Trial · NCT02369874
Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer
NCT02369874, Phase 3, Completed, AstraZeneca; results first posted 2019-10-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer. Trials, record NCT02369874. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02369874
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer
- NCT number
- NCT02369874
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 736 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck SCCHN
- Interventions
- MEDI4736, MEDI4736 + Tremelimumab, Standard of Care
- First posted
- 2015-02-24
- Last updated
- 2021-02-10
- Results first posted
- 2019-10-03
- Limitations and caveats
- Multiple testing was performed for OS analysis in the intent-to-treat (ITT) population and OS analysis in the PD-L1 negative population for durvalumab + tremelimumab versus SoC only.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | September 2015 to September 2018 (36 months) | OS is defined as the time from the date of randomization until death due to any cause. OS was analyzed for the full analysis set, regardless of programmed death-ligand 1 (PD-L1) status. |
| Secondary | Overall Survival (OS) in PD-L1 Negative Participants | September 2015 to September 2018 (36 months) | OS is defined as the time from the date of randomization until death due to any cause. PD-L1 negative was defined as \<25% of tumor cells with membrane staining for PD-L1 at any intensity. |
| Secondary | Overall Survival (OS) in PD-L1 Positive Participants | September 2015 to September 2018 (36 months) | OS is defined as the time from the date of randomization until death due to any cause. PD-L1 positive was defined as ≥25% of tumor cells with membrane staining for PD-L1 at any intensity. |
| Secondary | Progression Free Survival (PFS) | September 2015 to September 2018 (36 months) | PFS was defined as the time from the date of randomization until the date of objective disease progression or death based on investigator assessments, according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). Objective disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Objective Response Rate (ORR) | Assessed at randomization and every 8 weeks thereafter | The percentage of participants who experienced an objective response (complete response \[CR\] or partial response \[PR\]), based on investigator assessments according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A CR was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm. A PR was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters. |
| Secondary | Duration of Response (DoR) | September 2015 to September 2018 (36 months) | Median DoR, in months, based on investigator assessments, according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A complete response was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm. A partial response was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters. |
| Secondary | Disease Control Rate (DCR) | Baseline up to 6 months; baseline up to 12 months | 6 Months: The percentage of participants who had a best objective response of complete response (CR) or partial response (PR) in the first 6 months or had demonstrated stable disease (SD) for a minimum interval of 24 weeks following randomization. 12 Months: The percentage of participants who had a best objective response of CR or PR within 12 months or had demonstrated SD for a minimum interval of 48 weeks following randomization. Objective response was based on investigator assessments, according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A CR was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm. A PR was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters. |
| Secondary | Percentage of Participants Alive and Progression Free (APF) | Baseline up to 6 months; baseline up to 12 months | APF is defined as the percentage of participants who are alive and progression free at 6 months and 12 months after randomization. Estimates of progression free survival were based on investigator assessments according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). Objective disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Percentage of Participants Alive | 12, 18 and 24 months | Percentage of participants alive at 12, 18 and 24 months using a Kaplan Meier estimate. |
| Secondary | Progression Free Survival (PFS) in PD-L1 Negative Participants | September 2015 to September 2018 (36 months) | Number of participants with confirmed objective disease progression (PD) at the time of the participant's last evaluable response evaluation criteria in solid tumors 1.1 (RECIST1.1) assessment. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD-L1 negative was defined as \<25% of tumor cells with membrane staining for PD-L1 at any intensity. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | September 2015 to September 2018 (36 months) | Full analysis set - inclusive of all randomized participants. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in PD-L1 Negative Participants | September 2015 to September 2018 (36 months) | PD-L1-negative analysis set - inclusive of all randomized participants whose PD-L1 status is PD-L1-negative as defined by the Ventana PD-L1 SP263 IHC assay. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in PD-L1 Positive Participants | September 2015 to September 2018 (36 months) | PD-L1-positive analysis set - inclusive of all randomized participants whose PD-L1 status is PD-L1-positive as defined by the Ventana PD-L1 SP263 IHC assay. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | September 2015 to September 2018 (36 months) | Full analysis set - inclusive of all randomized participants. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Assessed at randomization and every 8 weeks thereafter | Full analysis set - inclusive of all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) | September 2015 to September 2018 (36 months) | Full analysis set, participants with objective response - inclusive of all randomized participants with an objective response (RECIST 1.1). | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | Baseline up to 6 months; baseline up to 12 months | Full analysis set - inclusive of all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Alive and Progression Free (APF) | Baseline up to 6 months; baseline up to 12 months | Full analysis set - inclusive of all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Alive | 12, 18 and 24 months | Full analysis set - inclusive of all randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) in PD-L1 Negative Participants | September 2015 to September 2018 (36 months) | PD-L1-negative analysis set - inclusive of all randomized participants whose PD-L1 status is PD-L1-negative as defined by the Ventana PD-L1 SP263 IHC assay. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group63
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Durvalumab + Tremelimumab | 6.5 | 95% Confidence Interval 5.5 to 8.2 | Months | |
| Overall Survival (OS) | Durvalumab | 7.6 | 95% Confidence Interval 6.1 to 9.8 | Months | |
| Overall Survival (OS) | Standard of Care (SoC) | 8.3 | 95% Confidence Interval 7.3 to 9.2 | Months | |
| Overall Survival (OS) in PD-L1 Negative Participants | Durvalumab + Tremelimumab | 7.8 | 95% Confidence Interval 5.9 to 10.3 | Months | |
| Overall Survival (OS) in PD-L1 Negative Participants | Durvalumab | 7.6 | 95% Confidence Interval 6.2 to 9.5 | Months | |
| Overall Survival (OS) in PD-L1 Negative Participants | Standard of Care (SoC) | 8.0 | 95% Confidence Interval 6.7 to 8.9 | Months | |
| Overall Survival (OS) in PD-L1 Positive Participants | Durvalumab + Tremelimumab | 4.8 | 95% Confidence Interval 3.3 to 6.4 | Months | |
| Overall Survival (OS) in PD-L1 Positive Participants | Durvalumab | 9.8 | 95% Confidence Interval 4.3 to 14.1 | Months | |
| Overall Survival (OS) in PD-L1 Positive Participants | Standard of Care (SoC) | 9.0 | 95% Confidence Interval 6.8 to 9.2 | Months | |
| Progression Free Survival (PFS) | Durvalumab + Tremelimumab | 2.0 | 95% Confidence Interval 1.9 to 2.3 | Months |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Durvalumab + Tremelimumab | 247 | |
| Overall Study | STARTED | Durvalumab | 240 | |
| Overall Study | STARTED | Standard of Care (SoC) | 249 | |
| Overall Study | Received Treatment | Durvalumab + Tremelimumab | 246 | |
| Overall Study | Received Treatment | Durvalumab | 237 | |
| Overall Study | Received Treatment | Standard of Care (SoC) | 240 | |
| Overall Study | COMPLETED | Durvalumab + Tremelimumab | 203 | |
| Overall Study | COMPLETED | Durvalumab | 183 | |
| Overall Study | COMPLETED | Standard of Care (SoC) | 188 | |
| Overall Study | NOT COMPLETED | Durvalumab + Tremelimumab | 44 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events594
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 | 55 | 246 | 68 |
| other | Anaemia | Blood and lymphatic system disorders | Durvalumab | 47 | 237 | 57 |
| other | Anaemia | Blood and lymphatic system disorders | Standard of Care (SoC) | 56 | 240 | 94 |
| other | Hypomagnesaemia | Metabolism and nutrition disorders | Durvalumab + Tremelimumab | 3 | 246 | 3 |
| other | Hypomagnesaemia | Metabolism and nutrition disorders | Durvalumab | 8 | 237 | 10 |
| other | Hypomagnesaemia | Metabolism and nutrition disorders | Standard of Care (SoC) | 20 | 240 | 25 |
| other | Leukopenia | Blood and lymphatic system disorders | Durvalumab + Tremelimumab | 10 | 246 | 19 |
| other | Leukopenia | Blood and lymphatic system disorders | Durvalumab | 2 | 237 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Standard of Care (SoC) | 13 | 240 | 42 |
| other | Neutropenia | Blood and lymphatic system disorders | Durvalumab + Tremelimumab | 11 | 246 | 16 |
1 to 10 of 594Source ClinicalTrials.gov
See all 594 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Durvalumab + Tremelimumab | 206 | 247 |
| Total, all-cause mortality | Durvalumab | 186 | 240 |
| Total, all-cause mortality | Standard of Care (SoC) | 199 | 249 |
| Total, other adverse events | Durvalumab + Tremelimumab | 203 | 246 |
| Total, other adverse events | Durvalumab | 180 | 237 |
| Total, other adverse events | Standard of Care (SoC) | 207 | 240 |
| Total, serious adverse events | Durvalumab + Tremelimumab | 79 | 246 |
| Total, serious adverse events | Durvalumab | 69 | 237 |
| Total, serious adverse events | Standard of Care (SoC) | 61 | 240 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32294530 | DERIVED |
Source PubMed
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/NCT02369874
GET https://conductscience.org/api/trials/v1/NCT02369874/results?page=2