Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer



Status:Recruiting
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:September 20, 2018
End Date:August 2020
Contact:Janine McDermott
Email:Janine.mcdermott@arrystherapeutics.com
Phone:781-392-5556

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An Open-label, Single-arm, Phase 1b Study to Evaluate the Safety and Efficacy of Grapiprant (ARY-007) in Combination With Pembolizumab in Patients With Advanced or Progressive Microsatellite Stable (MSS) Colorectal Cancer (CRC)

This study will be conducted in adult participants diagnosed with any form of an advanced or
progressive MSS CRC for which 1st and 2nd line standard therapy (at least one of which
contained fluorouracil) is no longer effective or is intolerable. This is a phase 1b,
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 and characterize the PK of grapiprant alone and in combination
with pembrolizumab. Disease response, pharmacodynamics, and response biomarkers will also be
assessed.


Key Inclusion Criteria:

- Male and female adult patients 18 years of age or older on day of signing informed
consent.

- Patients must have a histologically confirmed advanced, metastatic, or progressive
Microsatellite Stable (MSS) Colorectal Cancer (CRC) per institutional standards.

- Patient has received at least two prior lines of therapy for advanced or metastatic
CRC, at least one of which included fluorouracil.

- Highly effective birth control.

- Measurable disease.

- Accessible tumor that can be safely accessed for multiple core biopsies and patient is
willing to provide tissue from newly obtain biopsies before and during treatment.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

- Be able to swallow and absorb oral tablets.

- Adequate organ function.

Key Exclusion Criteria:

- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent
directed to another stimulatory or co-inhibitory T-cell receptor

- Current use of NSAIDs, COX-2 inhibitors.

- History of severe hypersensitivity reactions to chimeric or humanized antibodies.

- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in
dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior the first dose of study drug.

- Known additional malignancy that is progressing or has required active treatment
within the past 3 years.

- Known active CNS metastases and/or carcinomatous meningitis.

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

- History of non-infectious pneumonitis that required steroids or has current
pneumonitis.

- Active infection requiring systemic therapy.

- Recent (within the last 12 months) or current GI ulcer, colitis or non-immune colitis.

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

- Clinically significant (i.e. active) cardiovascular disease

- Medical conditions requiring concomitant administration of strong CYP3A4 or P
glycoprotein inhibitors or inducers.
We found this trial at
4
sites
Phoenix, Arizona 85054
Phone: 855-776-0015
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Nashville, Tennessee 37203
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