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Completed

NCT Number: NCT03114163

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

This is a German, observational study in adult participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) progressing on or after platinum-based therapy, who start a new systemic therapy with nivolumab in 1st line (cohort 2) or ≥2nd line (cohort 1) for the first time, and are treated within the market authorization approval. Participants 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Leipzig, 04103, Germany

Who can participate

Healthy volunteers accepted: No

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Adult participants (at least 18 years of age at time of treatment decision)
  • Diagnosis of Squamous cell carcinoma of the head and neck (SCCHN) and participants are progressing on or after platinum-based therapy, administered for locally advanced, metastatic or recurrent disease (Cohort 2: prior platinum-based therapy was administered for locally advanced disease in the adjuvant or primary setting, e.g. radiotherapy)
  • 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

Exclusion criteria

  • Current primary diagnosis of a cancer other than SCCHN, ie, a cancer other than SCCHN or cancer of unknown primary (CUP-syndrome) that requires systemic or other treatment, or has not been treated curatively (as per discretion of the investigator)
  • Previously treated with nivolumab and/or ipilimumab, an anti-PD-1, anti-programmed death ligand 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)
  • Currently included in an interventional clinical trial for their SCCHN. Participants who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for Overall survival (OS) can be enrolled

Treatment and study plan

Primary outcomes

  1. Overall Survival

    Time frame: Up to 5 years

Secondary outcomes

  1. Overall Survival

    Time frame: Up to 5 years

  2. Progression-Free Survival (PFS)

    Time frame: Up to 5 years

  3. Time to progression

    Time frame: Up to 5 years

  4. Overall Response Rate (ORR)

    Time frame: Up to 5 years

  5. Best overall response rate (BORR)

    Time frame: Up to 5 years

  6. Best overall response (BOR)

    Time frame: Up to 5 years

  7. Tumor response (Investigator assessed)

    Time frame: Up to 5 years

  8. Time to response (TTR)

    Time frame: Up to 5 years

  9. Duration of response (DOR)

    Time frame: Up to 5 years

  10. Description of socio-demographic characteristics of participants

    Time frame: Up to 5 years

  11. Description of clinical characteristics of participants

    Time frame: Up to 5 years

  12. Description of management of participants with treatment-related adverse events (AEs)

    Time frame: Up to 5 years

  13. Description of incidence of AEs

    Time frame: Up to 5 years

  14. Description of Severity of AEs

    Time frame: Up to 5 years

  15. Description of management of AEs

    Time frame: Up to 5 years

  16. Description of participant-reported outcomes (PROs) and health-related quality-of-life (QoL) of participants using the Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) questionnaires

    Time frame: Up to 5 years

  17. Description of participant-reported outcomes (PROs) and health-related quality-of-life (QoL) of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2017
Registry last updated
Jun 18, 2025

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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