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

Advanced Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098550
• Other study ID #: CA209-9GW
• Secondary ID: 2017-000367-33
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 15, 2017
• Est. completion date: July 6, 2020

Study information

• Verified date: July 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 6, 2020
• Est. primary completion date: July 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Triple Negative Breast Neoplasms

Intervention

Biological:
• Nivolumab
Specified dose on specified days
• Daratumumab
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution	St Leonards	New South Wales
Canada	Local Institution	Edmonton
France	Local Institution	Lyon Cedex 08
France	Local Institution	Marseille Cedex 9
France	Centre Paul Strauss	Strasbourg Cedex
Germany	Universitaetsklinikum Carl Gustav Carus	Dresden
Germany	Medizinische Universitaetsklinik Freiburg	Freiburg
Germany	Universitaetsklinik Heidelberg	Heidelberg
Italy	Local Institution	Milano
Italy	Istituto Nazionale Tumori Fondazione Pascale	Napoli
Puerto Rico	Fundacion De Investigacion	San Juan
Spain	Hospital Gral. Univ. Gregorio Maranon	Madrid
Spain	Local Institution	Majadahonda - Madrid
Switzerland	Klinik Fur Onkologie	Basel
Switzerland	University Hospital of Lausanne	Lausanne
United States	University Of Michigan	Ann Arbor	Michigan
United States	University Of Colorado	Aurora	Colorado
United States	Pacific Shores Medical Group	Long Beach	California
United States	Providence Portland Medical Center	Portland	Oregon
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Janssen Biotech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy,  Puerto Rico,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From first dose to 30 days post last dose (up to 34 months)
Primary	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	From first dose to 30 days post last dose (up to 34 months)
Primary	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	From first dose to 30 days post last dose (up to 34 months)
Primary	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	From first dose to 30 days post last dose (up to 34 months)
Primary	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	From first dose to 30 days post last dose (up to 34 months)
Secondary	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)	Up to 36 months
Secondary	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	Up to 36 months
Secondary	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.	Up to 36 months
Secondary	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.	Up to 36 months
Secondary	Nivolumab Serum Concentrations	Pharmacokinetics (PK) assessed using serum concentration data for Nivolumab	From day 1 to follow-up 2 (up to 36 months)
Secondary	Daratumumab Serum Concentrations	Pharmacokinetics (PK) assessed using serum concentration data for Daratumumab	From day 1 to follow-up 2 (up to 36 months)
Secondary	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	Up to 36 months

External Links

•   BMS Clinical Trial Information
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•   FDA Safety Alerts and Recalls