Trial · NCT02928224
Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
NCT02928224, Phase 3, Completed, Pfizer; results first posted 2020-07-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer. Trials, record NCT02928224. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02928224
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
- NCT number
- NCT02928224
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 702 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- BRAF V600E-mutant Metastatic Colorectal Cancer
- Interventions
- Encorafenib, Binimetinib, Cetuximab, Irinotecan, Folinic Acid, 5-Fluorouracil
- First posted
- 2016-10-10
- Last updated
- 2023-12-21
- Other registries' IDs
- eudract:2015-005805-35
- Results first posted
- 2020-07-14
Source ClinicalTrials.gov
Registered outcomes70
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | (Safety Lead-in) Number of Participants With Dose-Limiting Toxicities (DLTs) | Cycle 1 (up to 28 days) | |
| Primary | (Safety Lead-in) Number of Participants With Adverse Events (AEs) | Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants reporting AEs were reported in this outcome measure. |
| Primary | (Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Interim Analysis | Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants with dose interruptions, dose modifications and dose discontinuations due to AEs were reported in this outcome measure. |
| Primary | (Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Final Analysis | From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks) | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants according to incidence of dose interruptions, dose modifications and dose discontinuations due to AEs were reported in this outcome measure. |
| Primary | (Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Interim Analysis | From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.1 weeks for triplet arm and 52.4 weeks for control arm) | OS was defined as the time from randomization to death due to any cause. |
| Primary | (Phase 3) Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 of Triplet Arm vs. Control Arm | Duration of Phase 3, approximately 6 months (up to 28 days per cycle) | ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of complete response (CR) or partial response (PR), where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. |
| Secondary | (Safety Lead-in) Objective Response Rate (ORR) by Investigator | From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks) | ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. |
| Secondary | (Safety Lead-in) Objective Response Rate (ORR) by BICR | From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks) | ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. |
| Secondary | (Safety Lead-in) Duration of Response (DOR) by Investigator | From time of response to the earliest documented PD or death due to underlying disease (maximum treatment exposure of 280 weeks) | DOR was defined as the time from first radiographic evidence of response to the earliest documented disease progression (PD) or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. |
| Secondary | (Safety Lead-in) Duration of Response (DOR) by BICR | From time of response to the earliest documented PD or death due to underlying disease (maximum treatment exposure of 280 weeks) | DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 registered outcomesOutcomes70
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | (Safety Lead-in) Number of Participants With Dose-Limiting Toxicities (DLTs) | Cycle 1 (up to 28 days) | The dose-determining set (DDS) consisted of all CSLI participants from the safety set who either completed a minimum exposure requirement (received \>= 75% dose intensity of the planned dose for each binimetinib, encorafenib and cetuximab) and had sufficient safety evaluations or experienced a dose-limiting toxicity (DLT). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | (Safety Lead-in) Number of Participants With Adverse Events (AEs) | Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) | The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-treatment assessment, which may have included death. Participants were analyzed according to treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | (Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Interim Analysis | Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) | The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-treatment assessment, which may have included death. Participants were analyzed according to treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | (Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Final Analysis | From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks) | The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 posttreatment assessment, which may have included death. Participants were analyzed according to treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | (Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Interim Analysis | From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.1 weeks for triplet arm and 52.4 weeks for control arm) | The Full Analysis Set (FAS) for the Phase 3 portion of the study consisted of all randomized Phase 3 participants. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | (Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Final Analysis | From randomization to death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm) | The FAS for the Phase 3 portion of the study consisted of all randomized Phase 3 participants. | Months | MEDIAN |
| PRIMARY | (Phase 3) Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 of Triplet Arm vs. Control Arm | Duration of Phase 3, approximately 6 months (up to 28 days per cycle) | The Phase 3 Response Efficacy Set consisted of the first 330 participants randomized into the Phase 3 portion of the study and any additional participants randomized on the same day as the 330th randomized participant. | Percentage of participants | NUMBER |
| SECONDARY | (Safety Lead-in) Objective Response Rate (ORR) by Investigator | From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks) | The Safety Lead-in (SLI) Efficacy Set consisted of all CSLI participants in the FAS who were identified at screening as having a BRAF V600E mutation (per local or central testing). | Percentage of participants | NUMBER |
| SECONDARY | (Safety Lead-in) Objective Response Rate (ORR) by BICR | From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks) | The SLI Efficacy Set consisted of all CSLI participants in the FAS who were identified at screening as having a BRAF V600E mutation (per local or central testing). | Percentage of participants | NUMBER |
| SECONDARY | (Safety Lead-in) Duration of Response (DOR) by Investigator | From time of response to the earliest documented PD or death due to underlying disease (maximum treatment exposure of 280 weeks) | The SLI Efficacy Set consisted of all CSLI participants in the FAS who were identified at screening as having a BRAF V600E mutation (per local or central testing). Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Months | MEDIAN |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 outcomesResults by group599
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| (Safety Lead-in) Number of Participants With Dose-Limiting Toxicities (DLTs) | Combined Safety Lead-in (CSLI) | 5 | Participants | ||
| (Safety Lead-in) Number of Participants With Adverse Events (AEs) | Combined Safety Lead-in | 37 | Participants | ||
| (Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Interim Analysis | Combined Safety Lead-in | 26 | Participants | ||
| (Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Final Analysis | Combined Safety Lead-in | Dose interruptions | 30 | Participants | |
| (Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Final Analysis | Combined Safety Lead-in | Dose modifications | 16 | Participants | |
| (Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Final Analysis | Combined Safety Lead-in | Discontinuation due to AEs | 8 | Participants | |
| (Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Interim Analysis | Phase 3: Triplet Arm | 9.03 | 95% Confidence Interval 8.02 to 11.43 | Months | |
| (Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Interim Analysis | Phase 3: Control Arm | 5.42 | 95% Confidence Interval 4.76 to 6.57 | Months | |
| (Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Final Analysis | Phase 3: Triplet Arm | 9.82 | 95% Confidence Interval 8.34 to 11.73 | Months | |
| (Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Final Analysis | Phase 3:Control Arm | 5.88 | 95% Confidence Interval 5.09 to 7.16 | Months |
1 to 10 of 599Source ClinicalTrials.gov
See all 599 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combined Safety Lead-in | 37 | |
| Overall Study | STARTED | Phase 3: Triplet Arm | 224 | |
| Overall Study | STARTED | Phase 3: Doublet Arm | 220 | |
| Overall Study | STARTED | Phase 3: Control Arm | 221 | |
| Overall Study | Crossover Participants | Combined Safety Lead-in | 0 | |
| Overall Study | Crossover Participants | Phase 3: Triplet Arm | 0 | |
| Overall Study | Crossover Participants | Phase 3: Doublet Arm | 0 | |
| Overall Study | Crossover Participants | Phase 3: Control Arm | 3 | |
| Overall Study | COMPLETED | Combined Safety Lead-in | 0 | |
| Overall Study | COMPLETED | Phase 3: Triplet Arm | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events1,324
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 | Diarrhoea | Gastrointestinal disorders | Combined Safety Lead-in | 29 | 37 | |
| other | Diarrhoea | Gastrointestinal disorders | Phase 3: Triplet Arm | 150 | 222 | |
| other | Diarrhoea | Gastrointestinal disorders | Phase 3: Doublet Arm | 85 | 216 | |
| other | Diarrhoea | Gastrointestinal disorders | Phase 3: Control Arm | 96 | 193 | |
| other | Dermatitis acneiform | Skin and subcutaneous tissue disorders | Combined Safety Lead-in | 25 | 37 | |
| other | Dermatitis acneiform | Skin and subcutaneous tissue disorders | Phase 3: Triplet Arm | 113 | 222 | |
| other | Dermatitis acneiform | Skin and subcutaneous tissue disorders | Phase 3: Doublet Arm | 65 | 216 | |
| other | Dermatitis acneiform | Skin and subcutaneous tissue disorders | Phase 3: Control Arm | 77 | 193 | |
| other | Nausea | Gastrointestinal disorders | Combined Safety Lead-in | 22 | 37 | |
| other | Nausea | Gastrointestinal disorders | Phase 3: Triplet Arm | 107 | 222 |
1 to 10 of 1,324Source ClinicalTrials.gov
See all 1,324 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combined Safety Lead-in | 30 | 37 |
| Total, all-cause mortality | Phase 3: Triplet Arm | 209 | 224 |
| Total, all-cause mortality | Phase 3: Doublet Arm | 193 | 220 |
| Total, all-cause mortality | Phase 3: Control Arm | 198 | 221 |
| Total, other adverse events | Combined Safety Lead-in | 36 | 37 |
| Total, other adverse events | Phase 3: Triplet Arm | 218 | 222 |
| Total, other adverse events | Phase 3: Doublet Arm | 212 | 216 |
| Total, other adverse events | Phase 3: Control Arm | 187 | 193 |
| Total, serious adverse events | Combined Safety Lead-in | 22 | 37 |
| Total, serious adverse events | Phase 3: Triplet Arm | 118 | 222 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers7
The papers the trial lists on ClinicalTrials.gov.
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/NCT02928224
GET https://conductscience.org/api/trials/v1/NCT02928224/registered?page=2