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MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02669914
Recruitment Status : Terminated (Low accrual, funding withdrawn by AstraZeneca, and change in clinical practice)
First Posted : February 1, 2016
Results First Posted : October 10, 2018
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Non-Small Cell Lung Cancer
Nonsmall Cell Lung Cancer
Breast Cancer
Cancer of Breast
Cancer of the Breast
Gastroesophageal Cancer
Pancreatic Cancer
Cancer of the Pancreas
Colorectal Cancer
Colorectal Carcinoma
Renal Cancer
Kidney Cancer
Cancer of the Kidney
Cancer of Kidney
Ovarian Cancer
Ovary Cancer
Cancer of the Ovary
Cancer of Ovary
Intervention Drug: MEDI4736
Enrollment 4
Recruitment Details The study opened to participant enrollment on 09/12/2016 and closed to participant accrual on 11/16/2017.
Pre-assignment Details  
Arm/Group Title Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Hide Arm/Group Description -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. -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. -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.
Period Title: Overall Study
Started 4 0 0
Completed 4 0 0
Not Completed 0 0 0
Arm/Group Title Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids Total
Hide Arm/Group Description -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. -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. -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. Total of all reporting groups
Overall Number of Baseline Participants 4 0 0 4
Hide Baseline Analysis Population Description
There were not any participants enrolled in Cohort B or Cohort C so that is why the overall number of baseline participants is zero for these cohorts.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 0 participants 0 participants 4 participants
62
(55 to 76)
62
(55 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 0 participants 4 participants
Female
3
  75.0%
3
  75.0%
Male
1
  25.0%
1
  25.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 0 participants 4 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
Not Hispanic or Latino
4
 100.0%
4
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 0 participants 4 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
1
  25.0%
1
  25.0%
White
3
  75.0%
3
  75.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants 0 participants 0 participants 4 participants
4
 100.0%
4
 100.0%
1.Primary Outcome
Title Overall Response Rate of Intracranial Disease
Hide Description

-% 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 Frame Completion of treatment (estimated to be 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
There were not any participants enrolled in Cohort B or Cohort C.
Arm/Group Title Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Hide Arm/Group Description:
-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.
-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.
-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.
Overall Number of Participants Analyzed 4 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Safety of MEDI4736 in Advanced Solid Epithelial-derived Tumor Patients With Brain Metastases as Measured by Number of Participants With Treatment-emergent Adverse Events
Hide Description -The severity of AEs will be graded by the investigator according to the CTCAE, Version 4.03
Time Frame 30 days after completion of treatment (estimated to be 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
There were not any participants enrolled in Cohort B or Cohort C.
Arm/Group Title Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Hide Arm/Group Description:
-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.
-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.
-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.
Overall Number of Participants Analyzed 4 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1 anemia
1
  25.0%
Grade 2 anemia
1
  25.0%
Grade 1 bloating
1
  25.0%
Grade 2 constipation
1
  25.0%
Grade 2 diarrhea
1
  25.0%
Grade 1 nausea
1
  25.0%
Grade 1 chills
1
  25.0%
Grade 2 fever
1
  25.0%
Grade 1 non-cardiac chest pain
1
  25.0%
Grade 1 night sweats
1
  25.0%
Grade 2 sinusitis
1
  25.0%
Grade 1 lymphocyte count decreased
1
  25.0%
Grade 2 lymphocyte count decreased
2
  50.0%
Grade 2 weight loss
1
  25.0%
Grade 1 hypercalcemia
1
  25.0%
Grade 3 hypercalcemia
1
  25.0%
Grade 1 hyponatremia
1
  25.0%
Grade 1 arthralgia
1
  25.0%
Grade 3 paresthesia
1
  25.0%
Grade 1 productive cough
1
  25.0%
Grade 2 post nasal drip
1
  25.0%
Grade 1 hyperhidrosis
1
  25.0%
Grade 1 pruritus
1
  25.0%
Grade 1 hypertension
1
  25.0%
3.Secondary Outcome
Title Overall Disease Control Rate of Intracranial Disease
Hide Description
  • 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 Frame Completion of treatment (estimated to be 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
There were not any participants enrolled in Cohort B or Cohort C.
Arm/Group Title Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Hide Arm/Group Description:
-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.
-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.
-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.
Overall Number of Participants Analyzed 4 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
4.Secondary Outcome
Title Overall Response Rate of Extracranial Disease
Hide Description
  • 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 Frame Completion of treatment (estimated to be 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Hide Arm/Group Description:
-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.
-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.
-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.
Overall Number of Participants Analyzed 2 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Secondary Outcome
Title Overall Disease Control Rate of Extracranial Disease
Hide Description
  • 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 Frame Completion of treatment (estimated to be 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Hide Arm/Group Description:
-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.
-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.
-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.
Overall Number of Participants Analyzed 2 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
1
  50.0%
6.Secondary Outcome
Title Overall Response Rate Considering Both Intracranial and Extracranial Disease
Hide Description
  • 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 Frame Completion of treatment (estimated to be 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Hide Arm/Group Description:
-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.
-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.
-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.
Overall Number of Participants Analyzed 2 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
7.Secondary Outcome
Title Overall Disease Control Rate Considering Both Intracranial and Extracranial Disease
Hide Description
  • Defined as the percentage of subjects who achieve a complete response, partial response, or stable disease based on assessment of brain and systemic lesions
  • Intracranial disease: response and progression will be evaluated using the updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology (RANO) working group guideline
  • Extracranial disease: response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Time Frame Completion of treatment (estimated to be 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Hide Arm/Group Description:
-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.
-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.
-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.
Overall Number of Participants Analyzed 2 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
1
  50.0%
8.Secondary Outcome
Title Duration of Response of Intracranial Disease
Hide Description
  • Defined as the interval from the first documentation of objective response (complete response or partial response) to the earlier of the first documentation of disease progression or death from any cause
  • Intracranial disease: response and progression will be evaluated using the updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology (RANO) working group guideline
Time Frame Completion of treatment (estimated to be 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
None of the participants in Cohort A were evaluable for this outcome measure as they did not have an objective response per RANO guidelines. There were not any participants enrolled to Cohort B or Cohort C.
Arm/Group Title Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Hide Arm/Group Description:
-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.
-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.
-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.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Duration of Response of Extracranial Disease
Hide Description
  • Defined as the interval from the first documentation of objective response (complete response or partial response) to the earlier of the first documentation of disease progression or death from any cause
  • Extracranial disease: response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Time Frame Completion of treatment (estimated to be 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants were not evaluable in Cohort A as the extracranial response per RECIST was not done. The remaining two participants were not evaluable for this outcome measure because they didn't have an objective response per RECIST. There were not any participants enrolled in Cohort B or Cohort C.
Arm/Group Title Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Hide Arm/Group Description:
-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.
-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.
-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.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Duration of Response Considering Both Intracranial and Extracranial Disease
Hide Description
  • Defined as the interval from the first documentation of objective response (complete response or partial response) to the earlier of the first documentation of disease progression or death from any cause
  • Intracranial disease: response and progression will be evaluated using the updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology (RANO) working group guideline
  • Extracranial disease: response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Time Frame Completion of treatment (estimated to be 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Two participants were not evaluable in Cohort A as the extracranial response per RECIST was not done. The remaining two participants were not evaluable for this outcome measure because they didn't have an objective response. There were not any participants enrolled in Cohort B or Cohort C.
Arm/Group Title Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Hide Arm/Group Description:
-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.
-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.
-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.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description
  • PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
  • 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. (Note: the appearance of one or more new lesions is also considered progression). Unequivocal progression of existing non-target lesions.
Time Frame Up to 2 years after completion of treatment (estimated to be 2 years and 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
There were not any participants enrolled in Cohort B or Cohort C.
Arm/Group Title Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Hide Arm/Group Description:
-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.
-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.
-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.
Overall Number of Participants Analyzed 4 0 0
Median (Full Range)
Unit of Measure: days
51.5
(18 to 64)
12.Secondary Outcome
Title Overall Survival (OS)
Hide Description -Defined as the interval from the start of study therapy to death from any cause
Time Frame Up to 2 years after completion of treatment (estimated to be 2 years and 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in Cohort A was lost to follow-up and is not evaluable for this outcome measure. There were not any participants enrolled to Cohort B or Cohort C.
Arm/Group Title Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Hide Arm/Group Description:
-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.
-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.
-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.
Overall Number of Participants Analyzed 3 0 0
Median (Full Range)
Unit of Measure: days
197
(130 to 262)
Time Frame Adverse events were collected starting at baseline and ending 30 days after the completion of treatment.
Adverse Event Reporting Description 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.
 
Arm/Group Title Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Hide Arm/Group Description -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. -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. -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.
All-Cause Mortality
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/4 (50.00%)   0/0   0/0 
Hide Serious Adverse Events
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/4 (25.00%)   0/0   0/0 
Nervous system disorders       
Parasthesia  1  1/4 (25.00%)  0/0  0/0 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   0/0   0/0 
Blood and lymphatic system disorders       
Anemia  1  2/4 (50.00%)  0/0  0/0 
Gastrointestinal disorders       
Bloating  1  1/4 (25.00%)  0/0  0/0 
Constipation  1  1/4 (25.00%)  0/0  0/0 
Diarrhea  1  1/4 (25.00%)  0/0  0/0 
Nausea  1  1/4 (25.00%)  0/0  0/0 
General disorders       
Chills  1  1/4 (25.00%)  0/0  0/0 
Fatigue  1  1/4 (25.00%)  0/0  0/0 
Non-cardiac chest pain  1  1/4 (25.00%)  0/0  0/0 
Night sweats  1  1/4 (25.00%)  0/0  0/0 
Infections and infestations       
Sinusitis  1  1/4 (25.00%)  0/0  0/0 
Investigations       
Lymphocyte count decreased  1  3/4 (75.00%)  0/0  0/0 
Weight loss  1  1/4 (25.00%)  0/0  0/0 
Metabolism and nutrition disorders       
Hypercalcemia  1  1/4 (25.00%)  0/0  0/0 
Hyperglycemia  1  1/4 (25.00%)  0/0  0/0 
Hyponatremia  1  1/4 (25.00%)  0/0  0/0 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/4 (25.00%)  0/0  0/0 
Respiratory, thoracic and mediastinal disorders       
Productive cough  1  1/4 (25.00%)  0/0  0/0 
Post nasal drip  1  1/4 (25.00%)  0/0  0/0 
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  1/4 (25.00%)  0/0  0/0 
Pruritus  1  1/4 (25.00%)  0/0  0/0 
Vascular disorders       
Hypertension  1  1/4 (25.00%)  0/0  0/0 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ramaswamy Govindan, M.D.
Organization: Washington University School of Medicine
Phone: 314-362-5737
EMail: rgovindan@wustl.edu
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02669914    
Other Study ID Numbers: 201602169
First Submitted: January 22, 2016
First Posted: February 1, 2016
Results First Submitted: September 12, 2018
Results First Posted: October 10, 2018
Last Update Posted: November 6, 2018