A Study of Different Drug Therapies in People with Solid Tumors with Certain Genetic Changes

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Full Title

Tumor-Agnostic Precision Immuno-Oncology And Somatic Targeting Rational For You (TAPISTRY) Phase II Platform Trial

Purpose

Researchers are doing this study to learn if various targeted therapies and immunotherapies are effective and safe in people with advanced solid tumors that have specific genetic changes. A targeted therapy targets the genes or proteins that tell cancer cells to grow and survive. An immunotherapy helps the body’s immune cells to detect and destroy cancer cells.

Participants will be assigned to a treatment group based on the specific genetic changes in their tumors:

  • Participants with ROS1 fusion-positive tumors will receive entrectinib.
  • Those with ALK fusion-positive tumors will receive alectinib.
  • Patients with a genetic change called high tumor mutational burden (TMB) will receive atezolizumab immunotherapy.
  • Those with a genetic change called an AKT1/2/3 mutation will receive ipatasertib.
  • Participants with multiple PIK3CA mutations will receive inavolisib.

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have an inoperable or metastatic solid tumor that contains any of these genetic changes: ROS1 fusion, ALK fusion, high TMB, AKT1/2/3 mutation, or PIK3CA mutations.
  • Patients who already received treatment should recover from the serious side effects of those therapies before receiving the study treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients of all ages.

For more information about this study and to ask about eligibility, please contact the Early Drug Development service at 646-888-4226

Protocol

21-351

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators