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Checkpoint Inhibitor

Nivolumab + Brentuximab Vedotin for Hodgkin's Lymphoma

Phase 2
Waitlist Available
Led By Alex F Herrera
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed diagnosis of classical Hodgkin lymphoma (excluding nodular lymphocyte predominant Hodgkin lymphoma) according to the World Health Organization (WHO) classification, with hematopathology review at the participating institution
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first dose of study treatment to death from any cause, assessed up to 18 months
Awards & highlights

Study Summary

This trial is testing nivolumab and brentuximab vedotin to see if they can help treat high-risk classical Hodgkin lymphoma.

Who is the study for?
This trial is for adults with high-risk classical Hodgkin lymphoma that's returned or isn't responding to treatment. They must have completed a stem cell transplant, be Brentuximab Vedotin naive or responsive, and meet specific health criteria including organ function tests. Women of childbearing potential and men must use effective contraception.Check my eligibility
What is being tested?
The study is testing the effectiveness of Nivolumab and Brentuximab Vedotin after an autologous stem cell transplant (SCT). It aims to see if these immunotherapies can help the immune system fight cancer by preventing tumor growth and spread in patients with recurrent or refractory Hodgkin lymphoma.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions, fatigue, blood disorders like anemia or low platelet counts, possible nerve damage leading to neuropathy, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diagnosis is classical Hodgkin lymphoma, not the nodular type, confirmed by a specialist.
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I can take care of myself but might not be able to do heavy physical work.
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My Hodgkin lymphoma has come back or is not responding to treatment.
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I am planning to have or have had a stem cell transplant using my own cells.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first dose of study treatment to death from any cause, assessed up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of study treatment to death from any cause, assessed up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival at 18 Months
Secondary outcome measures
Overall Survival at 18 Months

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (brentuximab vedotin, nivolumab)Experimental Treatment3 Interventions
Beginning 30-60 days post-ASCT, patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab Vedotin
2015
Completed Phase 4
~1100
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,398 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,210 Total Patients Enrolled
Alex F HerreraPrincipal InvestigatorCity of Hope Comprehensive Cancer Center
11 Previous Clinical Trials
1,499 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations have been chosen to undertake this research?

"There are 6 medical centres participating in this research project, located across Duarte, New york and Rochester. For the comfort of those participating it is recommended that they select a centre nearest to them when signing up for the trial."

Answered by AI

Are there any vacancies open to participants in this trial?

"Based on the information available on clinicaltrials.gov, this medical trial is not actively seeking enrolment at this time. Initially posted on April 3rd 2017 and most recently updated March 17th 2022, it no longer looks for applicants; however there are 2488 other trials recruiting now."

Answered by AI

Does this assessment represent an innovative approach to research?

"Research using Brentuximab Vedotin commenced in 2011, with the first trial sponsored by Seagen Inc. This drug was granted Phase 2 approval shortly after and has been studied extensively since then - 765 trials are currently underway across 2473 cities and 52 nations."

Answered by AI

What other empirical investigations have been conducted on Brentuximab Vedotin?

"As of the present moment, there are 765 trials in progress for Brentuximab Vedotin with 88 Phase 3 examinations. Notably, 41274 different locations around the world have initiated studies on this drug, including a few sites located in Zürich, BE."

Answered by AI

How many participants are taking part in this research initiative?

"This trial has stopped recruiting participants, with the first post having been on April 3rd 2017 and the last update being March 17th 2022. Nonetheless, there are numerous alternative studies searching for sufferers of Hodgkin's Disease (1723) or requiring Brentuximab Vedotin patients (765)."

Answered by AI

What therapeutic applications is Brentuximab Vedotin typically employed for?

"Brentuximab Vedotin is a medication used to treat cancerous tumors, such as melanoma that cannot be surgically removed and metastatic esophageal adenocarcinoma. It can also cure squamous cell carcinomas."

Answered by AI

What risks do individuals run when taking Brentuximab Vedotin?

"Our team at Power assessed the safety of Brentuximab Vedotin with a score of 2 as this is still an experimental trial, thus there are few data points confirming its efficacy but some evidence supporting its safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma
2017. "Nivolumab & Brentuximab Vedotin Consolidation After Autologous SCT in Patients With High-Risk Classical Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03057795.
~8 spots leftby Apr 2025
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