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An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma

Primary Purpose

Non-Hodgkin's Lymphoma, Hodgkin Lymphoma, Multiple Myeloma

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Ipilimumab
Lirilumab
Daratumumab
Pomalidomide
Dexamethasone
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma

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:

  • Have received at least 3 prior lines of therapy, including a proteasome inhibitor [PI] and an immunomodulatory agent [IMiD] OR have disease that is double refractory to a PI and IMiD
  • More than 12 weeks post-transplant of your own blood forming stem cells (autologous transplant)
  • Have detectable disease measured by a specific protein in your blood and/or urine
  • Must consent to bone marrow aspirate or biopsy.

Exclusion Criteria:

  • Solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia, or monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, POEMS syndrome or active plasma cell leukemia
  • Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti CTLA 4, or anti-CD38 antibody, or allogeneic stem cell transplantation
  • Seropositive for human immunodeficiency virus (HIV), Hepatitis B surface antigen or Hepatitis C antibody positive (except if HCV-RNA negative), or history of active chronic hepatitis B or C
  • History of central nervous system involvement or symptoms suggestive of central nervous system involvement by multiple myeloma

Other protocol defined inclusion/exclusion criteria could apply

Sites / Locations

  • Local Institution - 0035
  • Division Of Hematology & Oncology Ctr. For Health Sciences
  • Local Institution - 0012
  • Local Institution - 0017
  • Yale University School Of Medicine
  • Local Institution - 0023
  • Local Institution - 0037
  • Local Institution - 0019
  • Local Institution - 0018
  • Local Institution - 0003
  • The Sidney Kimmel Comprehensive Cancer Center
  • Dana-Farber Cancer Institute
  • Local Institution - 0009
  • Local Institution - 0015
  • Local Institution - 0011
  • University Of Michigan Health System
  • Local Institution - 0002
  • Mayo Clinic
  • Local Institution - 0033
  • John Theurer Cancer Center
  • Local Institution - 0014
  • Local Institution - 0001
  • Memorial Sloan Kettering Cancer Center
  • Local Institution - 0028
  • Local Institution - 0006
  • OHSU Center for Hematologic Malignancies
  • Abramson Cancer Center
  • Local Institution - 0007
  • Fox Chase Cancer Center
  • Local Institution - 0004
  • Huntsman Cancer Institute At The Univ. Of Utah
  • Local Institution - 0005
  • Local Institution - 0045
  • Local Institution - 0047
  • Local Institution
  • Local Institution - 0043
  • Local Institution - 0044
  • Local Institution - 0039
  • Local Institution
  • Local Institution
  • Local Institution - 0040
  • Local Institution - 0049
  • Local Institution - 0042

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Nivolumab monotherapy (Dose Escalation)

Nivolumab + Ipilimumab

Nivolumab + Lirilumab

Nivo + Dara + Pom + Dexa vs. Nivo + Dara

Daratumumab vs. Nivolumab + Daratumumab

Arm Description

Nivolumab solution intravenously as specified Non-randomized Enrollment is closed for this cohort

Nivolumab and Ipilimumab solution intravenously as specified Non-randomized Enrollment is closed for this cohort

Non-randomized Nivolumab: 3 mg/kg given every 2 weeks Lirilumab: 3 mg/kg given every 4 weeks Enrollment is closed for this cohort

Randomized Nivolumab: Cycle 1: 240 mg Day 15 Cycle 2-6: 240 mg Days 1, 15 Cycle 7 & beyond: 480 mg Day 1 Daratumumab: Cycle 1-2: 16 mg/kg Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg Days 1, 15 Cycle 7 & beyond: 16 mg/kg Day 1 Pomalidomide: 4 mg po (by mouth) daily on Days 1 - 21 of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing: 40 mg po daily (Days 1, 8, 15, 22) of each 28-day cycle for participants ≤ 75 years old 20 mg po daily (Days 1, 8, 15, 22) of each 28-day cycle for participants > 75 years old Weeks with daratumumab dosing: 20 mg iv before the daratumumab infusion and 20 mg po after the daratumumab infusion in participants ≤ 75 years old 16 mg iv before the daratumumab infusion and 4 mg po after the daratumumab infusion in participants > 75 years old Enrollment is closed for this cohort

Randomized Nivolumab: Cycle 1: 240 mg Day 15 Cycle 2 & beyond: 480 mg Day 1 Daratumumab: Cycle 1-2: 16 mg/kg Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg Days 1, 15 Cycle 7 & beyond: 16 mg/kg Day 1

Outcomes

Primary Outcome Measures

Number of Participants That Experienced Drug Related Grade 3-4 AEs
Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug.
Number of Participants That Experienced Drug Related Grade 3-4 SAEs
Number and percent of participants that experienced drug related Grade 3-4 SAEs occurring up to 100 days after the last dose of study drug.
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver
Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug.
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid
Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort
Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort
Number of Participants That Experience Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid

Secondary Outcome Measures

Best Overall Response
the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Response and Partial Response
Best Overall Response - Multiple Myeloma Group
the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy.
Duration of Response
the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Remission and Partial Remission
Duration of Response - Multiple Myeloma Group
the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Response and Partial Response
Progression Free Survival
Progression free survival (PFS) is defined as the time between date of randomization and date of progression or death, whichever occurs first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Subjects who did not progress or die were censored on the date of their last efficacy assessment.
Progression Free Survival Rate
The percentage of participants remaining progression free at the specified timepoints (up to 48 Months)
Overall Survival
The percentage of participants remaining alive. Median values are computed using Kaplan-Meier method
Number of Participants With PD-L1 Expression
Number of Participants with PD-L1 expression in the following categories baseline PD-L1 expression ≥ 1% baseline PD-L1 expression < 1% without PD-L1 quantifiable at baseline
Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score
mSWAT is a scoring technique involving the direct assessment of the percentage of body-surface-area (BSA) affected by skin lesions. There are 12 body regions (each one assigned a different percentage of BSA). For each body region, the assigned BSA percentage is multiplied by a factor weighing the type and severity of lesion observed (patch= x1, plaque = x2, tumor= x4). The sum of the individual body region sub-scores is then summed to generate the final mSWAT score, which ranges from 0 (best outcome) to 400 (worst outcome).
Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort
Time to MRD Negativity status in specific NGS and NGF sensitivity levels
Objective Response Rate in the Nivolumab + Daratumumab Cohort
Duration of Response in the Nivolumab + Daratumumab Cohort
Progression Free Survival in the Nivolumab + Daratumumab Cohort
Cmax in the Nivolumab + Daratumumab Cohort
Maximum observed serum concentration
Tmax in the Nivolumab + Daratumumab Cohort
Time of maximum observed serum concentration
Cmin in the Nivolumab + Daratumumab Cohort
Serum concentration achieved at the end of dosing interval (trough concentration)
AUC (0-T) in the Nivolumab + Daratumumab Cohort
Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration
AUC (TAU) in the Nivolumab + Daratumumab Cohort
Area under the concentration-time curve in one dosing interval
End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort
Serum concentration achieved at the end of study drug infusion

Full Information

First Posted
May 3, 2012
Last Updated
September 11, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Janssen, LP
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1. Study Identification

Unique Protocol Identification Number
NCT01592370
Brief Title
An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma
Official Title
Multiple Phase 1/2 Cohorts of Nivolumab Monotherapy or Nivolumab Combination Regimens Across Relapsed/Refractory Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2, 2012 (Actual)
Primary Completion Date
September 25, 2020 (Actual)
Study Completion Date
December 22, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.
Detailed Description
NOTE: Currently, this study is only open to nivolumab+daratumumab vs daratumumab monotherapy in multiple myeloma patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Hodgkin Lymphoma, Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
316 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab monotherapy (Dose Escalation)
Arm Type
Experimental
Arm Description
Nivolumab solution intravenously as specified Non-randomized Enrollment is closed for this cohort
Arm Title
Nivolumab + Ipilimumab
Arm Type
Experimental
Arm Description
Nivolumab and Ipilimumab solution intravenously as specified Non-randomized Enrollment is closed for this cohort
Arm Title
Nivolumab + Lirilumab
Arm Type
Experimental
Arm Description
Non-randomized Nivolumab: 3 mg/kg given every 2 weeks Lirilumab: 3 mg/kg given every 4 weeks Enrollment is closed for this cohort
Arm Title
Nivo + Dara + Pom + Dexa vs. Nivo + Dara
Arm Type
Experimental
Arm Description
Randomized Nivolumab: Cycle 1: 240 mg Day 15 Cycle 2-6: 240 mg Days 1, 15 Cycle 7 & beyond: 480 mg Day 1 Daratumumab: Cycle 1-2: 16 mg/kg Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg Days 1, 15 Cycle 7 & beyond: 16 mg/kg Day 1 Pomalidomide: 4 mg po (by mouth) daily on Days 1 - 21 of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing: 40 mg po daily (Days 1, 8, 15, 22) of each 28-day cycle for participants ≤ 75 years old 20 mg po daily (Days 1, 8, 15, 22) of each 28-day cycle for participants > 75 years old Weeks with daratumumab dosing: 20 mg iv before the daratumumab infusion and 20 mg po after the daratumumab infusion in participants ≤ 75 years old 16 mg iv before the daratumumab infusion and 4 mg po after the daratumumab infusion in participants > 75 years old Enrollment is closed for this cohort
Arm Title
Daratumumab vs. Nivolumab + Daratumumab
Arm Type
Experimental
Arm Description
Randomized Nivolumab: Cycle 1: 240 mg Day 15 Cycle 2 & beyond: 480 mg Day 1 Daratumumab: Cycle 1-2: 16 mg/kg Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg Days 1, 15 Cycle 7 & beyond: 16 mg/kg Day 1
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, Opdivo
Intervention Description
Administered by intravenous (IV) infusion
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy, BMS-734016, MDX010
Intervention Description
Administered by IV infusion
Intervention Type
Biological
Intervention Name(s)
Lirilumab
Other Intervention Name(s)
BMS-986015
Intervention Description
Administered by IV infusion
Intervention Type
Biological
Intervention Name(s)
Daratumumab
Other Intervention Name(s)
Darzalex
Intervention Description
Administered by IV infusion
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Other Intervention Name(s)
Pomalyst
Intervention Description
Administered PO
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Intensol
Intervention Description
Administered PO and by IV infusion
Primary Outcome Measure Information:
Title
Number of Participants That Experienced Drug Related Grade 3-4 AEs
Description
Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug.
Time Frame
Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Title
Number of Participants That Experienced Drug Related Grade 3-4 SAEs
Description
Number and percent of participants that experienced drug related Grade 3-4 SAEs occurring up to 100 days after the last dose of study drug.
Time Frame
Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Title
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver
Description
Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug.
Time Frame
Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Title
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid
Time Frame
Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Title
Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort
Time Frame
approximately up to 4 years
Title
Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort
Time Frame
approximately up to 4 years
Title
Number of Participants That Experience Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort
Time Frame
approximately up to 4 years
Title
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology
Time Frame
approximately up to 4 years
Title
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver
Time Frame
approximately up to 4 years
Title
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid
Time Frame
approximately up to 4 years
Secondary Outcome Measure Information:
Title
Best Overall Response
Description
the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Response and Partial Response
Time Frame
Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Title
Best Overall Response - Multiple Myeloma Group
Description
the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy.
Time Frame
Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Title
Duration of Response
Description
the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Remission and Partial Remission
Time Frame
Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to approximately 37 months Nivo Liri: approximately up to 4 years 1 month
Title
Duration of Response - Multiple Myeloma Group
Description
the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Response and Partial Response
Time Frame
Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Title
Progression Free Survival
Description
Progression free survival (PFS) is defined as the time between date of randomization and date of progression or death, whichever occurs first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Subjects who did not progress or die were censored on the date of their last efficacy assessment.
Time Frame
From date of randomization to date of progression or death, whichever occurs first (up to approximately 24 months)
Title
Progression Free Survival Rate
Description
The percentage of participants remaining progression free at the specified timepoints (up to 48 Months)
Time Frame
From randomization to the specified timepoints (up to 48 months)
Title
Overall Survival
Description
The percentage of participants remaining alive. Median values are computed using Kaplan-Meier method
Time Frame
Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to3 years Nivo Liri: approximately up to 4 years 1 month
Title
Number of Participants With PD-L1 Expression
Description
Number of Participants with PD-L1 expression in the following categories baseline PD-L1 expression ≥ 1% baseline PD-L1 expression < 1% without PD-L1 quantifiable at baseline
Time Frame
At baseline (prior to start of study treatment)
Title
Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score
Description
mSWAT is a scoring technique involving the direct assessment of the percentage of body-surface-area (BSA) affected by skin lesions. There are 12 body regions (each one assigned a different percentage of BSA). For each body region, the assigned BSA percentage is multiplied by a factor weighing the type and severity of lesion observed (patch= x1, plaque = x2, tumor= x4). The sum of the individual body region sub-scores is then summed to generate the final mSWAT score, which ranges from 0 (best outcome) to 400 (worst outcome).
Time Frame
From baseline (last measurement before start of study treatment) to last available measurement after start of study treatment (88 weeks for Nivo mono, 93 weeks for nivo+ipi, 25 weeks for nivo+liri)
Title
Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort
Description
Time to MRD Negativity status in specific NGS and NGF sensitivity levels
Time Frame
approximately up to 4 years
Title
Objective Response Rate in the Nivolumab + Daratumumab Cohort
Time Frame
approximately up to 4 years
Title
Duration of Response in the Nivolumab + Daratumumab Cohort
Time Frame
approximately up to 4 years
Title
Progression Free Survival in the Nivolumab + Daratumumab Cohort
Time Frame
approximately up to 4 years
Title
Cmax in the Nivolumab + Daratumumab Cohort
Description
Maximum observed serum concentration
Time Frame
approximately up to 4 years
Title
Tmax in the Nivolumab + Daratumumab Cohort
Description
Time of maximum observed serum concentration
Time Frame
approximately up to 4 years
Title
Cmin in the Nivolumab + Daratumumab Cohort
Description
Serum concentration achieved at the end of dosing interval (trough concentration)
Time Frame
approximately up to 4 years
Title
AUC (0-T) in the Nivolumab + Daratumumab Cohort
Description
Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration
Time Frame
approximately up to 4 years
Title
AUC (TAU) in the Nivolumab + Daratumumab Cohort
Description
Area under the concentration-time curve in one dosing interval
Time Frame
approximately up to 4 years
Title
End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort
Description
Serum concentration achieved at the end of study drug infusion
Time Frame
Measurements collected at cycles 1, 2, 3, 5, 7, and 11; each cycle is 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Have received at least 3 prior lines of therapy, including a proteasome inhibitor [PI] and an immunomodulatory agent [IMiD] OR have disease that is double refractory to a PI and IMiD More than 12 weeks post-transplant of your own blood forming stem cells (autologous transplant) Have detectable disease measured by a specific protein in your blood and/or urine Must consent to bone marrow aspirate or biopsy. Exclusion Criteria: Solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia, or monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, POEMS syndrome or active plasma cell leukemia Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti CTLA 4, or anti-CD38 antibody, or allogeneic stem cell transplantation Seropositive for human immunodeficiency virus (HIV), Hepatitis B surface antigen or Hepatitis C antibody positive (except if HCV-RNA negative), or history of active chronic hepatitis B or C History of central nervous system involvement or symptoms suggestive of central nervous system involvement by multiple myeloma Other protocol defined inclusion/exclusion criteria could apply
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 - 0035
City
Clovis
State/Province
California
ZIP/Postal Code
93611
Country
United States
Facility Name
Division Of Hematology & Oncology Ctr. For Health Sciences
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Local Institution - 0012
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Local Institution - 0017
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Local Institution - 0023
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Local Institution - 0037
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Local Institution - 0019
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Local Institution - 0018
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Local Institution - 0003
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
The Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0009
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0015
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0011
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University Of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Local Institution - 0002
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Local Institution - 0033
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
John Theurer Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Local Institution - 0014
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Local Institution - 0001
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Local Institution - 0028
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Local Institution - 0006
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
OHSU Center for Hematologic Malignancies
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Local Institution - 0007
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Local Institution - 0004
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Huntsman Cancer Institute At The Univ. Of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Local Institution - 0005
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Local Institution - 0045
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution - 0047
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Local Institution
City
Yvoir
ZIP/Postal Code
B-5530
Country
Belgium
Facility Name
Local Institution - 0043
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Facility Name
Local Institution - 0044
City
Nantes Cedex 1
ZIP/Postal Code
44000
Country
France
Facility Name
Local Institution - 0039
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Local Institution
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Local Institution
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Local Institution - 0040
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Local Institution - 0049
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Local Institution - 0042
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27269947
Citation
Lesokhin AM, Ansell SM, Armand P, Scott EC, Halwani A, Gutierrez M, Millenson MM, Cohen AD, Schuster SJ, Lebovic D, Dhodapkar M, Avigan D, Chapuy B, Ligon AH, Freeman GJ, Rodig SJ, Cattry D, Zhu L, Grosso JF, Bradley Garelik MB, Shipp MA, Borrello I, Timmerman J. Nivolumab in Patients With Relapsed or Refractory Hematologic Malignancy: Preliminary Results of a Phase Ib Study. J Clin Oncol. 2016 Aug 10;34(23):2698-704. doi: 10.1200/JCO.2015.65.9789. Epub 2016 Jun 6.
Results Reference
derived
PubMed Identifier
25482239
Citation
Ansell SM, Lesokhin AM, Borrello I, Halwani A, Scott EC, Gutierrez M, Schuster SJ, Millenson MM, Cattry D, Freeman GJ, Rodig SJ, Chapuy B, Ligon AH, Zhu L, Grosso JF, Kim SY, Timmerman JM, Shipp MA, Armand P. PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. N Engl J Med. 2015 Jan 22;372(4):311-9. doi: 10.1056/NEJMoa1411087. Epub 2014 Dec 6.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form

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An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma

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