A Study to Evaluate MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors

August 22, 2019 updated by: MedImmune LLC

A Phase 1 Multicenter, Open-label, Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors

The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic agents in adult subjects with select 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 Phase 1 multicenter, open-label study to evaluate the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.

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.
58

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

  • France
      • Villejuif, France, 94805
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Research Site
      • Amsterdam, Netherlands, 1081 HV
        • Research Site
  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Research Site
    • New York
      • New York, New York, United States, 10032
        • Research Site
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • 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 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must meet all of the following criteria:

  1. Written and signed informed consent.
  2. Age ≥ 18 years at the time of study entry.
  3. Subjects must have received and have progressed, are refractory, or are intolerant to standard therapy appropriate for the specific tumor type. Subjects should not have received more than 3 prior lines of systemic therapy for recurrent or metastatic.
  4. Subjects in the dose-escalation phase, must have histologic documentation of advanced solid tumors, excluding primary CNS tumors and hematologic malignancies.
  5. Subjects in the dose-expansion phase, must have recurrent or metastatic disease solid tumors according to treatment arm as specified in the protocol.
  6. Subjects who have received prior therapy with regimens containing CTLA 4, PD L1, or PD 1 antagonists are permitted to enroll if additional protocol criteria are met.
  7. Subjects must have at least 1 lesion that is measurable using RECIST guidelines.
  8. Subjects must consent to provide archived tumor specimens for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use, subjects must consent and undergo fresh tumor biopsy.
  9. All subjects are encouraged to consent to and provide both pretreatment and on treatment tumor biopsies.
  10. ECOG Performance score of 0 or 1, unless protocol exceptions are met.
  11. In the opinion of the investigator likely to complete ≥ 8 weeks of treatment.
  12. Adequate hematologic, renal and hepatic function as determined by blood laboratory values.

  13. At the time of Day 1 of the study, subjects with CNS metastases must have been treated and must be asymptomatic and meet the following:

    1. No concurrent treatment, inclusive of, but not limited to surgery, radiation, and/or corticosteroids
    2. At least 42 days without progression of CNS metastases as evidenced by magnetic resonance imaging (MRI) or computed tomography (CT) after last day of treatment
    3. At least 14 days since last dose of corticosteroids Note: Subjects with leptomeningeal disease or cord compression are excluded from the study.
  14. Female subjects of childbearing potential who are sexually active with a non-sterilized male partner must use at least 1 highly effective method of contraception from screening, and must agree to continue using such precautions for 180 days after the final dose of investigational product.
  15. Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use male condom plus, if locally available, spermicide from Day 1 and for 180 days after receipt of the final dose of investigational product.

Exclusion Criteria:

Any of the following would exclude the subject from participation in the study:

  1. Prior treatment with TNFRSF agonists
  2. Prior treatment with IMT for certain disease types may be restricted per protocol.
  3. History of severe allergic reactions to any unknown allergens or any components of the study drug formulations
  4. Active or prior documented autoimmune disease within the past 2 years.
  5. Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow up period of an interventional study
  6. Receipt of any conventional or investigational anticancer therapy not otherwise specified above within 28 days prior to the first dose
  7. Any concurrent chemotherapy, IMT, or biologic or hormonal therapy for cancer treatment.
  8. Unresolved toxicities from prior anticancer therapy.
  9. Systemic therapeutic anticoagulation or daily aspirin dose exceeding 325 mg/per day.
  10. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of MEDI0562 with exceptions as per protocol.
  11. History of primary immunodeficiency, solid organ transplantation, or tuberculosis
  12. Test results indicating active infection with human immunodeficiency virus (HIV) or hepatitis B or C defined by positive serologic testing and confirmatory viral nucleic acid testing
  13. Pregnant or breastfeeding women
  14. Major surgery within 4 weeks prior to first dose of MEDI0562 or still recovering from prior surgery.
  15. Other invasive malignancy within 2 years with the exception of protocol specified criteria
  16. Any uncontrolled intercurent illness or condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.

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: Parallel 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: Arm A: MEDI0562 and durvalumab
MEDI0562 and durvalumab
Biological: MEDI0562
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
Biological: Durvalumab
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
Experimental: Arm B: MEDI0562 and tremelimumab
MEDI0562 and tremelimumab
Biological: MEDI0562
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
Biological: Tremelimumab
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.

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
Safety as defined by the presence of adverse events (AE), serious adverse events (SAE), and dose limiting toxicities (DLT).
Time Frame: From time of informed consent through 12 weeks after ending treatment with investigational product
The primary endpoint is safety as assessed by presence of adverse event (AE), serious adverse event (SAE), and dose limiting toxicity (DLT).
From time of informed consent through 12 weeks after ending treatment with investigational product

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
Preliminary Antitumor Activity:Best Overall Response
Time Frame: At approximately 3 time points through Day 113.
The endpoints for assessment of antitumor activity include Best Overall Response (BOR) and will be based on all post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
At approximately 3 time points through Day 113.
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: Cmax
Time Frame: To be assessed at approximately 12 clinic visits through Day 113
The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include, but are not limited to, maximum observed concentration (Cmax).
To be assessed at approximately 12 clinic visits through Day 113
Immunogenicity
Time Frame: At approximately 8 time points through Day 113.
The endpoints for assessment of immunogenicity of MEDI0562, durvalumab, and tremelimumab include the number and percentage of subjects who develop detectable anti drug antibodies (ADAs).
At approximately 8 time points through Day 113.
Pharmacodynamic Activity
Time Frame: At approximately 12 time points through Day 113.
The endpoints for assessment of pharmacodynamic activity include induction of proliferation markers in various lymphocyte populations and assessment of tumor-infiltrating lymphocytes (TILs) in tumor biopsy specimens.
At approximately 12 time points through Day 113.
Preliminary Antitumor Activity: Disease Control
Time Frame: At approximately 3 time points through Day 113.
The endpoints for assessment of antitumor activity include disease control and is defined as CR, PR, or SD according to RECIST v1.1
At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Duration of Response
Time Frame: At approximately 3 time points through Day 113.
The endpoints for assessment of antitumor activity include duration of response (DoR) and is defined as the duration from the first documentation of OR to the first documentation of disease progression or death due to any cause.
At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Progression-free Survival
Time Frame: At approximately 3 time points through Day 113.
The endpoints for assessment of antitumor activity include progression-free survival (PFS) and is defined as the duration measured from the start of treatment with investigational product to the first documentation of disease progression or death due to any cause
At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Overall Survival
Time Frame: At approximately 3 time points through Day 113.
The endpoints for assessment of antitumor activity include overall survival (OS) and is defined as the time from the start of treatment with Investigational Product until death due to any cause.
At approximately 3 time points through Day 113.
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: AUC
Time Frame: To be assessed at approximately 12 clinic visits through Day 113
The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include area under the concentration-time curve (AUC).
To be assessed at approximately 12 clinic visits through Day 113
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: Clearance
Time Frame: To be assessed at approximately 12 clinic visits through Day 113
The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include clearance (CL).
To be assessed at approximately 12 clinic visits through Day 113
Pharmacokinetics of MEDI0562/durvalumab or MEDI0562/tremelimumab: t½
Time Frame: To be assessed at approximately 12 clinic visits through Day 113
The endpoints for assessment of PK of MEDI0562 and durvalumab or tremelimumab include individual MEDI0562, durvalumab, and tremelimumab concentrations at different time points after administration. PK parameters that may be modeled on these data include terminal phase half-life (t½).
To be assessed at approximately 12 clinic visits through Day 113
Preliminary Antitumor Activity: Objective Response
Time Frame: At approximately 3 time points through Day 113.
The endpoints for assessment of antitumor activity include objective response (OR) and is defined as confirmed CR or confirmed PR based on RECIST v1.1
At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Time to Response
Time Frame: At approximately 3 time points through Day 113.
The endpoints for assessment of Time to Response TTR and is defined as the time of first treatment to a subsequently confirmed CR or confirmed PR based on RECIST v1.1
At approximately 3 time points through Day 113.
Preliminary Antitumor Activity: Percent Change from Baseline
Time Frame: At approximately 3 time points through Day 113.
The endpoints for assessment percent change from baseline in target lesion sum of diameters will be calculated at each adequate post baseline disease assessment with recorded measurement for all target lesions defined at baseline.
At approximately 3 time points through Day 113.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 30, 2016

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.
August 7, 2019

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.
August 7, 2019

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).
September 22, 2015

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 4, 2016

First Posted (Estimate)

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 10, 2016

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.
August 26, 2019

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.
August 22, 2019

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.
August 1, 2019

More Information

Terms related to this study

Keywords

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.
  • D6060C00002

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.

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