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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03098550




Registration number
NCT03098550
Ethics application status
Date submitted
28/03/2017
Date registered
31/03/2017
Date last updated
25/06/2020

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
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
Secondary ID [1] 0 0
2017-000367-33
Secondary ID [2] 0 0
CA209-9GW
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AE) - To establish the tolerability
Timepoint [1] 0 0
Up to 2.5 years
Primary outcome [2] 0 0
Incidence of serious adverse events (SAE) - To establish the tolerability
Timepoint [2] 0 0
Up to 2.5 years
Primary outcome [3] 0 0
Grade of laboratory abnormalities. - To establish the tolerability
Timepoint [3] 0 0
Up to 2.5 years
Secondary outcome [1] 0 0
Objective Response rate (ORR) - To evaluate ORR of nivolumab combined with daratumumab in participants with advanced or metastatic tumors in each cohort
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Progression Free Survival (PFS) - To assess PFS of nivolumab combined with daratumumab in participants with advanced or metastatic tumors in each cohort
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Anti-Drug Antibodies (ADA) positivity - To characterize the immunogenicity of nivolumab and daratumumab in participants with advanced or metastatic tumors
Timepoint [3] 0 0
Up to 2.5 years
Secondary outcome [4] 0 0
Area under the concentration-time curve (AUC) - To characterize the pharmacokinetics of nivolumab and daratumumab in participants with advanced or metastatic tumors
Timepoint [4] 0 0
Up to 2.5 years
Secondary outcome [5] 0 0
Minimum observed concentration (Cmin) - To characterize the pharmacokinetics of nivolumab and daratumumab in participants with advanced or metastatic tumors
Timepoint [5] 0 0
Up to 2.5 years

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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Local Institution - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
Canada
State/province [6] 0 0
Edmonton
Country [7] 0 0
France
State/province [7] 0 0
Lyon Cedex 08
Country [8] 0 0
France
State/province [8] 0 0
Marseille Cedex 9
Country [9] 0 0
France
State/province [9] 0 0
Strasbourg Cedex
Country [10] 0 0
Germany
State/province [10] 0 0
Dresden
Country [11] 0 0
Germany
State/province [11] 0 0
Freiburg
Country [12] 0 0
Germany
State/province [12] 0 0
Heidelberg
Country [13] 0 0
Italy
State/province [13] 0 0
Milano
Country [14] 0 0
Italy
State/province [14] 0 0
Napoli
Country [15] 0 0
Puerto Rico
State/province [15] 0 0
San Juan
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
Spain
State/province [17] 0 0
Majadahonda - Madrid
Country [18] 0 0
Switzerland
State/province [18] 0 0
Basel
Country [19] 0 0
Switzerland
State/province [19] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Janssen Biotech, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03098550
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications