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

NCT04416568 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-12-17

No results posted yet for this study

Summary

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

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

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

Sponsors & Collaborators

Principal Investigators

  • Suzanne Forrest, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-14
Primary Completion
2025-07-17
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04416568 on ClinicalTrials.gov