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Study of Nivolumab in Patient...

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

NCT ID: NCT02181738

Last Updated: 2023-11-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-12

Study Completion Date

2022-12-27

Brief Summary

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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.

Detailed Description

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Conditions

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Hodgkin Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Doxorubicin

Intervention Type DRUG

Specified dose on specified days

Vinblastine

Intervention Type DRUG

Specified dose on specified days

Dacarbazine

Intervention Type DRUG

Specified dose on specified days

Nivolumab

Intervention Type DRUG

Specified dose on specified days

Interventions

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Doxorubicin

Specified dose on specified days

Intervention Type DRUG

Vinblastine

Specified dose on specified days

Intervention Type DRUG

Dacarbazine

Specified dose on specified days

Intervention Type DRUG

Nivolumab

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-936558

Eligibility Criteria

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Inclusion Criteria

* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Must have received prior high-dose conditioning chemotherapy followed by autologous stem cell transplant (ASCT) as a part of salvage therapy for cHL (cohort A, B \& C - enrollment closed)
* Participants may be Brentuximab vedotin- naïve, or may have had prior Brentuximab vedotin treatment (cohort A, B \& C - enrollment closed)
* Newly diagnosed and previously untreated classical Hodgkin Lymphoma (cohort D)

Exclusion Criteria

* Known central nervous system lymphoma
* Participants with nodular lymphocyte-predominant Hodgkin Lymphoma
* Prior allogeneic stem cell transplantation (SCT)
* Chest radiation ≤ 24 weeks prior to first dose
* Carmustine ≥ 600 mg/m² received as part of the pre-transplant conditioning regimen

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0030

Los Angeles, California, United States

Site Status

Local Institution - 0009

Los Angeles, California, United States

Site Status

Local Institution - 0001

Atlanta, Georgia, United States

Site Status

Local Institution - 0002

Boston, Massachusetts, United States

Site Status

Local Institution - 0025

Boston, Massachusetts, United States

Site Status

Local Institution - 0041

Boston, Massachusetts, United States

Site Status

Local Institution - 0008

Detroit, Michigan, United States

Site Status

Local Institution - 0003

Rochester, Minnesota, United States

Site Status

Local Institution - 0047

Hackensack, New Jersey, United States

Site Status

Local Institution - 0040

Basking Ridge, New York, United States

Site Status

Local Institution - 0005

New York, New York, United States

Site Status

Local Institution - 0006

Allentown, Pennsylvania, United States

Site Status

Local Institution - 0004

Nashville, Tennessee, United States

Site Status

Local Institution - 0007

Houston, Texas, United States

Site Status

Local Institution - 0032

Innsbruck, , Austria

Site Status

Local Institution - 0031

Vienna, , Austria

Site Status

Local Institution - 0014

B-leuven, , Belgium

Site Status

Local Institution - 0015

Ghent, , Belgium

Site Status

Local Institution - 0046

Vancouver, British Columbia, Canada

Site Status

Local Institution - 0042

Toronto, Ontario, Canada

Site Status

Local Institution - 0044

Prague, , Czechia

Site Status

Local Institution - 0037

Berlin, , Germany

Site Status

Local Institution - 0033

Cologne, , Germany

Site Status

Local Institution - 0036

Hamburg, , Germany

Site Status

Local Institution - 0034

Ulm, , Germany

Site Status

Local Institution - 0019

Bologna, , Italy

Site Status

Local Institution - 0020

Napoli, , Italy

Site Status

Local Institution - 0035

Rozzano (milano), , Italy

Site Status

Local Institution - 0016

Amsterdam, , Netherlands

Site Status

Local Institution - 0038

Groningen, , Netherlands

Site Status

Local Institution - 0017

Utrecht, , Netherlands

Site Status

Local Institution - 0022

Hospitalet Llobregat- Barcelona, , Spain

Site Status

Local Institution - 0027

Majadahonda - Madrid, , Spain

Site Status

Local Institution - 0023

Marbella, , Spain

Site Status

Local Institution - 0043

Swansea, Carmarthenshire, United Kingdom

Site Status

Local Institution - 0012

Withington, Manchester, United Kingdom

Site Status

Local Institution - 0026

Oxford, Oxfordshire, United Kingdom

Site Status

Local Institution - 0013

Sutton, , United Kingdom

Site Status

Countries

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United States Austria Belgium Canada Czechia Germany Italy Netherlands Spain United Kingdom

References

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Cader FZ, Hu X, Goh WL, Wienand K, Ouyang J, Mandato E, Redd R, Lawton LN, Chen PH, Weirather JL, Schackmann RCJ, Li B, Ma W, Armand P, Rodig SJ, Neuberg D, Liu XS, Shipp MA. A peripheral immune signature of responsiveness to PD-1 blockade in patients with classical Hodgkin lymphoma. Nat Med. 2020 Sep;26(9):1468-1479. doi: 10.1038/s41591-020-1006-1. Epub 2020 Aug 10.

Reference Type DERIVED

PMID: 32778827 (View on PubMed)

Ramchandren R, Domingo-Domenech E, Rueda A, Trneny M, Feldman TA, Lee HJ, Provencio M, Sillaber C, Cohen JB, Savage KJ, Willenbacher W, Ligon AH, Ouyang J, Redd R, Rodig SJ, Shipp MA, Sacchi M, Sumbul A, Armand P, Ansell SM. Nivolumab for Newly Diagnosed Advanced-Stage Classic Hodgkin Lymphoma: Safety and Efficacy in the Phase II CheckMate 205 Study. J Clin Oncol. 2019 Aug 10;37(23):1997-2007. doi: 10.1200/JCO.19.00315. Epub 2019 May 21.

Reference Type DERIVED

PMID: 31112476 (View on PubMed)

Armand P, Engert A, Younes A, Fanale M, Santoro A, Zinzani PL, Timmerman JM, Collins GP, Ramchandren R, Cohen JB, De Boer JP, Kuruvilla J, Savage KJ, Trneny M, Shipp MA, Kato K, Sumbul A, Farsaci B, Ansell SM. Nivolumab for Relapsed/Refractory Classic Hodgkin Lymphoma After Failure of Autologous Hematopoietic Cell Transplantation: Extended Follow-Up of the Multicohort Single-Arm Phase II CheckMate 205 Trial. J Clin Oncol. 2018 May 10;36(14):1428-1439. doi: 10.1200/JCO.2017.76.0793. Epub 2018 Mar 27.

Reference Type DERIVED

PMID: 29584546 (View on PubMed)

Roemer MGM, Redd RA, Cader FZ, Pak CJ, Abdelrahman S, Ouyang J, Sasse S, Younes A, Fanale M, Santoro A, Zinzani PL, Timmerman J, Collins GP, Ramchandren R, Cohen JB, De Boer JP, Kuruvilla J, Savage KJ, Trneny M, Ansell S, Kato K, Farsaci B, Sumbul A, Armand P, Neuberg DS, Pinkus GS, Ligon AH, Rodig SJ, Shipp MA. Major Histocompatibility Complex Class II and Programmed Death Ligand 1 Expression Predict Outcome After Programmed Death 1 Blockade in Classic Hodgkin Lymphoma. J Clin Oncol. 2018 Apr 1;36(10):942-950. doi: 10.1200/JCO.2017.77.3994. Epub 2018 Feb 2.

Reference Type DERIVED

PMID: 29394125 (View on PubMed)

Hude I, Sasse S, Brockelmann PJ, von Tresckow B, Momotow J, Engert A, Borchmann S. Leucocyte and eosinophil counts predict progression-free survival in relapsed or refractory classical Hodgkin Lymphoma patients treated with PD1 inhibition. Br J Haematol. 2018 Jun;181(6):837-840. doi: 10.1111/bjh.14705. Epub 2017 Apr 25. No abstract available.

Reference Type DERIVED

PMID: 28439879 (View on PubMed)

Younes A, Santoro A, Shipp M, Zinzani PL, Timmerman JM, Ansell S, Armand P, Fanale M, Ratanatharathorn V, Kuruvilla J, Cohen JB, Collins G, Savage KJ, Trneny M, Kato K, Farsaci B, Parker SM, Rodig S, Roemer MG, Ligon AH, Engert A. Nivolumab for classical Hodgkin's lymphoma after failure of both autologous stem-cell transplantation and brentuximab vedotin: a multicentre, multicohort, single-arm phase 2 trial. Lancet Oncol. 2016 Sep;17(9):1283-94. doi: 10.1016/S1470-2045(16)30167-X. Epub 2016 Jul 20.

Reference Type DERIVED

PMID: 27451390 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

Document Type: Statistical Analysis Plan

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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2014-001509-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA209-205

Identifier Type: -

Identifier Source: org_study_id