Study on Tiragolumab and Atezolizumab for Treating Tumors with Missing SMARCB1 or SMARCA4 Genes

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05286801

Provider View

This clinical trial is testing two immunotherapy drugs, tiragolumab and atezolizumab, to see if they can help treat tumors in children and adults that have come back or don't respond to treatment. These tumors lack certain genes, making them hard to treat.

Patient Parameters

Program Overview

This study is exploring how well the immunotherapy drugs tiragolumab and atezolizumab work in treating tumors that are missing the SMARCB1 or SMARCA4 genes. These genes are often absent in aggressive cancers that are difficult to treat. The trial includes both children and adults whose tumors have either returned after treatment or have not responded to previous therapies. The goal is to see if these drugs can help the immune system attack the cancer and stop it from growing and spreading.

Description

The study is divided into two parts: Part A and Part B.

Part A:

  • Focuses on children under 18 years old.
  • Tests the safety of tiragolumab alone.
  • Patients receive tiragolumab through an IV on the first day of each cycle, and atezolizumab starting from the second cycle.
  • Treatment cycles repeat every 21 days for up to 5 years, as long as the disease doesn't progress and side effects are manageable.
  • Regular imaging scans and blood tests are conducted.

Part B:

  • Includes adults and children over 18 years old.
  • Tests the combination of tiragolumab and atezolizumab.
  • Patients receive both drugs through an IV on the first day of each cycle.
  • Treatment cycles repeat every 21 days for up to 5 years, as long as the disease doesn't progress and side effects are manageable.
  • Regular imaging scans and blood tests are conducted.

After completing the treatment, patients will have follow-up visits at various intervals for up to 5 years to monitor their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 12 months old. For Part A, must be under 18 years old. For Part B, no upper age limit.
  • Must have tumors missing SMARCB1 or SMARCA4 genes, confirmed by specific lab tests.
  • Must have tumors that have returned or not responded to treatment, or newly diagnosed tumors with no known cure.
  • Must be in good general health, able to perform daily activities.
  • Must have recovered from any previous cancer treatments.
  • Must not have had certain previous treatments or vaccines recently.
  • Must have adequate blood counts and organ function.
  • Must agree to use birth control during and after the study if of childbearing potential.

Exclusion Criteria

  • Pregnant or breastfeeding women cannot participate.
  • Cannot be taking certain medications, including other cancer treatments or investigational drugs.
  • Cannot have severe allergies to the study drugs.
  • Cannot have had a bone marrow or cell transplant from another person.
  • Cannot have active autoimmune diseases requiring treatment.
  • Cannot have active infections like tuberculosis or hepatitis.
  • Cannot have significant heart or lung diseases.
  • Cannot have had major surgery recently or need it during the study.
  • Cannot have uncontrolled fluid buildup in the body or active infections.
  • Cannot have received a solid organ transplant.
  • Must be able to comply with study requirements.

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