Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Antineoplastic Agents

All Drugs and Chemicals

Azacitidine

Durvalumab

Tremelimumab

Antimetabolites

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Evaluate MEDI4736 monotherapy and MEDI4736 in combination with azacitidine after monotherapy progression in MDS

Evaluate MEDI4736 in combination with tremelimumab

Evaluate MEDI4736 in combination with tremelimumab and azacitidine

MEDI4736 will be administered by IV infusion

MEDI4736 Evaluate MEDI4736 in MDS

VIDAZA will be administered subcutaneously as described on the package insert VIDAZA will be administered in combination with MEDI4736 upon progression from MEDI4736 monotherapy

VIDAZA

tremelimumab will be administered by IV infusion

tremelimumab

MedImmune LLC

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

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.

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

DLT (MEDI4736 monotherapy only) assessment will be done by reviewing adverse events (AEs), serious adverse events (SAEs), laboratory evaluations, vital signs, physical examinations, and electrocardiogram (ECG) results. For monotherapy or combo w/aza AEs, SAEs, lab evaluations, vital signs, physical exams, ECGs will be done.

Overall safety assessments will be done by reviewing adverse events (AEs, serious adverse events (SAEs), laboratory evaluations, vital signs, physical examinations and electrocardiogram (ECG) results.

As defined by IWG 2006 MDS response criteria

As defined by IWG 2006 MDS response criteria and incidence of transfusions.

As defined by IWG 2006 MDS response criteria and collection of survival data

Peak concentration of MEDI4736 and tremelimumab in serum

Analysis of area under the concentration-time curve

Rate of MEDI4736 and tremelimumab clearance

MEDI4736 and tremelimumab concentration terminal half-life

Determine by number of subjects who develop ADA (anti-drug antibody).

Analysis of reporting of disease- and treatment-related symptoms (Part 1 only)

Analysis of incidence of pain reporting (Part 1 only)

Analysis of reporting of health status. (Part 1 only)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome	NCT02117219	Myelodysplastic...	MEDI4736 Evalua... VIDAZA tremelimumab	18 Years - 99 Years	MedImmune LLC
Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome	NCT02117219	Myelodysplastic...	MEDI4736 Evalua... VIDAZA tremelimumab	18 Years - 99 Years	MedImmune LLC

Spots Global Cancer Trial Database for medi4736 evaluate medi4736 in mds