NCT03033914

A(B)VD Followed by Nivolumab as Frontline Therapy for Higher Risk Patients With Classical Hodgkin Lymphoma (HL)

Phase I/II of Nivolumab and A(B)VD in the Front-line Setting for High Risk Hodgkin Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to improve the chance of cure for people with higher risk Hodgkin lymphoma. The purpose of the Phase I study is to test any good and bad effects of the study drug called Nivolumab when combined with ABVD for the front-line treatment of HL.The purpose of this Phase II study is to test whether including nivolumab in treatment for untreated Hodgkin lymphoma can improve the chance of cure for patients with abnormal PET scans after 2 cycles of ABVD.

Detailed description

The phase II portion of cohort A will enroll patients with untreated stage III or IV Hodgkin lymphoma. All patients will begin with 2 cycles of ABVD as standard of care treatment. A PET scan will be performed after 2 cycles of ABVD. Enrollment at MSK may occur at any point during the first two cycles of ABVD treatment. Enrollment at non-MSK locations will occur after the PET scan is performed. MSK patients with a PET-negative response (defined by Deauville 1, 2 or 3) will proceed with 4 additional cycles of ABVD or AVD (per treating physician preference) on-study. Non-MSK patients with a PET-negative response are not eligible for this study. Patients with a PET-positive response (Deauville 4 or 5) will proceed with 4 cycles of AVD plus nivolumab on-study. Non-MSK patients must have a PET-positive response to enroll on this study

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	doxorubicin	Doxorubicin: 25 mg/m\^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
DRUG	Bleomycin	Bleomycin: 10 units/m\^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
DRUG	vinblastine	Vinblastine: 6 mg/m\^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
DRUG	dacarbazine	Dacarbazine (DTIC): 375 mg/m\^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle.
DRUG	Nivolumab	nivolumab 240mg q14 days

Timeline

• Start date: 2017-01-25
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2017-01-27
• Last updated: 2026-02-17

Locations

10 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study