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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03098550
Registration number
NCT03098550
Ethics application status
Date submitted
28/03/2017
Date registered
31/03/2017
Date last updated
23/07/2021
Titles & IDs
Public 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
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Scientific 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
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Secondary ID [1]
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2017-000367-33
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Secondary ID [2]
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CA209-9GW
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Nivolumab
Other interventions - Daratumumab
Experimental: Immunotherapy Combination - TNBC and PAC participants who are deriving clinical benefit will continue to be treated with the nivolumab plus daratumumab combination therapy
Experimental: Nivolumab Monotherapy - NSCLC patients who are deriving clinical benefit will be treated with nivolumab monotherapy
Other interventions: Nivolumab
Specified dose on specified days
Other interventions: Daratumumab
Specified dose on specified days
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events (AEs)
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Assessment method [1]
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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
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Timepoint [1]
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From first dose to 30 days post last dose (up to 34 months)
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Primary outcome [2]
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Number of Participants With Serious Adverse Events (SAEs)
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Assessment method [2]
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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
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Timepoint [2]
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From first dose to 30 days post last dose (up to 34 months)
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Primary outcome [3]
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Number of Participants With Laboratory Abnormalities in Specific Liver Tests
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Assessment method [3]
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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
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Timepoint [3]
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From first dose to 30 days post last dose (up to 34 months)
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Primary outcome [4]
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Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
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Assessment method [4]
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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
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Timepoint [4]
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From first dose to 30 days post last dose (up to 34 months)
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Primary outcome [5]
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Number of Participants With Laboratory Results of Worst CTC Grade
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Assessment method [5]
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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
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Timepoint [5]
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From first dose to 30 days post last dose (up to 34 months)
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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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)
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Timepoint [1]
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Up to 36 months
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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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
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Timepoint [2]
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Up to 36 months
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Secondary outcome [3]
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Best Overall Response (BOR)
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 36 months
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Secondary outcome [4]
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Progression Free Survival (PFS)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 36 months
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Secondary outcome [5]
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Nivolumab Serum Concentrations
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Assessment method [5]
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Pharmacokinetics (PK) assessed using serum concentration data for Nivolumab
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Timepoint [5]
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From day 1 to follow-up 2 (up to 36 months)
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Secondary outcome [6]
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Daratumumab Serum Concentrations
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Assessment method [6]
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Pharmacokinetics (PK) assessed using serum concentration data for Daratumumab
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Timepoint [6]
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From day 1 to follow-up 2 (up to 36 months)
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Secondary outcome [7]
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Percentage of Participants Anti Drug Antibody (ADA) by Positivity
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Assessment method [7]
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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
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Timepoint [7]
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Up to 36 months
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/06/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/07/2020
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Sample size
Target
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Accrual to date
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Final
105
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Local Institution - St Leonards
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Michigan
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Country [5]
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United States of America
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State/province [5]
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Oregon
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Country [6]
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Canada
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State/province [6]
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Edmonton
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Country [7]
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France
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State/province [7]
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Lyon Cedex 08
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Country [8]
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France
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State/province [8]
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Marseille Cedex 9
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Country [9]
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France
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State/province [9]
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Strasbourg Cedex
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Country [10]
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Germany
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State/province [10]
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Dresden
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Country [11]
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Germany
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State/province [11]
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Freiburg
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Country [12]
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Germany
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State/province [12]
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Heidelberg
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Country [13]
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Italy
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State/province [13]
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Milano
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Country [14]
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Italy
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State/province [14]
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Napoli
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Country [15]
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Puerto Rico
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State/province [15]
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San Juan
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Country [16]
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Spain
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State/province [16]
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Madrid
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Country [17]
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Spain
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State/province [17]
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Majadahonda - Madrid
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Country [18]
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Switzerland
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State/province [18]
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Basel
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Country [19]
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Switzerland
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State/province [19]
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Lausanne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Janssen Biotech, Inc.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03098550
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03098550
Download to PDF