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If a control arm patient receives capecitabine administered according to a 3- week cycle, timing of all study procedures and assessments scheduled according to 2-week treatment cycles (e.g. ECOG performance status) will be defined by the treatment cycles of concurrently administered bevacizumab.", "annotation_scope": "column", "referenced_elements": { "property_ids": [], "column_ids": [ "col-003" ], "activity_ids": [], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "schedule_cell", "row_position": 1, "column_position": 3 } ] }, { "annotation_id": "annot-002", "table_id": "table-005", "annotation_marker": "b", "annotation_type": "footnote", "annotation_text": "Patients who experience PD at any time during the Maintenance Treatment Phase, or who need to permanently discontinue study medication for any reason, will undergo a Study Treatment Discontinuation Visit within 30 days after the last dose of study medication. These patients will then enter the Post-Treatment Follow-up.", "annotation_scope": "column", "referenced_elements": { "property_ids": [], "column_ids": [ "col-004" ], "activity_ids": [], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "schedule_cell", "row_position": 1, "column_position": 4 } ] }, { "annotation_id": "annot-003", "table_id": "table-005", "annotation_marker": "c", "annotation_type": "footnote", "annotation_text": "After discontinuation of study treatment and the Study Treatment Discontinuation Visit, patients will enter the Post-Treatment Follow-up Phase. Beginning after the Study Treatment Discontinuation Visit, patients will be followed up every 3 months. Up to and including May 31, 2019, follow-up will include disease status (patients discontinuing study treatment prior to disease progression only), in addition to safety evaluations and recording of subsequent anti-cancer therapies and survival. After May 31, 2019, disease status will not be collected for the study. Treatment during the Post-Treatment Follow-up Phase is at the Investigator’s discretion, however, patients treated with atezolizumab should not receive other immunomodulatory agents for 10 weeks after study treatment discontinuation. Patients who discontinue study treatment prior to disease progression will be followed for PFS, with disease status followed every 8 weeks until progression or May 31, 2019, whichever comes first.", "annotation_scope": "multiple", "referenced_elements": { "property_ids": [], "column_ids": [ "col-005" ], "activity_ids": [ "act-025", "act-026" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "schedule_cell", "row_position": 1, "column_position": 5 }, { "table_number": 5, "location_type": "activity_name", "row_position": 27 }, { "table_number": 5, "location_type": "activity_name", "row_position": 28 } ] }, { "annotation_id": "annot-004", "table_id": "table-005", "annotation_marker": "d", "annotation_type": "footnote", "annotation_text": "Patients completing the Induction Treatment Phase, and who have not experienced PD can then proceed to the Maintenance Treatment Phase. Depending on the patient’s biomarker status (based on the archival sample from initial diagnosis), these patients will be assigned to a maintenance treatment cohort. Cohorts 2 and 4 are closed to further accrual. Patients with an adequate tumour sample but with unknown biomarker status due to lack of determinant result (e.g. due to technical issues) may still be included in the study depending on the addition of future cohorts.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-001" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 3 } ] }, { "annotation_id": "annot-005", "table_id": "table-005", "annotation_marker": "e", "annotation_type": "footnote", "annotation_text": "The cohort-specific exclusion criteria must be assessed prior to randomization to study maintenance treatment but assessment of cohort-specific eligibility can only be completed after the biomarker analysis results from the patient’s archival tumour tissue from initial diagnosis are known. Patients found ineligible for any cohort will undergo a Study Treatment Discontinuation Visit and enter the Post-Treatment Follow-up Phase.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-003" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 5 } ] }, { "annotation_id": "annot-006", "table_id": "table-005", "annotation_marker": "f", "annotation_type": "footnote", "annotation_text": "Each cohort will consist of an experimental treatment arm and a control arm. Randomised on a 2:1 (experimental:control) basis to either the experimental treatment arm or the control arm of that cohort. See Section 4.2.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-004" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 6 } ], "document_references": [ { "kind": "section", "target": "4.2" } ] }, { "annotation_id": "annot-007", "table_id": "table-005", "annotation_marker": "g", "annotation_type": "footnote", "annotation_text": "Vital signs include measurements of systolic and diastolic blood pressure while the patient is in a seated position, and temperature. Experimental arm only: For the first atezolizumab infusion, the patient’s vital signs (heart rate, respiratory rate, blood pressures, and temperature) should be determined within 60 minutes before the infusion, every 15 ± 5 minutes during the infusion, and 30 ± 10 minutes after the infusion. For subsequent infusions, vital signs will be collected within 60 minutes before the infusion and should be collected during or after the infusion if clinically indicated or if symptoms occurred in the prior infusion. Vital sign measurements from every second treatment cycle only will be recorded in the eCRF.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-005" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 7 } ] }, { "annotation_id": "annot-008", "table_id": "table-005", "annotation_marker": "h", "annotation_type": "footnote", "annotation_text": "Physical examinations will be symptom-directed, and will include changes from Baseline (pre-Induction) with new or worsened clinically significant abnormalities being reported as AEs if appropriate.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-006" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 8 } ] }, { "annotation_id": "annot-009", "table_id": "table-005", "annotation_marker": "i", "annotation_type": "source_note", "annotation_text": "See Appendix 8.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-007" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 9 } ], "document_references": [ { "kind": "appendix", "target": "8" } ] }, { "annotation_id": "annot-010", "table_id": "table-005", "annotation_marker": "j", "annotation_type": "footnote", "annotation_text": "Concomitant medication includes any prescription medications or over-the-counter preparations used by a patient between the 7 days prior to the date of informed consent up until the Study Treatment Discontinuation visit. Only concomitant medications used for supportive care, to alleviate symptoms of mCRC, or to treat adverse drug reactions should be recorded on the Concomitant Medications eCRF. At subsequent visits, only changes to current medications or medications used since the last documentation of medications will be recorded. Concomitant medications for treatment of AEs related to study medication will continue to be recorded while the AE is being followed. For permitted and prohibited concomitant medications, see Section 4.4.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-008" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 10 } ], "document_references": [ { "kind": "section", "target": "4.4" } ] }, { "annotation_id": "annot-011", "table_id": "table-005", "annotation_marker": "k", "annotation_type": "footnote", "annotation_text": "Haematology includes haemoglobin, haematocrit, platelet count, red blood cell count, white blood cell count, and differential. Blood chemistry includes ALT, AST, alkaline phosphatase, total bilirubin, total protein, albumin, blood urea nitrogen or urea, LDH, creatinine, glucose, calcium, phosphorus, sodium, potassium, chloride, bicarbonate. For experimental arm only patients, blood chemistry will also include magnesium, creatine phosphokinase, lipase and amylase. Haematology and blood chemistry tests must be conducted prior to treatment administration on Day 1 of each treatment cycle with the results available for review prior to start of treatment according to local standards for treatment management. Clinical laboratory results from every second cycle only will be recorded in the CRF. Clinical laboratory results constituting a clinically significant AE should be recorded as such.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-009" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 11 } ] }, { "annotation_id": "annot-012", "table_id": "table-005", "annotation_marker": "l", "annotation_type": "footnote", "annotation_text": "INR and aPTT only for patients receiving anticoagulants while on protocol-specified treatment.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-010" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 12 } ] }, { "annotation_id": "annot-013", "table_id": "table-005", "annotation_marker": "m", "annotation_type": "footnote", "annotation_text": "Urinalysis must be performed by dipstick within 48 hours prior to every treatment cycle. A 24-hour urine collection is needed in the event of proteinuria ≥ ± 2 by dipstick test. Urinalysis results from every second cycle only will be recorded in the CRF.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-011" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 13 } ] }, { "annotation_id": "annot-014", "table_id": "table-005", "annotation_marker": "n", "annotation_type": "footnote", "annotation_text": "Urine or blood pregnancy test, only for women of childbearing potential (i.e. not post-menopausal as indicated by < 12 months of non-therapy-induced amenorrhea, nor surgically sterile [absence of ovaries and/or uterus]), including those who have had a tubal ligation. If urine pregnancy test is positive, it must be confirmed by a serum pregnancy test.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-012" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 14, "method": "synthesized" } ] }, { "annotation_id": "annot-015", "table_id": "table-005", "annotation_marker": "o", "annotation_type": "footnote", "annotation_text": "Patients with active tuberculosis are not eligible for Cohort 4 and will be excluded from entering the Maintenance Phase of the study. Investigators must confirm absence of active disease in patients with a positive test.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-015" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 17 } ] }, { "annotation_id": "annot-016", "table_id": "table-005", "annotation_marker": "p", "annotation_type": "footnote", "annotation_text": "HIV testing performed in accordance with national and/or institutional guidelines. HBV serology includes HBsAg and anti-HBc. HCV serology includes anti-HCV. Results required to determine eligibility for Cohort 4.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-016" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 18 } ] }, { "annotation_id": "annot-017", "table_id": "table-005", "annotation_marker": "q", "annotation_type": "footnote", "annotation_text": "LVEF must be assessed in all Cohort 4 patients prior to randomization. Only experimental arm patients require subsequent LVEF monitoring which should be conducted every 6 cycles after Cycle 4. In addition, if any experimental arm patient develops clinical signs or symptoms suspicious of cardiac failure they should undergo an LVEF assessment without delaying until the next scheduled assessment (i.e. if indicated prior to the next scheduled assessment). For experimental arm patients who restart cobimetinib following a delay due to asymptomatic or symptomatic LVEF decrease, LVEF must be assessed at 2, 4, 10, and 16 weeks, then every 6 cycles after restarting treatment (see Appendix 16). Evaluation of LVEF must be performed by the same method (ECHO or MUGA) for each patient. It is strongly encouraged that the same laboratory and operator perform ECHO/MUGA scans for each individual patient. The treatment discontinuation visit evaluation of LVEF does not need to be performed at the treatment discontinuation visit if an evaluation has been performed within the last 12 weeks and there are no clinically significant findings and/or changes from baseline.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-017" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 19 } ], "document_references": [ { "kind": "appendix", "target": "16" } ] }, { "annotation_id": "annot-018", "table_id": "table-005", "annotation_marker": "r", "annotation_type": "footnote", "annotation_text": "If an ophthalmology exam was done within 12 weeks of the discontinuation visit and was normal, it does not need to be repeated.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-018" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 20 } ] }, { "annotation_id": "annot-019", "table_id": "table-005", "annotation_marker": "s", "annotation_type": "footnote", "annotation_text": "Up to and including May 31, 2019, tumour assessments will be conducted according to RECIST1.1, and additionally according to mRECIST for patients in the experimental arm. Assessments will include radiology, chest and abdominal CT or MRI, and other scans to document all sites of disease. A CT or MRI scan of the brain is required if there is a clinical suspicion of CNS metastases. Disease status during maintenance treatment will be determined based on comparison with the tumour assessment done at the end of induction treatment. Up to and including May 31, 2019, tumour assessments will be conducted every 8 weeks from the start of maintenance treatment regardless of treatment cycle delays. After May 31, 2019, disease status will not be collected for the study and tumour assessments may be conducting per local practice. Tumour assessments for control arm patients will not be collected for study purposes after disease progression per RECIST 1.1 has been documented or May 31, 2019, whichever occurs first. Tumour assessments for experimental arm patients will not be collected for study purposes after disease progression per mRECIST has been documented or May 31, 2019, whichever occurs first. Patients who discontinue study treatment during the Maintenance Treatment Phase prior to disease progression will also continue to be followed for progressive disease, with disease assessments per RECIST 1.1 or mRECIST (as described above) conducted every 8 weeks until progression or May 31, 2019, whichever comes first.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-019" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 21 } ] }, { "annotation_id": "annot-020", "table_id": "table-005", "annotation_marker": "t", "annotation_type": "footnote", "annotation_text": "Supplemental Biomarker Program closed as of May 2018. Collection of these samples has been discontinued (see Appendix 18).", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-020" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 22 } ], "document_references": [ { "kind": "appendix", "target": "18" } ] }, { "annotation_id": "annot-021", "table_id": "table-005", "annotation_marker": "u", "annotation_type": "footnote", "annotation_text": "Plasma samples will be collected from all patients for exploratory biomarker analyses. These samples will be sent to a designated laboratory. Samples during treatment should be taken within 48 hours prior to study treatment on the days indicated, unless otherwise specified (see Appendix 17 and the Laboratory Manual).", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-021" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 23 } ], "document_references": [ { "kind": "appendix", "target": "17" } ] }, { "annotation_id": "annot-022", "table_id": "table-005", "annotation_marker": "v", "annotation_type": "footnote", "annotation_text": "Patients in the experimental arm of Cohort 4 will be followed for new AEs for 90 days following the discontinuation of study treatment. Patients in the control arm will be followed for new AEs for 28 days following the discontinuation of study treatment. At the time of treatment discontinuation, any ongoing AE/SAE will be followed until the event resolves, the Investigator assesses the event as stable, the patient is lost to follow-up, dies or withdraws consent. Death related to disease progression is not considered to be an SAE. The Sponsor should be notified if the Investigator becomes aware of any SAE or AEs of special interest occurring after the end of the adverse event reporting period if the event is believed to be related to prior study treatment.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-023" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 25 } ] }, { "annotation_id": "annot-023", "table_id": "table-005", "annotation_marker": "w", "annotation_type": "footnote", "annotation_text": "Patients in the experimental arm will receive cobimetinib 60 mg orally once daily for 3 weeks followed by a 1 week treatment break (21/7 schedule). Treatment cycle length in this arm is 2 weeks. Cobimetinib will be administered daily every day of each odd numbered 2-week treatment cycle, and for the first 7 days only of each even numbered 2-week treatment cycle. Atezolizumab will be administered at a fixed dose of 840 mg administered via 60-minute IV infusion on Day 1 of every 2-week cycle (if initial infusion is well tolerated, subsequent infusions will be done over a 30-minute time period). Patients in the control arm will receive: 5-FU or capecitabine, dose and schedule will be according to local label, where applicable, or otherwise will be determined per the Investigator’s discretion, with bevacizumab 5 mg/kg via 15 – 30 minute IV infusion on Day 1 of every 2-week cycle. If a control arm patient receives capecitabine administered according to a 3- week cycle, timing of all study procedures and assessments scheduled according to 2-week treatment cycles (e.g. ECOG performance status) will be defined by the treatment cycles of concurrently administered bevacizumab.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-024" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 26 } ] }, { "annotation_id": "annot-024", "table_id": "table-005", "annotation_marker": "n1", "annotation_type": "footnote", "annotation_text": "Supplemental Biomarker Program closed as of May 2018. Collection of these samples has been discontinued.", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-020", "act-022" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 22, "method": "synthesized" }, { "table_number": 5, "location_type": "activity_name", "row_position": 24, "method": "synthesized" } ] }, { "annotation_id": "annot-025", "table_id": "table-005", "annotation_marker": "n2", "annotation_type": "footnote", "annotation_text": "Experimental Arm only", "annotation_scope": "activity", "referenced_elements": { "property_ids": [], "column_ids": [], "activity_ids": [ "act-013", "act-014" ], "cell_references": [] }, "marker_locations": [ { "table_number": 5, "location_type": "activity_name", "row_position": 15, "method": "synthesized" }, { "table_number": 5, "location_type": "activity_name", "row_position": 16, "method": "synthesized" } ] } ], "review_items": [] }