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

NCT03712202 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2024-11-06

No results posted yet for this study

Summary

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.

Conditions

  • 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

Interventions

DRUG

Bleomycin

Given IV

DRUG

Brentuximab Vedotin

Given IV

DRUG

Dacarbazine

Given IV

DRUG

Doxorubicin

Given IV

BIOLOGICAL

Nivolumab

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Vinblastine

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Alex F Herrera · City of Hope Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-28
Primary Completion
2024-12-23
Completion
2024-12-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03712202 on ClinicalTrials.gov