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

• ClinicalTrials.gov Identifier: NCT02181738
• Recruitment Status: Completed
• First Posted: July 4, 2014
• Results First Posted: December 11, 2018
• Last Update Posted: November 28, 2023
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

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.

Condition or disease	Intervention/treatment	Phase
Hodgkin Disease	Drug: Nivolumab; Drug: Doxorubicin; Drug: Vinblastine; Drug: Dacarbazine	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 294 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Non-Comparative, Multi-Cohort, Single Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Classical Hodgkin Lymphoma (cHL) Subjects
• Actual Study Start Date: August 12, 2014
• Actual Primary Completion Date: August 31, 2017
• Actual Study Completion Date: December 27, 2022

Arms and Interventions

Arm	Intervention/treatment
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	Drug: Nivolumab; Specified dose on specified days; Other Name: BMS-936558; Drug: Doxorubicin; Specified dose on specified days; Drug: Vinblastine; Specified dose on specified days; Drug: Dacarbazine; Specified dose on specified days

Outcome Measures

Primary Outcome Measures :

1. 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) ]

   ORR is the percent of participants achieving either a complete remission (CR) or partial remission (PR) 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 was required in all participants in lieu of bone marrow aspirate/ biopsy.

   CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment.

   PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment.

   Confidence interval based on Clopper-Pearson method.

2. Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D [ Time Frame: From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months) ]
   An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.

Secondary Outcome Measures :

1. Duration of Objective Response 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, or death whichever occurred first (up to approximately 100 months). ]

   DOR is the time from first response (complete remission (CR) or partial remission (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. For participants who neither progressed nor died, the DOR was censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy.

   CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment.

   PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment.

   Computed using Kaplan-Meier method.

2. Complete Remission (CR) Rate 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, or death whichever occurred first (up to approximately 100 months) ]

   The CR rate was defined as the percent of participants with a BOR of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment.

   Confidence interval based on Clopper-Pearson method.

3. Duration of Complete Remission (CR) Based on IRRC Assessments for Cohorts A, B, and C [ Time Frame: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months) ]

   The duration of CR was only evaluated in participants 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 (Any new lesion or increase by >=50% of previously involved sites from nadir) as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition.

   Computed using Kaplan-Meier method.

4. Partial Remission (PR) Rate 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, or death whichever occurred first (up to approximately 100 months) ]

   The PR rate was defined as the percent of participants with a BOR of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment.

   Confidence interval based on Clopper-Pearson method.

5. Duration of PR 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, or death whichever occurred first (up to approximately 100 months) ]

   The duration of PR was only evaluated in participants with BOR of PR and was defined as the time from first documentation of PR (regression of measurable disease and no new sites) to the date of initial objectively documented progression (any new lesion or increase by >=50% of previously involved sites from nadir) as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition.

   Computed using Kaplan-Meier method.

6. Objective Response Rates (ORR) Based on Investigator Assessments for Cohorts A, B, and C [ Time Frame: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months) ]

   ORR is the percent of participants achieving either a complete remission (CR) or partial remission (PR) 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 was required in all participants in lieu of bone marrow aspirate/ biopsy.

   CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment.

   PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment.

   Confidence interval based on Clopper-Pearson method.

7. Duration of Objective Response (DOR) Based on Investigator 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, or death whichever occurred first (up to approximately 100 months) ]

   DOR is the time from first response (complete remission (CR) or partial remission (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. For participants who neither progressed nor died, the DOR was censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy.

   CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment.

   PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment.

   Computed using Kaplan-Meier method.

8. Treatment Discontinuation Rate in Cohort D [ Time Frame: From first dose up until the date of treatment discontinuation (up to approximately 100 months). ]

   Treatment discontinuation rate (TDR) is the number of treated participants who received <4 doses of monotherapy or <12 doses of their assigned combination regimen. A participant is considered as having received an AVD/NAVD dose as soon as they received at least one drug of AVD/NAVD for the considered dose. Participants must have received at least one dose of Nivolumab during the combination therapy phase to be included in participants treated with NAVD. If a participant subsequently met Criteria to Resume Nivolumab Dosing, the combination of nivolumab and AVD could be used. Participants who underwent treatment beyond progression during the Monotherapy phase could use the combination of nivolumab and AVD if all 4 doses of nivolumab monotherapy are completed.

   Discontinuation can be due to any reason including, but not limited to, drug-related toxicity, diseases progression, or death.

9. Number of Participants Who Died in Cohort D [ Time Frame: From first dose of the considered therapy phase to 100 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 10 months up to a maximum of 13 months) ]
   Number of participants who died in Cohort D within 100 days after last dose of study therapy.
10. Number of Participants With Adverse Events (AEs) in Cohort D [ Time Frame: From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months) ]
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
11. Number of Participants With Serious Adverse Events (SAEs) in Cohort D [ Time Frame: From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months) ]
    A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
12. Number of Participants With AEs Leading to Discontinuation in Cohort D [ Time Frame: From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months) ]
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
13. Number of Participants With AEs Leading to Dose Delay in Cohort D [ Time Frame: From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months) ]
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
14. Number of Participants With Select AEs in Cohort D [ Time Frame: From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months) ]
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. 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.
15. Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase [ Time Frame: From first dose of monotherapy to 30 days after last dose of monotherapy phase (up to approximately 3 months) ]
    The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
16. Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase [ Time Frame: From first dose of the combination therapy to 30 days after last dose of combination therapy (an average of 8 months and a maximum of 11 months) ]
    The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
17. Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase [ Time Frame: From first dose of monotherapy to 30 days after last dose of monotherapy phase (up to approximately 3 months) ]
    The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase, AST = Aspartate Aminotransferase, ULN = Upper Limit of Normal.
18. Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Combination Therapy Phase [ Time Frame: From first dose of the combination therapy to 30 days after last dose of combination therapy (an average of 8 months and a maximum of 11 months) ]
    The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase, AST = Aspartate Aminotransferase, ULN = Upper Limit of Normal.
19. Complete Response (CR) Rate at Planned End of Therapy Based on IRRC Assessments in Cohort D [ Time Frame: From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months) ]

    CR rate is the percent of participants who show CR (disappearance of all evidence of disease) according to the 2007 IWG criteria at the planned end of study therapy radiographic tumor assessment.

    Confidence interval based on the Klopper and Pearson method.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Local Institution - 0030

Los Angeles, California, United States, 90048

Local Institution - 0009

Los Angeles, California, United States, 90095

United States, Georgia

Local Institution - 0001

Atlanta, Georgia, United States, 30322

United States, Massachusetts

Local Institution - 0002

Boston, Massachusetts, United States, 02215

Local Institution - 0025

Boston, Massachusetts, United States, 02215

Local Institution - 0041

Boston, Massachusetts, United States, 02215

United States, Michigan

Local Institution - 0008

Detroit, Michigan, United States, 48201

United States, Minnesota

Local Institution - 0003

Rochester, Minnesota, United States, 55905

United States, New Jersey

Local Institution - 0047

Hackensack, New Jersey, United States, 07601

United States, New York

Local Institution - 0040

Basking Ridge, New York, United States, 07920

Local Institution - 0005

New York, New York, United States, 10021

United States, Pennsylvania

Local Institution - 0006

Allentown, Pennsylvania, United States, 18103

United States, Tennessee

Local Institution - 0004

Nashville, Tennessee, United States, 37232-6307

United States, Texas

Local Institution - 0007

Houston, Texas, United States, 77030

Austria

Local Institution - 0032

Innsbruck, Austria, 6020

Local Institution - 0031

Wien, Austria, 1090

Belgium

Local Institution - 0014

B-leuven, Belgium, 3000

Local Institution - 0015

Gent, Belgium, 9000

Canada, British Columbia

Local Institution - 0046

Vancouver, British Columbia, Canada, V5Z 4E6

Canada, Ontario

Local Institution - 0042

Toronto, Ontario, Canada, M5G 2M9

Czechia

Local Institution - 0044

Praha 2, Czechia, 128 08

Germany

Local Institution - 0037

Berlin, Germany, 10117

Local Institution - 0036

Hamburg, Germany, 20099

Local Institution - 0033

Koeln, Germany, 50937

Local Institution - 0034

Ulm, Germany, 89081

Italy

Local Institution - 0019

Bologna, Italy, 40126

Local Institution - 0020

Napoli, Italy, 80131

Local Institution - 0035

Rozzano (milano), Italy, 20089

Netherlands

Local Institution - 0016

Amsterdam, Netherlands, 1066 CX

Local Institution - 0038

Groningen, Netherlands, 9713 GZ

Local Institution - 0017

Utrecht, Netherlands, 3584 CX

Spain

Local Institution - 0022

Hospitalet Llobregat- Barcelona, Spain, 9908

Local Institution - 0027

Majadahonda - Madrid, Spain, 28222

Local Institution - 0023

Marbella, Spain, 29603

United Kingdom

Local Institution - 0043

Swansea, Carmarthenshire, United Kingdom, SA2 8QA

Local Institution - 0012

Withington, Manchester, United Kingdom, M20 4BX

Local Institution - 0026

Oxford, Oxfordshire, United Kingdom, OX3 7LJ

Local Institution - 0013

Sutton, United Kingdom, SM2 5PT

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:

Study Protocol  [PDF] August 22, 2019

Statistical Analysis Plan  [PDF] June 8, 2018

More Information

Additional Information:

BMS Clinical Trial Information 

BMS Clinical Trial Patient Recruiting 

FDA Safety Alerts and Recalls 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

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.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02181738
• Other Study ID Numbers: CA209-205; 2014-001509-42 ( EudraCT Number )
• First Posted: July 4, 2014
• Results First Posted: December 11, 2018
• Last Update Posted: November 28, 2023
• Last Verified: November 2023

Additional relevant MeSH terms:

Hodgkin Disease; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Doxorubicin; Nivolumab; Dacarbazine; Vinblastine; Antibiotics, Antineoplastic; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Phytogenic; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators