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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT03884998
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Copanlisib — DRUG
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase I trial studies the best dose and how well copanlisib when given together with nivolumab works in treating patients with Richter's transformation or transformed indolent non-Hodgkin lymphoma. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving copanlisib and nivolumab may work better in treating patients with Richter's transformation or transformed non-Hodgkin lymphoma.

Key Dates

Start date
Feb 26, 2019
Status verified
Dec 2025
Primary completion
Nov 4, 2026
Completion
Nov 4, 2026

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (copanlisib and nivolumab)
    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.

Primary Outcome Measure

Incidence of dose-limiting toxicities of copanlisib in combination with nivolumab [ Time Frame: Up to day 28 ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
OHSU Knight Cancer InstitutePortlandOregon97239-

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