Brief Summary
This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.
Brief Title
A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors
Completion Date
Completion Date Type
Actual
Conditions
Advanced Solid Tumors
Eligibility Criteria
Inclusion Criteria:
* Male and female subjects
* 18 years and older
* Histologic confirmation of advanced solid tumors
* Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.
Exclusion Criteria:
* Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment
* Active or prior documented autoimmune disease within the past 2 years
* Current or prior use of immunosuppressive medication within 14 days with some exceptions.
* Male and female subjects
* 18 years and older
* Histologic confirmation of advanced solid tumors
* Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.
Exclusion Criteria:
* Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment
* Active or prior documented autoimmune disease within the past 2 years
* Current or prior use of immunosuppressive medication within 14 days with some exceptions.
Inclusion Criteria
Inclusion Criteria:
* Male and female subjects
* 18 years and older
* Histologic confirmation of advanced solid tumors
* Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.
* Male and female subjects
* 18 years and older
* Histologic confirmation of advanced solid tumors
* Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.
Gender
All
Gender Based
false
Keywords
advanced solid tumors
durvalumab
tremelimumab
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
99 Years
Minimum Age
18 Years
NCT Id
NCT02261220
Org Class
Industry
Org Full Name
MedImmune LLC
Org Study Id
D4190C00010
Overall Status
Completed
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Solid Tumors
Primary Outcomes
Outcome Measure
Number of subjects reporting adverse events
Outcome Time Frame
Screening through 15 months after the last subject enters re-treatment
Outcome Measure
Number of subjects reporting serious adverse events
Outcome Time Frame
Screening through 15 months after the last subject enters re-treatment
Outcome Measure
Number of subjects experiencing a dose-limiting toxicity
Outcome Time Frame
First dose of study medication through 4 weeks after the first dose of study medication
Outcome Measure
Change from Baseline in laboratory evaluations
Outcome Time Frame
Screening through 3 months after the last dose of study medication
Outcome Measure
Change from Baseline in vital signs
Outcome Time Frame
Screening through 3 months after the last dose of study medication
Outcome Measure
Change from Baseline in electrocardiogram evaluations
Outcome Time Frame
Screening through 3 months after the last dose of study medication
Outcome Measure
Overall Response Rate in Select Tumor Types
Outcome Time Frame
First dose of study medication through 15 months after the last subject enters re-treatment
Secondary Outcomes
Outcome Time Frame
First dose of study medication through 15 months after the last subject enters re-treatment
Outcome Measure
Overall Response Rate
Outcome Time Frame
First dose of study medication through 15 months after the last subject enters re-treatment
Outcome Measure
Disease Control Rate
Outcome Time Frame
First dose of study medication through 15 months after the last subject enters re-treatment
Outcome Measure
Duration of Response
Outcome Time Frame
First dose of study medication through 15 months after the last subject enters re-treatment
Outcome Measure
Progression-Free Survival
Outcome Time Frame
First dose of study medication through 15 months after the last subject enters re-treatment
Outcome Measure
Overall Survival
Outcome Time Frame
First dose of MEDI4736 through 3 months after the last dose of study medication
Outcome Measure
Individual MEDI4736 concentrations
Outcome Time Frame
First dose of tremelimumab through 3 months after the last dose of study medication
Outcome Measure
Individual tremelimumab concentrations
Outcome Time Frame
First dose of MEDI4736 through 3 months after the last dose of study medication
Outcome Measure
MEDI4736 area under the concentration-curve
Outcome Time Frame
First dose of tremelimumab through 3 months after the last dose of study medication
Outcome Measure
Tremelimumab area under the concentration-curve
Outcome Time Frame
First dose of MEDI4736 through 3 months after the last dose of study medication
Outcome Measure
Number of subjects that develop detectable antidrug antibodies to MEDI4736
Outcome Time Frame
First dose of tremelimumab through 3 months after the last dose of study medication
Outcome Measure
Number of subjects that develop antidrug antibodies to tremelimumab
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
99
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sanjay Goel
Investigator Email
sgoel@montefiore.org
Investigator Phone
718-405-8404
MeSH Terms
DURVALUMAB
TREMELIMUMAB