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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Nivolumab | ≥2nd line treatment for recurrent/ metastatic (R/M) Squamous cell carcinoma of the head and neck (SCCHN), prior platinum-based therapy was administered for locally advanced, metastatic or recurrent disease | ||
| Cohort 2: Nivolumab | 1st line treatment for R/M SCCHN, prior platinum-based therapy was administered for locally advanced disease in the adjuvant or primary setting |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Up to 5 years | |
| Progression-Free Survival (PFS) | Up to 5 years | |
| Time to progression |
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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)
Exclusion Criteria:
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The study will enroll adult participants who are at least 18 years of age at the time of the treatment decision, with the diagnosis of Squamous Cell Carcinoma of the Head and Neck (SCCHN) (either initial diagnosis or during later course histologically or cytologically confirmed). It is mandatory that the physician has already decided to initiate a treatment with nivolumab as 1st line or ≥2nd line therapy for the first time for the treatment of SCCHN, according to the label approved in Germany.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Leipzig | 04103 | Germany |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| Up to 5 years |
| Overall Response Rate (ORR) | Up to 5 years |
| Best overall response rate (BORR) | Up to 5 years |
| Best overall response (BOR) | Up to 5 years |
| Tumor response (Investigator assessed) | Up to 5 years |
| Time to response (TTR) | Up to 5 years |
| Duration of response (DOR) | Up to 5 years |
| Description of socio-demographic characteristics of participants | Up to 5 years |
| Description of clinical characteristics of participants | Up to 5 years |
| Description of management of participants with treatment-related adverse events (AEs) | Up to 5 years |
| Description of incidence of AEs | Up to 5 years |
| Description of Severity of AEs | Up to 5 years |
| Description of management of AEs | Up to 5 years |
| 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 | Up to 5 years |
| 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 | Up to 5 years |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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