A Phase IIA Study of Trastuzumab/Pertuzumab, Alectinib, and Atezolizumab in Patients with Advanced Cancer

Full 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

Purpose

In this study, researchers are assessing the safety and effectiveness of different drugs in patients with advanced solid tumors that have a certain genetic change in their tumor. Patients will be assigned to one of these treatment groups depending on the genetic changes in their tumors:

  • Atezolizumab for patients whose cancer has elevated TMB (tumor mutational burden). This must be diagnosed based on genetic testing done on the tumor by a company such as FoundationOne, MSK-IMPACT or Caris. Atezolizumab is an immunotherapy drug that boosts the power of the immune system to find and kill cancer cells. It is given intravenously (by vein).
  • Trastuzumab and pertuzumab for patients whose cancer cells express an elevated amount of the HER2 (also known as ERBB2) protein. Patients with cancers of the salivary gland, bladder, or biliary tract are eligible. Both of these drugs target HER2. They are given intravenously (by vein).
  • Alectinib for patients with cancers containing alterations in a gene called ALK. Alectinib blocks an enzyme that fuels cancer cell growth. It is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a metastatic solid tumor that either has a high TMB, contains HER2, or has the ALK gene mutation.
  • Patients may not have previously received treatment with the drug they will receive in this study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please call 646-888-4226.

Protocol

19-115

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators