Trial · NCT02091141
My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors
NCT02091141, Phase 2, Completed, Genentech, Inc.; results first posted 2024-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors. Trials, record NCT02091141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02091141
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors
- NCT number
- NCT02091141
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 673 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Neoplasms, Solid Tumors, Biliary Cancer, Salivary Cancer, Bladder Cancer
- Interventions
- Trastuzumab, Pertuzumab, Erlotinib, Vemurafenib, Cobimetinib, Vismodegib, Alectinib, Atezolizumab
- First posted
- 2014-03-19
- Last updated
- 2024-07-23
- Results first posted
- 2024-07-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator | From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months) | The Objective Response Rate (ORR) is defined as the percentage of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for all arms. |
| Primary | Percentage of Atezolizumab-Treated Participants With Tissue Tumor Mutational Burden (tTMB) ≥16 Mutations/Mb With Overall Response, as Assessed by the Independent Review Committee (IRC) | From the date of first study treatment until disease progression or death from any cause, whichever occurs first (68.9 months) | The Objective Response Rate (ORR) is defined as the proportion of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. |
| Secondary | Percentage of Participants With Disease Control | From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months) | Disease Control Rate (DCR) is defined as the proportion of patients whose best response is CR, PR or stable disease maintained more than 4 months (SD\>4 months). Tumor responses were assessed by investigators using RECIST version 1.1 for all arms. |
| Secondary | Progression-Free Survival (PFS) | From the date of first study treatment until disease progression as assessed by the investigator, or death from any cause, whichever occurs first (72.1 months) | PFS is defined as the time from the start of study treatment to the first occurrence of disease progression, or death, whichever occurs first. Tumor responses were assessed by investigators using RECIST version 1.1 for all arms. |
| Secondary | Overall Survival (OS) | 87.5 months | Overall Survival (OS, months) is defined as the time from the date of the first study treatment (Day 1) to the date of death from any cause. |
| Secondary | Duration of Response (DoR) | From the date of first documented response (complete response [CR] or partial response [PR]) to the time of disease progression or death from any cause, whichever occurs first (70.8 months) | Duration of Response (DoR) is defined as the time from the date of first documented response (CR or PR) to date of first occurrence of disease progression as determined by the investigator, or death from any cause, whichever occurs first. |
| Secondary | Number of Participants With Adverse Events | From first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years) | Incidence, nature, and severity of Adverse Events (AE), per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) for participants enrolled prior to Version 6 of the protocol. The NCI CTCAE (v5.0) grading scale was used for assessing AE severity for participants enrolled under Version 6 of the protocol and subsequent versions. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator | From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months) | The efficacy evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. The population includes the treated participants who have baseline tumor measurement and either have a post-baseline tumor measurement or have discontinued treatment for any reason. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Atezolizumab-Treated Participants With Tissue Tumor Mutational Burden (tTMB) ≥16 Mutations/Mb With Overall Response, as Assessed by the Independent Review Committee (IRC) | From the date of first study treatment until disease progression or death from any cause, whichever occurs first (68.9 months) | The efficacy evaluable population included all atezolizumab-treated participants with tumor mutation burden ≥16 Mutations/Mb and whose tumor responses were assessed by Independent Review Committee (IRC). | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control | From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months) | The efficacy evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. The population includes the treated participants who have baseline tumor measurement and either have a post-baseline tumor measurement or have discontinued treatment for any reason. | Percentage of Participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | From the date of first study treatment until disease progression as assessed by the investigator, or death from any cause, whichever occurs first (72.1 months) | The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen. The population includes the treated participants who have baseline tumor measurement and either have a post-baseline tumor measurement or have discontinued treatment for any reason. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | 87.5 months | The efficacy evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. The population includes the treated participants who have baseline tumor measurement and either have a post-baseline tumor measurement or have discontinued treatment for any reason. | Months | MEDIAN |
| SECONDARY | Duration of Response (DoR) | From the date of first documented response (complete response [CR] or partial response [PR]) to the time of disease progression or death from any cause, whichever occurs first (70.8 months) | Efficacy evaluable population who have achieved a complete or partial response. | Months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events | From first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years) | The safety (SAF) population is defined as enrolled patients who receive at least one dose of study medication. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group113
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator | Trastuzumab Plus Pertuzumab | 21.0 | 95% Confidence Interval 16.9 to 25.6 | Percentage of Participants | |
| Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator | Atezolizumab | 19.5 | 95% Confidence Interval 13.9 to 26.2 | Percentage of Participants | |
| Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator | Vemurafenib | 25.5 | 95% Confidence Interval 14.7 to 39.0 | Percentage of Participants | |
| Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator | Vemurafenib Plus Cobimetinib | 33.3 | 95% Confidence Interval 11.8 to 61.6 | Percentage of Participants | |
| Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator | Vismodegib | 10.8 | 95% Confidence Interval 3.0 to 25.4 | Percentage of Participants | |
| Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator | Alectinib | 14.3 | 95% Confidence Interval 3.0 to 36.3 | Percentage of Participants | |
| Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator | Erlotinib | 7.7 | 95% Confidence Interval 0.2 to 36.0 | Percentage of Participants | |
| Percentage of Atezolizumab-Treated Participants With Tissue Tumor Mutational Burden (tTMB) ≥16 Mutations/Mb With Overall Response, as Assessed by the Independent Review Committee (IRC) | Atezolizumab | 29.5 | 95% Confidence Interval 16.8 to 45.2 | Percentage of Participants | |
| Percentage of Participants With Disease Control | Trastuzumab Plus Pertuzumab | 41.5 | 95% Confidence Interval 36.3 to 46.8 | Percentage of Participants | |
| Percentage of Participants With Disease Control | Atezolizumab | 39.1 | 95% Confidence Interval 31.8 to 46.8 | Percentage of Participants |
1 to 10 of 113Source ClinicalTrials.gov
See all 113 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trastuzumab Plus Pertuzumab | 357 | |
| Overall Study | STARTED | Atezolizumab | 175 | |
| Overall Study | STARTED | Vemurafenib | 55 | |
| Overall Study | STARTED | Vemurafenib Plus Cobimetinib | 15 | |
| Overall Study | STARTED | Vismodegib | 37 | |
| Overall Study | STARTED | Alectinib | 21 | |
| Overall Study | STARTED | Erlotinib | 13 | |
| Overall Study | COMPLETED | Trastuzumab Plus Pertuzumab | 28 | |
| Overall Study | COMPLETED | Atezolizumab | 24 | |
| Overall Study | COMPLETED | Vemurafenib | 3 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events1,344
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 | Trastuzumab Plus Pertuzumab | 63 | 357 | |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab | 27 | 174 | |
| other | Anaemia | Blood and lymphatic system disorders | Vemurafenib | 10 | 55 | |
| other | Anaemia | Blood and lymphatic system disorders | Vemurafenib Plus Cobimetinib | 2 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | Vismodegib | 5 | 37 | |
| other | Anaemia | Blood and lymphatic system disorders | Alectinib | 4 | 21 | |
| other | Anaemia | Blood and lymphatic system disorders | Erlotinib | 3 | 13 | |
| other | Abdominal distension | Gastrointestinal disorders | Trastuzumab Plus Pertuzumab | 18 | 357 | |
| other | Abdominal distension | Gastrointestinal disorders | Atezolizumab | 8 | 174 | |
| other | Abdominal distension | Gastrointestinal disorders | Vemurafenib | 1 | 55 |
1 to 10 of 1,344Source ClinicalTrials.gov
See all 1,344 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trastuzumab Plus Pertuzumab | 285 | 357 |
| Total, all-cause mortality | Atezolizumab | 118 | 174 |
| Total, all-cause mortality | Vemurafenib | 46 | 55 |
| Total, all-cause mortality | Vemurafenib Plus Cobimetinib | 13 | 15 |
| Total, all-cause mortality | Vismodegib | 31 | 37 |
| Total, all-cause mortality | Alectinib | 16 | 21 |
| Total, all-cause mortality | Erlotinib | 12 | 13 |
| Total, other adverse events | Trastuzumab Plus Pertuzumab | 313 | 357 |
| Total, other adverse events | Atezolizumab | 147 | 174 |
| Total, other adverse events | Vemurafenib | 50 | 55 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers6
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/NCT02091141
GET https://conductscience.org/api/trials/v1/NCT02091141/results?page=2