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A Study of ARRY-382 in Combination With Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients With Advanced Solid Tumors
Phase 1b/Part A
Primary objective:
To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in patients with selected solid tumors
Secondary objectives:
To describe the preliminary antitumor activity of the combination based on the Response Criteria In Solid Tumors, version 1.1 (RECIST v1.1)
To describe the preliminary antitumor activity of the combination based on immune-related response criteria (irRC)
To characterize the safety and tolerability of the combination, including acute and chronic toxicities
To evaluate the pharmacokinetics (PK) of ARRY-382 in combination with pembrolizumab
Exploratory objectives:
To explore the effect of the combination on circulating biomarkers of immune response
To describe the preliminary antitumor activity of the combination in patients with programmed cell death ligand 1 (PD-L1) positive non small cell lung cancer (NSCLC), as determined using a United States Food and Drug Administration (FDA)-approved test, using RECIST
To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive NSCLC, as determined using an FDA-approved test, using irRC
Phase 1b/Part A
Primary objective:
To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in patients with selected solid tumors
Secondary objectives:
To describe the preliminary antitumor activity of the combination based on the Response Criteria In Solid Tumors, version 1.1 (RECIST v1.1)
To describe the preliminary antitumor activity of the combination based on immune-related response criteria (irRC)
To characterize the safety and tolerability of the combination, including acute and chronic toxicities
To evaluate the pharmacokinetics (PK) of ARRY-382 in combination with pembrolizumab
Exploratory objectives:
To explore the effect of the combination on circulating biomarkers of immune response
To describe the preliminary antitumor activity of the combination in patients with programmed cell death ligand 1 (PD-L1) positive non small cell lung cancer (NSCLC), as determined using a United States Food and Drug Administration (FDA)-approved test, using RECIST
To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive NSCLC, as determined using an FDA-approved test, using irRC
Recruitment Status
Past Studies