Ovarian Cancer Clinical Trial

A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors

Summary

This is an open-label, multicenter Phase 1b/2 study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in adult patients with selected advanced solid tumors (Part A/Phase 1b); and to estimate the efficacy of the combination in three separate cohorts: 1) patients with advanced solid tumors that have progressed on prior PD-1/PD-L1inhibitors, 2) patients with platinum-resistant ovarian cancer and 3) patients with pancreatic ductal adenocarcinoma (Phase 2).

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Full Description

ARRY-382 is an inhibitor of CSF1R (colony-stimulating factor-1 receptor).

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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria

All Study Parts:

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

Key Exclusion Criteria

Prior treatment as follows:

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)
Symptomatic brain metastasis at screening
Active autoimmune disease, documented history of autoimmune syndrome or disease, or a chronic medical condition that requires chronic steroid therapy or immunosuppressive medication
History of pneumonitis or interstitial lung disease
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
Ocular melanoma

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

82

Study ID:

NCT02880371

Recruitment Status:

Terminated

Sponsor:

Pfizer

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There are 20 Locations for this study

See Locations Near You

Ronald Reagan UCLA Medical Center
Los Angeles California, 90095, United States
UCLA Hematology/Oncology
Los Angeles California, 90095, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica California, 90404, United States
University of Colorado Denver
Aurora Colorado, 80045, United States
University of Colorado Hospital
Aurora Colorado, 80045, United States
Hem-Onc Associates of Treasure Coast
Port Saint Lucie Florida, 34952, United States
Parkview Cancer Institute
Fort Wayne Indiana, 46845, United States
Parkview Regional Medical Center
Fort Wayne Indiana, 46845, United States
Parkview Research Center
Fort Wayne Indiana, 46845, United States
PPG
Fort Wayne Indiana, 46845, United States
Horizon Oncology Research, Inc.
Lafayette Indiana, 47905, United States
Hall-Perrine Cancer Center Laboratory
Cedar Rapids Iowa, 52403, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Mayo Clinic Labs - Rochester Superior
Rochester Minnesota, 55901, United States
Regions Cancer Care Center
Saint Paul Minnesota, 55101, United States
Regions Hospital Pharmacy
Saint Paul Minnesota, 55101, United States
Regions Hospital
Saint Paul Minnesota, 55101, United States
HealthPartners Neurosciences Center
Saint Paul Minnesota, 55130, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
The Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
UT Health Cancer Center
San Antonio Texas, 78229, United States
UTAH Cancer Specialists
Salt Lake City Utah, 84106, United States
ARUP Laboratories, Inc.
Salt Lake City Utah, 84108, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22903, United States
UVA Health System
Charlottesville Virginia, 22908, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

82

Study ID:

NCT02880371

Recruitment Status:

Terminated

Sponsor:


Pfizer

How clear is this clinincal trial information?

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