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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer

• Study Type: Observational
• Enrollment (Actual): 485

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany, 04103
    • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to progression	Up to 5 years
Overall Survival	Up to 5 years
Progression-Free Survival (PFS)	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2017
• Primary Completion (Actual): April 28, 2025
• Study Completion (Actual): April 28, 2025

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Neoplasms, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell
• Other Study ID Numbers: CA209-99K