A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Advanced Solid Tumors
- Interventions
- Biological: MEDI4736Biological: tremelimumab
- Registration Number
- NCT02261220
- Lead Sponsor
- MedImmune LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 380
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MEDI4736 + Tremelimumab MEDI4736 Subjects with multiple tumor types. MEDI4736 + Tremelimumab tremelimumab Subjects with multiple tumor types.
- Primary Outcome Measures
Name Time Method Change from Baseline in vital signs Screening through 3 months after the last dose of study medication 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 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 Change from Baseline in electrocardiogram evaluations Screening through 3 months after the last dose of study medication Overall Response Rate in Select Tumor Types First dose of study medication through 15 months after the last subject enters re-treatment
- Secondary Outcome Measures
Name Time Method Overall Response 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 Overall Survival First dose of study medication through 15 months after the last subject enters re-treatment Tremelimumab area under the concentration-curve First dose of tremelimumab through 3 months after the last dose of study medication Disease Control Rate First dose of study medication through 15 months after the last subject enters re-treatment MEDI4736 area under the concentration-curve First dose of MEDI4736 through 3 months after the last dose of study medication Progression-Free 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 Individual tremelimumab concentrations First dose of tremelimumab 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
Trial Locations
- Locations (1)
Research Site
🇬🇧Wirral, United Kingdom