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Grapiprant (ARY-007) and Pembrolizumab in Patients With Advanced or Metastatic Post-PD-1/L1 NSCLC Adenocarcinoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Grapiprant (ARY-007) and Pembrolizumab in Patients With Advanced or Metastatic Post-PD-1/L1 NSCLC Adenocarcinoma

Open Label, Single Arm, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Grapiprant (ARY-007) in Combination With Pembrolizumab in Patients With Advanced or Metastatic Post-PD-1/L1 Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma

NCT03696212•Arrys Therapeutics

View on ClinicalTrials.gov

Summary

This study will be conducted in adult participants diagnosed with NSCLC who have been previously treated for a minimum of 12 weeks with any PD-1 or PD-L1 checkpoint inhibitor. This is a phase 1b/2, multi-center, open label study designed to assess safety and tolerability of grapiprant in combination with pembrolizumab, to determine the recommended phase 2 dose (RP2D) with pembrolizumab, and to evaluate disease response with grapiprant based on investigator assessments. Pharmacokinetics, pharmacodynamics and response biomarkers will also be assessed.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female adult patients at least 18 years of age on day of signing informed consent
•Histologically confirmed non-small cell lung cancer (NSCLC) adenocarcinoma
•Advanced (stage IIIb) disease that is not amenable to curative intent treatment with concurrent chemoradiation and metastatic (stage IV) patients
•Progressed clinically and/or radiographically per RECIST v1.1 after receiving a PD-1 or PD-L1 antagonist for a minimum of 12 weeks
•Measurable disease per RECIST v1.1
•Disease that can be safely accessed via bronchoscopic, thoracoscopic or percutaneous biopsy for multiple core biopsies and participant is willing to provide tissue from newly obtain biopsies on study in a subgroup of patients
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
•Adequate organ function
•Highly effective birth control
•Able to swallow and absorb oral tablets

Exclusion Criteria

•Current use of NSAIDs, COX-2 inhibitors
•Known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), ROS gene alteration
•No history of smoking (≤100 cigarettes lifetime)
•History of severe hypersensitivity reactions to a PD-1/L1 antibody
•Received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment or 5 half-lives, whichever is shorter
•Received prior radiotherapy within 2 weeks of start of study treatment
•Has received a live vaccine within 30 days prior to the first dose of study treatment
•Taking strong CYP3A4 or P-glycoprotein inhibitors or inducers
•Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
•Known additional malignancy that is progressing or has required active treatment within the past 3 years (with some permitted exceptions)
+8 more criteria

Locations (6)

Stanford University Medical Center

Stanford, California, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

START Midwest

Grand Rapids, Michigan, United States

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Key Dates

Start Date

January 8, 2019

Primary Completion Date

February 15, 2021

Completion Date

February 15, 2021

Last Updated

February 21, 2021

Enrollment

ACTUAL participants

Conditions

Non-small Cell Lung Cancer Adenocarcinoma

Interventions

grapiprant and pembrolizumab

DRUG