Study identifier:D4884C00001
ClinicalTrials.gov identifier:NCT02527434
EudraCT identifier:2015-002934-32
CTIS identifier:N/A
A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors
Urothelial bladder cancer
Phase 2
No
-
All
64
Interventional
18 Years - 150 Years
Allocation: N/A
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Oct 2023 by AstraZeneca
AstraZeneca
-
A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors
This is an open-label, multi-center study to determine the efficacy and safety of tremelimumab in the treatment of different cohorts of patients with selected advanced solid tumors. If eligible and at the discretion of the Investigator, after confirmed disease progression on tremelimumab monotherapy or during follow-up, patients will have the option of being sequenced to MEDI4736 (MedImmune 4736) monotherapy or MEDI4736 + tremelimumab combination therapy, for up to 12 months or until disease progression, whichever comes sooner.
Location
Location
Houston, TX, United States, 77030
Location
San Francisco, CA, United States, 94158
Location
Memphis, TN, United States, 38120
Location
Brussels, Belgium, 1090
Location
Wilrijk, Belgium, 2610
Location
Charleroi, Belgium, 6000
Location
Groningen, Netherlands, 9713 GZ
Location
UTRECHT, Netherlands, 3584 CX
Arms | Assigned Interventions |
---|---|
Experimental: treme mono to be sequenced to MEDI4736 mono or combination tremelimumab monotherapy, with the option for eligible patients to be sequenced to MEDI4736 monotherapy or MEDI4736 + tremelimumab combination therapy after progressive disease (PD) | Biological/Vaccine: Tremelimumab monotherapy IV infusion Biological/Vaccine: MEDI4736 monotherapy IV infusion Biological/Vaccine: MEDI4736 + tremelimumab combination therapy IV infusion |
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