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NCT Number: NCT02117219

Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome

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

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Key information

Conditions

Myelodysplastic Syndrome Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult male or female subjects with pathologically confirmed MDS who failed to respond, relapsed after an initial response, or were unable to tolerate hypomethylating agents, ECOG performance status of 0 - 2, and adequate organ and marrow function.

Exclusion criteria

Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, prior MAb against CTLA-4, PD-1, or PD-L1, alllogenic or haploidentical transplant, current immunosuppressive medication or autoimmune or inflammatory disease.

Treatment and study plan

MEDI4736 Evaluate MEDI4736 in MDS

Biological

MEDI4736 will be administered by IV infusion

Other names: durvalumab

Vidaza

Drug

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

Other names: azacitidine

Tremelimumab

Biological

tremelimumab will be administered by IV infusion

Primary outcomes

  1. Subject's safety where no more than one out of six subjects experience DLTs at a given dose

    Time frame: 180 days

    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.

  2. Subject's safety overall (monotherapy and combination therapies)

    Time frame: 730 days

    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.

Secondary outcomes

  1. Clinical outcome in terms of response: duration of response

    Time frame: 2 years

    As defined by IWG 2006 MDS response criteria

  2. Clinical outcome in terms of response: transfusion requirements

    Time frame: 2 years

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

  3. Clinical outcome in terms of response: progression-free survival (PFS)

    Time frame: 2 years

    As defined by IWG 2006 MDS response criteria

  4. Clinical outcome in terms of response: survival (OS)

    Time frame: 2 years

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

  5. Pharmacokinetics: MEDI4736 and tremelimumab concentrations in serum: peak concentration

    Time frame: 1 year

    Peak concentration of MEDI4736 and tremelimumab in serum

  6. Pharmacokinetics: MEDI4736 and tremelimumab concentrations in serum: area under the concentration-time curve

    Time frame: 1 year

    Analysis of area under the concentration-time curve

  7. Pharmacokinetics: MEDI4736 and tremelimumab concentration in serum: clearance

    Time frame: 1 year

    Rate of MEDI4736 and tremelimumab clearance

  8. Pharmacokinetics: MEDI4736 and tremelimumab concentration in serum: terminal half-life

    Time frame: 1 year

    MEDI4736 and tremelimumab concentration terminal half-life

  9. Immunogenicity

    Time frame: 1 year

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

  10. Health-related quality of life (QOL): disease- and treatment-related symptoms (Part 1 only)

    Time frame: 2 years

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

  11. Health-related quality of life (QOL): pain (Part 1 only)

    Time frame: 2 years

    Analysis of incidence of pain reporting (Part 1 only)

  12. Health-related quality of life (QOL): health status (Part 1 only)

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 17, 2014
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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