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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

Primary Purpose

Advanced Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Daratumumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Cancer focused on measuring Non-small cell lung cancer (NSCLC), Triple Negative Breast Cancer (TNBC), Pancreatic Cancer (PAC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pacific Shores Medical Group
  • University Of Colorado
  • Moffitt Cancer Center
  • University Of Michigan
  • Providence Portland Medical Center
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Centre Paul Strauss
  • Universitaetsklinikum Carl Gustav Carus
  • Medizinische Universitaetsklinik Freiburg
  • Universitaetsklinik Heidelberg
  • Local Institution
  • Istituto Nazionale Tumori Fondazione Pascale
  • Fundacion De Investigacion
  • Hospital Gral. Univ. Gregorio Maranon
  • Local Institution
  • Klinik Fur Onkologie
  • University Hospital of Lausanne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immunotherapy Combination

Nivolumab Monotherapy

Arm Description

TNBC and PAC participants who are deriving clinical benefit will continue to be treated with the nivolumab plus daratumumab combination therapy

NSCLC patients who are deriving clinical benefit will be treated with nivolumab monotherapy

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs)
Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab
Number of Participants With Serious Adverse Events (SAEs)
Number of participants with any grade of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN Total bilirubin > 2 x ULN ALP > 1.5 x ULN Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of subjects with the following laboratory abnormalities from on-treatment evaluations will be summarized: TSH value > ULN and with baseline TSH value <= ULN with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test with FT3/FT4 missing within 2-week window after the abnormal TSH test. TSH < LLN and with baseline TSH value >= LLN with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test with FT3/FT4 missing within 2-week window after the abnormal TSH test
Number of Participants With Laboratory Results of Worst CTC Grade
Number of participants with laboratory test results of worst (CTC v4.0) grades 0-4 to determine the safety and tolerability of Nivolumab and Daratumumab

Secondary Outcome Measures

Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the percentage of treated participants who achieve a best response of complete response (CR) or partial response (PR) based on investigator assessments (using RECIST v1.1 criteria)
Duration of Response (DOR)
Duration of response (DOR) is defined as the time between the date of first documented response (Complete response or partial response) to the date of the first documented tumor progression as determined by Investigator (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first
Best Overall Response (BOR)
Best overall response (BOR) is defined as the best response, as determined by Investigator, recorded between the date of first dose and the date of objectively documented progression per RECIST v1.1 criteria or the date of subsequent therapy, whichever occurs first.
Progression Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time between the date of treatment start day and the date of first documented tumor progression, based on Investigator assessments (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first.
Nivolumab Serum Concentrations
Pharmacokinetics (PK) assessed using serum concentration data for Nivolumab
Daratumumab Serum Concentrations
Pharmacokinetics (PK) assessed using serum concentration data for Daratumumab
Percentage of Participants Anti Drug Antibody (ADA) by Positivity
Percentage of participants Anti Drug Antibody (ADA) to assess immunogenicity by ADA positive status and ADA negative status, relative to baseline. ADA positive is a participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment. ADA Negative is a participant with no ADA-positive sample after initiation of treatment

Full Information

First Posted
March 28, 2017
Last Updated
July 2, 2021
Sponsor
Bristol-Myers Squibb
Collaborators
Janssen Biotech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03098550
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
July 6, 2020 (Actual)
Study Completion Date
July 6, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to determine 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer
Keywords
Non-small cell lung cancer (NSCLC), Triple Negative Breast Cancer (TNBC), Pancreatic Cancer (PAC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immunotherapy Combination
Arm Type
Experimental
Arm Description
TNBC and PAC participants who are deriving clinical benefit will continue to be treated with the nivolumab plus daratumumab combination therapy
Arm Title
Nivolumab Monotherapy
Arm Type
Experimental
Arm Description
NSCLC patients who are deriving clinical benefit will be treated with nivolumab monotherapy
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Daratumumab
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab
Time Frame
From first dose to 30 days post last dose (up to 34 months)
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
Number of participants with any grade of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab
Time Frame
From first dose to 30 days post last dose (up to 34 months)
Title
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Description
Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized: ALT or AST > 3 x ULN, > 5 x ULN, > 10 x ULN and > 20 x ULN Total bilirubin > 2 x ULN ALP > 1.5 x ULN Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 1.5 x ULN Concurrent (within 1 day) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN Concurrent (within 30 days) ALT or AST > 3 x ULN and total bilirubin > 2 x ULN
Time Frame
From first dose to 30 days post last dose (up to 34 months)
Title
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
Description
Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of subjects with the following laboratory abnormalities from on-treatment evaluations will be summarized: TSH value > ULN and with baseline TSH value <= ULN with at least one FT3/FT4 test value < LLN within 2-week window after the abnormal TSH test with all FT3/FT4 test values >= LLN within 2-week window after the abnormal TSH test with FT3/FT4 missing within 2-week window after the abnormal TSH test. TSH < LLN and with baseline TSH value >= LLN with at least one FT3/FT4 test value > ULN within 2-week window after the abnormal TSH test with all FT3/FT4 test values <= ULN within 2-week window after the abnormal TSH test with FT3/FT4 missing within 2-week window after the abnormal TSH test
Time Frame
From first dose to 30 days post last dose (up to 34 months)
Title
Number of Participants With Laboratory Results of Worst CTC Grade
Description
Number of participants with laboratory test results of worst (CTC v4.0) grades 0-4 to determine the safety and tolerability of Nivolumab and Daratumumab
Time Frame
From first dose to 30 days post last dose (up to 34 months)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Objective response rate (ORR) is defined as the percentage of treated participants who achieve a best response of complete response (CR) or partial response (PR) based on investigator assessments (using RECIST v1.1 criteria)
Time Frame
Up to 36 months
Title
Duration of Response (DOR)
Description
Duration of response (DOR) is defined as the time between the date of first documented response (Complete response or partial response) to the date of the first documented tumor progression as determined by Investigator (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first
Time Frame
Up to 36 months
Title
Best Overall Response (BOR)
Description
Best overall response (BOR) is defined as the best response, as determined by Investigator, recorded between the date of first dose and the date of objectively documented progression per RECIST v1.1 criteria or the date of subsequent therapy, whichever occurs first.
Time Frame
Up to 36 months
Title
Progression Free Survival (PFS)
Description
Progression Free Survival (PFS) is defined as the time between the date of treatment start day and the date of first documented tumor progression, based on Investigator assessments (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first.
Time Frame
Up to 36 months
Title
Nivolumab Serum Concentrations
Description
Pharmacokinetics (PK) assessed using serum concentration data for Nivolumab
Time Frame
From day 1 to follow-up 2 (up to 36 months)
Title
Daratumumab Serum Concentrations
Description
Pharmacokinetics (PK) assessed using serum concentration data for Daratumumab
Time Frame
From day 1 to follow-up 2 (up to 36 months)
Title
Percentage of Participants Anti Drug Antibody (ADA) by Positivity
Description
Percentage of participants Anti Drug Antibody (ADA) to assess immunogenicity by ADA positive status and ADA negative status, relative to baseline. ADA positive is a participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment. ADA Negative is a participant with no ADA-positive sample after initiation of treatment
Time Frame
Up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
University Of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University Of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Local Institution
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Local Institution
City
Edmonton
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Local Institution
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg Cedex
ZIP/Postal Code
67085
Country
France
Facility Name
Universitaetsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Medizinische Universitaetsklinik Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitaetsklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Fundacion De Investigacion
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Hospital Gral. Univ. Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution
City
Majadahonda - Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Klinik Fur Onkologie
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
University Hospital of Lausanne
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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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