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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Specified dose on specified days
Specified dose on specified days
Pacific Shores Medical Group
Long Beach, California, United States
University Of Colorado
Aurora, Colorado, United States
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
Time frame: From first dose to 30 days post last dose (up to 34 months)
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
Time frame: From first dose to 30 days post last dose (up to 34 months)
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
Time frame: From first dose to 30 days post last dose (up to 34 months)
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
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Moffitt Cancer Center
Tampa, Florida, United States
University Of Michigan
Ann Arbor, Michigan, United States
Providence Portland Medical Center
Portland, Oregon, United States
Local Institution
St Leonards, New South Wales, Australia
Local Institution
Edmonton, Canada
Local Institution
Lyon, France
Local Institution
Marseille, France
Centre Paul Strauss
Strasbourg, France
...and 10 more locations
Time frame: From first dose to 30 days post last dose (up to 34 months)
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
Time frame: From first dose to 30 days post last dose (up to 34 months)
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)
Time frame: Up to 36 months
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
Time frame: Up to 36 months
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.
Time frame: Up to 36 months
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.
Time frame: Up to 36 months
Nivolumab Serum Concentrations
Pharmacokinetics (PK) assessed using serum concentration data for Nivolumab
Time frame: From day 1 to follow-up 2 (up to 36 months)
Daratumumab Serum Concentrations
Pharmacokinetics (PK) assessed using serum concentration data for Daratumumab
Time frame: From day 1 to follow-up 2 (up to 36 months)
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
Time frame: Up to 36 months