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Monoclonal Antibodies

Brentuximab Vedotin for Hodgkin's Lymphoma

Phase 1 & 2

Waitlist Available

Led By Catherine S Diefenbach

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

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

Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CR rate (Phase II)

Maximum tolerated dose (MTD) of each combination (Phase I)

Secondary outcome measures

Complete response (CR) rate (Phase I)

DOR (Phase II)

Duration of response (DOR) (Phase I)

+7 more

Other outcome measures

Absolute CT tumor volumes

Absolute maximum standard uptake value (SUVmax) (Phase II)

Change in the percentage of activated T cells and natural killer cells (Phase I and II)

+9 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Phase II Arm II (brentuximab vedotin, nivolumab, ipilimumab)Experimental Treatment7 Interventions

Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16, nivolumab IV over 30 minutes on day 1 of cycles 1-34, and ipilimumab IV over 30 minutes on day 1 every 12 weeks for up to 9 doses. Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study.

Group II: Phase II Arm I (brentuximab vedotin, nivolumab)Experimental Treatment6 Interventions

Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16 and nivolumab IV over 30 minutes on day 1 of cycles 1-34. Treatment repeats every 21 days for up to 34 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study.

Group III: Phase I Arm III (brentuximab vedotin, nivolumab, ipilimumab)Experimental Treatment7 Interventions

Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16, nivolumab IV over 30 minutes on day 1 of cycles 1-46, and ipilimumab IV over 30 minutes on day 1 every 12 weeks for up to 9 doses. Treatment repeats every 21 days for up to 16 cycles and every 14 days beginning cycle 17 for up to 46 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study.

Group IV: Phase I Arm II (brentuximab vedotin, nivolumab)Experimental Treatment6 Interventions

Patients receive brentuximab vedotin IV over 90 minutes on day 1 of cycles 1-16 and nivolumab IV over 30 minutes on day 1 of cycles 1-46. Treatment repeats every 21 days for up to 16 cycles and every 14 days beginning cycle 17 for up to 46 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study.

Group V: Phase I Arm I (brentuximab vedotin, ipilimumab)Experimental Treatment6 Interventions

Patients receive brentuximab vedotin IV over 30 minutes on day 1 of cycles 1-16 and ipilimumab IV over 90 minutes on day 1 of cycles 1-4, 8, 12, and 16. Treatment repeats every 21 days for up to 16 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET scan throughout the trial. Patients undergo blood sample collection and may undergo tumor biopsy on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1730

Brentuximab Vedotin

2015

Completed Phase 4

~1100

Computed Tomography

2017

Completed Phase 2

~2720

Ipilimumab

2014

Completed Phase 3

~2620

Nivolumab

2014

Completed Phase 3

~4750

Positron Emission Tomography

2008

Completed Phase 2

~2240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,660 Previous Clinical Trials

40,924,126 Total Patients Enrolled

Catherine S DiefenbachPrincipal InvestigatorECOG-ACRIN Cancer Research Group

3 Previous Clinical Trials

114 Total Patients Enrolled

Frequently Asked Questions

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

Are there numerous centers that oversee this clinical trial?

"There are 100 sites participating in this clinical trial, such as Golisano Children's Hospital of Southwest Florida, Hope Cancer Care of Nevada and Mercy Hospital Washington. Additionally, there are 97 other locations available for enrollment."

Answered by AI

What is the size of the participant cohort for this experiment?

"Indeed, clinicaltrials.gov shows that this research is currently open for enrollment. The trial was first published on January 24th 2014 and most recently updated November 29th 2022 in search of 146 subjects from a hundred different sites."

Answered by AI

Are any slots remaining in this research endeavor for new participants?

"That is accurate. Clinicaltrials.gov reveals that this medical experiment, which was first made accessible on January 24th 2014, is currently seeking participants. In total, 146 individuals need to be recruited from 100 different clinical locations."

Answered by AI

Has Brentuximab Vedotin been evaluated in any prior clinical studies?

"In 2009, clinical trials exploring the efficacy and safety of Brentuximab Vedotin were first launched at Texas Children's Hospital. Since then 417 completed studies have been conducted with 812 currently active investigations located around Fort Myers, Florida."

Answered by AI

What are the primary aims of this medical trial?

"This clinical trial will be observing the primary outcome of Complete Response (CR) rate over a 21-day period, while also collecting data on Progression-free Survival (PFS), Duration-of-Response (DOR), and Objective Response Rate (ORR). Estimations such as Kaplan Meier methodology with Greenwood's formula to calculate 95% CI for Kaplan Meier estimates, Cox proportional regression modelling to estimate hazard ratios and assess prognostic factors. Point estimators accompanied by corresponding 90% confidence intervals will also be used. Descriptive statistics are employed to evaluate DOR achieved through protocol therapy compared to prior systemic therapies whereas CMH test"

Answered by AI

What medical ailments is Brentuximab Vedotin typically employed to treat?

"Brentuximab Vedotin is an effective treatment for unresectable melanomas, squamous cell carcinoma, and cases where there is a high likelihood of cancer recurrence."

Answered by AI

Recent research and studies

The Lancet HaematologyJournal

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

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.

clinicaltrials.govStudy

Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

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.