An Investigational Immuno-Therapy Study to Determine the... | NCT01592370 | Trialant
NCT01592370
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Oct 22, 2025Actual
Enrollment
320Actual
Phase
Phase 1Phase 2
Conditions
Non-Hodgkin's Lymphoma
Hodgkin Lymphoma
Multiple Myeloma
Interventions
Nivolumab
Ipilimumab
Lirilumab
Daratumumab
Pomalidomide
Dexamethasone
Countries
United States
Belgium
France
Greece
Italy
Poland
Protocol Section
Identification Module
NCT ID
NCT01592370
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA209-039
Secondary IDs
ID
Type
Description
Link
2018-001030-17
EudraCT Number
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
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2, 2012Actual
Primary Completion Date
Sep 25, 2020Actual
Completion Date
Jul 9, 2024Actual
First Submitted Date
May 3, 2012
First Submission Date that Met QC Criteria
May 4, 2012
First Posted Date
May 7, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 24, 2021
Results First Submitted that Met QC Criteria
Jan 27, 2022
Results First Posted Date
Feb 17, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 6, 2025
Last Update Posted Date
Oct 22, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Name
Class
Janssen, LP
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Non-Hodgkin's Lymphoma
Hodgkin Lymphoma
Multiple Myeloma
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
320Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Nivolumab monotherapy (Dose Escalation)
Experimental
Nivolumab solution intravenously as specified
Non-randomized
Enrollment is closed for this cohort
Biological: Nivolumab
Nivolumab + Ipilimumab
Experimental
Nivolumab and Ipilimumab solution intravenously as specified
Non-randomized
Enrollment is closed for this cohort
Biological: Nivolumab
Biological: Ipilimumab
Nivolumab + Lirilumab
Experimental
Non-randomized
Nivolumab: 3 mg/kg given every 2 weeks Lirilumab: 3 mg/kg given every 4 weeks
Enrollment is closed for this cohort
Biological: Nivolumab
Biological: Lirilumab
Nivo + Dara + Pom + Dexa vs. Nivo + Dara
Experimental
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
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Nivolumab
Biological
Administered by intravenous (IV) infusion
Daratumumab vs. Nivolumab + Daratumumab
Nivo + Dara + Pom + Dexa vs. Nivo + Dara
Nivolumab + Ipilimumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
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
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.
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
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.
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
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid
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
Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort
approximately up to 4 years
Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort
approximately up to 4 years
Secondary Outcomes
Measure
Description
Time Frame
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
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
Other Outcomes
Not provided
Eligibility Module
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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Local Institution - 0035
Clovis
California
93611
United States
Division Of Hematology & Oncology Ctr. For Health Sciences
For the phase 1 nivo monotherapy dose escalation included in this study, it was derived from CA209-003. It was concluded that 3mg/kg of nivolumab would be used for the dose expansion phase 2 of this study (CA209-039) based on the conclusions derived from CA209-003.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
FG001
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
= Number of participants randomized
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 23, 2019
Sep 24, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Biological: Nivolumab
Biological: Daratumumab
Drug: Pomalidomide
Drug: Dexamethasone
Daratumumab vs. Nivolumab + Daratumumab
Experimental
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
Biological: Nivolumab
Biological: Daratumumab
Nivolumab + Lirilumab
Nivolumab monotherapy (Dose Escalation)
BMS-936558
Opdivo
Ipilimumab
Biological
Administered by IV infusion
Nivolumab + Ipilimumab
Yervoy
BMS-734016
MDX010
Lirilumab
Biological
Administered by IV infusion
Nivolumab + Lirilumab
BMS-986015
Daratumumab
Biological
Administered by IV infusion
Daratumumab vs. Nivolumab + Daratumumab
Nivo + Dara + Pom + Dexa vs. Nivo + Dara
Darzalex
Pomalidomide
Drug
Administered PO
Nivo + Dara + Pom + Dexa vs. Nivo + Dara
Pomalyst
Dexamethasone
Drug
Administered PO and by IV infusion
Nivo + Dara + Pom + Dexa vs. Nivo + Dara
Intensol
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology
approximately up to 4 years
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver
approximately up to 4 years
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid
approximately up to 4 years
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.
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
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
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
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
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
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.
From date of randomization to date of progression or death, whichever occurs first (up to approximately 24 months)
Progression Free Survival Rate
The percentage of participants remaining progression free at the specified timepoints (up to 48 Months)
From randomization to the specified timepoints (up to 48 months)
Overall Survival
The percentage of participants remaining alive. Median values are computed using Kaplan-Meier method
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
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
At baseline (prior to start of study treatment)
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).
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)
Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort
Time to MRD Negativity status in specific NGS and NGF sensitivity levels
approximately up to 4 years
Objective Response Rate in the Nivolumab + Daratumumab Cohort
approximately up to 4 years
Duration of Response in the Nivolumab + Daratumumab Cohort
approximately up to 4 years
Progression Free Survival in the Nivolumab + Daratumumab Cohort
approximately up to 4 years
Cmax in the Nivolumab + Daratumumab Cohort
Maximum observed serum concentration
approximately up to 4 years
Tmax in the Nivolumab + Daratumumab Cohort
Time of maximum observed serum concentration
approximately up to 4 years
Cmin in the Nivolumab + Daratumumab Cohort
Serum concentration achieved at the end of dosing interval (trough concentration)
approximately up to 4 years
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
approximately up to 4 years
AUC (TAU) in the Nivolumab + Daratumumab Cohort
Area under the concentration-time curve in one dosing interval
approximately up to 4 years
End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort
Serum concentration achieved at the end of study drug infusion
Measurements collected at cycles 1, 2, 3, 5, 7, and 11; each cycle is 28 days
Los Angeles
California
90095
United States
Local Institution - 0012
Los Angeles
California
90095
United States
Local Institution - 0017
Aurora
Colorado
80045
United States
Local Institution - 013
New Haven
Connecticut
06520
United States
Local Institution - 0023
Orlando
Florida
32804
United States
Local Institution - 0037
Skokie
Illinois
60077
United States
Local Institution - 0019
Indianapolis
Indiana
46202
United States
Local Institution - 0018
Westwood
Kansas
66205
United States
Local Institution - 0003
Baltimore
Maryland
21231
United States
The Sidney Kimmel Comprehensive Cancer Center
Baltimore
Maryland
21231
United States
Dana-Farber Cancer Institute
Boston
Massachusetts
02215
United States
Local Institution - 0009
Boston
Massachusetts
02215
United States
Local Institution - 0015
Boston
Massachusetts
02215
United States
Local Institution - 0011
Ann Arbor
Michigan
48109
United States
University Of Michigan Health System
Ann Arbor
Michigan
48109
United States
Local Institution - 0002
Rochester
Minnesota
55905
United States
Mayo Clinic
Rochester
Minnesota
55905
United States
Local Institution - 0033
Omaha
Nebraska
68130
United States
John Theurer Cancer Center
Hackensack
New Jersey
07601
United States
Local Institution - 0014
Hackensack
New Jersey
07601
United States
Local Institution - 0001
New York
New York
10065
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Local Institution - 0028
Columbus
Ohio
43210
United States
Local Institution - 0006
Portland
Oregon
97239
United States
OHSU Center for Hematologic Malignancies
Portland
Oregon
97239
United States
Abramson Cancer Center
Philadelphia
Pennsylvania
19104
United States
Local Institution - 0007
Philadelphia
Pennsylvania
19104
United States
Fox Chase Cancer Center
Philadelphia
Pennsylvania
19111
United States
Local Institution - 0004
Philadelphia
Pennsylvania
19111
United States
Huntsman Cancer Institute At The Univ. Of Utah
Salt Lake City
Utah
84112
United States
Local Institution - 0005
Salt Lake City
Utah
84112
United States
Local Institution - 0045
Ghent
9000
Belgium
Local Institution - 0047
Sint-Niklaas
9100
Belgium
Local Institution
Yvoir
B-5530
Belgium
Local Institution - 0043
Poitiers
Vienne
86021
France
Local Institution - 0044
Nantes
44000
France
Local Institution - 0039
Athens
11528
Greece
Local Institution
Bologna
40138
Italy
Local Institution
Chorzów
41-500
Poland
Local Institution - 0040
Poznan
61-848
Poland
Local Institution - 0049
Warsaw
02-776
Poland
Local Institution - 0042
Wroclaw
50-367
Poland
Derived
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.
All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00045
BG00128
BG002
Ethnicity (NIH/OMB)
All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00013
BG0013
Race (NIH/OMB)
All treated participants for Nivo mono, Nivo + Ipi , Nivo + Liri and all randomized participants for Nivo Dara
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
All Treated Participants
Posted
Count of Participants
Participants
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
ID
Title
Description
OG000
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
OG001
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
OG002
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Units
Counts
Participants
OG000105
OG00165
OG00272
Title
Denominators
Categories
Title
Measurements
OG00019
OG00118
OG0020
Primary
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.
All Treated Participants
Posted
Count of Participants
Participants
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
ID
Title
Description
OG000
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
OG001
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
OG002
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Units
Counts
Participants
Primary
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.
All Treated Participants
Posted
Count of Participants
Participants
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
ID
Title
Description
OG000
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
OG001
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
OG002
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Units
Counts
Participants
Primary
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid
All Treated Participants
Posted
Count of Participants
Participants
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
ID
Title
Description
OG000
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
OG001
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
OG002
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Units
Counts
Participants
OG000
Primary
Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort
All treated participants in the nivo dara cohort
Posted
Count of Participants
Participants
approximately up to 4 years
ID
Title
Description
OG000
Nivolumab + Daratumumab_Cohort A1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Pomalidomide:
4 mg po daily (Days 1-21) of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old
OG001
Nivolumab + Daratumumab_Cohort A2
ND-Pd Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
OG002
Nivolumab + Daratumumab_Cohort B1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Primary
Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort
All treated participants in the nivo dara cohort
Posted
Count of Participants
Participants
approximately up to 4 years
ID
Title
Description
OG000
Nivolumab + Daratumumab_Cohort A1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Pomalidomide:
4 mg po daily (Days 1-21) of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old
OG001
Nivolumab + Daratumumab_Cohort A2
ND-Pd Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
OG002
Nivolumab + Daratumumab_Cohort B1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Primary
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology
All treated participants in the nivo dara cohort
Posted
Count of Participants
Participants
approximately up to 4 years
ID
Title
Description
OG000
Nivolumab + Daratumumab_Cohort A1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Pomalidomide:
4 mg po daily (Days 1-21) of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old
OG001
Nivolumab + Daratumumab_Cohort A2
ND-Pd Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
OG002
Nivolumab + Daratumumab_Cohort B1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Primary
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver
All treated participants in the nivo dara cohort
Posted
Count of Participants
Participants
approximately up to 4 years
ID
Title
Description
OG000
Nivolumab + Daratumumab_Cohort A1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Pomalidomide:
4 mg po daily (Days 1-21) of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old
OG001
Nivolumab + Daratumumab_Cohort A2
ND-Pd Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
OG002
Nivolumab + Daratumumab_Cohort B1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Primary
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid
All treated participants in the nivo dara cohort with at Least One On-Treatment TSH Measurement
Posted
Count of Participants
Participants
approximately up to 4 years
ID
Title
Description
OG000
Nivolumab + Daratumumab_Cohort A1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Pomalidomide:
4 mg po daily (Days 1-21) of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old
OG001
Nivolumab + Daratumumab_Cohort A2
ND-Pd Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
OG002
Nivolumab + Daratumumab_Cohort B1
Secondary
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
All treated participants with available measurements (excluding Multiple Myeloma (MM) Group)
Posted
Number
95% Confidence Interval
Percentage of participants
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
ID
Title
Description
OG000
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
OG001
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
OG002
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Units
Counts
Participants
Secondary
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.
All Treated participants with available measurements in the Multiple Myeloma (MM) Group
Posted
Number
95% Confidence Interval
Percentage
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
ID
Title
Description
OG000
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
OG001
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
OG002
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Units
Counts
Participants
Secondary
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
All Responding participants (Complete Response and Partial Response) with available measurements (excluding Multiple Myeloma (MM) Group)
Posted
Median
Full Range
Months
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
ID
Title
Description
OG000
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
OG001
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
OG002
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Units
Counts
Secondary
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
All Responding participants (Complete Response and Partial Response) in the Multiple Myeloma (MM) Group
Posted
Median
Full Range
Months
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
ID
Title
Description
OG000
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
OG001
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
OG002
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Units
Counts
Participants
Secondary
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.
All Treated Participants with available measurements
Posted
Median
95% Confidence Interval
Months
From date of randomization to date of progression or death, whichever occurs first (up to approximately 24 months)
ID
Title
Description
OG000
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
OG001
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
OG002
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Units
Counts
Secondary
Progression Free Survival Rate
The percentage of participants remaining progression free at the specified timepoints (up to 48 Months)
All Treated Participants with available measurements
Posted
Number
95% Confidence Interval
Percentage of Participants
From randomization to the specified timepoints (up to 48 months)
ID
Title
Description
OG000
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
OG001
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
OG002
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Units
Counts
Participants
OG000
Secondary
Overall Survival
The percentage of participants remaining alive. Median values are computed using Kaplan-Meier method
All Treated Participants with available measurements
Posted
Median
95% Confidence Interval
Months
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
ID
Title
Description
OG000
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
OG001
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
OG002
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Units
Counts
Participants
Secondary
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
All Treated Participants
Posted
Number
Number of Participants
At baseline (prior to start of study treatment)
ID
Title
Description
OG000
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
OG001
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
OG002
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
Units
Counts
Participants
Secondary
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).
All Treated Participants with cutaneous T Cell lymphoma and available measurements
Posted
Mean
Standard Deviation
Percent of change from baseline
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)
ID
Title
Description
OG000
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
OG001
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
OG002
Nivolumab + Lirilumab
Secondary
Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort
Time to MRD Negativity status in specific NGS and NGF sensitivity levels
All Randomized MRD Evaluable Subjects Achieving MRD Negativity
Posted
Mean
Standard Deviation
Months
approximately up to 4 years
ID
Title
Description
OG000
Cohort A-1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Pomalidomide:
4 mg po daily (Days 1-21) of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old
OG001
Cohort A-2
ND-Pd Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
OG002
Cohort B-1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Secondary
Objective Response Rate in the Nivolumab + Daratumumab Cohort
All randomized participants in the nivo dara cohort
Posted
Number
95% Confidence Interval
Percentage
approximately up to 4 years
ID
Title
Description
OG000
Cohort A-1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Pomalidomide:
4 mg po daily (Days 1-21) of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old
OG001
Cohort A-2
ND-Pd Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
OG002
Cohort B-1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Secondary
Duration of Response in the Nivolumab + Daratumumab Cohort
All randomized participants in the nivo dara cohort
Posted
Median
95% Confidence Interval
Months
approximately up to 4 years
ID
Title
Description
OG000
Cohort A-1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Pomalidomide:
4 mg po daily (Days 1-21) of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old
OG001
Cohort A-2
ND-Pd Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
OG002
Cohort B-1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Secondary
Progression Free Survival in the Nivolumab + Daratumumab Cohort
All randomized participants in the nivo dara cohort
Posted
Median
95% Confidence Interval
Months
approximately up to 4 years
ID
Title
Description
OG000
Cohort A-1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Pomalidomide:
4 mg po daily (Days 1-21) of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old
OG001
Cohort A-2
ND-Pd Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
OG002
Cohort B-1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Secondary
Cmax in the Nivolumab + Daratumumab Cohort
Maximum observed serum concentration
All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0
Posted
approximately up to 4 years
ID
Title
Description
OG000
Cohort A-1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Pomalidomide:
4 mg po daily (Days 1-21) of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old
OG001
Cohort A-2
ND-Pd Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Secondary
Tmax in the Nivolumab + Daratumumab Cohort
Time of maximum observed serum concentration
All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0
Posted
approximately up to 4 years
ID
Title
Description
OG000
Cohort A-1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Pomalidomide:
4 mg po daily (Days 1-21) of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old
OG001
Cohort A-2
ND-Pd Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Secondary
Cmin in the Nivolumab + Daratumumab Cohort
Serum concentration achieved at the end of dosing interval (trough concentration)
All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0
Posted
approximately up to 4 years
ID
Title
Description
OG000
Cohort A-1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Pomalidomide:
4 mg po daily (Days 1-21) of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old
OG001
Cohort A-2
ND-Pd Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Secondary
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
All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0
Posted
approximately up to 4 years
ID
Title
Description
OG000
Cohort A-1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Pomalidomide:
4 mg po daily (Days 1-21) of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old
OG001
Cohort A-2
ND-Pd Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Secondary
AUC (TAU) in the Nivolumab + Daratumumab Cohort
Area under the concentration-time curve in one dosing interval
All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0
Posted
approximately up to 4 years
ID
Title
Description
OG000
Cohort A-1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Pomalidomide:
4 mg po daily (Days 1-21) of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old
OG001
Cohort A-2
ND-Pd Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Secondary
End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort
Serum concentration achieved at the end of study drug infusion
All treated participants in the nivo dara cohort - pharmacokinetic subset
Posted
Mean
Standard Deviation
ug/mL
Measurements collected at cycles 1, 2, 3, 5, 7, and 11; each cycle is 28 days
ID
Title
Description
OG000
Cohort A-1
ND Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
Pomalidomide:
4 mg po daily (Days 1-21) of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects > 75 years old
OG001
Cohort A-2
ND-Pd Regimen
Each cycle is 28 days
Nivolumab:
Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 & beyond: 480 mg iv Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 & beyond: 16 mg/kg iv Day 1
OG002
Cohort B-1
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 Nivo Dara: approximately 4 years
Description
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
53
105
50
105
102
105
EG001
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
33
65
39
65
62
65
EG002
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
42
72
34
72
69
72
EG003
Nivolumab + Daratumumab Cohort A1
ND regimen: Nivolumab (240 mg up to cycle 6, then 480 mg) + Daratumumab (16 mg/Kg)