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

NCT02261220 | Completed Phase 1 FDA Drug

• 1 other identifier: D4190C00010
• Study Type: interventional
• Target: 380
• Locations: 9 countries
• Sites: 75

Brief Summary

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.

Conditions

Advanced Solid Tumors

Keywords

advanced solid tumors; durvalumab; tremelimumab

Outcome Measures

Primary Outcomes (7)

• Number of subjects reporting adverse events

  Screening through 15 months after the last subject enters re-treatment

• Number of subjects reporting serious adverse events

  Screening through 15 months after the last subject enters re-treatment

• Number of subjects experiencing a dose-limiting toxicity

  First dose of study medication through 4 weeks after the first dose of study medication

• Change from Baseline in laboratory evaluations

  Screening through 3 months after the last dose of study medication

• Change from Baseline in vital signs

  Screening through 3 months after the last dose of study medication

• Change from Baseline in electrocardiogram evaluations

  Screening through 3 months after the last dose of study medication

• Overall Response Rate in Select Tumor Types

  First dose of study medication through 15 months after the last subject enters re-treatment

Secondary Outcomes (11)

• Overall Response Rate

  First dose of study medication through 15 months after the last subject enters re-treatment

• Disease Control Rate

  First dose of study medication through 15 months after the last subject enters re-treatment

• Duration of Response

  First dose of study medication through 15 months after the last subject enters re-treatment

• Progression-Free Survival

  First dose of study medication through 15 months after the last subject enters re-treatment

• Overall Survival

  First dose of study medication through 15 months after the last subject enters re-treatment

Other Outcomes (1)

• Change in Biomarkers

  Screening through 3 months following the last dose of study medication

Study Arms (1)

MEDI4736 + Tremelimumab

EXPERIMENTAL

Subjects with multiple tumor types.

Biological: MEDI4736; Biological: tremelimumab

Interventions

MEDI4736 BIOLOGICAL

MEDI4736 is administered by IV infusion in combination with tremelimumab

MEDI4736 + Tremelimumab

tremelimumab BIOLOGICAL

Tremelimumab is administered by IV infusion in combination with MEDI4736

MEDI4736 + Tremelimumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (75)

Research Site

Scottsdale, Arizona, 85258, United States

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Duarte, California, 91010, United States

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La Jolla, California, 92093, United States

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Los Angeles, California, 90025, United States

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Los Angeles, California, 90095, United States

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Whittier, California, 90603, United States

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Aurora, Colorado, 80045, United States

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New Haven, Connecticut, 06510, United States

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Miami Beach, Florida, 33140, United States

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Tampa, Florida, 33612, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60637, United States

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Iowa City, Iowa, 52242-1008, United States

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Louisville, Kentucky, 40202, United States

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Ann Arbor, Michigan, 48109, United States

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New York, New York, 10065, United States

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New York, New York, 10116, United States

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The Bronx, New York, 10461, United States

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Cincinnati, Ohio, 45219, United States

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Cleveland, Ohio, 44106, United States

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Portland, Oregon, 97213, United States

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Portland, Oregon, 97239, United States

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Philadelphia, Pennsylvania, 19111, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Greenville, South Carolina, 29605, United States

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Dallas, Texas, 75230, United States

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Houston, Texas, 77521, United States

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San Antonio, Texas, 78229, United States

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Fairfax, Virginia, 22031, United States

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Seattle, Washington, 98104, United States

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London, Ontario, N6A 4L6, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5G 1X5, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Québec, Quebec, G1R 2J6, Canada

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Angers, 49055, France

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Besançon, 25030, France

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Bordeaux, 33075, France

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Lyon, 69008, France

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Marseille, 13005, France

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Montpellier, 34298, France

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Pierre-Bénite, 69495, France

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Vandœuvre-lès-Nancy, 54519, France

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Villejuif, 94805, France

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Jena, 07747, Germany

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Münster, 48149, Germany

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Tübingen, 72076, Germany

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Haifa, 31096, Israel

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Jerusalem, 91031, Israel

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Kfar Saba, 44410, Israel

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Tel Aviv, 64239, Israel

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Amsterdam, 1066 CX, Netherlands

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Amsterdam, 1081 HV, Netherlands

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Tilburg, 5042AD, Netherlands

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Busan, 49241, South Korea

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Daegu, 41404, South Korea

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Daegu, 42601, South Korea

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Gwangju, 61469, South Korea

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Seongnam-si, 13620, South Korea

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Seoul, 03722, South Korea

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Seoul, 06591, South Korea

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Seoul, 135-710, South Korea

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Barcelona, 08026, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Madrid, 28034, Spain

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Madrid, 28041, Spain

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Pamplona, 31008, Spain

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Valencia, 46010, Spain

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Glasgow, G12 0YN, United Kingdom

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London, EC1M 6BQ, United Kingdom

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London, NW1 2BU, United Kingdom

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Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

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Middlesbrough, TS4 3BW, United Kingdom

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Oxford, OX3 7LE, United Kingdom

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Related Publications (1)

• Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.

  PMID: 32816849 DERIVED

MeSH Terms

Interventions

durvalumab; tremelimumab

Study Officials

• MedImmune LLC

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 10, 2014
• Study Start: October 13, 2014
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: March 6, 2020

Record last verified: 2020-03

Locations

FR (9); IL (4); US (30); CA (5); NL (3); KR (8); DE (3); ES (7); GB (6)