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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Biological

Specified dose on specified days

Daratumumab

Biological

Specified dose on specified days

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: 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

  2. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: 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

  3. Number of Participants With Laboratory Abnormalities in Specific Liver Tests

    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 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
  4. Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

    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 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
  5. Number of Participants With Laboratory Results of Worst CTC Grade

    Time frame: 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

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 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)

  2. Duration of Response (DOR)

    Time frame: 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

  3. Best Overall Response (BOR)

    Time frame: 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.

  4. Progression Free Survival (PFS)

    Time frame: 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.

  5. Nivolumab Serum Concentrations

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

    Pharmacokinetics (PK) assessed using serum concentration data for Nivolumab

  6. Daratumumab Serum Concentrations

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

    Pharmacokinetics (PK) assessed using serum concentration data for Daratumumab

  7. Percentage of Participants Anti Drug Antibody (ADA) by Positivity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Janssen Biotech, Inc.

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 31, 2017
Registry last updated
Jul 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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