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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

380

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

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)

October 13, 2014

Primary Completion (Actual)

January 27, 2020

Study Completion (Actual)

January 27, 2020

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Actual)

March 6, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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