Advanced Solid Tumors
Conditions
Keywords
advanced solid tumors, durvalumab, tremelimumab
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.
Interventions
BIOLOGICALMEDI4736
MEDI4736 is administered by IV infusion in combination with tremelimumab
BIOLOGICALtremelimumab
Tremelimumab is administered by IV infusion in combination with MEDI4736
Sponsors
MedImmune LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate in Select Tumor Types | First dose of study medication through 15 months after the last subject enters re-treatment |
| Number of subjects reporting adverse events | Screening through 15 months after the last subject enters re-treatment |
| Number of subjects reporting serious adverse events | Screening through 15 months after the last subject enters re-treatment |
| Number of subjects experiencing a dose-limiting toxicity | First dose of study medication through 4 weeks after the first dose of study medication |
| Change from Baseline in laboratory evaluations | Screening through 3 months after the last dose of study medication |
| Change from Baseline in vital signs | Screening through 3 months after the last dose of study medication |
| Change from Baseline in electrocardiogram evaluations | Screening through 3 months after the last dose of study medication |
Secondary
| Measure | Time frame |
|---|---|
| Individual tremelimumab concentrations | First dose of tremelimumab through 3 months after the last dose of study medication |
| MEDI4736 area under the concentration-curve | First dose of MEDI4736 through 3 months after the last dose of study medication |
| Number of subjects that develop detectable antidrug antibodies to MEDI4736 | First dose of MEDI4736 through 3 months after the last dose of study medication |
| Number of subjects that develop antidrug antibodies to tremelimumab | First dose of tremelimumab through 3 months after the last dose of study medication |
| Tremelimumab area under the concentration-curve | First dose of tremelimumab through 3 months after the last dose of study medication |
| Overall Response Rate | First dose of study medication through 15 months after the last subject enters re-treatment |
| Disease Control Rate | First dose of study medication through 15 months after the last subject enters re-treatment |
| Duration of Response | First dose of study medication through 15 months after the last subject enters re-treatment |
| Progression-Free Survival | First dose of study medication through 15 months after the last subject enters re-treatment |
| Overall Survival | First dose of study medication through 15 months after the last subject enters re-treatment |
| Individual MEDI4736 concentrations | First dose of MEDI4736 through 3 months after the last dose of study medication |
Other
| Measure | Time frame |
|---|---|
| Change in Biomarkers | Screening through 3 months following the last dose of study medication |
Countries
Canada, France, Germany, Israel, Netherlands, South Korea, Spain, United Kingdom, United States
Outcome results
None listed