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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02181738
First received: July 1, 2014
Last updated: August 23, 2016
Last verified: June 2016
  Purpose
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 subjects.

Condition Intervention Phase
Hodgkin Disease
Drug: Nivolumab
Drug: Doxorubicin
Drug: Vinblastine
Drug: Dacarbazine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Independent radiologic review committee (IRRC) assessed objective response rate (ORR) [ Time Frame: Up to one year after last patient first treatment ] [ Designated as safety issue: No ]
    Number of subjects with a best overall response (BOR) of CR or PR, according to the 2007 International Working Group (IWG) criteria, based on Independent Radiographic Review Committee assessment, divided by the number of treated subjects

  • proportion of subjects who experienced at least one treatment-related Grade 3 5 AEs (per NCI CTCAE version 4.0 criteria, any PT term) with an onset date after or on the first dose date and no later than 30 days after the last study dose date [ Time Frame: Approximately 10 months after last cohort D patient first treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of response (DOR) [ Time Frame: Up to one year after last patient first treatment ] [ Designated as safety issue: No ]
    DOR is defined as the time from first response (CR or PR) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurs first

  • Complete remission (CR) rate [ Time Frame: Up to one year after last patient first treatment ] [ Designated as safety issue: No ]
    CR rate is 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

  • CR duration [ Time Frame: Up to one year after last patient first treatment ] [ Designated as safety issue: No ]
    CR duration is defined as the time from first documentation of CR to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurs first

  • Partial remission (PR) rate [ Time Frame: Up to one year after last patient first treatment ] [ Designated as safety issue: No ]
    PR rate is 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

  • PR duration [ Time Frame: Up to one year after last patient first treatment ] [ Designated as safety issue: No ]
    PR duration is 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 occurs first

  • Investigator-assessed ORR [ Time Frame: Up to one year after last patient first treatment ] [ Designated as safety issue: No ]
    Investigator-assessed ORR is defined similarly as described for ORR per IRRC assessment above, but will be assessed per investigator

  • Investigator-assessed DOR [ Time Frame: Up to one year after last patient first treatment ] [ Designated as safety issue: No ]
    DOR is defined similarly as described for DOR per IRRC assessment above, but will be assessed per investigator

  • Treatment discontinuation rate, defined by the number of subjects who were treated with fewer than 12 doses [ Time Frame: Approximately 10 months after last cohort D patient first treatment ] [ Designated as safety issue: Yes ]
  • Treatment discontinuation rate of nivolumab monotherapy [ Time Frame: Approximately 10 months after last cohort D patient first treatment ] [ Designated as safety issue: Yes ]
  • Treatment discontinuation rate of the Nivolumab-AVD combination therapy [ Time Frame: Approximately 10 months after last cohort D patient first treatment ] [ Designated as safety issue: Yes ]
  • Treatment discontinuation rate of the combination therapy [ Time Frame: Approximately 10 months after last cohort D patient first treatment ] [ Designated as safety issue: Yes ]
  • Incidence of treatment related grade 3-5 AEs during the monotherapy phase [ Time Frame: Approximately 10 months after last cohort D patient first treatment ] [ Designated as safety issue: Yes ]
  • Incidence of treatment related grade 3-5 AEs during the combination phase [ Time Frame: Approximately 10 months after last cohort D patient first treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 294
Study Start Date: July 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nivolumab (Cohort A, B, C and D)

Cohort (A, B, C): Nivolumab: IV injection 3 mg/kg every 2 weeks

Cohort (D): Nivolumab: IV injection 240 mg every 2 weeks + Doxorubicin: 25 mg/m² + Vinblastine: 6 mg/m² + Dacarbazine 375 mg/m²

Drug: Nivolumab
Other Name: BMS-936558
Drug: Doxorubicin Drug: Vinblastine Drug: Dacarbazine

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 - enrolment closed)
  • Subjects may be Brentuximab vedotin- naïve, or may have had prior Brentuximab vedotin treatment (cohort A, B & C - enrolment closed)
  • Newly diagnosed and previously untreated classical Hodgkin Lymphoma (cohort D)

Exclusion Criteria:

  • Known central nervous system lymphoma
  • Subjects 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02181738

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 38 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02181738     History of Changes
Other Study ID Numbers: CA209-205  2014-001509-42 
Study First Received: July 1, 2014
Last Updated: August 23, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Hodgkin Disease
Nivolumab
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Liposomal doxorubicin
Vinblastine
Antibodies, Monoclonal
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 25, 2016