A Phase 1/2 Study of Durvalumab(MEDI4736) and Tremelimumab in Chinese Patients With Advanced Malignancies
- Sponsor
- AstraZeneca
- Study ID
- NCT02978482
- Phase
- PHASE1
- Status
- Completed
Conditions
- Advanced Malignancy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 130 Years
- Healthy Volunteers
- Not accepted
Interventions
- durvalumab — DRUGdurvalumab (MEDI4736) 20mg/kg via IV infusion every 4 weeks until confirmed disease progression or unacceptable toxicity
- tremelimumab + durvalumab — DRUG20 mg/kg durvalumab (MEDI4736) via IV infusion q4w and 1 mg/kg tremelimumab via IV infusion q4w for up to 4 doses/cycles, and then continue 20 mg/kg durvalumab (MEDI4736) q4w starting on Week 16 for up to confirmed disease progression
Study Details
A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Durvalumab (MEDI4736) in combination with tremelimumab in Chinese Patients with Advanced Malignancies
Key Dates
- Start date
- Dec 1, 2016
- Status verified
- Aug 2021
- Primary completion
- Jan 28, 2018
- Completion
- Nov 26, 2020
Study Design
- Enrollment
- 26 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: durvalumabdurvalumab alone
- Experimental: durvalumab+tremelimumabdurvalumab plus tremelimumab
Primary Outcome Measure
Maximum plasma concentration (Cmax) [ Time Frame: approximately 6 months after the last evaluable patient in Phase 1 portion is first dosed ]