Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Phase 2 Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors

Summary: This study will be looking at whether MK-3475 (an antibody that blocks negative signals to T cells) is effective (anti-tumor activity) and safe in three different patient populations. These include: 1. patients with MSI positive colon cancer, 2. patients with MSI negative colon cancer, and 3. patients with other MSI positive cancers.


Eligibility: Inclusion Criteria:
  1. Arm 1 only: Patients with MSI positive colorectal cancer
  2. Arm 2 only: Patients with MSI negative colorectal cancer
  3. Arm 3 only: Patients with MSI positive non-colorectal cancer
  4. Have measurable disease
  5. ECOG Performance Status of 0 to 1
  6. Adequate organ function as defined by study-specified laboratory tests
  7. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
  8. Signed informed consent form
  9. Willing and able to comply with study procedures
  10. Agree to have a biopsy of their cancer
  11. Patients with colon cancer must have received at least two prior cancer therapy regimens.
  12. Patients with other cancer types must have received at least one prior cancer therapy
  Exclusion Criteria:
  1. Patients with uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements
  2. Patients who have had chemotherapy or biological cancer therapy within 2 weeks prior to the first dose of study drug
  3. Patients who have had radiation within 2 weeks prior to the first dose of study drug
  4. Patients who have undergone major surgery within 4 weeks of dosing of investigational agent
  5. Patients who have received another investigational product or investigational device within 4 weeks prior to receiving study drug
  6. Patients who have received any of the following concomitant therapy: IL-2, interferon, or other non-study immunotherapy regimens, immunosuppressive agents, other investigational therapies or chronic use of systemic corticosteroids within one week prior to first dose of study drug
  7. Patients who have received a live vaccine within 4 weeks prior to or after any dose of MK-3475
  8. Patients who have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 2 weeks of study drug administration
  9. Patient who have had prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, or anti-CTLA-4 antibodies
  10. Patients with history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythmatosus (SLE) autoimmune vasculitis, CNS or motor neuropathy considered to be of autoimmune origin.
  11. Patients who have known history of infection with HIV, hepatitis B, or hepatitis C
  12. Patients with evidence of interstitial lung disease
  13. Systemically active steroid use
  14. Patients on home oxygen
  15. Patients with oxygen saturation of <92% on room air by pulse oximetry
  16. Pregnant or lactating
  17. Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures

Relevance to patient case: not relevant