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MEDI5083 Alone and in Combination With Durvalumab, Tremelimumab, and/or Docetaxel.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03089645
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Brief Summary:
The purpose of this study is to evaluate the safety, pharmacokinetics and Immunogenicity of Medi5083 alone or in combination with Durvalumab,Tremelimumab, and/or Docetaxel in adult subjects with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Biological: MEDI5083 monotherapy Biological: MEID5083 with Durvalumab or Tremelimumab Biological: Medi5083 with Durvalumab and Docetaxel Phase 1

Detailed Description:
This is a global Phase 1, first-time-in-human, multicenter, dose-escalation and dose-expansion study of MEDI5083 alone or in combination with Durvalumab, Tremelimumab, and/or Docetaxel.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 First Time in Human Study to Evaluate the Safety, Pharmacokinetics and Immunogenicity of MEDI5083 Alone or in Combination With Durvalumab, Tremelimumab, and/or Docetaxel in Advanced Solid Tumors
Actual Study Start Date : March 21, 2017
Actual Primary Completion Date : June 23, 2020
Actual Study Completion Date : June 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1
MEDI5083 monotherapy followed by Durvalumab monotherapy in subjects with advanced solid tumors
Biological: MEDI5083 monotherapy
Dose-escalation MEDI5083 monotherapy followed by monotherapy with Durvalumab

Experimental: Part 2
Sequential MEDI5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab in subjects with advanced solid tumors.
Biological: MEID5083 with Durvalumab or Tremelimumab
Sequential Medi5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab

Experimental: Part 3
Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel in subjects with IO refractory/relapsed 2/3L in NSCLC
Biological: Medi5083 with Durvalumab and Docetaxel
Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel




Primary Outcome Measures :
  1. Number of participants with Adverse Events (AEs) as a measure of safety [ Time Frame: From the time of consent through 120 days after last treatment ]
    Safety Endpoint

  2. Number of participants with Serious Adverse Events (SAEs) as a measure of safety [ Time Frame: From the time of consent through 120 days after last treatment ]
    Safety Endpoint

  3. Number of participants with Dose Limiting Toxicities (DLTs) as a measure of safety [ Time Frame: From the time of first dose through 28 days thereafter ]
    Safety Endpoint

  4. The Maximum Tolerated Dose (MTD) or Highest Protocol-Defined Dose [ Time Frame: From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion) ]
    Safety Endpoint

  5. Discontinuation of investigational products due to toxicity [ Time Frame: From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion) ]
    Safety Endpoint

  6. Clinically significant alterations in vital signs, laboratory parameters, physical examination, and electrocardiogram (ECG) results. [ Time Frame: From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion) ]
    Safety Endpoint

  7. Antitumor activity endpoints OR, based on RECIST v1.1 [ Time Frame: Part 3 ]
    Safety Endpoint


Secondary Outcome Measures :
  1. Serum MEDI5083 concentration levels [ Time Frame: From the time of first dose through 57 days after first treatment ]
    Pharmacokinetics (PK)

  2. Reduction in peripheral blood CD19+ B cells [ Time Frame: From the time of first dose through 57 days after first treatment ]
    Pharmacodynamics (PD)

  3. Incidence of anti-drug antibody (ADA) responses to MEDI5083 [ Time Frame: From the time of first dose through 2 years after last treatment ]
    Immunogenicity

  4. Objective Response Rate (ORR) [ Time Frame: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion) ]
    Clinical Activity Endpoint

  5. Progression Free Survival (PFS) at 6 months (PFS-6) [ Time Frame: From the time of first dose until 6 months after the last subject is dosed ]
    Clinical Activity Endpoint

  6. Overall Survival (OS) [ Time Frame: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion) ]
    Clinical Activity Endpoint

  7. Disease Control Rate (DCR) [ Time Frame: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion) ]
    Clinical Activity Endpoint

  8. Duration of Response (DoR) [ Time Frame: From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion) ]
    Clinical Activity Endpoint

  9. Serum Durvalumab concentration levels collected over time [ Time Frame: From the time of first dose through 29 days after first treatment ]
    Pharmacokinetics (PK)

  10. Incidence of anti-drug antibody (ADA) responses to Durvalumab [ Time Frame: From the time of first dose through 2 years after last treatment ]
    Immunogenicity

  11. Incidence of anti-drug antibody (ADA) responses to tremelilumab [ Time Frame: From the time of first dose through 2 years after last treatment ]
    Immunogenicity

  12. Serum tremelimumab concentration levels collected over time [ Time Frame: From the time of first dose through 57 days after first treatment ]
    Pharmacodynamics (PD)

  13. PD of MEDI5083 alone and in combination with Durvalumab and tremelimumab [ Time Frame: From the time of first dose through 57 days after first treatment ]
    Pharmacodynamics (PD)

  14. Safety and tolerability of MEDI5083 with durvalumamb and docetaxel and in subjects with IO relapsed/refractory 2/3L NSCLC [ Time Frame: From the time of first dose through 57 days after first treatment ]
    Safety



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 101 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years at the time of screening or age of consent according to local law
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  3. Histologically or cytologically confirmed metastatic or recurrent tumor types
  4. Subjects who have received prior immunotherapy may be eligible
  5. Subjects must have at least one measurable lesion
  6. Consent to provide archival tumor tissue and pre/on-treatment biopsies
  7. Adequate organ and marrow function
  8. Consent to use one highly effective method of contraception

Exclusion Criteria:

  1. Receipt of any systemic anticancer therapy within 28 days prior to the first dose of MEDI5083
  2. Concurrent enrollment in another clinical study
  3. Active/prior autoimmune of inflammatory disorders
  4. History of immunodeficiency, solid organ transplant, or tuberculosis
  5. Known allergy/hypersensitivity to drug or components
  6. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression
  7. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI5083

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089645


Locations
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United States, New Jersey
Research Site
Hackensack, New Jersey, United States, 07601-2191
United States, Rhode Island
Research Site
Providence, Rhode Island, United States, 02903
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37203
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84112
Australia
Research Site
Clayton, Australia, 3168
Research Site
Melbourne, Australia, 3000
Research Site
Melbourne, Australia, 3004
Research Site
Randwick, Australia, 2031
Sponsors and Collaborators
MedImmune LLC
Investigators
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Study Director: MedImmune LLC Sponsor GmbH
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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT03089645    
Other Study ID Numbers: D6840C00001
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Docetaxel
Durvalumab
Tremelimumab
Antibodies, Monoclonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Immunologic Factors
Physiological Effects of Drugs