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
My Pathway: An Open-Label Phase IIa Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetinib, Vismodegib, Alectinib, and Atezolizumab in Patients Who Have Advanced Solid Tumors With Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents
2 other identifiers
interventional
673
1 country
60
Brief Summary
This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and/or are not suitable options per the treating physician's judgment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2014
Longer than P75 for phase_2
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2014
CompletedFirst Posted
Study publicly available on registry
March 19, 2014
CompletedStudy Start
First participant enrolled
April 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2023
CompletedResults Posted
Study results publicly available
July 23, 2024
CompletedJuly 23, 2024
June 1, 2024
9.1 years
March 17, 2014
May 23, 2024
June 26, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator
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.
From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months)
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)
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.
From the date of first study treatment until disease progression or death from any cause, whichever occurs first (68.9 months)
Secondary Outcomes (5)
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)
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)
Overall Survival (OS)
87.5 months
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)
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)
Study Arms (7)
Trastuzumab Plus Pertuzumab
EXPERIMENTALParticipants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
Atezolizumab
EXPERIMENTALParticipants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
Vemurafenib
EXPERIMENTALParticipants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
Vemurafenib Plus Cobimetinib
EXPERIMENTALParticipants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
Vismodegib
EXPERIMENTALParticipants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
Alectinib
EXPERIMENTALParticipants will receive alectinib 600 mg orally BID in each 28-day cycle.
Erlotinib
EXPERIMENTALParticipants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
Interventions
Trastuzumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Pertuzumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Erlotinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Vemurafenib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Cobimetinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Vismodegib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Alectinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Atezolizumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Eligibility Criteria
You may qualify if:
- Life expectancy greater than or equal to (≥) 12 weeks
- Histologically documented metastatic cancer (solid tumors, not including hematologic malignancies)
- Participants who have received standard first-line therapy for metastatic cancer (except for the tumors for which no first-line therapy exists) and in whom a trial of targeted therapy is considered the best available treatment option. Eligible participants should not have available therapies that will convey clinical benefit and/or are not suitable options per the treating physician's judgment
- No previous treatment with the specific assigned study drug or any other drug sharing the same target
- Measurable disease by RECIST v1.1
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 (For patients enrolling in the atezolizumab arm, ECOG score must be documented within 7 days prior to first treatment and confirmation of ECOG PS must be entered into the interactive web response system \[IWRS\] prior to initiation of treatment)
- Adequate hematologic, renal, and liver function as defined by the protocol
- If applicable, use of contraception methods or abstinence as defined by the protocol
- Trastuzumab plus Pertuzumab
- Molecular testing results from clinical laboratory improvement amendments (CLIA)-certified laboratories (using tissue and/or blood) demonstrating HER2 overexpression or amplification. Participants must have one of the following tumor types: biliary cancer, salivary cancer, or bladder cancer
- a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)
- Left ventricular ejection fraction (LVEF) greater than (\>) 50 percent (%) or above the lower limit of the institutional normal range, whichever is lower
- Availability of an archival or new pre-treatment tissue sample is required if molecular testing was not performed by Foundation Medicine. Any available tumor tissue sample can be submitted. The tissue sample must be submitted within 4 weeks after enrollment
- Erlotinib
- Molecular testing results from CLIA-certified laboratories (using tissue and/or blood) demonstrating epidermal growth factor receptor (EGFR)-activating mutations
- +11 more criteria
You may not qualify if:
- Participants with hematologic malignancies
- Concurrent administration of any other anti-cancer therapy (except male participants with prostate cancer receiving androgen blockade): Bisphosphonates and denosumab are allowed; Most recent anti-cancer therapy ≤28 days and have not recovered from the side effects, excluding alopecia; Radiation therapy within ≤14 days
- Active or untreated brain metastases
- History of carcinomatous meningitis
- Uncontrolled concurrent malignancy (early stage is allowed if not requiring active therapy or intervention)
- Pregnant or breastfeeding women, or intending to become pregnant during the study
- Any significant cardiovascular events within 6 months prior to study entry
- Pulmonary embolism within 30 days prior to study entry
- History or presence of clinically significant ventricular or atrial dysrhythmia \>Grade 2 per NCI CTCAE v4.0
- Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
- Trastuzumab plus Pertuzumab
- Previous treatment with any HER2-targeted therapy
- Erlotinib
- Non-small cell lung cancer (NSCLC) or pancreatic cancer identified by exon 19 deletions or exon 21 L858R substitution mutations
- +53 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (60)
Western Regional Medical Center at Cancer Treatment Centers of America
Goodyear, Arizona, 85338, United States
Mayo Clinic Arizona
Phoenix, Arizona, 85259, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
Science 37, Inc
Culver City, California, 90230, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Moores UCSD Cancer Center; Dept Clinical Trials Office
La Jolla, California, 92093-0698, United States
Eisenhower Medical Center
Rancho Mirage, California, 92270, United States
Stanford Comprehensive Cancer Center
Stanford, California, 94305, United States
Kaiser Permanente - Vallejo
Vallejo, California, 94589, United States
University of Colorado
Aurora, Colorado, 80045-2517, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, 33916, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Florida Hospital Cancer Inst; Memorial System Onc Clin Rsch
Orlando, Florida, 32804, United States
Florida Cancer Specialist, North Region
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists, Research Department
West Palm Beach, Florida, 33401, United States
University Cancer & Blood Center, LLC; Research
Athens, Georgia, 30607, United States
Northeast Georgia Medical Center; Oncology Research Dept-5C
Gainesville, Georgia, 30501, United States
Southeastern Regional Medical Center, Inc.
Newnan, Georgia, 30265, United States
Northwestern University; Robert H. Lurie Comp Can Ctr; Northwestern Medicine Development Inst
Chicago, Illinois, 60611, United States
University Of Chicago Medical Center; Section Of Hematology/Oncology
Chicago, Illinois, 60637, United States
Midwestern Regional Med Center
Zion, Illinois, 60099, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287, United States
Mayo Foundation
Rochester, Minnesota, 55905, United States
Research Medical Center - Antibiotic Research Associates, Inc.
Kansas City, Missouri, 64132, United States
Memorial Sloan Kettering - Monmouth
Middletown, New Jersey, 07748, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87102, United States
University of New Mexico Comprehensive Cancer Center - Albuquerque Cedar Street; Drug Shipment
Albuquerque, New Mexico, 87106, United States
University of New Mexico Comprehensive Cancer Center - Albuquerque Lang NE; Drug Shipment
Albuquerque, New Mexico, 87109, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
Memorial Sloan Kettering Cancer Center at Westchester
Harrison, New York, 10604, United States
Weill Cornell Univ Medical Ctr; Breast Cancer Center
New York, New York, 10021, United States
Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Univ No Carolina School of Med; Physicians Office Bldg
Chapel Hill, North Carolina, 27599-7305v, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest Univ Health Svcs; Internal Medicine
Winston-Salem, North Carolina, 27157, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58102, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242, United States
Cleveland Clinic
Cleveland, Ohio, 44106, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Eastern Regional Medical Ctr
Philadelphia, Pennsylvania, 19124, United States
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins
Willow Grove, Pennsylvania, 19090, United States
Sanford Cancer Cnt Onco Clinic
Sioux Falls, South Dakota, 57104, United States
Sarah Cannon Research Institute / Tennessee Oncology
Chattanooga, Tennessee, 37404, United States
West Clinic
Germantown, Tennessee, 38138, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37920, United States
Tennessee Oncology - Nashville
Nashville, Tennessee, 37203, United States
Vanderbilt Ingram Cancer Clinic
Nashville, Tennessee, 37232, United States
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth, Texas, 76104, United States
MD Anderson
Houston, Texas, 77030, United States
Virginia Cancer Institute
Richmond, Virginia, 23229, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (6)
Sweeney CJ, Hainsworth JD, Bose R, Burris HA, Kurzrock R, Swanton C, Friedman CF, Spigel DR, Szado T, Schulze K, Price R, Malato J, Lo AA, Levy J, Wang Y, Yu W, Meric-Bernstam F. MyPathway Human Epidermal Growth Factor Receptor 2 Basket Study: Pertuzumab + Trastuzumab Treatment of a Tissue-Agnostic Cohort of Patients With Human Epidermal Growth Factor Receptor 2-Altered Advanced Solid Tumors. J Clin Oncol. 2024 Jan 20;42(3):258-265. doi: 10.1200/JCO.22.02636. Epub 2023 Oct 4.
PMID: 37793085DERIVEDNarita Y, Yoshimoto T, Namai T, Asakawa T, Kawakami S, Gower-Page C, Reyes-Rivera I, Patel A, Nakamura Y. Pertuzumab Plus Trastuzumab for Treatment-Refractory HER2-Amplified Metastatic Colorectal Cancer: Comparison of the MyPathway Trial With a Real-World External Control Arm. JCO Clin Cancer Inform. 2022 May;6:e2200022. doi: 10.1200/CCI.22.00022.
PMID: 35649212DERIVEDFriedman CF, Hainsworth JD, Kurzrock R, Spigel DR, Burris HA, Sweeney CJ, Meric-Bernstam F, Wang Y, Levy J, Grindheim J, Shames DS, Schulze K, Patel A, Swanton C. Atezolizumab Treatment of Tumors with High Tumor Mutational Burden from MyPathway, a Multicenter, Open-Label, Phase IIa Multiple Basket Study. Cancer Discov. 2022 Mar 1;12(3):654-669. doi: 10.1158/2159-8290.CD-21-0450.
PMID: 34876409DERIVEDJavle M, Borad MJ, Azad NS, Kurzrock R, Abou-Alfa GK, George B, Hainsworth J, Meric-Bernstam F, Swanton C, Sweeney CJ, Friedman CF, Bose R, Spigel DR, Wang Y, Levy J, Schulze K, Cuchelkar V, Patel A, Burris H. Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2021 Sep;22(9):1290-1300. doi: 10.1016/S1470-2045(21)00336-3. Epub 2021 Jul 30.
PMID: 34339623DERIVEDMeric-Bernstam F, Hurwitz H, Raghav KPS, McWilliams RR, Fakih M, VanderWalde A, Swanton C, Kurzrock R, Burris H, Sweeney C, Bose R, Spigel DR, Beattie MS, Blotner S, Stone A, Schulze K, Cuchelkar V, Hainsworth J. Pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer (MyPathway): an updated report from a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2019 Apr;20(4):518-530. doi: 10.1016/S1470-2045(18)30904-5. Epub 2019 Mar 8.
PMID: 30857956DERIVEDHainsworth JD, Meric-Bernstam F, Swanton C, Hurwitz H, Spigel DR, Sweeney C, Burris H, Bose R, Yoo B, Stein A, Beattie M, Kurzrock R. Targeted Therapy for Advanced Solid Tumors on the Basis of Molecular Profiles: Results From MyPathway, an Open-Label, Phase IIa Multiple Basket Study. J Clin Oncol. 2018 Feb 20;36(6):536-542. doi: 10.1200/JCO.2017.75.3780. Epub 2018 Jan 10.
PMID: 29320312DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Genentech, Inc.
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2014
First Posted
March 19, 2014
Study Start
April 14, 2014
Primary Completion
May 24, 2023
Study Completion
May 24, 2023
Last Updated
July 23, 2024
Results First Posted
July 23, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient-level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).