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
- Conditions
- Advanced Cancer
- Interventions
- Biological: NivolumabBiological: Daratumumab
- Registration Number
- NCT03098550
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nivolumab Monotherapy Nivolumab NSCLC patients who are deriving clinical benefit will be treated with nivolumab monotherapy Immunotherapy Combination Nivolumab TNBC and PAC participants who are deriving clinical benefit will continue to be treated with the nivolumab plus daratumumab combination therapy Immunotherapy Combination Daratumumab TNBC and PAC participants who are deriving clinical benefit will continue to be treated with the nivolumab plus daratumumab combination therapy
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) From first dose to 30 days post last dose (up to 34 months) 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) From first dose to 30 days post last dose (up to 34 months) 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 From first dose to 30 days post last dose (up to 34 months) 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 ULNNumber of Participants With Laboratory Results of Worst CTC Grade From first dose to 30 days post last dose (up to 34 months) 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
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests From first dose to 30 days post last dose (up to 34 months) 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
- Secondary Outcome Measures
Name Time Method Best Overall Response (BOR) Up to 36 months 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.
Nivolumab Serum Concentrations From day 1 to follow-up 2 (up to 36 months) Pharmacokinetics (PK) assessed using serum concentration data for Nivolumab
Objective Response Rate (ORR) Up to 36 months 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)
Progression Free Survival (PFS) Up to 36 months 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.
Daratumumab Serum Concentrations From day 1 to follow-up 2 (up to 36 months) Pharmacokinetics (PK) assessed using serum concentration data for Daratumumab
Duration of Response (DOR) Up to 36 months 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
Percentage of Participants Anti Drug Antibody (ADA) by Positivity Up to 36 months 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
Trial Locations
- Locations (15)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
University Of Michigan
🇺🇸Ann Arbor, Michigan, United States
Local Institution
🇪🇸Majadahonda - Madrid, Spain
Centre Paul Strauss
🇫🇷Strasbourg Cedex, France
Universitaetsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Universitaetsklinik Heidelberg
🇩🇪Heidelberg, Germany
Fundacion De Investigacion
🇵🇷San Juan, Puerto Rico
Hospital Gral. Univ. Gregorio Maranon
🇪🇸Madrid, Spain
Istituto Nazionale Tumori Fondazione Pascale
🇮🇹Napoli, Italy
Medizinische Universitaetsklinik Freiburg
🇩🇪Freiburg, Germany
Klinik Fur Onkologie
🇨ðŸ‡Basel, Switzerland
University Hospital of Lausanne
🇨ðŸ‡Lausanne, Switzerland
University Of Colorado
🇺🇸Aurora, Colorado, United States