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A Study to Test the Safety and Effectiveness of Nivolumab Combined With Daratumumab in Patients With Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, That Have Advanced or Have Spread

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ClinicalTrials.gov Identifier: NCT03098550
Recruitment Status : Active, not recruiting
First Posted : March 31, 2017
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
Janssen Biotech, Inc.
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine whether a combination of Nivolumab and Daratumumab is safe and effective when treating Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, that have advanced or have spread.

Condition or disease Intervention/treatment Phase
Advanced Cancer Biological: Nivolumab Biological: Daratumumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab Combined With Daratumumab in Participants With Advanced or Metastatic Solid Tumors
Actual Study Start Date : June 7, 2017
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immunotherapy Combination
TNBC and PAC participants who are deriving clinical benefit will continue to be treated with the nivolumab plus daratumumab combination therapy
Biological: Nivolumab
Specified dose on specified days

Biological: Daratumumab
Specified dose on specified days

Experimental: Nivolumab Monotherapy
NSCLC patients who are deriving clinical benefit will be treated with nivolumab monotherapy
Biological: Nivolumab
Specified dose on specified days




Primary Outcome Measures :
  1. Incidence of adverse events (AE) [ Time Frame: Up to 2.5 years ]
    To establish the tolerability

  2. Incidence of serious adverse events (SAE) [ Time Frame: Up to 2.5 years ]
    To establish the tolerability

  3. Grade of laboratory abnormalities. [ Time Frame: Up to 2.5 years ]
    To establish the tolerability


Secondary Outcome Measures :
  1. Objective Response rate (ORR) [ Time Frame: Up to 3 years ]
    To evaluate ORR of nivolumab combined with daratumumab in participants with advanced or metastatic tumors in each cohort

  2. Progression Free Survival (PFS) [ Time Frame: Up to 3 years ]
    To assess PFS of nivolumab combined with daratumumab in participants with advanced or metastatic tumors in each cohort

  3. Anti-Drug Antibodies (ADA) positivity [ Time Frame: Up to 2.5 years ]
    To characterize the immunogenicity of nivolumab and daratumumab in participants with advanced or metastatic tumors

  4. Area under the concentration-time curve (AUC) [ Time Frame: Up to 2.5 years ]
    To characterize the pharmacokinetics of nivolumab and daratumumab in participants with advanced or metastatic tumors

  5. Minimum observed concentration (Cmin) [ Time Frame: Up to 2.5 years ]
    To characterize the pharmacokinetics of nivolumab and daratumumab in participants with advanced or metastatic tumors



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

  • Patients with metastatic or advanced solid tumors
  • Women with histologically or cytologically confirmed triple negative breast carcinoma
  • Participants with histologically or cytologically confirmed pancreatic adenocarcinoma
  • Participants with histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC)

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases.
  • Any serious or uncontrolled medical disorder
  • Prior malignancy active within the previous 3 years

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098550


Locations
United States, California
Pacific Shores Medical Group
Huntington Beach, California, United States, 92648
United States, Colorado
University Of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Michigan
University Of Michigan
Ann Arbor, Michigan, United States, 48109-5247
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Australia, New South Wales
Local Institution
St Leonards, New South Wales, Australia, 2065
Canada
Local Institution
Edmonton, Canada, T6G 1Z2
France
Local Institution
Lyon Cedex 08, France, 69373
Local Institution
Marseille Cedex 9, France, 13273
Local Institution
Strasbourg Cedex, France, 67085
Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Medizinische Universitaetsklinik Freiburg
Freiburg, Germany, 79106
Universitaetsklinik Heidelberg
Heidelberg, Germany, 69120
Italy
Local Institution
Milano, Italy, 20132
Local Institution
Napoli, Italy, 80131
Puerto Rico
Fundacion De Investigacion
San Juan, Puerto Rico, 00927
Spain
Hospital Gral. Univ. Gregorio Maranon
Madrid, Spain, 28007
Local Institution
Majadahonda - Madrid, Spain, 28222
Switzerland
Klinik Fur Onkologie
Basel, Switzerland, 4031
University Hospital of Lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Bristol-Myers Squibb
Janssen Biotech, Inc.
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03098550     History of Changes
Other Study ID Numbers: CA209-9GW
2017-000367-33 ( EudraCT Number )
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bristol-Myers Squibb:
Non-small cell lung cancer (NSCLC)
Triple Negative Breast Cancer (TNBC)
Pancreatic Cancer (PAC)

Additional relevant MeSH terms:
Triple Negative Breast Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Nivolumab
Daratumumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs