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Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational) (CheckMate 205)

Primary Purpose

Hodgkin Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Doxorubicin
Vinblastine
Dacarbazine
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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

Sites / Locations

  • Local Institution - 0030
  • Local Institution - 0009
  • Local Institution - 0001
  • Local Institution - 0002
  • Local Institution - 0025
  • Local Institution - 0041
  • Local Institution - 0008
  • Local Institution - 0003
  • Local Institution - 0040
  • Local Institution - 0047
  • Local Institution - 0005
  • Local Institution - 0006
  • Local Institution - 0004
  • Local Institution - 0007
  • Local Institution - 0032
  • Local Institution - 0031
  • Local Institution - 0014
  • Local Institution - 0015
  • Local Institution - 0046
  • Local Institution - 0042
  • Local Institution - 0044
  • Local Institution - 0037
  • Local Institution - 0036
  • Local Institution - 0033
  • Local Institution - 0034
  • Local Institution - 0019
  • Local Institution - 0020
  • Local Institution - 0035
  • Local Institution - 0016
  • Local Institution - 0038
  • Local Institution - 0017
  • Local Institution - 0022
  • Local Institution - 0027
  • Local Institution - 0023
  • Local Institution - 0043
  • Local Institution - 0012
  • Local Institution - 0026
  • Local Institution - 0013

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nivolumab (Cohort A, B, C and D)

Arm Description

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

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C
To assess the clinical benefit of nivolumab, as measured by ORR based on IRRC assessment, and defined as proportion of subjects achieving either a PR or CR according to the 2007 IWG criteria. Analyses of efficacy endpoints were performed separately for each cohort, according to IWG 2007. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow will be required in all patients in lieu of bone marrow aspirate/ biopsy.
Duration of Objective Response in Cohorts A, B, and C
DOR was defined as the time from first response (CR or PR) to the date of the first documented tumor progression as determined by the investigator using the 2007 IWG criteria or death due to any cause, whichever occurred first. Appearance of any new lesion > 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size. Increased FDG uptake in a previously unaffected site should only be considered relapsed or PD after confirmation with other modalities.
Complete Remission Rate in Cohorts A, B, and C
The CR rate was defined as the number of subjects with a BOR of CR according to the 2007 IWG criteria, based on IRRC assessment, divided by the number of treated subjects.
Duration of Complete Remission (CR) for Cohorts A, B, and C
The CR rate was defined as the number of subjects with a BOR of CR according to the 2007 IWG criteria, based on IRRC assessment, divided by the number of treated subjects. The duration of CR was only evaluated in subjects with BOR of CR and was defined as the time from first documentation of CR (the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow (if required), whichever occurred later) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition.
Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D
To evaluate the safety and tolerability of nivolumab monotherapy during the monotherapy phase and the safety and tolerability of nivolumab in combination with AVD during the combination phase

Secondary Outcome Measures

Partial Remission (PR) Rate in Cohorts A, B, and C
The PR rate was defined as the number of subjects with a BOR of PR according to the 2007 IWG criteria, based on IRRC assessment, divided by the number of treated subjects.
Duration of PR in Cohorts A, B, and C
The duration of PR was only evaluated in subjects with BOR of PR and was defined as the time from first documentation of PR to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition.
ORR Based on Investigator Assessments for Cohorts A, B, and C
Investigator-assessed ORR and DOR were defined similarly as described for ORR and DOR per IRRC assessment above, but were assessed per investigator using the 2007 IWG criteria.
Duration of Objective Response (DOR) Based on Investigator Assessments in Cohorts A, B, and C
Investigator-assessed ORR and DOR were defined similarly as described for ORR and DOR per IRRC assessment above, but were assessed per investigator using the 2007 IWG criteria.
Treatment Discontinuation Rate in Cohort D
Subjects were treated with four doses of nivolumab flat dose 240 mg IV every 2 weeks (monotherapy phase), followed by twelve doses of the combination of AVD (Adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase). Each 28-day dosing period constituted a Combocycle: two doses of the combination therapy per cycle, except for Combocycle 6, which was only a 15-day cycle. The combination therapy was administered every 2 weeks for 12 doses (two doses, Dose 1 on Day 1 and Dose 2 on Day 15, of each Combocycle x 6 cycles). The combination phase ended at Dose 2 (Day 15) of Combocycle 6. The primary analysis for Cohort D was conducted when all treated patients for Cohort D had completed follow-up visit 1 and end-of- therapy response assessment. All analyses for Cohort D were performed separately from other cohorts.
Incidence of Deaths in Cohort D
Safety was analyzed through the incidence of deaths, adverse events, serious adverse events, adverse events leading to discontinuation, adverse events leading to dose delay, select adverse events and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety of subjects was analyzed per treatment phase (monotherapy phase, combination therapy phase) and overall.
Incidence of Adverse Events (AEs) in Cohort D
Safety was analyzed through the incidence of deaths, adverse events, serious adverse events, adverse events leading to discontinuation, adverse events leading to dose delay, select adverse events and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety of subjects was analyzed per treatment phase (monotherapy phase, combination therapy phase) and overall.
Incidence of Serious Adverse Events (SAEs) in Cohort D
Safety was analyzed through the incidence of deaths, adverse events, serious adverse events, adverse events leading to discontinuation, adverse events leading to dose delay, select adverse events and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety of subjects was analyzed per treatment phase (monotherapy phase, combination therapy phase) and overall.
Incidence of AEs Leading to Discontinuation in Cohort D
Safety was analyzed through the incidence of deaths, adverse events, serious adverse events, adverse events leading to discontinuation, adverse events leading to dose delay, select adverse events and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety of subjects was analyzed per treatment phase (monotherapy phase, combination therapy phase) and overall.
Incidence of AEs Leading to Dose Delay in Cohort D
Safety was analyzed through the incidence of deaths, adverse events, serious adverse events, adverse events leading to discontinuation, adverse events leading to dose delay, select adverse events and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety of subjects was analyzed per treatment phase (monotherapy phase, combination therapy phase) and overall.
Incidence of Select AEs in Cohort D
Select AEs have been categorized into seven areas: pulmonary toxicity, gastrointestinal toxicity, hepatotoxicity, endocrinopathy, skin toxicity, neurological toxicity and renal toxicity. Select AEs, in particular pneumonitis, are considered clinically meaningful as they require greater vigilance and for early recognition and prompt intervention.
Incidence of Grade 3-4 Laboratory Abnormalities in Cohort D
Specific laboratory abnormalities (worst grade).

Full Information

First Posted
July 1, 2014
Last Updated
January 20, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02181738
Brief Title
Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational)
Acronym
CheckMate 205
Official Title
Non-Comparative, Multi-Cohort, Single Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Classical Hodgkin Lymphoma (cHL) Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2014 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
December 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
294 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab (Cohort A, B, C and D)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Vinblastine
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C
Description
To assess the clinical benefit of nivolumab, as measured by ORR based on IRRC assessment, and defined as proportion of subjects achieving either a PR or CR according to the 2007 IWG criteria. Analyses of efficacy endpoints were performed separately for each cohort, according to IWG 2007. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow will be required in all patients in lieu of bone marrow aspirate/ biopsy.
Time Frame
From the date of first study drug dose up to approximately 28 months
Title
Duration of Objective Response in Cohorts A, B, and C
Description
DOR was defined as the time from first response (CR or PR) to the date of the first documented tumor progression as determined by the investigator using the 2007 IWG criteria or death due to any cause, whichever occurred first. Appearance of any new lesion > 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size. Increased FDG uptake in a previously unaffected site should only be considered relapsed or PD after confirmation with other modalities.
Time Frame
From the date of first study drug dose up to approximately 28 months
Title
Complete Remission Rate in Cohorts A, B, and C
Description
The CR rate was defined as the number of subjects with a BOR of CR according to the 2007 IWG criteria, based on IRRC assessment, divided by the number of treated subjects.
Time Frame
From the date of first study drug dose up to approximately 28 months
Title
Duration of Complete Remission (CR) for Cohorts A, B, and C
Description
The CR rate was defined as the number of subjects with a BOR of CR according to the 2007 IWG criteria, based on IRRC assessment, divided by the number of treated subjects. The duration of CR was only evaluated in subjects with BOR of CR and was defined as the time from first documentation of CR (the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow (if required), whichever occurred later) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition.
Time Frame
from date of first documented CR up to approximately 28 months
Title
Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D
Description
To evaluate the safety and tolerability of nivolumab monotherapy during the monotherapy phase and the safety and tolerability of nivolumab in combination with AVD during the combination phase
Time Frame
From last dose up to 120 days
Secondary Outcome Measure Information:
Title
Partial Remission (PR) Rate in Cohorts A, B, and C
Description
The PR rate was defined as the number of subjects with a BOR of PR according to the 2007 IWG criteria, based on IRRC assessment, divided by the number of treated subjects.
Time Frame
From the time of the first documented PR up to approximately 28 months
Title
Duration of PR in Cohorts A, B, and C
Description
The duration of PR was only evaluated in subjects with BOR of PR and was defined as the time from first documentation of PR to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition.
Time Frame
From the time of the first documented PR up to approximately 28 months
Title
ORR Based on Investigator Assessments for Cohorts A, B, and C
Description
Investigator-assessed ORR and DOR were defined similarly as described for ORR and DOR per IRRC assessment above, but were assessed per investigator using the 2007 IWG criteria.
Time Frame
From the first dose to first progression, death, or start of other therapy up to 28 months
Title
Duration of Objective Response (DOR) Based on Investigator Assessments in Cohorts A, B, and C
Description
Investigator-assessed ORR and DOR were defined similarly as described for ORR and DOR per IRRC assessment above, but were assessed per investigator using the 2007 IWG criteria.
Time Frame
From the date of first study drug dose up to approximately 28 months
Title
Treatment Discontinuation Rate in Cohort D
Description
Subjects were treated with four doses of nivolumab flat dose 240 mg IV every 2 weeks (monotherapy phase), followed by twelve doses of the combination of AVD (Adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase). Each 28-day dosing period constituted a Combocycle: two doses of the combination therapy per cycle, except for Combocycle 6, which was only a 15-day cycle. The combination therapy was administered every 2 weeks for 12 doses (two doses, Dose 1 on Day 1 and Dose 2 on Day 15, of each Combocycle x 6 cycles). The combination phase ended at Dose 2 (Day 15) of Combocycle 6. The primary analysis for Cohort D was conducted when all treated patients for Cohort D had completed follow-up visit 1 and end-of- therapy response assessment. All analyses for Cohort D were performed separately from other cohorts.
Time Frame
From date of first dose to end of combination therapy up to 28 months
Title
Incidence of Deaths in Cohort D
Description
Safety was analyzed through the incidence of deaths, adverse events, serious adverse events, adverse events leading to discontinuation, adverse events leading to dose delay, select adverse events and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety of subjects was analyzed per treatment phase (monotherapy phase, combination therapy phase) and overall.
Time Frame
From first dose up to 28 months
Title
Incidence of Adverse Events (AEs) in Cohort D
Description
Safety was analyzed through the incidence of deaths, adverse events, serious adverse events, adverse events leading to discontinuation, adverse events leading to dose delay, select adverse events and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety of subjects was analyzed per treatment phase (monotherapy phase, combination therapy phase) and overall.
Time Frame
From last dose up to 120 days
Title
Incidence of Serious Adverse Events (SAEs) in Cohort D
Description
Safety was analyzed through the incidence of deaths, adverse events, serious adverse events, adverse events leading to discontinuation, adverse events leading to dose delay, select adverse events and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety of subjects was analyzed per treatment phase (monotherapy phase, combination therapy phase) and overall.
Time Frame
From last dose up to 120 days
Title
Incidence of AEs Leading to Discontinuation in Cohort D
Description
Safety was analyzed through the incidence of deaths, adverse events, serious adverse events, adverse events leading to discontinuation, adverse events leading to dose delay, select adverse events and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety of subjects was analyzed per treatment phase (monotherapy phase, combination therapy phase) and overall.
Time Frame
From last dose up to 120 days
Title
Incidence of AEs Leading to Dose Delay in Cohort D
Description
Safety was analyzed through the incidence of deaths, adverse events, serious adverse events, adverse events leading to discontinuation, adverse events leading to dose delay, select adverse events and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety of subjects was analyzed per treatment phase (monotherapy phase, combination therapy phase) and overall.
Time Frame
From last dose up to 120 days
Title
Incidence of Select AEs in Cohort D
Description
Select AEs have been categorized into seven areas: pulmonary toxicity, gastrointestinal toxicity, hepatotoxicity, endocrinopathy, skin toxicity, neurological toxicity and renal toxicity. Select AEs, in particular pneumonitis, are considered clinically meaningful as they require greater vigilance and for early recognition and prompt intervention.
Time Frame
From last dose up to 120 days
Title
Incidence of Grade 3-4 Laboratory Abnormalities in Cohort D
Description
Specific laboratory abnormalities (worst grade).
Time Frame
From last dose up to 120 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0030
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Local Institution - 0009
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Local Institution - 0001
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Local Institution - 0002
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0025
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0041
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0008
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Local Institution - 0003
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Local Institution - 0040
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Local Institution - 0047
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Local Institution - 0005
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Local Institution - 0006
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Local Institution - 0004
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
Local Institution - 0007
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 0032
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Local Institution - 0031
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution - 0014
City
B-leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution - 0015
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution - 0046
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Local Institution - 0042
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution - 0044
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Local Institution - 0037
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Local Institution - 0036
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Local Institution - 0033
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Local Institution - 0034
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Local Institution - 0019
City
Bologna
ZIP/Postal Code
40126
Country
Italy
Facility Name
Local Institution - 0020
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution - 0035
City
Rozzano (milano)
ZIP/Postal Code
20089
Country
Italy
Facility Name
Local Institution - 0016
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Local Institution - 0038
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Local Institution - 0017
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Local Institution - 0022
City
Hospitalet Llobregat- Barcelona
ZIP/Postal Code
9908
Country
Spain
Facility Name
Local Institution - 0027
City
Majadahonda - Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Local Institution - 0023
City
Marbella
ZIP/Postal Code
29603
Country
Spain
Facility Name
Local Institution - 0043
City
Swansea
State/Province
Carmarthenshire
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Local Institution - 0012
City
Withington
State/Province
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution - 0026
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Local Institution - 0013
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32778827
Citation
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.
Results Reference
derived
PubMed Identifier
31112476
Citation
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.
Results Reference
derived
PubMed Identifier
29584546
Citation
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. Erratum In: J Clin Oncol. 2018 Sep 10;36(26):2748.
Results Reference
derived
PubMed Identifier
29394125
Citation
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PubMed Identifier
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Citation
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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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https://www.bmsstudyconnect.com/s/US/English/USenHome
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BMS Clinical Trial Patient Recruiting
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https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
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FDA Safety Alerts and Recalls

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

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