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NCT03884998

Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from City of Hope Medical Center

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Record History

All 16 versions: 16 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Nov 4, 2026 to Oct 7, 2027
    • Eligibility criteria expanded, about 54 words
    • Secondary endpoints: details revised at 1 of 3 entries
  2. Start date: Feb 26, 2019 to Jul 10, 2019v15
  3. Primary and study completion dates: Nov 28, 2025 to Nov 4, 2026v14
  4. Primary and study completion dates: Jul 16, 2025 to Nov 28, 2025v13
  5. Primary and study completion dates: Dec 16, 2024 to Jul 16, 2025v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary and study completion dates: Jul 16, 2024 to Dec 16, 2024v11
  2. Primary and study completion dates: Dec 16, 2023 to Jul 16, 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 21 to confirmed 27
    • Site details revised at 3 of 3 sites
    v10
  3. Primary and study completion dates: Jul 16, 2023 to Dec 16, 2023v9
  4. Primary endpoints revised (2)v8 Show 8 more changesShow less
    • Enrollment target: 15 to 21
    • Start date: Jul 10, 2019 to Feb 26, 2019
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: 4 to 3
    • Study sites revised (3)
    • Collaborators: 2 to 1
    • Study title revised
    • Study description shortened, about 4 words
  5. Primary and study completion dates pushed to Jul 16, 2023v7
  6. Primary completion date: Jan 6, 2021 to Dec 6, 2022
    • Start date: Mar 18, 2019 to Jul 10, 2019
    v6
  7. Study sites: 2 to 3v5
  8. Lead sponsor: OHSU Knight Cancer Institute to City of Hope Medical Center
    • Study sites revised (2)
    v4
  9. Site details revised at 1 of 2 sitesv3
  10. Study sites: 1 to 2v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence of dose-limiting toxicities of copanlisib in combination with nivolumab
Timeframe: Up to day 28
Incidence of adverse events
Timeframe: Up to 48 weeks

Secondary (3)

Overall response rate (ORR) or complete response (CR) + partial response (PR)
Duration of response
Progression-free survival (PFS)

Arms and interventions

Treatment (copanlisib and nivolumab)Experimental

Patients receive copanlisib IV over 60 minutes on days 1, 8, and 15 and nivolumab IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Drugs: Copanlisib

Biologicals: Nivolumab

Sites

3 sites in 1 country