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

NCT03114163 | Completed

• 1 other identifier: CA209-99K
• Study Type: observational
• Target: 485
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Up to 5 years

Secondary Outcomes (17)

• Overall Survival

  Up to 5 years

• Progression-Free Survival (PFS)

  Up to 5 years

• Time to progression

  Up to 5 years

• Overall Response Rate (ORR)

  Up to 5 years

• Best overall response rate (BORR)

  Up to 5 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Leipzig, 04103, Germany

Location

Related Links

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

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 14, 2017
• Study Start: May 12, 2017
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

DE (1)