A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

March 5, 2020 updated by: MedImmune LLC

A Phase I Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Tremelimumab (Anti-CTLA-4 Antibody) in Subjects With Advanced Solid Tumors

This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in 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.

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.
380

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

  • Canada
      • Quebec, Canada, G1R 2J6
        • Research Site
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Research Site
      • Toronto, Ontario, Canada, M5G 1X5
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Research Site
  • France
      • Angers Cedex 02, France, 49055
        • Research Site
      • BESANCON Cedex, France, 25030
        • Research Site
      • Bordeaux Cedex, France, 33075
        • Research Site
      • Lyon, France, 69008
        • Research Site
      • Marseille, France, 13005
        • Research Site
      • Montpellier, France, 34298
        • Research Site
      • Pierre Benite, France, 69495
        • Research Site
      • Vandoeuvre les Nancy, France, 54519
        • Research Site
      • Villejuif, France, 94805
        • Research Site
  • Germany
      • Jena, Germany, 07747
        • Research Site
      • Münster, Germany, 48149
        • Research Site
      • Tübingen, Germany, 72076
        • Research Site
  • Israel
      • Haifa, Israel, 31096
        • Research Site
      • Jerusalem, Israel, 91031
        • Research Site
      • Kfar Saba, Israel, 44410
        • Research Site
      • Tel-Aviv, Israel, 64239
        • Research Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Research Site
      • Daegu, Korea, Republic of, 42601
        • Research Site
      • Daegu, Korea, Republic of, 41404
        • Research Site
      • Gwangju, Korea, Republic of, 61469
        • Research Site
      • Seongnam-si, Korea, Republic of, 13620
        • Research Site
      • Seoul, Korea, Republic of, 03722
        • Research Site
      • Seoul, Korea, Republic of, 135-710
        • Research Site
      • Seoul, Korea, Republic of, 06591
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Research Site
      • Amsterdam, Netherlands, 1081 HV
        • Research Site
      • Tilburg, Netherlands, 5042AD
        • Research Site
  • Spain
      • Barcelona, Spain, 08035
        • Research Site
      • Barcelona, Spain, 08036
        • Research Site
      • Barcelona, Spain, 08026
        • Research Site
      • Madrid, Spain, 28034
        • Research Site
      • Madrid, Spain, 28041
        • Research Site
      • Pamplona, Spain, 31008
        • Research Site
      • Valencia, Spain, 46010
        • Research Site
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Research Site
      • London, United Kingdom, EC1M 6BQ
        • Research Site
      • London, United Kingdom, NW1 2BU
        • Research Site
      • Middlesborough, United Kingdom, TS4 3BW
        • Research Site
      • Oxford, United Kingdom, OX3 7LE
        • Research Site
      • Wirral, United Kingdom, CH63 4JY
        • Research Site
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Research Site
    • California
      • Duarte, California, United States, 91010
        • Research Site
      • La Jolla, California, United States, 92093
        • Research Site
      • Los Angeles, California, United States, 90025
        • Research Site
      • Los Angeles, California, United States, 90095
        • Research Site
      • Whittier, California, United States, 90603
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Research Site
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Research Site
      • Tampa, Florida, United States, 33612
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Research Site
      • Chicago, Illinois, United States, 60611
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242-1008
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
    • New York
      • Bronx, New York, United States, 10461
        • Research Site
      • New York, New York, United States, 10065
        • Research Site
      • New York, New York, United States, 10116
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Cleveland, Ohio, United States, 44106
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97213
        • Research Site
      • Portland, Oregon, United States, 97239
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Research Site
      • Houston, Texas, United States, 77521
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98104
        • 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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female subjects
  • 18 years and older
  • Histologic confirmation of advanced solid tumors
  • Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.

Exclusion Criteria:

  • Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment
  • Active or prior documented autoimmune disease within the past 2 years
  • Current or prior use of immunosuppressive medication within 14 days with some exceptions.

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: N/A
  • Interventional Model: Single Group 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: MEDI4736 + Tremelimumab
Subjects with multiple tumor types.
Biological: MEDI4736
MEDI4736 is administered by IV infusion in combination with tremelimumab
Biological: tremelimumab
Tremelimumab is administered by IV infusion in combination with MEDI4736

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
Time Frame
Change from Baseline in laboratory evaluations
Time Frame: Screening through 3 months after the last dose of study medication
Screening through 3 months after the last dose of study medication
Number of subjects reporting adverse events
Time Frame: Screening through 15 months after the last subject enters re-treatment
Screening through 15 months after the last subject enters re-treatment
Number of subjects reporting serious adverse events
Time Frame: Screening through 15 months after the last subject enters re-treatment
Screening through 15 months after the last subject enters re-treatment
Number of subjects experiencing a dose-limiting toxicity
Time Frame: First dose of study medication through 4 weeks after the first dose of study medication
First dose of study medication through 4 weeks after the first dose of study medication
Change from Baseline in vital signs
Time Frame: Screening through 3 months after the last dose of study medication
Screening through 3 months after the last dose of study medication
Change from Baseline in electrocardiogram evaluations
Time Frame: Screening through 3 months after the last dose of study medication
Screening through 3 months after the last dose of study medication
Overall Response Rate in Select Tumor Types
Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment
First dose of study medication through 15 months after the last subject enters re-treatment

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
Time Frame
Overall Response Rate
Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment
First dose of study medication through 15 months after the last subject enters re-treatment
Disease Control Rate
Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment
First dose of study medication through 15 months after the last subject enters re-treatment
Duration of Response
Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment
First dose of study medication through 15 months after the last subject enters re-treatment
Progression-Free Survival
Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment
First dose of study medication through 15 months after the last subject enters re-treatment
Overall Survival
Time Frame: First dose of study medication through 15 months after the last subject enters re-treatment
First dose of study medication through 15 months after the last subject enters re-treatment
Individual MEDI4736 concentrations
Time Frame: First dose of MEDI4736 through 3 months after the last dose of study medication
First dose of MEDI4736 through 3 months after the last dose of study medication
Individual tremelimumab concentrations
Time Frame: First dose of tremelimumab through 3 months after the last dose of study medication
First dose of tremelimumab through 3 months after the last dose of study medication
MEDI4736 area under the concentration-curve
Time Frame: First dose of MEDI4736 through 3 months after the last dose of study medication
First dose of MEDI4736 through 3 months after the last dose of study medication
Tremelimumab area under the concentration-curve
Time Frame: First dose of tremelimumab through 3 months after the last dose of study medication
First dose of tremelimumab through 3 months after the last dose of study medication
Number of subjects that develop detectable antidrug antibodies to MEDI4736
Time Frame: First dose of MEDI4736 through 3 months after the last dose of study medication
First dose of MEDI4736 through 3 months after the last dose of study medication
Number of subjects that develop antidrug antibodies to tremelimumab
Time Frame: First dose of tremelimumab through 3 months after the last dose of study medication
First dose of tremelimumab through 3 months after the last dose of study medication

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change in Biomarkers
Time Frame: Screening through 3 months following the last dose of study medication
Screening through 3 months following the last dose of study medication

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.
October 13, 2014

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.
January 27, 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.
January 27, 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).
October 2, 2014

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.
October 6, 2014

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.
October 10, 2014

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.
March 6, 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.
March 5, 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.
March 1, 2020

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.
  • D4190C00010

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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