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NCT03114163 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03114163
Other study ID # CA209-99K
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 12, 2017
Est. completion date April 30, 2025

Study information
Verified date August 2021
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 485
Est. completion date April 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Local Institution Leipzig

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall Survival Up to 5 years
Secondary Overall Survival Up to 5 years
Secondary Progression-Free Survival (PFS) Up to 5 years
Secondary Time to progression Up to 5 years
Secondary Overall Response Rate (ORR) Up to 5 years
Secondary Best overall response rate (BORR) Up to 5 years
Secondary Best overall response (BOR) Up to 5 years
Secondary Tumor response (Investigator assessed) Up to 5 years
Secondary Time to response (TTR) Up to 5 years
Secondary Duration of response (DOR) Up to 5 years
Secondary Description of socio-demographic characteristics of participants Up to 5 years
Secondary Description of clinical characteristics of participants Up to 5 years
Secondary Description of management of participants with treatment-related adverse events (AEs) Up to 5 years
Secondary Description of incidence of AEs Up to 5 years
Secondary Description of Severity of AEs Up to 5 years
Secondary Description of management of AEs Up to 5 years
Secondary 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
Secondary 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
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