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

NCT03098550 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: CA209-9GW2017-000367-33
• Study Type: interventional
• Target: 105
• Locations: 9 countries
• Sites: 20

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.

Conditions

Advanced Cancer

Keywords

Non-small cell lung cancer (NSCLC); Triple Negative Breast Cancer (TNBC); Pancreatic Cancer (PAC)

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (7)

• Objective Response Rate (ORR)

  Up to 36 months

• Duration of Response (DOR)

  Up to 36 months

• Best Overall Response (BOR)

  Up to 36 months

• Progression Free Survival (PFS)

  Up to 36 months

• Nivolumab Serum Concentrations

  From day 1 to follow-up 2 (up to 36 months)

Study Arms (2)

Immunotherapy Combination

EXPERIMENTAL

TNBC and PAC participants who are deriving clinical benefit will continue to be treated with the nivolumab plus daratumumab combination therapy

Biological: Nivolumab; Biological: Daratumumab

Nivolumab Monotherapy

EXPERIMENTAL

NSCLC patients who are deriving clinical benefit will be treated with nivolumab monotherapy

Biological: Nivolumab

Interventions

Nivolumab BIOLOGICAL

Specified dose on specified days

Immunotherapy Combination; Nivolumab Monotherapy

Daratumumab BIOLOGICAL

Specified dose on specified days

Immunotherapy Combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Active brain metastases or leptomeningeal metastases.
• Any serious or uncontrolled medical disorder
• Prior malignancy active within the previous 3 years

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Janssen Biotech, Inc.: collaborator

Study Sites (20)

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

University Of Colorado

Aurora, Colorado, 80045, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University Of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Local Institution

St Leonards, New South Wales, 2065, Australia

Location

Local Institution

Edmonton, T6G 1Z2, Canada

Location

Local Institution

Lyon, 69373, France

Location

Local Institution

Marseille, 13273, France

Location

Centre Paul Strauss

Strasbourg, 67085, France

Location

Universitaetsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Medizinische Universitaetsklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitaetsklinik Heidelberg

Heidelberg, 69120, Germany

Location

Local Institution

Milan, 20132, Italy

Location

Istituto Nazionale Tumori Fondazione Pascale

Napoli, 80131, Italy

Location

Fundacion De Investigacion

San Juan, 00927, Puerto Rico

Location

Hospital Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

Location

Local Institution

Majadahonda - Madrid, 28222, Spain

Location

Klinik Fur Onkologie

Basel, 4031, Switzerland

Location

University Hospital of Lausanne

Lausanne, 1011, Switzerland

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms; Pancreatic Neoplasms

Interventions

Nivolumab; daratumumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: March 31, 2017
• Study Start: June 15, 2017
• Primary Completion: July 6, 2020
• Study Completion: July 6, 2020
• Last Updated: July 23, 2021
• Results First Posted: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); FR (3); AU (1); DE (3); PR (1); US (5); CA (1); ES (2); CH (2)