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

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary endpoint removed 2 → 1 primary endpoints
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Record History

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  1. Primary endpoint(s) modified Show 6 more changesShow less
    • Results posted: Oct 20, 2026
    • Study completion pushed from Jun 2026 to Jul 1, 2027
    • Eligibility criteria expanded, about 53 words
    • Secondary endpoints: 4 to 3
    • Site details revised at 6 of 8 sites
    • Study description expanded, about 2 words
  2. Enrollment target: estimated 45 to confirmed 30v17
  3. Primary completion date changed from estimate of Nov 2025 to Jul 17, 2025v16
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 8 of 8 sites
    v15
  5. Primary completion date: Jun 2025 to Nov 2025
    • Study completion date: Dec 2025 to Jun 2026
    • Site contacts updated at 1 of 8 sites
    v14
Show 12 earlier versionsHide 12 earlier versions
  1. Primary completion date: Oct 2024 to Jun 2025
    • Study completion date: Oct 2025 to Dec 2025
    v13
  2. Re-verified, no change to tracked fieldsv12
  3. Primary completion date: Oct 2023 to Oct 2024v11
  4. Eligibility criteria expanded, about 26 wordsv10
  5. Re-verified, no change to tracked fieldsv9
  6. Study sites: 7 to 8v8
  7. Study sites: 3 to 7
    • Eligibility criteria shortened, about 6 words
    v7
  8. Study sites: 1 to 3
    • Collaborators expanded, about 4 words
    v6
  9. Start date changed from estimate of Aug 2020 to Aug 14, 2020v5
  10. Start date: Jul 2020 to Aug 2020v4
  11. Start date: Jun 2020 to Jul 2020v3
  12. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Oct 1, 2023 to Oct 2023
    • Study completion date: Oct 1, 2025 to Oct 2025
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This clinical trial is studying two immunotherapy drugs (nivolumab and ipilimumab) given together as a possible treatment for INI1-negative tumors.
Trial Details
NCT Number NCT04416568
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Gateway for Cancer Research
Conditions
(from sponsor)		 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)
Related terms Chordoma, Rhabdoid Tumor, Sarcoma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov