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



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:January 8, 2019
End Date:September 2020
Contact:Janine McDermott, MS
Email:janine.mcdermott@arrystherapeutics.com
Phone:781-392-5556

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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

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.


Key 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

Key Exclusion Criteria:

- Current use of NSAIDs, COX-2 inhibitors

- Known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), ROS
gene alteration, BRAF gene mutation

- 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

- 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)

- Known active CNS metastases and/or carcinomatous meningitis

- Active autoimmune disease that has required systemic treatment in past 2 years

- History of pneumonitis that required steroids or has current pneumonitis

- Has an active infection requiring systemic therapy

- Recent or current GI ulcer, colitis or non-immune colitis

- Known history of human immunodeficiency virus (HIV) infection, Hepatitis B, or active
Hepatitis C virus infection

- Clinically significant (i.e.active) cardiovascular disease
We found this trial at
5
sites
Philadelphia, Pennsylvania 19111
Phone: 215-728-5623
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4100 John R
Detroit, Michigan 48201
800-527-6266
Phone: 313-576-8411
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Phone: 703-208-9268
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Philadelphia, Pennsylvania 19104
Phone: 215-220-9703
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Phone: 650-724-1388
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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