NCT02527434

Study of Tremelimumab in Patients With Advanced Solid Tumors

A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 150 Years
• Healthy volunteers: Not accepted

Summary

A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients with Advanced Solid Tumors

Detailed description

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.

Conditions

• Urothelial Bladder Cancer
• Triple-negative Breast Cancer
• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Tremelimumab monotherapy	IV infusion
BIOLOGICAL	MEDI4736 monotherapy	IV infusion
BIOLOGICAL	MEDI4736 + tremelimumab combination therapy	IV infusion

Timeline

• Start date: 2015-11-02
• Primary completion: 2018-02-17
• Completion: 2023-03-28
• First posted: 2015-08-19
• Last updated: 2023-11-15
• Results posted: 2019-03-05

Locations

14 sites across 5 countries: United States, Belgium, Netherlands, Poland, South Korea

Regulatory

• FDA-regulated drug study