Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03038672
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • ALK-Positive Large B-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma Activated B-Cell Type
  • Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation
  • Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
  • Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • EBV-Positive Mucocutaneous Ulcer
  • HHV8-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
  • High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Intravascular Large B-Cell Lymphoma
  • Large B-Cell Lymphoma With 11q Aberration
  • Large B-Cell Lymphoma With IRF4 Rearrangement
  • Plasmablastic Lymphoma
  • Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System
  • Primary Effusion Lymphoma
  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Burkitt Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Gray-Zone Lymphoma
  • Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
  • Recurrent Lymphomatoid Granulomatosis
  • Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
  • Recurrent Primary Mediastinal Large B-Cell Lymphoma
  • Recurrent T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Burkitt Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Gray-Zone Lymphoma
  • Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
  • Refractory Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
  • Refractory Primary Mediastinal Large B-Cell Lymphoma
  • Refractory T-Cell/Histiocyte-Rich Large B-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Given IV
  • Varlilumab — DRUG
    Given IV

Study Details

This phase II trial studies how well nivolumab with or without varlilumab works in treating patients with aggressive B-cell lymphomas that have come back (recurrent) or do not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as varlilumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date
Dec 21, 2018
Status verified
Apr 2026
Primary completion
May 26, 2023
Completion
Oct 24, 2026

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group I (nivolumab)
    Patients receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may cross over to Group II at the time of disease progression.
  • Experimental: Group II (varlilumab, nivolumab)
    Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Response Rate [ Time Frame: 2 years ]

Locations (33)

FacilityCityStateZIPSite coordinators
Mayo Clinic Hospital in ArizonaPhoenixArizona85054-
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Moffitt Cancer CenterTampaFlorida33612-
Moffitt Cancer Center - McKinley CampusTampaFlorida33612-
Moffitt Cancer Center-International PlazaTampaFlorida33607-
Northside HospitalAtlantaGeorgia30342-
Northwestern UniversityChicagoIllinois60611-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
University of Kansas Clinical Research CenterFairwayKansas66205-
HaysMedHaysKansas67601-
University of Kansas Cancer CenterKansas CityKansas66160-
Lawrence Memorial HospitalLawrenceKansas66044-
The University of Kansas Cancer Center - OlatheOlatheKansas66061-
University of Kansas Cancer Center-Overland ParkOverland ParkKansas66210-
University of Kansas Hospital-Indian Creek CampusOverland ParkKansas66211-
Mercy Hospital PittsburgPittsburgKansas66762-
Salina Regional Health CenterSalinaKansas67401-
University of Kansas Health System Saint Francis CampusTopekaKansas66606-
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205-
Mayo Clinic in RochesterRochesterMinnesota55905-
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersMissouri63376-
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141-
University Health Truman Medical CenterKansas CityMissouri64108-
University of Kansas Cancer Center - NorthKansas CityMissouri64154-
University of Kansas Cancer Center - Lee's SummitLee's SummitMissouri64064-
University of Kansas Cancer Center at North Kansas City HospitalNorth Kansas CityMissouri64116-
Siteman Cancer Center-South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanonNew Hampshire03756-
Roswell Park Cancer InstituteBuffaloNew York14263-
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016-
UT Southwestern/Simmons Cancer Center-DallasDallasTexas75390-

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Mayo Clinic Hospital in Arizona· Phoenix, AZMayo Clinic in Arizona· Scottsdale, AZMayo Clinic in Florida· Jacksonville, FLMoffitt Cancer Center· Tampa, FLMoffitt Cancer Center - McKinley Campus· Tampa, FLMoffitt Cancer Center-International Plaza· Tampa, FL

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