Study on Tazemetostat, Nivolumab, and Ipilimumab for Treating Specific Tumors Lacking INI1 or SMARCA4 Proteins

Sponsor: Susan Chi, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05407441

Provider View

This clinical trial is testing a combination of three drugs—Tazemetostat, Nivolumab, and Ipilimumab—as a potential treatment for certain tumors that lack specific proteins (INI1 or SMARCA4). The study aims to find the safest dose and determine if this combination can effectively treat these cancers.

Patient Parameters

Program Overview

This study is exploring a new treatment using three drugs together—Tazemetostat, Nivolumab, and Ipilimumab—for cancers like malignant rhabdoid tumor, atypical teratoid rhabdoid tumor, epithelioid sarcoma, chordoma, or other tumors missing INI1 or SMARCA4 proteins. The goal is to find the safest dose and see if this combination can help treat these cancers. Participants will receive the treatment for up to 2 years, as long as it is beneficial and there are no serious side effects. The study will involve about 49 participants and includes regular check-ups and tests to monitor health and treatment effects.

Description

This clinical trial involves a combination of three drugs: Tazemetostat, which targets a specific protein in cancer cells, and two immunotherapy drugs, Nivolumab and Ipilimumab, which help the immune system fight cancer. The study is in two parts: the first part aims to find the safest dose for children with these specific cancers, and the second part aims to see if the treatment is effective.

Participants will undergo screening to ensure they are eligible, receive the study treatment, and have follow-up visits. They will provide blood samples and may undergo additional procedures. The treatment will last up to 2 years, with follow-up for another 2 years after stopping treatment.

The FDA has not approved this combination for these specific cancers, but Tazemetostat is approved for epithelioid sarcoma, and Nivolumab and Ipilimumab are approved for other uses. The study is supported by pharmaceutical companies Bristol-Myers Squibb and Epizyme, and the Dana-Farber Cancer Institute.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with specific tumors lacking INI1 or SMARCA4 proteins, such as atypical teratoid rhabdoid tumor or epithelioid sarcoma.
  • Must have completed initial treatment for their cancer.
  • Have cancer that can be evaluated or measured by scans.
  • Be between 6 months and 21 years old.
  • Have a performance status score of 50% or higher, meaning they can perform daily activities with some assistance.
  • Have a life expectancy of more than 2 months.
  • Must have recovered from previous cancer treatments.
  • Have adequate organ function, including bone marrow, liver, and kidneys.
  • Women of childbearing potential must agree to use contraception during and after treatment.
  • Men must agree to use barrier contraception during and after treatment.
  • Must be able to understand and agree to the study requirements, with consent from a parent or guardian if underage.

Exclusion Criteria

  • Currently taking other investigational or anti-cancer drugs.
  • Taking medications that affect the liver enzyme CYP3A4.
  • Have a history of HIV, hepatitis B, or hepatitis C.
  • Have uncontrolled illnesses or infections.
  • Have a history of lung inflammation or active autoimmune diseases requiring treatment.
  • Have a history of certain blood disorders or cancers.
  • Have received a solid organ transplant.
  • Are pregnant or breastfeeding.
  • Have previously received similar immunotherapy drugs.
  • Have received a live vaccine within 30 days of starting the study.
  • Have allergies to similar drugs or ingredients.
  • May not be able to comply with study requirements.

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