Study of Nivolumab and Ipilimumab in Children and Young Adults with INI1-Negative Cancers

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04416568

Provider View

This clinical trial is exploring the use of two immunotherapy drugs, nivolumab and ipilimumab, to treat tumors that lack a specific protein called INI1 in children and young adults.

Patient Parameters

Program Overview

This study is testing whether a combination of two immunotherapy drugs, nivolumab and ipilimumab, can help treat cancers that are missing a protein called INI1. These drugs are being studied to see if they are safe and effective for this specific type of cancer. Although this combination is not yet approved for these cancers, it has been approved for other diseases. The study aims to find out if these drugs can work together to treat INI1-negative cancers in children and young adults.

Description

This research is a Phase II clinical trial, which means it is testing the safety and effectiveness of a new drug combination to see if it works for treating a specific disease. The drugs being studied are called nivolumab (OPDIVO) and ipilimumab (YERVOY). The trial is investigating whether these drugs can help treat cancers that are missing a protein called INI1. While the combination of nivolumab and ipilimumab is not yet approved for these specific cancers, it has been approved for other conditions. The study will help determine if this treatment is safe and effective for children and young adults with INI1-negative cancers.

Eligibility Criteria

Inclusion Criteria

  • Must have one of the following confirmed tumors:
    • Malignant rhabdoid tumor (MRT)
    • Rhabdoid tumor of the kidney (RTK)
    • Epithelioid sarcoma
    • Chordoma (poorly differentiated or de-differentiated)
    • Other INI1-negative or SMARCA4-deficient malignant tumors (with approval)
  • Must have a tumor assessment showing:
    • Loss of INI1 confirmed by specific tests, OR
    • Molecular confirmation of INI1 or SMARCA4 loss or mutation
  • Must have relapsed or treatment-resistant disease with no standard treatment options available
  • Must have measurable disease as defined by specific criteria
  • Must have a performance status score of at least 50%
  • Must have recovered from any previous cancer treatments and meet specific timeframes since last treatment
  • Must have adequate organ function, including:
    • Bone marrow function
    • Liver function
    • Kidney function
    • Lung function
    • Pancreatic function
  • Females of childbearing potential must have a negative pregnancy test and agree to use contraception
  • Must be able to understand and agree to participate in the study

Exclusion Criteria

  • Cannot be receiving other investigational drugs
  • Cannot be on systemic steroid medications, except for certain approved uses
  • Cannot have a history of HIV, hepatitis B, or hepatitis C
  • Cannot have uncontrolled illnesses or infections
  • Cannot have a history of certain lung conditions or active autoimmune diseases
  • Cannot have had a solid organ transplant
  • Cannot be pregnant or breastfeeding
  • Cannot have received certain immune therapies or vaccines recently

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