Trial · NCT02551159
Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
NCT02551159, Phase 3, Completed, AstraZeneca; results first posted 2021-10-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer. Trials, record NCT02551159. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02551159
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Open Label Study of MEDI 4736 With/Without Tremelimumab Versus Standard of Care (SOC) in Recurrent/Metastatic Head and Neck Cancer
- NCT number
- NCT02551159
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 823 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Interventions
- MEDI4736, Tremelimumab, MEDI4736+Tremelimumab, Cetuximab, 5-fluorouracil (5FU), Cisplatin, Carboplatin
- First posted
- 2015-09-16
- Last updated
- 2021-10-13
- Results first posted
- 2021-10-13
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) | From date of randomization until time of final analysis, an average of approximately 4 years | Number of participants with Overall Survival (OS) |
| Primary | Overall Survival (OS) Median Duration in the PD-L1 TC/IC High Subgroup | 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) |
| Secondary | Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab + Tremelimumab Versus Standard of Care (SOC) | From date of randomization until time of final analysis, an average of approximately 4 years | Number of participants with Overall Survival (OS) |
| Secondary | Percentage of Patients Alive at 12, 18 and 24 Months in the PD-L1 TC/IC High Subgroup | 12, 18 and 24 months after randomization | Percentage of patients alive |
| Secondary | Progression Free Survival (PFS) in the PD-L1 TC/IC High Subgroup | 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 |
| Secondary | Objective Response Rate (ORR) in the PD-L1 TC/IC High Subgroup | 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) |
| Secondary | Duration of Response (DoR) in the PD-L1 TC/IC High Subgroup | 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 |
| Secondary | Overall Survival (OS) Status in the All-comers (Full Analysis Set) | From date of randomization until time of final analysis, an average of approximately 4 years | Number of participants with Overall Survival (OS) |
| Secondary | Overall Survival (OS) Median Duration in the All-comers (Full Analysis Set) | 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) |
| Secondary | Percentage of Patients Alive at 12, 18 and 24 Months in the All-comers (Full Analysis Set) | 12, 18 and 24 months after randomization | Percentage of patients alive |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) | From date of randomization until time of final analysis, an average of approximately 4 years | PD-L1 TC/IC subgroup | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Survival (OS) Median Duration in the PD-L1 TC/IC High Subgroup | From date of randomization until time of final analysis, an average of approximately 4 years | PD-L1 TC/IC subgroup | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab + Tremelimumab Versus Standard of Care (SOC) | From date of randomization until time of final analysis, an average of approximately 4 years | PD-L1 TC/IC subgroup | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Alive at 12, 18 and 24 Months in the PD-L1 TC/IC High Subgroup | 12, 18 and 24 months after randomization | PD-L1 TC/IC subgroup | % of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) in the PD-L1 TC/IC High Subgroup | 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 | PD-L1 TC/IC subgroup | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) in the PD-L1 TC/IC High Subgroup | 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 | PD-L1 TC/IC subgroup | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DoR) in the PD-L1 TC/IC High Subgroup | 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 | PD-L1 TC/IC subgroup | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) Status in the All-comers (Full Analysis Set) | From date of randomization until time of final analysis, an average of approximately 4 years | All-comers (Full analysis set) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) Median Duration in the All-comers (Full Analysis Set) | From date of randomization until time of final analysis, an average of approximately 4 years | All-comers (Full analysis set) | Months | MEDIAN |
| SECONDARY | Percentage of Patients Alive at 12, 18 and 24 Months in the All-comers (Full Analysis Set) | 12, 18 and 24 months after randomization | All-comers (Full analysis set) | % of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) | Durvalumab + Tremelimumab | Death | 162 | Participants | |
| Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) | Durvalumab | Death | 84 | Participants | |
| Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) | Standard of Care (SOC) | Death | 77 | Participants | |
| Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) | Durvalumab + Tremelimumab | Voluntary Discontinuation by subject | 1 | Participants | |
| Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) | Durvalumab | Voluntary Discontinuation by subject | 1 | Participants | |
| Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) | Standard of Care (SOC) | Voluntary Discontinuation by subject | 3 | Participants | |
| Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) | Durvalumab + Tremelimumab | Alive or lost to follow up | 27 | Participants | |
| Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) | Durvalumab | Alive or lost to follow up | 14 | Participants | |
| Overall Survival (OS) Status in the PD-L1 TC/IC High Subgroup - Durvalumab Versus Standard of Care (SOC) | Standard of Care (SOC) | Alive or lost to follow up | 14 | Participants | |
| Overall Survival (OS) Median Duration in the PD-L1 TC/IC High Subgroup | Durvalumab + Tremelimumab | 11.2 | 95% Confidence Interval 9.5 to 13.9 | Months |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Durvalumab + Tremelimumab | 413 | |
| Overall Study | STARTED | Durvalumab | 204 | |
| Overall Study | STARTED | Standard of Care (SOC) | 206 | |
| Overall Study | Full Analysis Set | Durvalumab + Tremelimumab | 413 | |
| Overall Study | Full Analysis Set | Durvalumab | 204 | |
| Overall Study | Full Analysis Set | Standard of Care (SOC) | 206 | |
| Overall Study | Safety Analysis Set | Durvalumab + Tremelimumab | 408 | |
| Overall Study | Safety Analysis Set | Durvalumab | 202 | |
| Overall Study | Safety Analysis Set | Standard of Care (SOC) | 196 | |
| Overall Study | PD-L1 TC/IC High Subgroup Analysis Set | Durvalumab + Tremelimumab | 190 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events846
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Durvalumab + Tremelimumab | 61 | 408 | 68 |
| other | Anaemia | Blood and lymphatic system disorders | Durvalumab | 22 | 202 | 26 |
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care (SOC) | 65 | 196 | 97 |
| other | Leukopenia | Blood and lymphatic system disorders | Durvalumab + Tremelimumab | 2 | 408 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Durvalumab | 2 | 202 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Standard of Care (SOC) | 26 | 196 | 48 |
| other | Neutropenia | Blood and lymphatic system disorders | Durvalumab + Tremelimumab | 2 | 408 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | Durvalumab | 0 | 202 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Standard of Care (SOC) | 63 | 196 | 103 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Durvalumab + Tremelimumab | 6 | 408 | 24 |
1 to 10 of 846Source ClinicalTrials.gov
See all 846 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Durvalumab + Tremelimumab | 356 | 413 |
| Total, all-cause mortality | Durvalumab | 176 | 204 |
| Total, all-cause mortality | Standard of Care (SOC) | 171 | 206 |
| Total, other adverse events | Durvalumab + Tremelimumab | 317 | 408 |
| Total, other adverse events | Durvalumab | 153 | 202 |
| Total, other adverse events | Standard of Care (SOC) | 182 | 196 |
| Total, serious adverse events | Durvalumab + Tremelimumab | 168 | 408 |
| Total, serious adverse events | Durvalumab | 78 | 202 |
| Total, serious adverse events | Standard of Care (SOC) | 94 | 196 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02551159
GET https://conductscience.org/api/trials/v1/NCT02551159/results?page=2