Fact CheckerSign in

NCT02758717Active, not recruitingPhase 2

Nivolumab and Brentuximab Vedotin in Treating Older Patients With Untreated Hodgkin Lymphoma

Phase II, Multi-Center Trial of Nivolumab and Brentuximab Vedotin in Patients With Untreated Hodgkin Lymphoma Over the Age of 60 Years or Unable to Receive Standard Adriamycin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) Chemotherapy

Source: ClinicalTrials.gov · Last updated 9 Sept 2025

Brief summary (registry, in English)

This phase II trial studies how well nivolumab and brentuximab vedotin work in treating older patients with untreated Hodgkin lymphoma. 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. Biological therapies, such as brentuximab vedotin, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Nivolumab and brentuximab vedotin may work better in treating older patients with untreated Hodgkin lymphoma.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
46 (actual)
First submitted
12 Apr 2016
Start date
13 May 2016
Primary completion date
13 Aug 2019
Lead sponsor
Academic and Community Cancer Research United
NCT number
NCT02758717

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 46
  • From 13 May 2016 to the primary completion date, 13 Aug 2019
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant women
    • Nursing women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Use of systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications =\< 14 days of registration; Note: Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
  • Immunocompromised patients, patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) and currently receiving antiretroviral therapy, patients with a prior history of known or suspected autoimmune disease, active hepatitis B virus surface antigen (HBV sAg+), active hepatitis C (if antibody \[Ab\]+ then polymerase chain reaction \[PCR\]+) indicating acute or chronic infection, and/or history of interstitial lung disease
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Have had prior chemotherapy or radiotherapy for Hodgkin lymphoma
  • Have received either of the study drugs

Other illness

  • Active, known or suspected autoimmune disease; note: subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
  • Allergy to brentuximab vedotin and/or nivolumab
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Known history of pancreatitis

Age

  • \< 60 years who are considered candidates for standard chemotherapy
  • Other active malignancy =\< 2 years prior to registration, unless treated with curative intent; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer

Other

  • \>= grade 2 peripheral neuropathy
  • Active central nervous system (CNS) involvement or leptomeningeal metastases involvement

Who the study is looking for

  • Classical Hodgkin lymphoma determined by local hematopathology review
  • One of the following:
    • Age \>= 60 years
    • Age \< 60 years but unsuitable for standard chemotherapy because of a cardiac ejection fraction of \< 50%, a pulmonary diffusion capacity \< 80%, or a creatinine clearance \>= 30 and \< 60 mL/min, or refused standard chemotherapy despite efforts to convince them otherwise
  • Requirement for systemic chemotherapy: all stages except IA (not bulky disease), if involved field is considered radiotherapy (RT) curative
  • Previously untreated with either chemotherapy, radiation therapy or either brentuximab vedotin or nivolumab, or another check point inhibitor
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  • Absolute neutrophil count (ANC) \>= 1500/mm\^3, unless secondary to bone marrow involvement; obtained =\< 7 days prior to registration
  • Leukocytes \>= 3,000/mm\^3, obtained =\< 7 days prior to registration
  • Platelet count \>= 100,000/mm\^3, obtained =\< 7 days prior to registration
  • Hemoglobin \> 9.0 g/dL - unless determined by treating physician to be disease related, obtained =\< 7 days prior to registration
  • Total bilirubin =\< 1.5 x upper limit of normal (ULN), obtained =\< 7 days prior to registration
  • Aspartate aminotransferase (aspartate transaminase \[AST\]) =\< 2.5 x ULN, obtained =\< 7 days prior to registration
  • Alanine aminotransferase (alanine transaminase \[ALT\]) =\< 2.5 x ULN, obtained =\< 7 days prior to registration
  • Creatinine =\< 2.0 mg/dL, obtained =\< 7 days prior to registration
  • Amylase and/or lipase =\< 1.5 x ULN, obtained =\< 7 days prior to registration
  • Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to registration
    • Note: women of child-bearing potential (WOCBP) must use appropriate method(s) of contraception; WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug; men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year; men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product; women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
    • Note: during the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up
  • Ability to understand and willingness to sign an informed written consent
  • Provide blood and tissue samples for mandatory correlative research purposes

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory University Hospital/Winship Cancer Institute
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Ohio State University Comprehensive Cancer Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Hackensack University Medical Center
Coordinator of this site? Confirm its status
HackensackUnited StatesUnknown status
M D Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Stanford Cancer Institute Palo Alto
Coordinator of this site? Confirm its status
Palo AltoUnited StatesUnknown status
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
MedStar Georgetown University Hospital
Coordinator of this site? Confirm its status
Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.