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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT03114163

Studienbeginn:
Mai 2017

Letztes Update:
17.12.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Bristol-Myers Squibb

Collaborator:
-

Studienleiter

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Kontakt

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Kontakt:
Phone: please email:
E-Mail: Clinical.Trials@bms.com
» Kontaktdaten anzeigen
First line of the email MUST contain NCT # and Site #.

Studienlocations
(1 von 1)

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Overall Survival (Time Frame - Up to 5 years)



Secondary outcome:

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)

Studien-Arme

  • 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

Geprüfte Regime

  • Non-Interventional:
    Non-Interventional

Quelle: ClinicalTrials.gov


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