Clinical trial NCT03098550: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Cancer
Keywords: Non-small cell lung cancer (NSCLC)
Triple Negative Breast Cancer (TNBC)
Pancreatic Cancer (PAC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Janssen Biotech, Inc.
First posted: 2017-03-31
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose to 30 days post last dose (up to 34 months)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From first dose to 30 days post last dose (up to 34 months)
measure: Number of Participants With Laboratory Abnormalities in Specific Liver Tests
timeFrame: From first dose to 30 days post last dose (up to 34 months)
measure: Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
timeFrame: From first dose to 30 days post last dose (up to 34 months)
measure: Number of Participants With Laboratory Results of Worst CTC Grade
timeFrame: From first dose to 30 days post last dose (up to 34 months)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 36 months
measure: Duration of Response (DOR)
timeFrame: Up to 36 months
measure: Best Overall Response (BOR)
timeFrame: Up to 36 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 36 months
measure: Nivolumab Serum Concentrations
timeFrame: From day 1 to follow-up 2 (up to 36 months)
measure: Daratumumab Serum Concentrations
timeFrame: From day 1 to follow-up 2 (up to 36 months)
measure: Percentage of Participants Anti Drug Antibody (ADA) by Positivity
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Aurora
country: United States
facility: University Of Colorado
state: Colorado
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Ann Arbor
country: United States
facility: University Of Michigan
state: Michigan
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: St Leonards
country: Australia
facility: Local Institution
state: New South Wales
city: Edmonton
country: Canada
facility: Local Institution
city: Lyon Cedex 08
country: France
facility: Local Institution
city: Marseille Cedex 9
country: France
facility: Local Institution
city: Strasbourg Cedex
country: France
facility: Centre Paul Strauss
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus
city: Freiburg
country: Germany
facility: Medizinische Universitaetsklinik Freiburg
city: Heidelberg
country: Germany
facility: Universitaetsklinik Heidelberg
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione Pascale
city: San Juan
country: Puerto Rico
facility: Fundacion De Investigacion
city: Madrid
country: Spain
facility: Hospital Gral. Univ. Gregorio Maranon
city: Majadahonda - Madrid
country: Spain
facility: Local Institution
city: Basel
country: Switzerland
facility: Klinik Fur Onkologie
city: Lausanne
country: Switzerland
facility: University Hospital of Lausanne
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: