Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Arrys Therapeutics
With
Merck Sharp & Dohme LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
Adequate organ function.
Able to swallow and absorb oral tablets.
You may not be if
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 and aspirin products within 3 days (preferably 7 days) before treatment initiation or at anytime during the study unless used for management of AE.
History of severe hypersensitivity reactions to chimeric or humanized antibodies
Has received prior systemic anticancer therapy including investigational agents within 4 weeks prior to treatment, or 5 half-lives, whichever is shorter.
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 active Hepatitis C virus infection.
