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
Neoplasms · Solid Tumors · Biliary Cancer · Salivary Cancer · Bladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02091141 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Trastuzumab (Drug); Pertuzumab (Drug); Erlotinib (Drug); Vemurafenib (Drug); Cobimetinib (Drug); Vismodegib (Drug); Alectinib (Drug); Atezolizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator |
21.0; 19.5; 25.5; 33.3; 10.8; 14.3 | — |
| 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) |
29.5 | — |
| SECONDARY Percentage of Participants With Disease Control |
41.5; 39.1; 34.5; 66.7; 16.2; 42.9 | — |
| SECONDARY Progression-Free Survival (PFS) |
2.8; 2.7; 3.1; 8.2; 1.8; 3.2 | — |
| SECONDARY Overall Survival (OS) |
10.1; 13.5; 10.6; 15.6; 9.8; 14.1 | — |
| SECONDARY Duration of Response (DoR) |
7.3; 32.1; 6.0; 17.2; 14.1; 6.6 | — |
| SECONDARY Number of Participants With Adverse Events |
334; 162; 54; 15; 35; 21 | — |
Summary
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 epidermal growth factor receptor (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
Data sourced from ClinicalTrials.gov (NCT02091141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.