Trial · NCT01693562
A Phase 1/2 Study to Evaluate MEDI4736
NCT01693562, Phase 1, Phase 2, Completed, MedImmune LLC; results first posted 2021-05-13
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ConductScience Library. A Phase 1/2 Study to Evaluate MEDI4736. Trials, record NCT01693562. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01693562
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1/2 Study to Evaluate MEDI4736
- NCT number
- NCT01693562
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 1,022 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Advanced Solid Tumors
- Interventions
- MEDI4736
- First posted
- 2012-09-26
- Last updated
- 2021-05-13
- Results first posted
- 2021-05-13
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase | For MEDI4736 0.1 to MEDI4736 10 mg/kg arms: from Day 1 to Day 28 of first dose; for MEDI4736 15 mg/kg arm: from Day 1 to Day 42 of first dose | A DLT was defined as any Grade 3 or higher treatment-related toxicity that occurred during the DLT-evaluation period including any \>= Grade 3 colitis or \>= Grade 3 immune-related adverse event (irAE; AEs of immune nature in the absence of a clear alternative etiology) including rash, pruritus, or diarrhea that did not downgrade to =\< Grade 2 within 3 days after onset of the event despite maximal supportive care including systemic corticosteroids. The DLT-evaluation period for 0.1 to 10 mg/kg arms was from Day 1 to Day 28 of first dose and for 15 mg/kg arm was from Day 1 to Day 42 of first dose. |
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase | From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. |
| Primary | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase | From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years) | Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of coagulation, urine, hematology, and serum chemistry. |
| Primary | Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase | From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years) | Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (body weight, body temperature, blood pressure, pulse rate, and respiratory rate). |
| Primary | Number of Participants With Change From Baseline in QT/QTc Interval in Local Electrocardiogram in the Dose-escalation, Dose-exploration, and Dose-expansion Phase | From Baseline (Day 1) through 90 days after the last dose of study drug (approximately 5.25 years) | Number of participants with change from baseline in notable QT/QTc interval in local electrocardiogram (ECG) are reported. The data for \>0 participants with notable QT/QTc interval in local ECG from baseline are reported. |
| Primary | Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) in Participants With Non-squamous NSCLC Who Had Received 2 or More Prior Lines of Therapy in the Dose-expansion Phase | From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years) | The ORR assessed by BICR in participants with non-squamous NSCLC who had received 2 or more prior lines of therapy is reported. The ORR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1). The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between. |
| Primary | ORR Assessed by BICR in Participants With Squamous NSCLC Who Had Received 1 and 2 or More Prior Lines of Therapy in the Dose-expansion Phase | From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years) | The ORR assessed by BICR in participants with squamous NSCLC who had received 1 and 2 or more prior lines of therapy is reported. The ORR is defined as BOR of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between. |
| Primary | ORR Assessed by BICR in Participants With UC Post-platinum (Programmed Cell Death Ligand [PD-L1] Status High) Who Had Received at Least 1 Line of Prior Therapy (2L+) in the Dose-expansion Phase | From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years) | The ORR assessed by BICR in participants with UC post-platinum PD-L1 status high 2L+ is reported. The ORR is defined as BOR of confirmed CR or confirmed PR based on RECIST v1.1. The CR is defined as disappearance of all target and non-target lesions and no new lesions. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as \>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between. |
| Secondary | Area Under the Serum Concentration-time Curve up to the Last Measurable Concentration (AUClast) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase | After the first dose between Day 0 and Day 15 (Day 1 [pre and post dose] and predose of Dose 2 for all cohorts; Days 3, 5, 10 for Cohorts 0.1mg/kg to 10 mg/kg; Days 3, 5, 10, 15 for Cohort 15 mg/kg; Day 15 for Cohort 20 mg/kg) | Area under the concentration-time curve from time zero to the last measurable concentration (AUClast) of MEDI4736 is reported. |
| Secondary | Maximum Serum Concentration (Cmax) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase | After the first dose between Day 0 and Day 15 (Day 1 [pre and post dose] and predose of Dose 2 for all cohorts; Days 3, 5, 10 for Cohorts 0.1mg/kg to 10 mg/kg; Days 3, 5, 10, 15 for Cohort 15 mg/kg; Day 15 for Cohort 20 mg/kg) | The Cmax of MEDI4736 is reported. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase | For MEDI4736 0.1 to MEDI4736 10 mg/kg arms: from Day 1 to Day 28 of first dose; for MEDI4736 15 mg/kg arm: from Day 1 to Day 42 of first dose | DLT-evaluable population included all participants in the dose-escalation phase who received at least 2 doses of study drug and completed safety follow-up through DLT-evaluable period or experienced any DLT during the DLT-evaluation period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase | From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years) | As-treated population included all participants who received any dose of study drug. Participants enrolled in the 10 mg/kg Q2W Expansion and Escalation Cohort have been summarized as a total only. This is because the safety profile of durvalumab monotherapy 10 mg/kg Q2W was manageable and generally consistent with the known safety profile of the anti-programmed cell death ligand (PD-L1/PD-1) drug class. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase | From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years) | As-treated population included all participants who received any dose of study drug. Participants enrolled in the 10 mg/kg Q2W Expansion and Escalation Cohort have been summarized as a total only. This is because the safety profile of durvalumab monotherapy 10 mg/kg Q2W was manageable and generally consistent with the known safety profile of the anti-PD-L1/PD-1 drug class. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase | From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years) | As-treated population included all participants who received any dose of study drug. Participants enrolled in the 10 mg/kg Q2W Expansion and Escalation Cohort have been summarized as a total only. This is because the safety profile of durvalumab monotherapy 10 mg/kg Q2W was manageable and generally consistent with the known safety profile of the anti-PD-L1/PD-1 drug class. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Change From Baseline in QT/QTc Interval in Local Electrocardiogram in the Dose-escalation, Dose-exploration, and Dose-expansion Phase | From Baseline (Day 1) through 90 days after the last dose of study drug (approximately 5.25 years) | As-treated population included all participants who received any dose of study drug were analyzed. Participants with ECG readings available were evaluable for this analysis. Participants enrolled in the 10 mg/kg Q2W Expansion and Escalation Cohort have been summarized as a total only. This is because the safety profile of durvalumab monotherapy 10 mg/kg Q2W was manageable and generally consistent with the known safety profile of the anti-PD-L1/PD-1 drug class. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) in Participants With Non-squamous NSCLC Who Had Received 2 or More Prior Lines of Therapy in the Dose-expansion Phase | From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years) | Participants with non-squamous NSCLC in Full analysis set (FAS) population who had received 2 or more prior line of therapy were analyzed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017. | Percentage of participants | NUMBER |
| PRIMARY | ORR Assessed by BICR in Participants With Squamous NSCLC Who Had Received 1 and 2 or More Prior Lines of Therapy in the Dose-expansion Phase | From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years) | Participants with squamous NSCLC in FAS population who had received 1 and 2 or more prior lines of therapy were analyzed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017. | Percentage of participants | NUMBER |
| PRIMARY | ORR Assessed by BICR in Participants With UC Post-platinum (Programmed Cell Death Ligand [PD-L1] Status High) Who Had Received at Least 1 Line of Prior Therapy (2L+) in the Dose-expansion Phase | From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years) | Participants with UC in FAS population with 2L+ post-platinum PD-L1 status high (\>= 25% tumor cell membrane or \>= 25% immune cell staining) were analyzed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017. | Percentage of participants | NUMBER |
| SECONDARY | Area Under the Serum Concentration-time Curve up to the Last Measurable Concentration (AUClast) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase | After the first dose between Day 0 and Day 15 (Day 1 [pre and post dose] and predose of Dose 2 for all cohorts; Days 3, 5, 10 for Cohorts 0.1mg/kg to 10 mg/kg; Days 3, 5, 10, 15 for Cohort 15 mg/kg; Day 15 for Cohort 20 mg/kg) | Pharmacokinetics (PK) evaluable population included all participants who received any dose of study drug and had at least one postdose PK concentration. Non-compartmental PK analysis was conducted using the data from dose escalation and exploration phases only. The Number of participants Analyzed denotes the number of participants evaluated for this outcome measure. | Day*µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Serum Concentration (Cmax) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase | After the first dose between Day 0 and Day 15 (Day 1 [pre and post dose] and predose of Dose 2 for all cohorts; Days 3, 5, 10 for Cohorts 0.1mg/kg to 10 mg/kg; Days 3, 5, 10, 15 for Cohort 15 mg/kg; Day 15 for Cohort 20 mg/kg) | The PK evaluable population included all participants who received any dose of study drug and had at least one postdose PK concentration. Non-compartmental PK analysis was conducted using the data from dose escalation and exploration phases only. The Number of participants Analyzed denotes the number of participants evaluated for this outcome measure. | µg/mL | GEOMETRIC_MEAN |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group1,040
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase | Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase | Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase | Escalation Cohort (MEDI4736 1 mg/kg Q2W) | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase | Escalation Cohort (MEDI4736 3 mg/kg Q2W) | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase | Escalation Cohort (MEDI4736 10 mg/kg Q2W) | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase | Escalation Cohort (MEDI4736 15 mg/kg Q3W) | 0 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase | Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) | Any TEAEs | 3 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase | Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) | Any TEAEs | 4 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase | Escalation Cohort (MEDI4736 1 mg/kg Q2W) | Any TEAEs | 3 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase | Escalation Cohort (MEDI4736 3 mg/kg Q2W) | Any TEAEs | 3 | Participants |
1 to 10 of 1,040Source ClinicalTrials.gov
See all 1,040 results by groupParticipant flow207
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Escalation Phase | STARTED | Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) | 4 | |
| Escalation Phase | STARTED | Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) | 4 | |
| Escalation Phase | STARTED | Escalation Cohort (MEDI4736 1 mg/kg Q2W) | 3 | |
| Escalation Phase | STARTED | Escalation Cohort (MEDI4736 3 mg/kg Q2W) | 3 | |
| Escalation Phase | STARTED | Escalation Cohort (MEDI4736 10 mg/kg Q2W) | 6 | |
| Escalation Phase | STARTED | Escalation Cohort (MEDI4736 15 mg/kg Q3W) | 7 | |
| Escalation Phase | STARTED | Exploration Durvalumab 20 mg/kg (Q4W) | 0 | |
| Escalation Phase | STARTED | Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 0 | |
| Escalation Phase | STARTED | Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) | 0 | |
| Escalation Phase | STARTED | Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 0 |
1 to 10 of 207Source ClinicalTrials.gov
See all 207 participant flowAdverse events12,006
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 | Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) | 1 | 4 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) | 0 | 4 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Escalation Cohort (MEDI4736 1 mg/kg Q2W) | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Escalation Cohort (MEDI4736 3 mg/kg Q2W) | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Escalation Cohort (MEDI4736 10 mg/kg Q2W) | 1 | 6 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Escalation Cohort (MEDI4736 15 mg/kg Q3W) | 0 | 7 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Exploration Durvalumab 20 mg/kg (Q4W) | 0 | 21 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 10 | 62 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) | 5 | 22 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 47 | 304 | 74 |
1 to 10 of 12,006Source ClinicalTrials.gov
See all 12,006 adverse eventsAdverse event totals69
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) | 4 | 4 |
| Total, all-cause mortality | Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) | 2 | 4 |
| Total, all-cause mortality | Escalation Cohort (MEDI4736 1 mg/kg Q2W) | 0 | 3 |
| Total, all-cause mortality | Escalation Cohort (MEDI4736 3 mg/kg Q2W) | 3 | 3 |
| Total, all-cause mortality | Escalation Cohort (MEDI4736 10 mg/kg Q2W) | 6 | 6 |
| Total, all-cause mortality | Escalation Cohort (MEDI4736 15 mg/kg Q3W) | 4 | 7 |
| Total, all-cause mortality | Exploration Durvalumab 20 mg/kg (Q4W) | 17 | 21 |
| Total, all-cause mortality | Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) | 42 | 62 |
| Total, all-cause mortality | Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) | 17 | 22 |
| Total, all-cause mortality | Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) | 208 | 304 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse event totalsPapers13
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/NCT01693562
GET https://conductscience.org/api/trials/v1/NCT01693562/registered?page=2