NCT02117219

Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome

A Phase 1 Study to Evaluate the Safety and Tolerability of MEDI4736 as Monotherapy or in Combination With Tremelimumab With or Without Azacitidine in Subjects With Myelodysplastic Syndrome After Treatment With Hypomethylating Agents

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in Subjects with myelodysplastic syndrome after treatment with hypomethylating agents

Detailed description

A dose-escalation and dose-expansion study of MEDI4736 (a monoclonal antibody that targets programmed cell death-1 ligand 1 \[PD-L1\]) to evaluate the safety, tolerability, PK, IM, and antitumor activity of MEDI4736 as monotherapy or in combination with Tremelimumab with or without Azacitidine in adult patients with myelodysplastic syndrome.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	MEDI4736 Evaluate MEDI4736 in MDS	MEDI4736 will be administered by IV infusion
DRUG	VIDAZA	VIDAZA will be administered subcutaneously as described on the package insert VIDAZA will be administered in combination with MEDI4736 upon progression from MEDI4736 monotherapy
BIOLOGICAL	tremelimumab	tremelimumab will be administered by IV infusion

Timeline

• Start date: 2014-05-20
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2014-04-17
• Last updated: 2019-05-10

Locations

21 sites across 4 countries: United States, France, Germany, United Kingdom

Regulatory

• FDA-regulated drug study