Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fluoropyrimidine · 1 trial · 1 indication
PFS is defined as the time from randomization to the first occurrence of disease progression according to RECIST v1.1, or death from any cause, whichever occurs first. Progressive disease (PD) for target lesion: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/=5 mm. PD for non-target lesion: Unequivocal progression of existing non-target lesions.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Induction Phase (IP) | OTHER | Includes participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt). All participants will receive either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab. |
| Cohort 2 (IP) | OTHER | Includes participants with BRAFwt. All participants will receive either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab. |
| Cohort 3 (IP) | OTHER | Includes participants with human epidermal growth factor receptor 2 positive (HER2+). All participants will receive either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab. |
| Cohort 4 (IP) | OTHER | Includes participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut). All participants will receive either eight 2-week cycles of 5-fluorouracil (5-FU)/ leucovorin calcium (LV) and oxaliplatin (FOLFOX) in combination with bevacizumab, or six 2-week cycles of FOLFOX in combination with bevacizumab, followed by two 2-week cycles of 5-FU/LV with bevacizumab. |
| Cohort 1 (Maintenance Phase[MP]):5-FU/LV,cetuximab,vemurafenib | EXPERIMENTAL | Participants with v-raf murine sarcoma viral oncogene homolog B1 mutation positive (BRAFmut)/human epidermal growth factor receptor 2 negative (HER2-)/microsatellite stable (MSS)/rat sarcoma wild type (RASwt) will receive 1600-2400 milligrams per square meter (mg/m\^2) 5-FU via 46-hour intravenous (IV) infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle with 500 mg/m\^2 cetuximab via infusion on Day 1 of every 2-week cycle and 960 milligrams (mg) vemurafenib twice daily (BID) by mouth. |
| Cohort 1 Control (MP): 5-FU/LV or capecitabin, bevacizumab | ACTIVE_COMPARATOR | Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle. |
| Cohort 2 (MP):5-FU/LV or capecitabine,bevacizumab,atezolizumab | EXPERIMENTAL | Participants with BRAFwt will receive fluoropyrimidine (1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle or 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break) with 5 milligrams per kilogram (mg/kg) bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle and 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle. |
| Cohort 2 Control (MP): 5-FU/LV or capecitabin, bevacizumab | ACTIVE_COMPARATOR | Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle. |
| Cohort 3 (MP): capecitabine,trastuzumab,pertuzumab | EXPERIMENTAL | Participants with human epidermal growth factor receptor 2 positive (HER2+) will receive 1000 mg/m\^2 twice-daily capecitabine BID by mouth on Days 1-14 every 2 weeks followed by a 1-week break with trastuzumab by IV infusion on Day 1 of every 3-week treatment cycle at an initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses, and pertuzumab by IV infusion on Day 1 of each 3-week treatment cycle at an initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses. |
| Cohort 3 Control (MP): 5-FU/LV or capecitabin, bevacizumab | ACTIVE_COMPARATOR | Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle. |
| Cohort 4 (MP): Cobimetinib,atezolizumab | EXPERIMENTAL | Participants with HER2-/high microsatellite instability (MSI-H); HER2-/MSS/v-raf murine sarcoma viral oncogene homolog B1 wild type (BRAFwt); HER2-/MSS/BRAFmut/rat sarcoma mutation positive (RASmut) will receive 60 mg cobimetinib orally for 3 weeks followed by a 1-week treatment break and atezolizumab at a fixed dose of 840 mg via 60-minute IV infusion on Day 1 of every 2-week cycle. |
| Cohort 4 Control (MP): 5-FU/LV or capecitabin, bevacizumab | ACTIVE_COMPARATOR | Per Investigator discretion, participants will receive fluoropyrimidine (5-FU/LV or capecitabine) at a dose and schedule per the Investigator's discretion in accordance with locally approved prescribing information and 5 mg/kg bevacizumab via 1-30 minute IV on Day 1 of every 2-week cycle. |
| Early Progressing BRAFmut Cohort | OTHER | BRAFmut participants experiencing early disease progression during induction treatment will have the option of proceeding immediately to receive second-line treatment with 5-FU/LV, cetuximab and vemurafenib if their primary tumor is MSS, or with a fluoropyrimidine (5-FU/LV or capecitabine), bevacizumab, and atezolizumab if their primary tumor is MSI-H. This cohort will be followed for adverse events during the study, but is not part of the Maintenance Phase study objectives. |
| Name | Type | Description |
|---|---|---|
| Cetuximab | DRUG | 500 mg/m\^2 via IV infusion on Day 1 of every 2-week cycle |
| FOLFOX induction regimen | DRUG | Administered per the Investigator's discretion in accordance with locally approved prescribing information. |
| Fluoropyrimidine (5-FU/LV or capecitabine) | DRUG | Per Investigator's discretion: 5-FU 1600-2400 mg/m\^2 administered via 46-hour IV infusion on Day 1 of every 2-week cycle and LV 400 mg/m\^2 administered via a 2-hour infusion on Day 1 every 2 weeks or 1000 mg/m\^2 twice-daily capecitabine (BID) by mouth given days 1-14 every 2 weeks. The chosen fluoropyrimidine should be administered in accordance with local prescribing information. |
| Atezolizumab | DRUG | 800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle, or a fixed dose of 840 mg |
| Vemurafenib | DRUG | 960 mg vermurafenib BID by mouth |
| Bevacizumab | DRUG | 5 mg/kg bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle per local prescribing information |
| Trastuzumab | DRUG | Initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses by IV infusion on Day 1 of every 3-week treatment cycle |
| Pertuzumab | DRUG | Initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses by IV infusion on Day 1 of each 3-week treatment cycle |
| Cobimetinib | DRUG | 60 mg orally once daily for 3 weeks followed by a 1-week treatment break |
| 5-FU/LV | DRUG | 1600-2400 mg/m\^2 5-FU via 46-hour IV infusion in combination with 400 mg/m\^2 LV via 2-hour infusion on Day 1 of every 2-week cycle until disease progression per the Investigator's assessment using modified Response Evaluation Criteria in Solid Tumors or death from any cause, whichever occurs first. The fluoropyrimidine should be administered in accordance with local prescribing information. |
| Capecitabine | DRUG | 1000 mg/m\^2 twice-daily capecitabine (BID) by mouth given days 1-14 every 2 weeks. The fluoropyrimidine should be administered in accordance with local prescribing information. |
Inclusion Criteria: * ECOG PS of less than or equal to (\<=) 2 * At least 16 weeks of life expectancy at time of entry into the study * Histologically confirmed colorectal cancer (CRC) with mCRC confirmed radiologically * Measureable, unresectable disease according to RECIST 1.1 * No prior chemothe...
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Fluoropyrimidine is used in the treatment of colorectal cancer. It is a small molecule oncology therapy studied in metastatic colorectal cancer, including biomarker-selected patient populations. It is given as part of combination regimens, specifically 5-FU/LV or capecitabine, in a Phase 2 development program.
Fluoropyrimidine is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating fluoropyrimidine in colorectal cancer.
Fluoropyrimidine is in Phase 2 clinical development for colorectal cancer. It is investigational and has not been approved by the FDA. The Phase 2 program includes one completed trial, and no trials are currently active.
Fluoropyrimidine has been studied in one completed Phase 2 trial, NCT02291289, titled A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC). That trial enrolled 1,044 patients across 23 countries, used an active-controlled design, and included biomarker-selected participants aged 18 years and older.