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Monoclonal Antibodies

Brentuximab Vedotin + Nivolumab ± Ipilimumab 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

No Placebo-Only Group

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.

Who is the study for?

Adults with recurrent or refractory classical Hodgkin lymphoma can join this trial. They must have finished previous treatments at least 21 days before, not be pregnant or breastfeeding, and agree to use contraception. Those with serious autoimmune diseases, uncontrolled infections like HIV, severe lung issues, recent monoclonal antibody therapy within 6 months (except ipilimumab in some cases), or a history of certain severe drug reactions are excluded.

What is being tested?

The trial is testing the combination of brentuximab vedotin and nivolumab with or without ipilimumab to see how well they work against Hodgkin lymphoma that has come back or hasn't responded to treatment. It's looking for the best dose and side effects while checking if these drugs help the immune system fight cancer more effectively.

What are the potential side effects?

Possible side effects include allergic reactions to medication components, organ inflammation due to immune response changes, fatigue from treatment burden on the body, potential blood disorders affecting overall health status, increased risk of infection due to immune modulation by drugs.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CR rate (Phase II)

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

Secondary study objectives

Complete response (CR) rate (Phase I)

DOR (Phase II)

Duration of response (DOR) (Phase I)

+7 more

Other study objectives

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)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1150

Biospecimen Collection

2004

Completed Phase 3

~2030