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

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Brief 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

Official Title

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

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator

Secondary Outcome

 Percentage of Participants With Disease Control

Condition

Neoplasms

Intervention

Trastuzumab

Study Arms / Comparison Groups

 Trastuzumab Plus Pertuzumab
Description:  Participants 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. This treatment arm is now closed for screening and enrollment.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

676

Start Date

April 14, 2014

Completion Date

December 30, 2022

Primary Completion Date

December 30, 2022

Eligibility Criteria

        General Inclusion Criteria:

          -  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

        Study-Drug Specific Inclusion Criteria:

        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 EGFR-activating mutations

        Vemurafenib plus Cobimetinib

          -  Molecular testing results from CLIA-certified laboratories (using tissue and/or blood)
             demonstrating BRAF V600 mutations a) For participants screened using a blood assay:
             obtain tissue-based testing result confirming study eligibility (within first 4 weeks
             after enrollment)

        Vismodegib

          -  Molecular testing results from CLIA-certified laboratories (using tissue and/or blood)
             demonstrating hedgehog pathway relevant mutation (activating mutation of smoothened
             [SMO] or loss-of-function mutation of protein patched homolog-1 [PTCH-1])

             a) For participants screened using a blood assay: obtain tissue-based testing result
             confirming study eligibility (within first 4 weeks after enrollment)

          -  All non-hematological adverse events related to any prior chemotherapy, surgery, or
             radiotherapy must have resolved to National Cancer Institute Common Terminology
             Criteria for Adverse Events (NCI CTCAE) Grade less than or equal to (≤) 2 prior to
             starting therapy

        Alectinib

          -  Molecular testing results from CLIA-certified laboratories (using tissue and/or blood)
             demonstrating anaplastic lymphoma kinase (ALK) gene rearrangements, ALK mutations, ALK
             copy number gain or (for melanoma only) increased ALK expression or presence of
             ALK-alternative transcription initiation transcript (ALKATI) a) For participants
             screened using a blood assay: obtain tissue-based testing result confirming study
             eligibility (within first 4 weeks after enrollment)

        Atezolizumab

          -  Molecular testing results from CLIA-certified laboratories (using tissue)
             demonstrating elevated tissue tumor mutational burden (tTMB ≥10 mutations/ Megabase
             [Mb])

          -  For patients where molecular testing was not performed using Foundation Medicine,
             submission of an archival or new pretreatment tissue sample is mandatory. For patients
             where molecular testing was performed using Foundation Medicine, submission of an
             archival or new pretreatment tissue sample is required, if available. The tissue
             sample must be submitted within 4 weeks after enrollment

        General Exclusion Criteria:

          -  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

        Study-Drug Specific Exclusion Criteria:

        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

          -  EGFR amplifications in the absence of EGFR-activating mutations

          -  Cancers with exon 20 mutations

          -  Previous treatment with erlotinib or any other EGFR inhibitor

          -  Inability to swallow pills

          -  Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant
             bowel resection that would preclude absorption of erlotinib

        Vemurafenib plus Cobimetinib

          -  Malignant melanoma, papillary thyroid cancer, colorectal cancer, or hematologic
             malignancy including multiple myeloma

          -  LVEF below institutional lower level of normal (LLN) or below 50%, whichever is lower

          -  History of or evidence of retinal pathology on ophthalmologic examination that is
             considered a risk factor for neurosensory retinal detachment, retinal vein occlusion
             (RVO), or neovascular macular degeneration

          -  Presence of any of the following conditions, which are risk factors for RVO:
             Uncontrolled glaucoma with intraocular pressure >21 millimetres of mercury (mm Hg);
             Serum cholesterol ≥Grade 2; Hypertriglyceridemia ≥Grade 2; Hyperglycemia (fasting)
             ≥Grade 2; Grade ≥2 uncontrolled hypertension (participants with a history of
             hypertension controlled with anti-hypertensive medication to Grade 					

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Clinical Trials, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02091141

Organization ID

ML28897

Secondary IDs

PRO 02

Responsible Party

Sponsor

Study Sponsor

Genentech, Inc.


Study Sponsor

Clinical Trials, Study Director, Hoffmann-La Roche


Verification Date

October 2021