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Observational Study of Nivolumab in Patients in Germany With Squamous Cell Carcinoma of the Head and Neck Progressing on or After Platinum-Based Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114163
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This is an observational study in adult patients in Germany diagnosed with SCCHN progressing on or after platinum-based therapy, who start a new systemic therapy with nivolumab for the first time, and are treated within the market authorization approval. Patients are to be enrolled into the study no earlier than the decision to initiate treatment with nivolumab and no later than the first dose of nivolumab treatment.

Condition or disease Intervention/treatment
Head and Neck Cancer Other: Non-Interventional

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Study Type : Observational
Estimated Enrollment : 385 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN) Progressing on or After Platinum-Based Therapy
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
SCCHN patients in Germany
Patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) in Germany
Other: Non-Interventional
Non-Interventional




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 5 years ]
    Overall Survival will be measured from first treatment with nivolumab until date of death due to any cause.


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Up to 5 years ]
    Progression-Free Survival will be measured from first treatment with nivolumab to date of disease progression or death.

  2. Overall Response Rate (ORR) [ Time Frame: Up to 5 years ]
    The total number of patients whose best overall response (BOR) equals Complete Response (CR) or Partial Response (PR), divided by the total number of patients.

  3. Best Overall Response per RECIST [ Time Frame: Approximately 5 years ]
    The highest level of response among all available best therapy responses in tumor assessment during follow-up assessed by Response Evaluation Criteria in Solid Tumors (RECIST).

  4. Distribution of Gender in patients treated with nivolumab [ Time Frame: At Baseline ]
    Measured by investigator assessment

  5. Distribution of Age in patients treated with nivolumab [ Time Frame: At Baseline ]
    Measured by investigator assessment

  6. Distribution of Height in patients treated with nivolumab [ Time Frame: At Baseline ]
    Measured by investigator assessment

  7. Distribution of weight in patients treated with nivolumab [ Time Frame: Up to 5 years ]
    Measured by investigator assessment

  8. Distribution of Initial Diagnosis of SCCHN in patients treated with nivolumab [ Time Frame: At Baseline ]
    Measured by investigator assessment

  9. Distribution of Comorbidities in patients treated with nivolumab [ Time Frame: At Baseline ]
    Measured by investigator assessment

  10. Distribution of History of Cancer in patients treated with nivolumab [ Time Frame: At Baseline ]
    Measured by investigator assessment

  11. Distribution of previous randomized clinical trial enrollment (RCT) in patients treated with nivolumab [ Time Frame: At Baseline ]
    Measured by investigator assessment

  12. Distribution of Eastern Cooperative Oncology Group (ECOG) scores in patients treated with nivolumab [ Time Frame: Up to 5 years ]
    Measured by investigator assessment

  13. Distribution of Adverse Events (AEs) [ Time Frame: Up to 5 years ]
    Measured by investigator assessment

  14. Distribution of Treatment-Related Adverse Events (AEs) [ Time Frame: Up to 5 years ]
    Measured by investigator assessment

  15. Distribution of Select Adverse Events (AEs) [ Time Frame: Up to 5 years ]

    Select Adverse Events Include:

    • Pneumonitis
    • Interstitial nephritis
    • Diarrhea/colitis
    • Hepatitis
    • Rash
    • Endocrinopathies

  16. Distribution of other Immune-Related Adverse Events (AEs) [ Time Frame: Up to 5 years ]

    Other Immune-related AEs Include:

    • Severe infusion reactions
    • Uveitis
    • Pancreatitis
    • Demyelination
    • Guillan-Barre Syndrome
    • Myasthenic syndrome
    • Encephalitis
    • Toxic epidermal necrolysis

  17. European Quality of Life-5 Dimensions (EQ-5D) Questionnaire [ Time Frame: Up to 5 years ]
    Measured by Patient-Reported Outcomes

  18. Functional Assessment of Cancer Therapy (FACT-H&N) Questionnaire [ Time Frame: Up to 5 years ]
    Measured by Patient-Reported Outcomes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will enroll adult patients in Germany who are at least 18 years of age at the time of the treatment decision, with the diagnosis of SCCHN.
Criteria

Inclusion Criteria:

  1. Adult patients (at least 18 years of age at time of treatment decision)

    • Diagnosis of SCCHN and patients are progressing on or after platinum-based therapy
    • Diagnosis of SCCHN has been confirmed by histology or cytology (either at initial diagnosis or any time later during the course of the disease)
    • Treatment decision to initiate a treatment with nivolumab for the first time for the treatment of SCCHN (according to the label approved in Germany) has already been taken
  2. Patients who provided informed consent to participate in the study

Exclusion Criteria:

  1. Patients with a current primary diagnosis of a cancer other than SCCHN, ie, a cancer other than SCCHN that requires systemic or other treatment, or has not been treated curatively (as per discretion of the investigator)
  2. Patients previously treated with nivolumab and/or ipilimumab, an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways (applicable for any indication)
  3. Patients currently included in an interventional clinical trial for their SCCHN. Patients who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for OS can be enrolled

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114163


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Germany
Local Institution Recruiting
Leipzig, Germany, 04103
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03114163    
Other Study ID Numbers: CA209-99K
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site