Brentuximab Vedotin and Nivolumab in Treating Patients With Early Stage Classic Hodgkin Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-28

Study Completion Date

2024-12-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This phase II trial studies how well brentuximab vedotin and nivolumab work in treating patients with stage I-II classic Hodgkin lymphoma. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. 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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Brentuximab Vedotin and Nivolumab for the Treatment of Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

NCT04561206

Relapsed Classic Hodgkin Lymphoma

RECRUITING PHASE2

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

NCT02758717

Ann Arbor Stage IB Hodgkin Lymphoma Ann Arbor Stage II Hodgkin Lymphoma Ann Arbor Stage IIA Hodgkin Lymphoma +8 more

ACTIVE_NOT_RECRUITING PHASE2

Doxorubicin, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma

NCT03233347

Ann Arbor Stage I Hodgkin Lymphoma Ann Arbor Stage IA Hodgkin Lymphoma Ann Arbor Stage IB Hodgkin Lymphoma +4 more

ACTIVE_NOT_RECRUITING PHASE2

Brentuximab Vedotin and Nivolumab for the Treatment of Relapsed/Refractory Classic Hodgkin Lymphoma Previously Treated With Brentuximab Vedotin or Checkpoint Inhibitors

NCT05039073

Recurrent Classic Hodgkin Lymphoma Refractory Classic Hodgkin Lymphoma

RECRUITING PHASE2

Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma

NCT03907488

Ann Arbor Stage III Hodgkin Lymphoma Ann Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma Ann Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma +7 more

ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVE:

I. Determine the 18-month progression free survival (PFS) for each arm of therapy stratified by positron emission tomography (PET)/computed tomography (CT)-2 response.

SECONDARY OBJECTIVES:

I. Assess safety, tolerability, and quality of life (QOL) for each arm of therapy.

II. Measure PET/CT-2 negativity rate after 2 lead-in cycles of standard of care doxorubicin, bleomycin, vinblastine, dacarbazine (ABVD).

III. Evaluate the 3-year PFS and overall survival (OS) for each arm of treatment.

EXPLORATORY OBJECTIVES:

I. Evaluate if a baseline antitumor immune response, as assessed by a Nanostring gene panel, correlates with PFS.

II. Evaluate if minimal residual disease (MRD) status, as monitored by cancer personalized profiling by deep sequencing (CAPP-Seq) of circulating tumor (ct) deoxyribonucleic acid (DNA), can be correlated with PFS.

OUTLINE: Patients are assigned to 1 of 2 groups based on their PET/CT-2 scans.

GROUP I (PET/CT-2 NEGATIVE): Patients without bulky disease are randomized to either Arm A or B and patients with bulky disease are assigned to Arm B.

ARM A: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive doxorubicin IV, bleomycin IV, vinblastine IV, dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Treatment with nivolumab repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

GROUP II (PET/CT-2 POSITIVE): Patients receive doxorubicin IV, vinblastine IV, dacarbazine, IV and brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients that are PET/CT negative receive nivolumab IV over 60 minutes on day 1. Treatment with nivolumab repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 3 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ann Arbor Stage I Hodgkin Lymphoma Ann Arbor Stage I Mixed Cellularity Classic Hodgkin Lymphoma Ann Arbor Stage I Nodular Sclerosis Classic Hodgkin Lymphoma Ann Arbor Stage IA Hodgkin Lymphoma Ann Arbor Stage IB Hodgkin Lymphoma Ann Arbor Stage II Hodgkin Lymphoma Ann Arbor Stage IIA Hodgkin Lymphoma Ann Arbor Stage IIB Hodgkin Lymphoma Classic Hodgkin Lymphoma Lymphocyte-Rich Classic Hodgkin Lymphoma Ann Arbor Stage I Lymphocyte-Depleted Classic HL Ann Arbor Stage II Lymphocyte-Depleted Classic HL Ann Arbor Stage II Mixed Cellularity Classic HL Ann Arbor Stage II Nodular Sclerosis Classic HL

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

Given IV

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BLEO BLM ADC SGN-35 Adcetris Anti-CD30 Antibody-Drug Conjugate SGN-35 Anti-CD30 Monoclonal Antibody-MMAE SGN-35 Anti-CD30 Monoclonal Antibody-Monomethylauristatin E SGN-35 cAC10-vcMMAE SGN-35 4-(Dimethyltriazeno)imidazole-5-carboxamide 5-(Dimethyltriazeno)imidazole-4-carboxamide Asercit Biocarbazine Dacarbazina Dacarbazina Almirall Dacarbazine - DTIC Dacatic Dakarbazin Deticene Detimedac DIC Dimethyl (triazeno) imidazolecarboxamide Dimethyl Triazeno Imidazol Carboxamide Dimethyl Triazeno Imidazole Carboxamide dimethyl-triazeno-imidazole carboxamide Dimethyl-triazeno-imidazole-carboximide DTIC DTIC-Dome Fauldetic Imidazole Carboxamide Imidazole Carboxamide Dimethyltriazeno WR-139007 Adriablastin Hydroxydaunomycin Hydroxyl Daunorubicin Hydroxyldaunorubicin BMS-936558 MDX-1106 NIVO ONO-4538 Opdivo Quality of Life Assessment Vincaleucoblastine VLB

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Documented informed consent of the participant and/or legally authorized representative.

* Assent, when appropriate, will be obtained per institutional guidelines.
* Eastern Cooperative Oncology Group (ECOG) =\< 2.
* Histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) by current World Health Organization classification (nodular sclerosis, mixed cellularity, lymphocyte rich, lymphocyte depleted, or classical Hodgkin lymphoma, NOS \[not otherwise specified\]) at local enrolling center. Nodular lymphocyte-predominant Hodgkin lymphoma is excluded
* Stage IA, IB, IIA, or IIB cHL by Cotswold modified Ann Arbor staging done prior to any treatment with ABVD.
* Must have prior to standard of care ABVD treatment at least one lesion that is \> 1.5 cm in the longest diameter on cross-sectional imaging and measureable in two perpendicular dimensions on CT and fludeoxyglucose (FDG) avid by PET.

Exclusion Criteria

* Patients must be naive in terms of any prior therapy for Hodgkin lymphoma (including immunotherapy, chemotherapy or radiation therapy) with the exception that they may have received up to 2 cycles of ABVD as standard of care therapy prior to enrollment, as long as they can start protocol therapy (therapy administered in Arms A, B1/B2, or C) within timelines specified by the trial.
* Peripheral sensory neuropathy \> grade 1 or any peripheral motor neuropathy.
* History of another primary malignancy that has not been in remission for at least 3 years. (The following are exempt from the 3-year limit: nonmelanoma skin cancer, fully excised melanoma in situ \[Stage 0\], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolau \[PAP\] smear)
* Known cerebral/meningeal disease.
* History of progressive multifocal leukoencephalopathy (PML).
* Known history of pancreatitis.
* Documented 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 enrollment
* Uncontrolled cardiac disease including ventricular dysfunction, left ventricular ejection fraction \< 45%, coronary artery disease, or arrhythmias.
* Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin, nivolumab, or any component of ABVD.
* Known active infection with hepatitis B or hepatitis C. Patients who are hepatitis B carriers can enroll if have a negative hepatitis B polymerase chain reaction (PCR) DNA test and are on hepatitis B suppressive medication management with entecavir or lamivudine. Patients with past active hepatitis C virus (HCV) infection are eligible if they are PCR negative after curative therapy. Testing to be done only in patients suspected of having infections or exposures.
* Known active infection with human immunodeficiency virus (HIV). Patients who are HIV positive can enroll if CD4 count is \> 200/uL and have an undetectable or unquantifiable HIV viral load within 28 days of enrollment, have concurrent management with infectious disease specialists, and are on stable combination antiretroviral therapy. Participants are required to be on antiretroviral regimens that are in accordance with the current International acquired immune deficiency syndrome (AIDS) Society guidelines concurrently with chemotherapy. The specific agents are at the discretion of the Investigator and the use of investigational agents currently available on an expanded access basis is allowed. Use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) or ritonavir (includes Norvir or Kaletra), Cobicistat, Didanosine (Videx or Videx EC), or similar potent CYP3 inhibitors are prohibited. In order to be eligible, participants taking zidovudine or ritonavir, Cobicistat, Didanosine, or other CYP3 inhibitors must change to a different regimen 7 days prior to therapy initiation. Changes to highly active antiretroviral therapy (HAART) therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.). Participants must be on HAART for at least 7 days prior to therapy. HIV testing to be done only in patients suspected of having infections or exposures
* Subjects with active interstitial pneumonitis.
* Subjects with active, known or suspected autoimmune disease. Subjects with 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 are permitted to enroll.
* Females only: 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).

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No