Copanlisib Hydrochloride and Nivolumab in Treating Patients With Recurrent or Refractory Diffuse Large B-cell Lymphoma or Primary Mediastinal Large B-cell Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03484819
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Primary Mediastinal Large B-Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Primary Mediastinal Large B-Cell Lymphoma

Eligibility Criteria

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

Interventions

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

Study Details

This phase II trial studies how well copanlisib hydrochloride and nivolumab work in treating patients with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma that has come back (recurrent) or does not responded to the treatment (refractory). Copanlisib hydrochloride 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 hydrochloride and nivolumab may work better in treating patients with diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma compared to standard of care.

Key Dates

Start date
Dec 13, 2019
Status verified
Feb 2025
Primary completion
Nov 18, 2022
Completion
Aug 14, 2024

Study Design

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

Arms

  • Experimental: Treatment (copanlisib hydrochloride, nivolumab)
    Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8 and 15 of cycles 1-8 and days 1 and 15 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 of cycles 1-8 and on day 1 of subsequent cycles. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response Rate [ Time Frame: 23 months ]

Locations (15)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Cancer CenterBirminghamAlabama35233-
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242-
HaysMedHaysKansas67601-
University of Kansas Cancer CenterKansas CityKansas66160-
The University of Kansas Cancer Center - OlatheOlatheKansas66061-
Ascension Via Christi - PittsburgPittsburgKansas66762-
Salina Regional Health CenterSalinaKansas67401-
University of Kansas Health System Saint Francis CampusTopekaKansas66606-
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205-
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536-
Mayo Clinic in RochesterRochesterMinnesota55905-
University Health Truman Medical CenterKansas CityMissouri64108-
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanonNew Hampshire03756-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Cancer Center· Birmingham, ALUniversity of Iowa/Holden Comprehensive Cancer Center· Iowa City, IAHaysMed· Hays, KSUniversity of Kansas Cancer Center· Kansas City, KSThe University of Kansas Cancer Center - Olathe· Olathe, KSAscension Via Christi - Pittsburg· Pittsburg, KS

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