Study on Nivolumab and Tovorafenib for Treating Craniopharyngioma in Children and Young Adults

Sponsor: Sabine Mueller, MD, PhD

Sponsor score: 0

ClinicalTrials ID:NCT05465174

Provider View

This clinical trial is testing a combination of two drugs, Nivolumab and Tovorafenib, to see if they are safe and effective in treating craniopharyngioma, a type of brain tumor, in children and young adults.

Patient Parameters

Program Overview

The study aims to find out if using Nivolumab and Tovorafenib together can help control craniopharyngioma in children and young adults. Researchers are looking at how well the treatment works and if it helps maintain quality of life over a year. They will also check for any changes in vision and hormone levels over three years.

Description

The main goal of this study is to see if the combination of Nivolumab and Tovorafenib can help patients with craniopharyngioma live longer without the disease getting worse, while maintaining their quality of life. Researchers will also look at how many patients have vision or hormone problems over time.

The study will explore how the treatment affects the tumor and the body by examining tumor samples and fluid before and after treatment. This includes looking at proteins, cells, and other factors that might change during treatment.

Participants will be divided into groups based on whether they have a new diagnosis or a recurring tumor. Each group will have different treatment plans, including receiving one or both drugs before surgery. Participants will continue treatment for up to two years and be monitored for three years.

The study will also assess how satisfied patients and their families are with the treatment and any side effects, considering factors like race and social risks.

Participants will be randomly assigned to receive one of the treatments and will have regular follow-ups to monitor their health and the tumor's response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Children and young adults aged 1 to 39 years with a new or recurring diagnosis of craniopharyngioma.
  • Must be able to undergo surgery for a biopsy or tumor removal.
  • For new diagnoses, the tumor must be confirmed by imaging and not suggest another type of lesion.
  • For recurring cases, the tumor must have been confirmed at the initial diagnosis.
  • Must have measurable disease if continuing treatment after surgery.
  • Must have good overall health, with specific blood counts and organ functions within normal limits.
  • Must not be pregnant and agree to use birth control during and after the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Cannot have had any previous treatment for newly diagnosed tumors.
  • Cannot have had recent chemotherapy or radiation for recurring tumors.
  • Cannot have rapidly worsening symptoms that need immediate surgery or radiation.
  • Cannot have uncontrolled hormone-related symptoms or certain eye conditions.
  • Cannot have significant heart or lung problems, or a history of severe allergic reactions to similar drugs.
  • Cannot have active infections or be taking other experimental drugs.
  • Cannot have received a live vaccine recently or have certain immune system disorders.
  • Cannot be pregnant or breastfeeding, or have had a previous organ transplant.
  • Cannot be taking certain medications that affect the study drugs.

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