Mode
Text Size
Log in / Sign up
Phase 2 N=673 Treatment

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

Enrolled (actual)
673
Serious AEs
31.6%
Results posted
Jul 2024
Primary outcome: 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 Percentage of Participants

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

OutcomeResultp-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

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.

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
View full record on ClinicalTrials.gov →

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.

Back to search