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Last updated on December 2018

Durvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer

Brief description of study

This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To evaluate the objective response rate (confirmed and unconfirmed, complete and partial) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 among patients treated with durvalumab (MEDI4736) plus tremelimumab.

SECONDARY OBJECTIVES:

I. To estimate the duration of response (DoR) among patients who achieve a complete response (CR) or partial response (PR) (confirmed and unconfirmed) by RECIST 1.1.

II. To estimate the duration of response (DoR) per immune-related response criteria among patients who achieve a complete response (CR) or partial response (PR) (confirmed and unconfirmed) by RECIST 1.1.

III. To evaluate overall survival (OS) among patients treated with durvalumab (MEDI4736) plus tremelimumab.

IV. To evaluate investigator-assessed progression-free survival (IA-PFS) among patients treated with durvalumab (MEDI4736) plus tremelimumab.

V. To evaluate IA-PFS assessed by immune-related response criteria (irRC-IA-PFS) among patients treated with durvalumab (MEDI4736) plus tremelimumab.

VI. To evaluate the frequency and severity of toxicities associated with durvalumab (MEDI4736) plus tremelimumab.

TERTIARY OBJECTIVES:

I. To explore the association of potential predictive markers identified in S1400A, with response and progression-free survival (PFS).

II. To explore the association of PD-L1 expression status with response and PFS.

III. To contribute to an ongoing serum and tumor bank in S1400.

OUTLINE

Patients receive tremelimumab intravenously (IV) over 60 minutes on day 1 for courses 1-4 and durvalumab IV over 60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years, and then at the end of year 3.

Clinical Study Identifier: NCT03373760

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Rockwood Clinic Cancer Treatment Center-Valley

Spokane Valley, WA United States
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Rockwood Cancer Treatment Center-DHEC-Downtown

Spokane, WA United States
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Rockwood North Cancer Treatment Center

Spokane, WA United States
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PeaceHealth Southwest Medical Center

Vancouver, WA United States
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Providence Saint Mary Regional Cancer Center

Walla Walla, WA United States
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Providence Regional Cancer System-Yelm

Yelm, WA United States
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Saint Mary's Medical Center

Huntington, WV United States
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Saint Vincent Hospital Cancer Center Green Bay

Green Bay, WI United States
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Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, WI United States
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Gundersen Lutheran Medical Center

La Crosse, WI United States
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Holy Family Memorial Hospital

Manitowoc, WI United States
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Community Memorial Hospital

Menomonee Falls, WI United States
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Froedtert and the Medical College of Wisconsin

Milwaukee, WI United States
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Cancer Center of Western Wisconsin

New Richmond, WI United States
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Green Bay Oncology - Oconto Falls

Oconto Falls, WI United States
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HSHS Saint Nicholas Hospital

Sheboygan, WI United States
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Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, WI United States
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The Alyce and Elmore Kraemer Cancer Care Center

West Bend, WI United States
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Cheyenne Regional Medical Center-West

Cheyenne, WY United States
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Billings Clinic-Cody

Cody, WY United States
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Welch Cancer Center

Sheridan, WY United States
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