A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors
NCT ID: NCT02880371
Last Updated: 2022-06-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
82 participants
INTERVENTIONAL
2016-09-01
2019-10-24
Brief Summary
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Detailed Description
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Each phase of the study consists of a 28-day screening period; 21-day treatment cycles with the combination of ARRY-382 and pembrolizumab until disease progression as determined by the Investigator, unacceptable toxicity, withdrawal of consent, or death (or other discontinuation criteria are met), and a 30-day safety follow-up period. Patients in all cohorts/phases will be monitored for overall survival (OS) until 1 year after the date of the last patient's first visit.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1b/Part A
Patients in Part A will receive escalating doses of single-agent ARRY-382 in combination with 2 mg/kg pembrolizumab.
ARRY-382
ARRAY-382 will be taken by mouth once daily at a fixed dose.
Pembrolizumab
Pembrolizumab will be administered intravenously over 30 minutes every 3 weeks.
Phase 2
Patients in Phase 2 will receive the MTD/RP2D dose of ARRY-382 determined during Part A in combination with 200mg pembrolizumab.
ARRY-382
ARRAY-382 will be taken by mouth once daily at a fixed dose.
Pembrolizumab
Pembrolizumab will be administered intravenously over 30 minutes every 3 weeks.
Interventions
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ARRY-382
ARRAY-382 will be taken by mouth once daily at a fixed dose.
Pembrolizumab
Pembrolizumab will be administered intravenously over 30 minutes every 3 weeks.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of cancer that has been histologically or cytologically confirmed
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
Part A (1 of the following):
* Ovarian cancer, triple-negative breast cancer, head and neck squamous cell cancer, bladder cancer, metastatic colorectal cancer, pancreatic ductal adenocarcinoma, or gastric cancer that is measurable or evaluable, nonmeasurable as defined by RECIST v1.1 and meets 1 of the following criteria:
* is refractory to standard of care
* no standard therapy available
* patient refuses standard therapy
* Advanced, unresectable, or metastatic melanoma with or without prior treatment and measurable or evaluable, nonmeasurable disease as defined by RECIST v1.1
* Advanced/metastatic PD-L1-positive NSCLC (defined as a tumor proportion score \[TPS\] ≥ 50%) with measurable or evaluable, non-measurable disease as defined by RECIST v1.1 (1 of the following):
* 1\) No prior systemic chemotherapy if tumor does not have EGFR or ALK genomic aberrations
* 2\) Disease progression on or after platinum-containing chemotherapy;
* 3\) If tumor has EGFR or ALK genomic aberrations, disease progression on an FDA-approved therapy for EGFR or ALK genomic tumor aberrations
Phase 2 (1 of the following):
* Advanced/metastatic solid tumor with PD as defined by RECIST 1.1 or irRC on an anti-PD-1- or anti-PD-L1-containing regimen as their most recent prior therapy
* Advanced/metastatic epithelial ovarian cancer, peritoneal cancer or tubal cancer with measurable disease as defined by RECIST 1.1, that had progressed within 6 months of completing ≥ 4 cycles of platinum-based therapy
* Advanced/metastatic PDA that is locally advanced, unresectable or metastatic with measurable disease as defined by RECIST v1.1 in patients who have received at least one prior line of systemic therapy for their disease
Exclusion Criteria
* Part A: an immune CPI (e.g., PD-1, PD-L1, or cytotoxic T-lymphocyte antigen 4 \[CTLA-4\] inhibitor).
NOTE: For patients with melanoma, prior treatment with ipilimumab is allowed if it was administered as adjuvant therapy and treatment was completed at least 3 months prior to enrollment.
* Phase 2:
* A CSF-1R inhibitor or CSF-1 (or MCSF) inhibitor.
* prOVCA and PDA patients only: an immune CPI (e.g., PD-1, PD-L1, or CTLA-4 inhibitor)
2. Symptomatic brain metastasis at screening
3. Active autoimmune disease, documented history of autoimmune syndrome or disease, or a chronic medical condition that requires chronic steroid therapy or immunosuppressive medication
4. History of pneumonitis or interstitial lung disease
5. Severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study
6. Ocular melanoma
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCLA Hematology/Oncology
Los Angeles, California, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States
University of Colorado Denver
Aurora, Colorado, United States
University of Colorado Hospital
Aurora, Colorado, United States
Hem-Onc Associates of Treasure Coast
Port Saint Lucie, Florida, United States
Parkview Cancer Institute
Fort Wayne, Indiana, United States
Parkview Regional Medical Center
Fort Wayne, Indiana, United States
Parkview Research Center
Fort Wayne, Indiana, United States
PPG
Fort Wayne, Indiana, United States
Horizon Oncology Research, Inc.
Lafayette, Indiana, United States
Hall-Perrine Cancer Center Laboratory
Cedar Rapids, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic Labs - Rochester Superior
Rochester, Minnesota, United States
Regions Cancer Care Center
Saint Paul, Minnesota, United States
Regions Hospital Pharmacy
Saint Paul, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
HealthPartners Neurosciences Center
Saint Paul, Minnesota, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, United States
UT Health Cancer Center
San Antonio, Texas, United States
UTAH Cancer Specialists
Salt Lake City, Utah, United States
ARUP Laboratories, Inc.
Salt Lake City, Utah, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
UVA Health System
Charlottesville, Virginia, United States
Countries
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References
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Johnson M, Dudek AZ, Sukari A, Call J, Kunk PR, Lewis K, Gainor JF, Sarantopoulos J, Lee P, Golden A, Harney A, Rothenberg SM, Zhang Y, Goldman JW. ARRY-382 in Combination with Pembrolizumab in Patients with Advanced Solid Tumors: Results from a Phase 1b/2 Study. Clin Cancer Res. 2022 Jun 13;28(12):2517-2526. doi: 10.1158/1078-0432.CCR-21-3009.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4261001
Identifier Type: OTHER
Identifier Source: secondary_id
ARRAY-382-201
Identifier Type: -
Identifier Source: org_study_id
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