Suspended

Brentuximab Vedotin and Nivolumab for CD30+ Refractory Malignancies

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Study Aim

This phase 2 study aims to evaluate the effectiveness of Brentuximab Vedotin and Nivolumab treatment in individuals with CD30+ refractory malignancies, measuring the overall response rate as per the Cheson 2007 criteria.

What is being tested

Brentuximab Vedotin

+ Laboratory Biomarker Analysis

+ Brentuximab Vedotin

DrugOtherBiological
Who is being recruted

Hemic and Lymphatic Diseases+7

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorUniversity of Washington
Last updated: May 12, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 20, 2013

Actual date on which the first participant was enrolled.

OUTLINE: ARM A (CLOSED TO ACCRUAL): Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3-5 weeks, every 3 months for 1 year, and then every 6 months for 4 years.

NCT01703949
Principal SponsorUniversity of Washington
Last updated: May 12, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeHodgkin DiseaseLymphoma, Non-Hodgkin

Criteria

13 inclusion criteria required to participate
Absolute neutrophil count (ANC) > 1,000/uL
Age >= 18 yrs at the time of the first dose of study drug
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN
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11 exclusion criteria prevent from participating
Active infection or other medical condition which would preclude treatment in the opinion of the principal investigator; this would include a corrected diffusing capacity of the lungs for carbon monoxide (DLCO) of < 60% predicted or symptomatic interstitial lung disease
Concurrent use of other anti-cancer agents or experimental treatments
Eastern Cooperative Oncology Group (ECOG) performance status > 2
Intolerance to brentuximab vedotin
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Group II

Experimental
Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Fred Hutch/University of Washington Cancer Consortium

Seattle, United StatesOpen Fred Hutch/University of Washington Cancer Consortium in Google Maps
SuspendedOne Study Center