Adults 18 to 130, any sex, with Squamous Cell Carcinoma of the Head and 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.
Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC)Primary· From date of randomization until time of final analysis, an average of approximately 4 years
Number of participants with Overall Survival (OS)
Group
Value
95% CI
Durvalumab + Tremelimumab
162
Durvalumab
84
Standard of Care (SOC)
77
Durvalumab + Tremelimumab
1
Durvalumab
1
Standard of Care (SOC)
3
Durvalumab + Tremelimumab
27
Durvalumab
14
Standard of Care (SOC)
14
Overall Survival (OS) Median Duration in the PD-L1 TC/IC High SubgroupPrimary· From date of randomization until time of final analysis, an average of approximately 4 years
Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)
Group
Value
95% CI
Durvalumab + Tremelimumab
11.2
9.5 – 13.9
Durvalumab
10.9
9.0 – 14.3
Standard of Care (SOC)
10.9
8.3 – 13.4
Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab + Tremelimumab Versus Standard of Care (SOC)Secondary· From date of randomization until time of final analysis, an average of approximately 4 years
Number of participants with Overall Survival (OS)
Group
Value
95% CI
Durvalumab + Tremelimumab
162
Durvalumab
84
Standard of Care (SOC)
77
Percentage of Patients Alive at 12, 18 and 24 Months in the PD-L1 TC/IC High SubgroupSecondary· 12, 18 and 24 months after randomization
Percentage of patients alive
at 12 months
Group
Value
95% CI
Durvalumab + Tremelimumab
49.3
42.0 – 56.2
Durvalumab
48.0
37.8 – 57.4
Standard of Care (SOC)
44.0
33.6 – 53.8
at 18 months
Group
Value
95% CI
Durvalumab + Tremelimumab
31.8
25.3 – 38.5
Durvalumab
34.7
25.5 – 44.1
Standard of Care (SOC)
30.8
21.6 – 40.4
at 24 months
Group
Value
95% CI
Durvalumab + Tremelimumab
23.9
18.0 – 30.1
Durvalumab
27.6
19.2 – 36.6
Standard of Care (SOC)
26.4
17.8 – 35.7
Progression Free Survival (PFS) in the PD-L1 TC/IC High SubgroupSecondary· Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years
Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Group
Value
95% CI
Durvalumab + Tremelimumab
2.8
2.6 – 3.3
Durvalumab
2.8
1.7 – 4.2
Standard of Care (SOC)
5.3
4.3 – 5.8
Objective Response Rate (ORR) in the PD-L1 TC/IC High SubgroupSecondary· Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years
Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: \>= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)
Group
Value
95% CI
Durvalumab + Tremelimumab
48
Durvalumab
16
Standard of Care (SOC)
47
Durvalumab + Tremelimumab
142
Durvalumab
83
Standard of Care (SOC)
47
Duration of Response (DoR) in the PD-L1 TC/IC High SubgroupSecondary· Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years
Time from the date of first documented response until the first date of documented progression or death in the absence of disease progression
Group
Value
95% CI
Durvalumab + Tremelimumab
6.5
4.5 – 16.1
Durvalumab
12.3
5.6 – NA
Standard of Care (SOC)
4.2
3.0 – 5.7
Overall Survival (OS) Status in the All-comers (Full Analysis Set)Secondary· From date of randomization until time of final analysis, an average of approximately 4 years
Number of participants with Overall Survival (OS)
Group
Value
95% CI
Durvalumab + Tremelimumab
356
Durvalumab
176
Standard of Care (SOC)
171
Durvalumab + Tremelimumab
4
Durvalumab
3
Standard of Care (SOC)
6
Durvalumab + Tremelimumab
53
Durvalumab
25
Standard of Care (SOC)
29
Overall Survival (OS) Median Duration in the All-comers (Full Analysis Set)Secondary· From date of randomization until time of final analysis, an average of approximately 4 years
Time from the date of randomization until death due to any cause (i.e., date of death or censoring - date of randomization + 1)
Group
Value
95% CI
Durvalumab + Tremelimumab
10.7
9.6 – 12.2
Durvalumab
9.9
8.9 – 11.9
Standard of Care (SOC)
10.3
9.0 – 12.1
Percentage of Patients Alive at 12, 18 and 24 Months in the All-comers (Full Analysis Set)Secondary· 12, 18 and 24 months after randomization
Percentage of patients alive
at 12 months
Group
Value
95% CI
Durvalumab + Tremelimumab
46.5
41.6 – 51.2
Durvalumab
42.8
35.9 – 49.5
Standard of Care (SOC)
43.8
36.8 – 50.5
at 18 months
Group
Value
95% CI
Durvalumab + Tremelimumab
30.7
26.3 – 35.2
Durvalumab
31.2
24.9 – 37.7
Standard of Care (SOC)
29.7
23.5 – 36.1
at 24 months
Group
Value
95% CI
Durvalumab + Tremelimumab
22.9
18.9 – 27.0
Durvalumab
24.7
18.9 – 30.8
Standard of Care (SOC)
23.2
17.6 – 29.2
Progression Free Survival (PFS) in the All-comers (Full Analysis Set)Secondary· Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years
Time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression).
Progression is defined using Response Evaluation Criteria in Solid Tumours criteria (RECIST v1.1), as ≥20% increase in the sum of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Group
Value
95% CI
Durvalumab + Tremelimumab
2.8
2.6 – 2.9
Durvalumab
2.8
2.0 – 2.8
Standard of Care (SOC)
5.4
4.4 – 5.7
Objective Response Rate (ORR) in the All-comers (Full Analysis Set)Secondary· Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter, up to approximately 4 years
Number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions (TL) and assessed by MRI or CT: CR: Disappearance of all TLs since baseline; PR: \>= 30% decrease in the sum of diameters of TLs; Overall Response (OR = CR + PR)
Group
Value
95% CI
Durvalumab + Tremelimumab
90
Durvalumab
35
Standard of Care (SOC)
101
Durvalumab + Tremelimumab
323
Durvalumab
169
Standard of Care (SOC)
105
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events and serious adverse events will be collected from the time of signature of informed consent throughout the treatment period and including the follow-up period (up to 90 days after the last dose of investigational product or until initiation of another therapy) for an average of approximately 4 years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Durvalumab + Tremelimumab
Serious: 168/408 (41%)
Deaths: 356/413
Durvalumab
Serious: 78/202 (39%)
Deaths: 176/204
Standard of Care (SOC)
Serious: 94/196 (48%)
Deaths: 171/206
Serious adverse events (234 terms)
Reaction
System
Durvalumab + Tremelimumab
Durvalumab
Standard of Care (SOC)
Pneumonia
Infections and infestations
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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 recruiting trials for Squamous Cell Carcinoma of the Head and Neck
Currently open trials in the same condition.
NCT07465276 — Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC
· Phase 2
· recruiting
NCT06736379 — Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer
· Phase 1
· recruiting
NCT06223568 — Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subject
· Phase 2
· recruiting
NCT05983133 — A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors
· Phase 1
· active not recruiting
NCT05208762 — A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
· Phase 1
· recruiting
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
Publications: Europe PMC API search by NCT ID, retrieved 9 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: 13 October 2021
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/NCT02551159.