An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma (CheckMate 602)

February 28, 2023 updated by: Bristol-Myers Squibb

An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma

The purpose of this study is to evaluate the safety and effectiveness of several combination therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized (assigned by chance) to receive either:

Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone.

Enrollment is closed for all groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4020
        • Local Institution - 0029
      • Salzburg, Austria, 5020
        • Universitaetsklinik Salzburg
      • Vienna, Austria, 1090
        • Local Institution - 0026
      • Wels, Austria, 4600
        • Klinikum Wels-Grieskirchen GmbH
      • Wien, Austria, 1160
        • Wilhelminenspital
  • Canada
      • Quebec, Canada, G1R 2J6
        • Local Institution
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Local Institution
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0074
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • MUHC - Glen Site
      • Montreal, Quebec, Canada, H2X 3E4
        • Local Institution - 0039
      • Montreal, Quebec, Canada, H4J 1C5
        • Local Institution - 0154
      • Rimouski, Quebec, Canada, G5L 5T1
        • Local Institution - 0157
  • Czechia
      • Brno, Czechia, 625 00
        • Interni hematologicka a onkologicka klinika
      • Ostrava-Poruba, Czechia, 708 52
        • Klinika Hematoonkologie
      • Praha 2, Czechia, 128 08
        • I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze
  • Denmark
      • Aarhus, Denmark, 8200
        • Local Institution
      • Odense, Denmark, 5000
        • Local Institution
  • Germany
      • Berlin, Germany, 12200
        • Local Institution - 0050
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus
      • Duesseldorf, Germany, 40225
        • Uniklinikum Duesseldorf
      • Kiel, Germany, 24105
        • Local Institution - 0135
      • Mainz, Germany, 55101
        • Klinikum Der Johannes Gutenberg Universitaet Mainz
      • Ulm, Germany, 89081
        • Local Institution - 0054
  • Greece
      • Athens, Greece, 11528
        • Alexandra General Hospital of Athens
  • Israel
      • Beer Sheva, Israel, 84101
        • Local Institution - 0087
      • Jerusalem, Israel, 9112001
        • Local Institution
      • Petah Tikva, Israel, 4941492
        • Local Institution
      • Ramat-gan, Israel, 52621
        • Local Institution
      • Tel Aviv, Israel, 64239
        • Local Institution
  • Italy
      • Ancona, Italy, 60126
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
      • Bergamo, Italy, 24127
        • Local Institution - 0089
      • Bologna, Italy, 40138
        • A. O. U. Di Bologna, Policlinico S. Orsola Malpighi
      • Meldola (FC), Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
      • Terni, Italy, 05100
        • Azienda Ospedaliera Santa Maria Terni
    • Piemonte
      • Torino, Piemonte, Italy, 10126
        • Local Institution - 0042
  • Norway
      • Oslo, Norway, 0372
        • Local Institution
      • Stavanger, Norway, 4011
        • Local Institution - 0075
  • Portugal
      • Porto, Portugal, 4200-072
        • Local Institution
    • Lisboa
      • Lisbon, Lisboa, Portugal, 1400-038
        • Local Institution - 0132
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • Local Institution - 0071
  • Spain
      • Badalona-Barcelona, Spain, 08916
        • Local Institution - 0098
      • Barcelona, Spain, 08035
        • Local Institution - 0100
      • Pamplona, Spain, 31008
        • Local Institution - 0097
      • Salamanca, Spain, 37007
        • Local Institution - 0099
    • Madrid
      • Pozuelo De Alarcon, Madrid, Spain, 28223
        • Local Institution - 0101
  • Sweden
      • Huddinge, Sweden, 14186
        • Local Institution - 0064
  • Switzerland
      • Geneve, Switzerland, 1211
        • Hôpitaux Universitaires de Genève
  • Turkey
      • Istanbul, Turkey, 34899
        • Local Institution - 0186
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • Local Institution - 0020
      • Mobile, Alabama, United States, 36608
        • Local Institution - 0160
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Local Institution - 0163
    • California
      • Bakersfield, California, United States, 93309
        • Local Institution - 0118
      • Corona, California, United States, 92879
        • Local Institution - 0093
      • Fountain Valley, California, United States, 92708
        • Local Institution - 0016
      • La Jolla, California, United States, 92093-0698
        • UC San Diego Moores Cancer Ctr
      • La Jolla, California, United States, 92037
        • Local Institution - 0164
      • Los Angeles, California, United States, 90017
        • Local Institution - 0138
      • Los Angeles, California, United States, 90095
        • Local Institution - 0155
      • Redondo Beach, California, United States, 90277
        • Local Institution - 0117
      • Riverside, California, United States, 92501
        • Local Institution - 0092
      • San Luis Obispo, California, United States, 93401
        • Coastal Integrative Cancer Care
      • Santa Maria, California, United States, 93454
        • Local Institution - 0113
    • Colorado
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
      • Fort Collins, Colorado, United States, 80528
        • Poudre Valley Health Care
      • Grand Junction, Colorado, United States, 81501
        • Local Institution - 0116
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Local Institution - 0147
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Local Institution - 0011
      • Fort Myers, Florida, United States, 33916
        • Florida Cancer Specialists S.
      • Hollywood, Florida, United States, 33021
        • Local Institution - 0114
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North FL
      • Pensacola, Florida, United States, 32504
        • Local Institution - 0082
      • Saint Petersburg, Florida, United States, 33705
        • Local Institution - 0126
      • Tallahassee, Florida, United States, 32308
        • Local Institution - 0130
      • West Palm Beach, Florida, United States, 33401
        • Local Institution - 0125
    • Georgia
      • Athens, Georgia, United States, 30607
        • Local Institution - 0119
      • Atlanta, Georgia, United States, 30318
        • Local Institution - 0009
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0024
      • Augusta, Georgia, United States, 30912
        • Augusta University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Local Institution - 0035
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Local Institution - 0111
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Ctr
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Local Institution - 0018
    • Massachusetts
      • Baltimore, Massachusetts, United States, 21229
        • Local Institution - 0006
      • Worcester, Massachusetts, United States, 01655
        • Local Institution - 0123
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Local Institution - 0150
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Local Institution - 0137
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • St. Louis Cancer Care, LLP
      • Kansas City, Missouri, United States, 64132
        • Local Institution - 0128
      • Saint Louis, Missouri, United States, 63110
        • Washington University
      • Springfield, Missouri, United States, 65806
        • Local Institution - 0049
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Local Institution - 0079
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Local Institution - 0076
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0002
      • New Brunswick, New Jersey, United States, 08903
        • Local Institution - 0095
      • Paramus, New Jersey, United States, 07652
        • Local Institution - 0142
    • New York
      • Buffalo, New York, United States, 14263
        • Local Institution - 0010
      • Johnson City, New York, United States, 13790
        • Broome Oncology LLC
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10065
        • Local Institution - 0017
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Local Institution - 0001
      • Winston-Salem, North Carolina, United States, 27157
        • Local Institution - 0096
    • Ohio
      • Columbus, Ohio, United States, 43219
        • Local Institution - 0012
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma
    • Oregon
      • Portland, Oregon, United States, 97213
        • Local Institution - 0145
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Local Institution - 0136
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 0021
      • Sayre, Pennsylvania, United States, 18840
        • Local Institution - 0036
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Local Institution - 0152
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Local Institution - 0069
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC - SCRI - PPDS
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Research Institute
      • Houston, Texas, United States, 77090
        • Local Institution - 0044
      • San Antonio, Texas, United States, 78229
        • Local Institution - 0037
      • Temple, Texas, United States, 76508-0001
        • Local Institution - 0046
    • Utah
      • Ogden, Utah, United States, 84403
        • Local Institution - 0022
      • Salt Lake City, Utah, United States, 84106
        • Local Institution - 0153
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Emily Couric Clinical Cancer Center
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98108
        • Local Institution - 0144

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Refractory or relapsed and refractory multiple myeloma
  • Measurable disease
  • Have received ≥ 2 lines of prior therapy which must have included an immune modulatory drug (IMiD) and a proteasome inhibitor alone or in combination

Exclusion Criteria:

  • Solitary bone or extramedullary plasmacytoma disease only
  • Active plasma cell leukemia

Other protocol defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational Arm

Nivolumab, Pomalidomide and Dexamethasone

Enrollment is closed for this arm
Biological: Nivolumab
Specified dose on specified days, IV (intravenous)
Other Names:
  • BMS-936558
Drug: Pomalidomide
Specified dose on specified days, PO (by mouth)
Drug: Dexamethasone
Specified dose on specified days, PO
Active Comparator: Control Arm

Pomalidomide and Dexamethasone

Enrollment is closed for this arm
Drug: Pomalidomide
Specified dose on specified days, PO (by mouth)
Drug: Dexamethasone
Specified dose on specified days, PO
Experimental: Exploratory Arm

Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone

Enrollment is closed for this arm
Biological: Nivolumab
Specified dose on specified days, IV (intravenous)
Other Names:
  • BMS-936558
Drug: Pomalidomide
Specified dose on specified days, PO (by mouth)
Drug: Dexamethasone
Specified dose on specified days, PO
Biological: Elotuzumab
Specified dose on specified days, IV
Other Names:
  • BMS-901608

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month)
Randomization to first documented tumor progression or death due to any cause, whichever occurred first. Participants who die without reported prior progression are considered to have progressed on date of their death. Participants who did not progress or die will be censored at their last efficacy assessment. Participants who did not have on study efficacy assessments and alive will be censored on randomization date. Participants who started subsequent anti-cancer therapy without prior reported progression will be censored at last efficacy assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), >/= 50% increase from nadir in SPD of > 1 lesion, or >/= 50% increase in the longest diameter of a previous lesion > 1 cm in short axis.
From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization to the date of death due to any cause (up to approximately 64 months)
The time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.
From randomization to the date of death due to any cause (up to approximately 64 months)
Objective Response Rate (ORR)
Time Frame: From randomization up to approximately 64 months

The percentage of randomized participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using International Myeloma Working Group (IMWG) criteria.

sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry.

CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates.

VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h.

PR = >/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by >/= 90% or to < 200 mg per 24 h.
From randomization up to approximately 64 months
Time to Objective Response (TTR)
Time Frame: From the date of randomization to the date of the first sCR, CR, VGPR, or PR (up to approximately 64 months)

The time from the date of randomization to the date of the first stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).

sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry.

CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow aspirates.

VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 h.

PR = >/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by >/= 90% or to < 200 mg per 24 h.
From the date of randomization to the date of the first sCR, CR, VGPR, or PR (up to approximately 64 months)
Duration of Objective Response (DOR)
Time Frame: From randomization to the date of the first objectively documented tumor progression or death due to any cause prior to subsequent anti-cancer therapy (up to approximately 64 months)
The time between the date of first response to the date of the first objectively documented tumor progression as assessed by the investigator according to International Myeloma Working Group (IMWG) criteria or death due to any cause prior to subsequent anti-cancer therapy. Participants who neither progress nor die will be censored on the date of their last tumor assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), >/= 50% increase from nadir in SPD of > 1 lesion, or >/= 50% increase in the longest diameter of a previous lesion > 1 cm in short axis.
From randomization to the date of the first objectively documented tumor progression or death due to any cause prior to subsequent anti-cancer therapy (up to approximately 64 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2016

Primary Completion (Actual)

March 9, 2022

Study Completion (Actual)

March 9, 2022

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

April 1, 2016

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-602
  • 2015-005699-21 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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