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New treatment option for Relapsed Classic Hodgkin Lymphoma
Official title Brentuximab Vedotin and Nivolumab for the Treatment of Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT04561206
What this study is testing
What is Brentuximab Vedotin?
Brentuximab Vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed classic hodgkin lymphoma.
Also referred to as ADC SGN-35, Adcetris.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial investigates how well brentuximab vedotin and nivolumab work in treating patients with classical Hodgkin lymphoma that has come back after initial treatment (relapsed) or has not responded to initial treatment (refractory). Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
- Be willing to provide tissue (either from a fresh core or excisional biopsy performed as standard of care, or from archival tissue) of a biopsy that...
- If unavailable, exceptions may be granted with study principal investigator (PI) approval
- Eastern Cooperative Oncology Group (ECOG) =\< 2
You likely can't join if
- Concomitant investigational therapy
- Live vaccine within 30 days prior to day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, bacillus...
- Grade \>= 2 peripheral neuropathy
- History of prior \>= grade 3 hypersensitivity to either brentuximab vedotin or nivolumab
- Known active central nervous system (CNS) involvement by lymphoma, including parenchymal and/or lymphomatous meningitis
- History of another primary malignancy that has not been in remission for at least 3 years, with the following exceptions:
See the full eligibility criteria
Who can join
- Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
- Be willing to provide tissue (either from a fresh core or excisional biopsy performed as standard of care, or from archival tissue) of a biopsy that was performed after frontline systemic therapy, and prior to starting...
- If unavailable, exceptions may be granted with study principal investigator (PI) approval
- Eastern Cooperative Oncology Group (ECOG) =\< 2
- Histologically confirmed diagnosis of classical Hodgkin lymphoma (excluding nodular lymphocyte predominant Hodgkin lymphoma) according to the World Health Organization (WHO) classification, with hematopathology review...
- Relapsed or refractory disease after no more than 1 line of prior therapy (not counting radiotherapy). However, a maximum of 5 patients with primary refractory disease may be enrolled in this study. Note: Patients who...
- Not a candidate for ASCT, based on age, co-morbidities, or patient preference. The reason for ASCT non-candidacy must be documented in the Case Report Form and verified by the site PI
- Measurable disease (at least one non-bony fludeoxyglucose F-18 [FDG]-avid lesion \>= 1.5 cm in long axis)
- Absolute neutrophil count (ANC) \>= 1,000/mm\^3
- NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement
- Platelets \>= 50,000/mm\^3
- NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement
- Hemoglobin \>= 8 g/dL (no transfusion allowed within 3 days prior to screening)
- Total bilirubin =\< 1.5 x upper limit of normal (ULN) or direct bilirubin =\< 1.5 x ULN for patients with Gilbert's disease
- Aspartate aminotransferase (AST) =\< 2.5 x ULN
- Alanine aminotransferase (ALT) =\< 2.5 x ULN
- Creatinine clearance of \>= 40 mL/min per 24 hour urine test or the Cockcroft-Gault formula
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Agreement by women and men of childbearing potential\ to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 5 months (women) or 7 months (men)...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
What rules you out
- Concomitant investigational therapy
- Live vaccine within 30 days prior to day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, bacillus Calmette-Guerin [BCG], oral polio vaccine, and oral typhoid)
- Grade \>= 2 peripheral neuropathy
- History of prior \>= grade 3 hypersensitivity to either brentuximab vedotin or nivolumab
- Known active central nervous system (CNS) involvement by lymphoma, including parenchymal and/or lymphomatous meningitis
- History of another primary malignancy that has not been in remission for at least 3 years, with the following exceptions:
- Non-melanoma skin cancer treated with curative intent
- In situ cervical cancer
- If the malignancy is expected to not require any treatment for at least 2 years (this exception should be discussed with the study PI)
- Condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Exceptions are:
- Inhaled or topical steroids and
- Adrenal replacement doses \> 10 mg daily prednisone equivalents in the absence of active autoimmune disease
- History of progressive multifocal leukoencephalopathy (PML)
- Prior diagnosis of inherited or acquired immunodeficiency
- Active pneumonitis or interstitial lung disease
- Active, known or suspected autoimmune disease. The following are exceptions:
- Vitiligo
- Psoriasis not requiring systemic treatment
- Hemolytic anemia associated with the lymphoma
- Type I diabetes mellitus, if adequately controlled with therapy
- Thyroid disease, if adequately controlled with therapy
- Conditions not expected to recur in the absence of an external trigger (such exceptions should be discussed with the study PI)
- Active history of:
- Hepatitis B (hepatitis B virus [HBV]) or C (hepatitis C virus [HCV]) infection. Patients with past HBV infection (defined as negative hepatitis B surface antigen [HBsAg] and positive hepatitis B core antibody [HBcAb])...
- Human immunodeficiency virus (HIV) infection. people who have an undetectable or unquantifiable human immunodeficiency virus (HIV) viral load with CD4 \>= 200 and are on highly active antiretroviral therapy (HAART)...
- History of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association class III-IV within 6 months prior to...
- Pregnant or breastfeeding
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Hackensack, New Jersey, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Hackensack, New Jersey, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.