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

July 24, 2020 updated by: MedImmune LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Clayton, Australia, 3168
        • Research Site
      • Melbourne, Australia, 3004
        • Research Site
      • Melbourne, Australia, 3000
        • Research Site
      • Randwick, Australia, 2031
        • Research Site
  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601-2191
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From the time of consent through 120 days after last treatment
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
From the time of consent through 120 days after last treatment
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
From the time of first dose through 28 days thereafter
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
From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
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
From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
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
From the time of first dose through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Antitumor activity endpoints OR, based on RECIST v1.1
Time Frame: Part 3
Safety Endpoint
Part 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum MEDI5083 concentration levels
Time Frame: From the time of first dose through 57 days after first treatment
Pharmacokinetics (PK)
From the time of first dose through 57 days after first treatment
Reduction in peripheral blood CD19+ B cells
Time Frame: From the time of first dose through 57 days after first treatment
Pharmacodynamics (PD)
From the time of first dose through 57 days after first treatment
Incidence of anti-drug antibody (ADA) responses to MEDI5083
Time Frame: From the time of first dose through 2 years after last treatment
Immunogenicity
From the time of first dose through 2 years after last treatment
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
From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
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
From the time of first dose until 6 months after the last subject is dosed
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
From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
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
From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
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
From the time of consent through end of study (2 years after last subject enrolled or earlier at sponsor discretion)
Serum Durvalumab concentration levels collected over time
Time Frame: From the time of first dose through 29 days after first treatment
Pharmacokinetics (PK)
From the time of first dose through 29 days after first treatment
Incidence of anti-drug antibody (ADA) responses to Durvalumab
Time Frame: From the time of first dose through 2 years after last treatment
Immunogenicity
From the time of first dose through 2 years after last treatment
Incidence of anti-drug antibody (ADA) responses to tremelilumab
Time Frame: From the time of first dose through 2 years after last treatment
Immunogenicity
From the time of first dose through 2 years after last treatment
Serum tremelimumab concentration levels collected over time
Time Frame: From the time of first dose through 57 days after first treatment
Pharmacodynamics (PD)
From the time of first dose through 57 days after first treatment
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)
From the time of first dose through 57 days after first treatment
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
From the time of first dose through 57 days after first treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MedImmune LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 23, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D6840C00001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Solid Tumors

Clinical Trials on MEDI5083 monotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings