Non-Hodgkin's LymphomaPhase 1/2NCT01592370

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

A Phase 1/2 study testing Nivolumab, Ipilimumab and Lirilumab in people with Non-Hodgkin's Lymphoma and Hodgkin Lymphoma, run by Bristol-Myers Squibb at 43 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Hodgkin's Lymphoma, Hodgkin Lymphoma, Multiple Myeloma
What is being tested?: Nivolumab, Ipilimumab and Lirilumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 320 participants
Where: 43 sitesin 6 countries
Study dates: 2 Aug 2012to 9 Jul 2024
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

43 sites in 6 countries.

Country

City, postcode or hospital

43 sites in 6 countries

United States32 sites

Local Institution - 0011
Ann Arbor, Michigan, 48109
University Of Michigan Health System
Ann Arbor, Michigan, 48109
Local Institution - 0017
Aurora, Colorado, 80045
Local Institution - 0003
Baltimore, Maryland, 21231
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Local Institution - 0009
Boston, Massachusetts, 02215
Local Institution - 0015
Boston, Massachusetts, 02215
Local Institution - 0035
Clovis, California, 93611
Local Institution - 0028
Columbus, Ohio, 43210
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Local Institution - 0014
Hackensack, New Jersey, 07601
Local Institution - 0019
Indianapolis, Indiana, 46202
Division Of Hematology & Oncology Ctr. For Health Sciences
Los Angeles, California, 90095
Local Institution - 0012
Los Angeles, California, 90095
Local Institution - 013
New Haven, Connecticut, 06520
Local Institution - 0001
New York, New York, 10065
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Local Institution - 0033
Omaha, Nebraska, 68130
Local Institution - 0023
Orlando, Florida, 32804
Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Local Institution - 0007
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Local Institution - 0004
Philadelphia, Pennsylvania, 19111
Local Institution - 0006
Portland, Oregon, 97239
OHSU Center for Hematologic Malignancies
Portland, Oregon, 97239
Local Institution - 0002
Rochester, Minnesota, 55905
Mayo Clinic
Rochester, Minnesota, 55905
Huntsman Cancer Institute At The Univ. Of Utah
Salt Lake City, Utah, 84112
Local Institution - 0005
Salt Lake City, Utah, 84112
Local Institution - 0037
Skokie, Illinois, 60077
Local Institution - 0018
Westwood, Kansas, 66205

Other trials in United States

Poland4 sites

Local Institution
Chorzów, 41-500
Local Institution - 0040
Poznan, 61-848
Local Institution - 0049
Warsaw, 02-776
Local Institution - 0042
Wroclaw, 50-367

Other trials in Poland

Belgium3 sites

Local Institution - 0045
Ghent, 9000
Local Institution - 0047
Sint-Niklaas, 9100
Local Institution
Yvoir, B-5530

Other trials in Belgium

France2 sites

Local Institution - 0044
Nantes, 44000
Local Institution - 0043
Poitiers, Vienne, 86021

Other trials in France

Greece1 site

Local Institution - 0039
Athens, 11528

Other trials in Greece

Italy1 site

Local Institution
Bologna, 40138

Other trials in Italy

About this study

Official title: Multiple Phase 1/2 Cohorts of Nivolumab Monotherapy or Nivolumab Combination Regimens Across Relapsed/Refractory Hematologic Malignancies

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.

Read the detailed description

NOTE: Currently, this study is only open to nivolumab+daratumumab vs daratumumab monotherapy in multiple myeloma patients.

Conditions: Non-Hodgkin's Lymphoma, Hodgkin Lymphoma, Multiple Myeloma
Being tested: Nivolumab, Ipilimumab, Lirilumab, Daratumumab, Pomalidomide
Medical subject headings: Lymphoma, Non-Hodgkin, Hodgkin Disease, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NivolumabBiological
Also called BMS-936558, Opdivo
Administered by intravenous (IV) infusion
IpilimumabBiological
Also called Yervoy, BMS-734016, MDX010
Administered by IV infusion
LirilumabBiological
Also called BMS-986015
Administered by IV infusion
DaratumumabBiological
Also called Darzalex
Administered by IV infusion
PomalidomideDrug
Also called Pomalyst
Administered PO
DexamethasoneDrug
Also called Intensol
Administered PO and by IV infusion

Study groups in NCT01592370
Study group	Role	What they receive
Nivolumab monotherapy (Dose Escalation)	Experimental	Nivolumab solution intravenously as specified Non-randomized Enrollment is closed for this cohort Receives: Biological: Nivolumab
Nivolumab + Ipilimumab	Experimental	Nivolumab and Ipilimumab solution intravenously as specified Non-randomized Enrollment is closed for this cohort Receives: 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 Receives: 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 Receives: 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 Receives: Biological: Nivolumab; Biological: Daratumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: approximately up to 4 years
Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort
Measured: approximately up to 4 years
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology
Measured: approximately up to 4 years
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver
Measured: approximately up to 4 years
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid
Measured: approximately up to 4 years

Secondary outcomes (19)

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
Measured: 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
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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).
Measured: 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
Measured: approximately up to 4 years
Objective Response Rate in the Nivolumab + Daratumumab Cohort
Measured: approximately up to 4 years
Duration of Response in the Nivolumab + Daratumumab Cohort
Measured: approximately up to 4 years
Progression Free Survival in the Nivolumab + Daratumumab Cohort
Measured: approximately up to 4 years
Cmax in the Nivolumab + Daratumumab Cohort
Maximum observed serum concentration
Measured: approximately up to 4 years
Tmax in the Nivolumab + Daratumumab Cohort
Time of maximum observed serum concentration
Measured: approximately up to 4 years
Cmin in the Nivolumab + Daratumumab Cohort
Serum concentration achieved at the end of dosing interval (trough concentration)
Measured: 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
Measured: approximately up to 4 years
AUC (TAU) in the Nivolumab + Daratumumab Cohort
Area under the concentration-time curve in one dosing interval
Measured: 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
Measured: Measurements collected at cycles 1, 2, 3, 5, 7, and 11; each cycle is 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 20129 Jul 2024

First posted7 May 2012 (estimated)
Study start2 Aug 2012
Primary completion25 Sep 2020
Study completion9 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 320 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01592370
Sponsor's protocol ID: CA209-039
Other IDs: 2018-001030-17, 2018
Status last verified: Oct 2025
First submitted: 3 May 2012
Last updated: 22 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 27269947
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.
PubMed 25482239

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multiple Phase 1/2 Cohorts of Nivolumab Monotherapy or Nivolumab Combination Regimens Across Relapsed/Refractory Hematologic Malignancies
ClinicalTrials.gov ID: NCT01592370
Acronym / sponsor ID: CA209-039
Conditions: Non-Hodgkin's Lymphoma, Hodgkin Lymphoma, Multiple Myeloma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 320 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Collaborators: Janssen, LP
Study start: 2 Aug 2012 (actual)
Primary completion: 25 Sep 2020 (actual)
Study completion: 9 Jul 2024 (actual)
First posted: 7 May 2012 (estimated)
Results: Posted 17 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Nivolumab monotherapy (Dose Escalation)	Experimental	Biological: NivolumabNivolumab solution intravenously as specified Non-randomized Enrollment is closed for this cohort
Nivolumab + Ipilimumab	Experimental	Biological: Nivolumab, Biological: IpilimumabNivolumab and Ipilimumab solution intravenously as specified Non-randomized Enrollment is closed for this cohort
Nivolumab + Lirilumab	Experimental	Biological: Nivolumab, Biological: LirilumabNon-randomized Nivolumab: 3 mg/kg given every 2 weeks Lirilumab: 3 mg/kg given every 4 weeks Enrollment is closed for this cohort
Nivo + Dara + Pom + Dexa vs. Nivo + Dara	Experimental	Biological: Nivolumab, Biological: Daratumumab, Drug: Pomalidomide, Drug: DexamethasoneRandomized 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
Daratumumab vs. Nivolumab + Daratumumab	Experimental	Biological: Nivolumab, Biological: DaratumumabRandomized 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NivolumabAlso: BMS-936558, OpdivoAdministered by intravenous (IV) infusion	Biological	Daratumumab vs. Nivolumab + Daratumumab, Nivo + Dara + Pom + Dexa vs. Nivo + Dara, Nivolumab + Ipilimumab, Nivolumab + Lirilumab, Nivolumab monotherapy (Dose Escalation)
IpilimumabAlso: Yervoy, BMS-734016, MDX010Administered by IV infusion	Biological	Nivolumab + Ipilimumab
LirilumabAlso: BMS-986015Administered by IV infusion	Biological	Nivolumab + Lirilumab
DaratumumabAlso: DarzalexAdministered by IV infusion	Biological	Daratumumab vs. Nivolumab + Daratumumab, Nivo + Dara + Pom + Dexa vs. Nivo + Dara
PomalidomideAlso: PomalystAdministered PO	Drug	Nivo + Dara + Pom + Dexa vs. Nivo + Dara
DexamethasoneAlso: IntensolAdministered PO and by IV infusion	Drug	Nivo + Dara + Pom + Dexa vs. Nivo + Dara

Primary outcome

Number of Participants That Experienced Drug Related Grade 3-4 AEs
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
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
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
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
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
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
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
Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology
Time frame: approximately up to 4 years
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver
Time frame: approximately up to 4 years
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid
Time frame: approximately up to 4 years

19 secondary outcomes

Best Overall 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
Best Overall Response - Multiple Myeloma Group
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
Duration of Response
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
Duration of Response - Multiple Myeloma Group
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
Progression Free Survival
Time frame: From date of randomization to date of progression or death, whichever occurs first (up to approximately 24 months)
Progression Free Survival Rate
Time frame: From randomization to the specified timepoints (up to 48 months)
Overall Survival
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
Number of Participants With PD-L1 Expression
Time frame: At baseline (prior to start of study treatment)
Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score
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)
Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
Objective Response Rate in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
Duration of Response in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
Progression Free Survival in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
Cmax in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
Tmax in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
Cmin in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
AUC (0-T) in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
AUC (TAU) in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort
Time frame: Measurements collected at cycles 1, 2, 3, 5, 7, and 11; each cycle is 28 days

Results and safety

Results posted to the registry on 17 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nivolumab Monotherapy (Expansion)	105	1
Nivolumab + Ipilimumab	65	40
Nivolumab + Lirilumab	72	0
Nivolumab + Daratumumab_Cohort A1	6	1
Nivolumab + Daratumumab_Cohort A2	7	1
Nivolumab + Daratumumab_Cohort B1	43	7
Nivolumab + Daratumumab_Cohort B2	22	6

Primary outcome: Number of Participants That Experienced Drug Related Grade 3-4 AEs

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. Count of participants. Unit: Participants

Measure	Nivolumab Monotherapy (Expansion) n = 105	Nivolumab + Ipilimumab n = 65	Nivolumab + Lirilumab n = 72
Value	19	18	0

Population analysed: All Treated Participants

Primary outcome: Number of Participants That Experienced Drug Related Grade 3-4 SAEs

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. Count of participants. Unit: Participants

Measure	Nivolumab Monotherapy (Expansion) n = 105	Nivolumab + Ipilimumab n = 65	Nivolumab + Lirilumab n = 72
Value	28	8	3

Population analysed: All Treated Participants

Primary outcome: Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver

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. Count of participants. Unit: Participants

Measure	Nivolumab Monotherapy (Expansion) n = 105	Nivolumab + Ipilimumab n = 65	Nivolumab + Lirilumab n = 72
ALT OR AST > 3XULN	3	1	4
ALT OR AST > 5XULN	1	0	2
ALT OR AST > 10XULN	1	0	1
ALT OR AST > 20XULN	1	0	0
TOTAL BILIRUBIN > 2XULN	1	1	2
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN ONE DAY	1	0	1
CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN 30 DAYS	1	0	1

Population analysed: All Treated Participants

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Nivolumab Monotherapy (Expansion) n = 83	Nivolumab + Ipilimumab n = 47	Nivolumab + Lirilumab n = 72
TSH > ULN	14	19	15
TSH > ULN WITH TSH <= ULN AT BASELINE	11	13	9
TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN	0	7	1
TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN	1	1	1
TSH > ULN WITH FT3/FT4 TEST MISSING	13	11	13
TSH < LLN	8	6	6
TSH < LLN WITH TSH >= LLN AT BASELINE	5	6	4
TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN	0	1	1

Population analysed: All Treated Participants

19 secondary outcomes are reported in the full results.

Adverse events

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. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nivolumab Monotherapy (Expansion)	50 of 105 (47.6%)	102 of 105 (97.1%)	53 of 105
Nivolumab + Ipilimumab	39 of 65 (60%)	62 of 65 (95.4%)	33 of 65
Nivolumab + Lirilumab	34 of 72 (47.2%)	69 of 72 (95.8%)	42 of 72
Nivolumab + Daratumumab Cohort A1	3 of 6 (50%)	6 of 6 (100%)	1 of 6
Nivolumab + Daratumumab_Cohort A2	5 of 5 (100%)	5 of 5 (100%)	3 of 7
Nivolumab + Daratumumab_Cohort B1	15 of 41 (36.6%)	35 of 41 (85.4%)	24 of 42
Nivolumab + Daratumumab_Cohort B2	9 of 22 (40.9%)	16 of 22 (72.7%)	13 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27269947Lesokhin 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.
Derived from this study: PubMed 25482239Ansell 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.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

43 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nivolumab, Ipilimumab and Lirilumab in people with Non-Hodgkin's Lymphoma and Hodgkin Lymphoma, run by Bristol-Myers Squibb at 43 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Poland, Belgium, France, Greece and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants That Experienced Drug Related Grade 3-4 AEs (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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01592370, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.