Finding studies
Finding studies
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Lead
SWOG Cancer Research Network
With
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.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
