A Phase II Study of MEDI4736 (Durvalumab) Plus Tremelimumab as Therapy for Patients With Previously Treated Anti-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-Map Non-Match Sub-Study)
A Phase II Study of MEDI4736 (Durvalumab) Plus Tremelimumab as Therapy for Patients With Previously Treated Anti-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-Map Non-Match Sub-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.
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.
Inclusion Criteria:
Burbank, California 91505, United States
Cameron Park, California 95682, United States
Roseville, California 95661, United States
Sacramento, California 95817, United States
Vacaville, California 95687, United States
Englewood, Colorado 80113, United States
West Haven, Connecticut 06516, United States
Washington D.C., District of Columbia 20002, United States
Deerfield Beach, Florida 33442, United States
Miami, Florida 33136, United States
Highland Park, Illinois 60035, United States
Pekin, Illinois 61554, United States
Houma, Louisiana 70360, United States
Baltimore, Maryland 21237, United States
Brownstown, Michigan 48183, United States
East China Township, Michigan 48054, United States
Grosse Pointe Woods, Michigan 48236, United States
Rochester Hills, Michigan 48309, United States
Warren, Michigan 48093, United States
West Branch, Michigan 48661, United States
Jefferson City, Missouri 65109, United States
Las Vegas, Nevada 89109, United States
Las Vegas, Nevada 89113, United States
Las Vegas, Nevada 89149, United States
Huntersville, North Carolina 28078, United States
Mooresville, North Carolina 28117, United States
Charleston, South Carolina 29414, United States
Spartanburg, South Carolina 29307, United States
Houston, Texas 77030, United States
American Fork, Utah 84003, United States
Berlin Corners, Vermont 05602, United States
Yakima, Washington 98902, United States
Sturgeon Bay, Wisconsin 54235-1495, United States
Summit, Wisconsin 53066, United States