A Study Evaluating TAS-102 Plus Nivolumab in Patients With MSS CRC
Condition: Refractory Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: TAS-102; nivolumab
Intervention description: One Arm Only (of TAS 102 plus nivolumab); One Arm Only (of TAS 102 plus nivolumab)
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Refractory; Metastatic; Colorectal cancer; TAS-102; Nivolumab; Microsatellite Stable; Programmed cell death protein1 (PD 1)

Summary:

      A Phase 2 Study with Safety Lead-in, Evaluating TAS-102 Plus Nivolumab in Participants with
      Microsatellite Stable Refractory Metastatic Colorectal Cancer
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has provided written informed consent.

          2. Participants with confirmed histologically proven metastatic or locally advanced
             colorectal adenocarcinoma who are microsatellite stable (MSS) (ie, not microsatellite
             instable [MSI]) based on either an analysis of tissue from a prior biopsy or based on
             tissue from a new biopsy.

          3. Participants with the presence of at least 1 lesion with measurable disease as defined
             by 10 millimeters (mm) in the longest diameter for a soft tissue lesions or 15 mm in
             the short axis for a lymph node by response evaluation criteria in solid tumors
             (RECIST) and immune related response-criteria (irRC) for a response assessment.

          4. Participants has received at least 2 prior lines of standard chemotherapies for
             metastatic colorectal cancer (mCRC) and is refractory to or failing those
             chemotherapies.

          5. Age greater than or equal to (>=) 18 years.

          6. Eastern Cooperative Oncology Group performance status of 0 to 1

          7. Life expectancy of >=4 months.

          8. Has adequate organ function.

          9. Women of childbearing potential must have a negative pregnancy test (urine or serum)
             within 7 days before starting study drugs. Is able to take medications orally.

         10. Is able to take medications "orally".

        Exclusion Criteria:

          1. Has a serious illness or medical condition.

          2. Treatment with any of the following within the specified time frame before enrollment:

               1. Major surgery within the past 4 weeks (the surgical incision should be fully
                  healed before study drug administration).

               2. Any anticancer therapy within the past 3 weeks before enrollment.

               3. Extended field radiation within the past 4 weeks or limited field radiation
                  within the past 2 weeks before enrollment.

               4. Any investigational drug/device received within the past 4 weeks or 5 times the
                  half-life (whichever is shorter) before enrollment.

          3. Previous treatment with TAS-102.

          4. Prior treatment with anti-programmed cell death-1 (anti-PD-1), anti-programmed cell
             death ligand (anti-PD-L1), anti programmed cell death ligand 2, anti-CD137,
             anti-OX-40, anti CD40, anti cytotoxic T lymphocyte associated antigen-4 antibodies, or
             any other immune checkpoint inhibitors.

          5. Unresolved toxicity of >=Common Terminology Criteria for Adverse Events version
             (CTCAE) version 4.03 grade 2 attributed to any prior therapies (excluding anemia,
             alopecia, skin pigmentation, and platinum induced neurotoxicity).

          6. Prior events of immune-mediated pneumonitis, immune-mediated colitis, immune-mediated
             hepatitis, immune-mediated endocrinopathies, immune mediated nephritis and renal
             dysfunction, immune mediated rash, immune mediated encephalitis, and history of
             infusion reactions to nivolumab.

          7. Known or assumed hypersensitivity to TAS-102 or nivolumab or any of its ingredients,
             including polysorbate 80-containing infusion.

          8. Previous severe hypersensitivity reaction to treatment with another mAb.

          9. Pregnant or lactating female.

         10. Inappropriate for entry into this study in the judgment of the investigator.