Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02181738
Phase
PHASE2
Status
Completed

Conditions

  • Hodgkin Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Specified dose on specified days
  • Doxorubicin — DRUG
    Specified dose on specified days
  • Vinblastine — DRUG
    Specified dose on specified days
  • Dacarbazine — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously treated (cohorts, A, B \& C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma participants.

Key Dates

Start date
Aug 12, 2014
Status verified
Nov 2023
Primary completion
Aug 31, 2017
Completion
Dec 27, 2022

Study Design

Enrollment
294 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab (Cohort A, B, C and D)
    Cohort (A, B, C): Nivolumab: Specified dose on specified days Cohort (D): Nivolumab: Specified dose on specified days + Doxorubicin: Specified dose on specified days + Vinblastine: Specified dose on specified days + Dacarbazine: Specified dose on specified days

Primary Outcome Measure

Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C [ Time Frame: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, whichever occurred first (up to approximately 28 months) ]

Locations (14)

FacilityCityStateZIPSite coordinators
Local Institution - 0009Los AngelesCalifornia90095-
Local Institution - 0030Los AngelesCalifornia90048-
Local Institution - 0001AtlantaGeorgia30322-
Local Institution - 0002BostonMassachusetts02215-
Local Institution - 0025BostonMassachusetts02215-
Local Institution - 0041BostonMassachusetts02215-
Local Institution - 0008DetroitMichigan48201-
Local Institution - 0003RochesterMinnesota55905-
Local Institution - 0047HackensackNew Jersey07601-
Local Institution - 0040Basking RidgeNew York07920-
Local Institution - 0005New YorkNew York10021-
Local Institution - 0006AllentownPennsylvania18103-
Local Institution - 0004NashvilleTennessee37232-6307-
Local Institution - 0007HoustonTexas77030-

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By research site
Local Institution - 0009· Los Angeles, CALocal Institution - 0030· Los Angeles, CALocal Institution - 0001· Atlanta, GALocal Institution - 0002· Boston, MALocal Institution - 0025· Boston, MALocal Institution - 0041· Boston, MA

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