Brentuximab Vedotin for Lymphoma
Phase-Based Progress Estimates
Effectiveness
Safety
Lymphoma+3 More
Brentuximab Vedotin - DrugEligibility
Any Age
All Sexes
What conditions do you have?
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Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary
This trial is studying ipilimumab, nivolumab, and brentuximab vedotin to see how well they work in treating patients with Hodgkin lymphoma that has returned or has not responded to previous treatment.
Eligible Conditions
- Lymphoma
- Hodgkin Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 10 Secondary · Reporting Duration: Up to 5 years
1 year
Differentially expressed genes between two groups (patients who fail at 1-year vs. patients who are event-free at 1-year or responders vs. non-responders) (Phase I and II)
21 days
Maximum tolerated dose (MTD) of each combination (Phase I)
Week 9
Change in the percentage of activated T cells and natural killer cells (Phase I and II)
Week 6
Effects of combinations on systemic immunity (Phase I and II)
Pre- and post-treatment levels of cytokines and T cell specific biomarkers (Phase I and II)
Baseline up to cycle 10
Cognitive Therapy
Percent change in SUVmax, MTV and TLG between baseline and during therapy
Percent change in size (sum of perpendicular diameters [SPD]) on computed tomography (CT)
Completion of study treatment
Microbiome analysis (Phase I and II)
Week 9
Body Weight Changes
Year 3
Progression-free survival (PFS) (Phase I)
Year 5
OS (Phase II)
PFS (or modified PFS) (Phase II)
Year 3
Overall survival (OS) (Phase I)
Year 3
Duration of response (DOR) (Phase I)
Year 5
DOR (Phase II)
Up to 3 years
Complete response (CR) rate (Phase I)
Overall response rate (ORR) rate (Phase I)
Partial response (PR) rate (Phase I)
Up to 5 years
CR rate (Phase II)
ORR (Phase II)
Up to cycle 10
Absolute CT tumor volumes
Absolute maximum standard uptake value (SUVmax) (Phase II)
Metabolic whole body tumor volume (MTV) and tumor lesion glycolysis (TLG)
Trial Safety
Safety Progress
Trial Design
5 Treatment Groups
Phase I Arm III (brentuximab vedotin, nivolumab, ipilimumab)
1 of 5
Phase II Arm I (brentuximab vedotin, nivolumab)
1 of 5
Phase II Arm II (brentuximab vedotin, nivolumab, ipilimumab)
1 of 5
Phase I Arm I (brentuximab vedotin, ipilimumab)
1 of 5
Phase I Arm II (brentuximab vedotin, nivolumab)
1 of 5
Experimental Treatment
146 Total Participants · 5 Treatment Groups
Primary Treatment: Brentuximab Vedotin · No Placebo Group · Phase 1 & 2
Phase I Arm III (brentuximab vedotin, nivolumab, ipilimumab)Experimental Group · 3 Interventions: Brentuximab Vedotin, Ipilimumab, Nivolumab · Intervention Types: Drug, Biological, Biological
Phase II Arm I (brentuximab vedotin, nivolumab)Experimental Group · 2 Interventions: Brentuximab Vedotin, Nivolumab · Intervention Types: Drug, Biological
Phase II Arm II (brentuximab vedotin, nivolumab, ipilimumab)Experimental Group · 3 Interventions: Brentuximab Vedotin, Ipilimumab, Nivolumab · Intervention Types: Drug, Biological, Biological
Phase I Arm I (brentuximab vedotin, ipilimumab)Experimental Group · 2 Interventions: Brentuximab Vedotin, Ipilimumab · Intervention Types: Drug, Biological
Phase I Arm II (brentuximab vedotin, nivolumab)Experimental Group · 2 Interventions: Brentuximab Vedotin, Nivolumab · Intervention Types: Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brentuximab vedotin
FDA approved
Ipilimumab
FDA approved
Nivolumab
FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
12,991 Previous Clinical Trials
41,298,347 Total Patients Enrolled
1,337 Trials studying Lymphoma
380,453 Patients Enrolled for Lymphoma
Catherine S DiefenbachPrincipal InvestigatorECOG-ACRIN Cancer Research Group
3 Previous Clinical Trials
114 Total Patients Enrolled
3 Trials studying Lymphoma
114 Patients Enrolled for Lymphoma
Eligibility Criteria
Age Any Age · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are a female of childbearing potential who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Diefenbach, Catherine S, Fangxin Hong, Richard F Ambinder, Jonathon B Cohen, Michael J Robertson, Kevin A David, Ranjana H Advani, et al.. 2020. “Ipilimumab, Nivolumab, and Brentuximab Vedotin Combination Therapies in Patients with Relapsed or Refractory Hodgkin Lymphoma: Phase 1 Results of an Open-label, Multicentre, Phase 1/2 Trial”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(20)30221-0.
- 2014. "Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01896999.
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