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NCT04416568 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Atypical Teratoid/Rhabdoid Tumor and Malignant Rhabdoid Tumor, sponsored by Dana-Farber Cancer Institute.

Active
Registry status
Phase 2
Development phase
45
Enrollment target
8
Study locations

NCT04416568 is a Phase 2 study of Atypical Teratoid/Rhabdoid Tumor and Malignant Rhabdoid Tumor that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 45 participants, below the 82-participant average among 7 other Atypical Teratoid/Rhabdoid Tumor trials with a reported enrollment target (45% lower). The trial reports 8 study locations across 5 states.

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The verdict

NCT04416568, a Phase 2 study of Atypical Teratoid/Rhabdoid Tumor and Malignant Rhabdoid Tumor, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
45 participants
Enrollment target
8
Study locations

Study Summary

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

Conditions Studied

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

Interventions

  • DRUG Nivolumab
  • DRUG Ipilimumab

Study Locations (8)

Massachusetts

  • Massachusetts General Hospital - Boston
  • Boston Children's Hospital - Boston
  • Dana-Farber Cancer Institute - Boston

Georgia

  • Children's Healthcare of Atlanta-Egleston - Atlanta
  • Children's Healthcare of Atlanta-Scottish Rite - Atlanta

California

  • UCSF Benioff Children's Hospital - San Francisco

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Texas

  • Texas Children's Hospital - Houston

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2020-08-14
Est. Completion 2026-06
Phase Phase 2

Sponsor

Dana-Farber Cancer Institute

781 total trials

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What the Registry Record Tells You About NCT04416568

The ClinicalTrials.gov registry entry for NCT04416568 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 82-participant average among 7 other Atypical Teratoid/Rhabdoid Tumor trials with a reported enrollment target (45% lower). The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Atypical Teratoid/Rhabdoid Tumor appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.

NCT04416568 reports 8 study locations spanning 5 distinct geographic areas - top geographies include Massachusetts, Georgia, California.

Frequently Asked Questions

What is clinical trial NCT04416568 about?

NCT04416568 is a clinical study titled "Study of Nivolumab and Ipilimumab in Children and Young Adults With INI1-Negative Cancers". This clinical trial is studying two immunotherapy drugs (nivolumab and ipilimumab) given together as a possible treatment for INI1-negative tumors.

What is the current status of trial NCT04416568?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2020-08-14. Estimated completion is 2026-06.

What conditions does trial NCT04416568 study?

This clinical trial studies the following conditions: Atypical Teratoid/Rhabdoid Tumor, Malignant Rhabdoid Tumor, Epithelioid Sarcoma, Rhabdoid Tumor of the Kidney, Chordoma (Poorly Differentiated or De-differentiated).

What interventions are being tested in trial NCT04416568?

The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG).

Who is sponsoring clinical trial NCT04416568?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04416568 being conducted?

This trial has 8 study locations across California, Georgia, Massachusetts, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.