TriangleNCT02669914 · STUDY IN CONTEXT
MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
-% of subjects who achieve a complete response (CR) or partial response (CR) based on assessment of brain lesions * CR: Requires: complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; No new lesions; stable or improved nonenhancing (T2/FLAIR) lesions.; off corticosteroids (or on physiologic replacement doses only) and stable or improved clinically. * PR: Requires:• ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. • No progression of nonmeasurable disease. • Stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; the corticosteroid dose at the time of the scan evaluation should be no greater than the dose at time of baseline scan. • Stable or improved clinically
-The severity of AEs will be graded by the investigator according to the CTCAE, Version 4.03
* Defined as the percentage of patients who achieve a complete response, partial response, or stable disease based on assessment of brain lesions * CR: Requires: complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; No new lesions; stable or improved nonenhancing (T2/FLAIR) lesions.; off corticosteroids (or on physiologic replacement doses only) and stable or improved clinically. * PR: Requires:• ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. • No progression of nonmeasurable disease. • Stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; the corticosteroid dose at the time of the scan evaluation should be no greater than the dose at time of baseline scan. • Stable or improved clinically
* Defined as the percentage of patients who achieve a complete response or partial response based on assessment of systemic lesions * Complete response: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters
* Defined as the percentage of patients who achieve a complete response, partial response, or stable disease based on assessment of systemic lesions * Complete response: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters * Stable disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study
* Defined as the percentage of patients who achieve a complete response or partial response based on assessment of brain and systemic lesions * Intracranial disease * Complete response: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters * Extracranial disease * Complete response: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- trial label
- MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0000
- source section id
- NCT02669914-om-0000
- source outcome index
- 0
- endpoint
- Overall Response Rate of Intracranial Disease
- endpoint definition
- -% of subjects who achieve a complete response (CR) or partial response (CR) based on assessment of brain lesions * CR: Requires: complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; No new lesions; stable or improved nonenhancing (T2/FLAIR) lesions.; off corticosteroids (or on physiologic replacement doses only) and stable or improved clinically. * PR: Requires:• ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. • No progression of nonmeasurable disease. • Stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; the corticosteroid dose at the time of the scan evaluation should be no greater than the dose at time of baseline scan. • Stable or improved clinically
- time origin
- Completion of treatment (estimated to be 6 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- There were not any participants enrolled in Cohort B or Cohort C.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0001
- source section id
- NCT02669914-om-0001
- source outcome index
- 1
- endpoint
- Safety of MEDI4736 in Advanced Solid Epithelial-derived Tumor Patients With Brain Metastases as Measured by Number of Participants With Treatment-emergent Adverse Events
- endpoint definition
- -The severity of AEs will be graded by the investigator according to the CTCAE, Version 4.03
- time origin
- 30 days after completion of treatment (estimated to be 7 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- There were not any participants enrolled in Cohort B or Cohort C.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0002
- source section id
- NCT02669914-om-0002
- source outcome index
- 2
- endpoint
- Overall Disease Control Rate of Intracranial Disease
- endpoint definition
- * Defined as the percentage of patients who achieve a complete response, partial response, or stable disease based on assessment of brain lesions * CR: Requires: complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; No new lesions; stable or improved nonenhancing (T2/FLAIR) lesions.; off corticosteroids (or on physiologic replacement doses only) and stable or improved clinically. * PR: Requires:• ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. • No progression of nonmeasurable disease. • Stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; the corticosteroid dose at the time of the scan evaluation should be no greater than the dose at time of baseline scan. • Stable or improved clinically
- time origin
- Completion of treatment (estimated to be 6 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- There were not any participants enrolled in Cohort B or Cohort C.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0003
- source section id
- NCT02669914-om-0003
- source outcome index
- 3
- endpoint
- Overall Response Rate of Extracranial Disease
- endpoint definition
- * Defined as the percentage of patients who achieve a complete response or partial response based on assessment of systemic lesions * Complete response: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters
- time origin
- Completion of treatment (estimated to be 6 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Two participants were not evaluable in Cohort A as the extracranial response per RECIST was not done. There were not any participants enrolled in Cohort B or Cohort C.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0004
- source section id
- NCT02669914-om-0004
- source outcome index
- 4
- endpoint
- Overall Disease Control Rate of Extracranial Disease
- endpoint definition
- * Defined as the percentage of patients who achieve a complete response, partial response, or stable disease based on assessment of systemic lesions * Complete response: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters * Stable disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study
- time origin
- Completion of treatment (estimated to be 6 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Two participants were not evaluable in Cohort A as the extracranial response per RECIST was not done. There were not any participants enrolled in Cohort B or Cohort C.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0005
- source section id
- NCT02669914-om-0005
- source outcome index
- 5
- endpoint
- Overall Response Rate Considering Both Intracranial and Extracranial Disease
- endpoint definition
- * Defined as the percentage of patients who achieve a complete response or partial response based on assessment of brain and systemic lesions * Intracranial disease * Complete response: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters * Extracranial disease * Complete response: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters
- time origin
- Completion of treatment (estimated to be 6 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Two participants were not evaluable in Cohort A as the extracranial response per RECIST was not done. There were not any participants enrolled in Cohort B or Cohort C.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids
- regimen
- -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02669914-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids
- regimen
- -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02669914-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
- regimen
- -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02669914-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids
- regimen
- -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02669914-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids
- regimen
- -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02669914-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
- regimen
- -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02669914-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids
- regimen
- -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02669914-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids
- regimen
- -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02669914-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
- regimen
- -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02669914-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids
- regimen
- -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02669914-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids
- regimen
- -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02669914-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
- regimen
- -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02669914-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- harm key
- EG000
- source section id
- NCT02669914-ae
- event group key
- EG000
- event group label
- Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids
- serious affected
- 1
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- collection period
- Adverse events were collected starting at baseline and ending 30 days after the completion of treatment.
- event definition
- There were no participants enrolled in Cohort B or C and that is why the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events is zero.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- harm key
- EG001
- source section id
- NCT02669914-ae
- event group key
- EG001
- event group label
- Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- Adverse events were collected starting at baseline and ending 30 days after the completion of treatment.
- event definition
- There were no participants enrolled in Cohort B or C and that is why the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events is zero.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-kidney-neoplasm
- nct id
- NCT02669914
- harm key
- EG002
- source section id
- NCT02669914-ae
- event group key
- EG002
- event group label
- Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- Adverse events were collected starting at baseline and ending 30 days after the completion of treatment.
- event definition
- There were no participants enrolled in Cohort B or C and that is why the number of participants at risk for All-Cause Mortality, Serious Adverse Events, and Other Adverse Events is zero.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice