NCT04416568

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

Phase 2 Proof of Concept Study of Nivolumab and Ipilimumab in Children and Young Adults With Relapsed or Refractory INI1-negative Cancers

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 6 Months – 40 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is studying two immunotherapy drugs (nivolumab and ipilimumab) given together as a possible treatment for INI1-negative tumors.

Detailed description

This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug or drug combination to learn whether the drug or drug combination works in treating a specific disease. "Investigational" means that the drug combination is being studied. The names of the study drugs involved in this study are: * Nivolumab (OPDIVO) * Ipilimumab (YERYOY) This trial is studying whether nivolumab and ipilimumab work to treat INI1-negative cancers. The U.S. Food and Drug Administration (FDA) has not approved combination nivolumab and ipilimumab for the specific diseases in this study but it has been approved for other diseases. Nivolumab and ipilimumab have been tested in children to find out a safe dose of this combination.

Conditions

• Malignant Rhabdoid Tumor
• Rhabdoid Tumor of the Kidney
• Epithelioid Sarcoma
• Chordoma (Poorly Differentiated or De-differentiated)
• Atypical Teratoid/Rhabdoid Tumor
• Other INI1 Negative Tumors (With PI Approval)
• Other SMARCA4-deficient Malignant Tumors (With PI Approval)

Interventions

Type	Name	Description
DRUG	Nivolumab	Combination Therapy: Nivolumab at predetermined dosage day 1 of a 21-day cycle for 4 cycles. Monotherapy: Starting with cycle 5 nivolumab at predetermined dosage on day 1 and day 15 of a 28-day cycle
DRUG	Ipilimumab	Combination Therapy: Ipilimumab at predetermined dosage day 1 of a 21-day cycle for 4 cycles

Timeline

• Start date: 2020-08-14
• Primary completion: 2025-07-17
• Completion: 2026-06-01
• First posted: 2020-06-04
• Last updated: 2025-12-17

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study