bacterial	Infections and infestations	—	—	—
Hypernatraemia	Metabolism and nutrition disorders	—	—	—
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Dizziness	Nervous system disorders	—	—	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—
Angina pectoris	Cardiac disorders	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Bradycardia	Cardiac disorders	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—

Other adverse events (41 terms — click to expand)

Reaction	System	MEDI4736 AND TREMELIMUMAB …	MEDI4736	Tremelimumab
Diarrhoea	Gastrointestinal disorders	—	—	—
Fatigue	General disorders	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Asthenia	General disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Weight decreased	Investigations	—	—	—
Pyrexia	General disorders	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Pain	General disorders	—	—	—
Hypertension	Vascular disorders	—	—	—
Oedema peripheral	General disorders	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Hypotension	Vascular disorders	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Tachycardia	Cardiac disorders	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Paraesthesia	Nervous system disorders	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—
Mucosal inflammation	General disorders	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—

Most-reported serious reactions: Pneumonia, Diarrhoea, Lung infection, Dehydration, Hypercalcaemia, Dyspnoea, Nausea, Pyrexia.

Data from ClinicalTrials.gov NCT02319044 adverse events section.

Sponsor's own description

The purpose of this study is to determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or after treatment with a platinum containing regimen for recurrent/metastatic disease.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Combination strategies with PD-1/PD-L1 blockade: current advances and future directions.
Yi M, Zheng X, Niu M, Zhu S, et al · · 2022 · cited 1018× · PMID 35062949 · DOI 10.1186/s12943-021-01489-2
Immunology and Immunotherapy of Head and Neck Cancer.
Ferris RL. · · 2015 · cited 515× · PMID 26351330 · DOI 10.1200/jco.2015.61.1509
Cold and hot tumors: from molecular mechanisms to targeted therapy.
Wu B, Zhang B, Li B, Wu H, et al · · 2024 · cited 280× · PMID 39420203 · DOI 10.1038/s41392-024-01979-x
Safety and Efficacy of Durvalumab With or Without Tremelimumab in Patients With PD-L1-Low/Negative Recurrent or Metastatic HNSCC: The Phase 2 CONDOR Randomized Clinical Trial.
Siu LL, Even C, Mesía R, Remenar E, et al · · 2019 · cited 234× · PMID 30383184 · DOI 10.1001/jamaoncol.2018.4628
Durvalumab: First Global Approval.
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Verify or expand the search:

Other trials of MEDI4736

Trials testing the same drug.

NCT02546661 — Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer · Phase 1 · active not recruiting
NCT02669914 — MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors · Phase 2 · terminated
NCT02868632 — Study of Immune Checkpoint Inhibition With Radiation Therapy in Unresectable, Non-metastatic Pancreatic Cancer · Phase 1 · withdrawn
NCT02549651 — MEDI4736 Alone and in Combination With Tremelimumab or AZD9150 in Adult Subjects With Relapsed/Refractory DLBCL (D4190C0 · Phase 1 · completed
NCT02592551 — MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma · Phase 2 · completed

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02319044 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 29 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02319044.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing