Trial · NCT02291289
A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)
NCT02291289, Phase 2, Completed, Hoffmann-La Roche; results first posted 2020-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC). Trials, record NCT02291289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02291289
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)
- NCT number
- NCT02291289
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,044 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Colorectal Cancer
- Interventions
- Cetuximab, FOLFOX induction regimen, Fluoropyrimidine (5-FU/LV or capecitabine), Atezolizumab, Vemurafenib, Bevacizumab, Trastuzumab, Pertuzumab, Cobimetinib, 5-FU/LV, Capecitabine
- First posted
- 2014-11-14
- Last updated
- 2024-05-06
- Other registries' IDs
- eudract:2014-001017-61
- Results first posted
- 2020-07-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | From randomization until disease progression or death from any cause, up to 5 years | 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. |
| Secondary | Overall Survival (OS) | From randomization until death from any cause, up to 5 years | OS is defined as the time from randomization into the MTP to time of death from any cause. |
| Secondary | Percentage of Participants With Adverse Events | From baseline until end of study (up to 5 years) | |
| Secondary | Overall Response | From randomization until disease progression, up to 5 years | Calculated as the number of participants with a best overall response of CR or PR according to RECIST 1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR= CR + PR. |
| Secondary | Disease Control Rate (DCR) | From randomization until disease progression, up to 5 years | DCR is defined as the percentage of participants with CR, PR, or stable disease (SD) at 16 weeks. Per RECIST v1.1, CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum on study. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline, or the appearance of one or more new lesions. |
| Secondary | Time to Treatment Response | From randomization until disease progression or death from any cause, up to 5 years | Calculated as the time from randomization to the first Occurrence of a documented Objective Response (CR or PR) determined according to RECIST 1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Duration of Response | From first objective response until disease progression or death from any cause, up to 5 years | Defined as the time from the first assessment of CR or PR until disease progression or death from any cause, whichever occurs first. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Percentage of Participants With Improvement and/or Stayed the Same on the Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score | From baseline until end of study (up to 5 years) |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) | From randomization until disease progression or death from any cause, up to 5 years | Participants that were in the Maintenance Phase of the study, which included the experimental and control arms of Cohorts 1-4. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization until death from any cause, up to 5 years | Participants that were in the Maintenance Phase of the study, which included the experimental and control arms of Cohorts 1-4. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Adverse Events | From baseline until end of study (up to 5 years) | Safety population: all participants who received an intervention during the study. | percentage of participants | NUMBER |
| SECONDARY | Overall Response | From randomization until disease progression, up to 5 years | Participants that were in the Maintenance Phase of the study, which included the experimental and control arms of Cohorts 1-4. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (DCR) | From randomization until disease progression, up to 5 years | Participants that were in the Maintenance Phase of the study, which included the experimental and control arms of Cohorts 1-4. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Treatment Response | From randomization until disease progression or death from any cause, up to 5 years | Participants that were in the Maintenance Phase of the study, which included the experimental and control arms of Cohorts 1-4. | months | MEDIAN |
| SECONDARY | Duration of Response | From first objective response until disease progression or death from any cause, up to 5 years | Participants that were in the Maintenance Phase of the study, which included the experimental and control arms of Cohorts 1-4. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Improvement and/or Stayed the Same on the Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score | From baseline until end of study (up to 5 years) | Participants that were in the Maintenance Phase of the study, which included the experimental and control arms of Cohorts 1-4. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group77
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib | 9.99 | 95% Confidence Interval 7.72 to 12.55 | months | |
| Progression-Free Survival (PFS) | Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 11.60 | 95% Confidence Interval 3.58 to 15.67 | months | |
| Progression-Free Survival (PFS) | Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab | 7.13 | 95% Confidence Interval 6.14 to 8.41 | months | |
| Progression-Free Survival (PFS) | Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 7.36 | 95% Confidence Interval 5.82 to 8.94 | months | |
| Progression-Free Survival (PFS) | Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab | 4.44 | 95% Confidence Interval 3.55 to 14.69 | months | |
| Progression-Free Survival (PFS) | Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 4.04 | 95% Confidence Interval 4.04 to 5.39 | months | |
| Progression-Free Survival (PFS) | Cohort 4 (MP): Cobimetinib,Atezolizumab | 3.75 | 95% Confidence Interval 3.42 to 3.91 | months | |
| Progression-Free Survival (PFS) | Cohort 4 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 7.79 | 95% Confidence Interval 3.98 to 9.46 | months | |
| Overall Survival (OS) | Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib | 24.02 | 95% Confidence Interval 16.07 to 34.00 | months | |
| Overall Survival (OS) | Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 21.73 | 95% Confidence Interval 7.92 to 37.19 | months |
1 to 10 of 77Source ClinicalTrials.gov
See all 77 results by groupParticipant flow143
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Treatment | STARTED | Cohort 1: Induction Phase (IP) | 93 | |
| Induction Treatment | STARTED | Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib | 0 | |
| Induction Treatment | STARTED | Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 0 | |
| Induction Treatment | STARTED | Cohort 2 (IP) | 635 | |
| Induction Treatment | STARTED | Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab | 0 | |
| Induction Treatment | STARTED | Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 0 | |
| Induction Treatment | STARTED | Cohort 3 (IP) | 6 | |
| Induction Treatment | STARTED | Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab | 0 | |
| Induction Treatment | STARTED | Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 0 | |
| Induction Treatment | STARTED | Cohort 4 (IP) | 310 |
1 to 10 of 143Source ClinicalTrials.gov
See all 143 participant flowAdverse events5,343
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1: Induction Phase (IP) | 20 | 93 | 28 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib | 7 | 40 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 1 | 18 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 (IP) | 87 | 632 | 114 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab | 21 | 293 | 27 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 8 | 143 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3 (IP) | 1 | 6 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 0 | 2 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 4 (IP) | 49 | 309 | 62 |
1 to 10 of 5,343Source ClinicalTrials.gov
See all 5,343 adverse eventsAdverse event totals39
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Induction Phase (IP) | 25 | 93 |
| Total, all-cause mortality | Cohort 1 (Maintenance Phase[MP]):5-FU/LV,Cetuximab,Vemurafenib | 29 | 40 |
| Total, all-cause mortality | Cohort 1 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 16 | 20 |
| Total, all-cause mortality | Cohort 2 (IP) | 111 | 635 |
| Total, all-cause mortality | Cohort 2 (MP):5-FU/LV or Capecitabine,Bevacizumab,Atezolizumab | 188 | 297 |
| Total, all-cause mortality | Cohort 2 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 107 | 148 |
| Total, all-cause mortality | Cohort 3 (IP) | 1 | 6 |
| Total, all-cause mortality | Cohort 3 (MP): Capecitabine,Trastuzumab,Pertuzumab | 1 | 3 |
| Total, all-cause mortality | Cohort 3 Control (MP): 5-FU/LV or Capecitabin, Bevacizumab | 1 | 2 |
| Total, all-cause mortality | Cohort 4 (IP) | 82 | 310 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36921494 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02291289
GET https://conductscience.org/api/trials/v1/NCT02291289/results?page=2