A Study of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Participants With Advanced or Metastatic Gastric Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT05165264

Studienbeginn:
Februar 2022

Letztes Update:
25.02.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Stomach Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Bristol-Myers Squibb

Collaborator:
-

Studienleiter

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Kontakt

BMS Study Connect Contact Center www.BMSStudyConnect.com
Kontakt:
Phone: 855-907-3286
E-Mail: Clinical.Trials@bms.com» Kontaktdaten anzeigen

First line of the email MUST contain NCT # and Site #.

Studienlocations
(1 von 1)

Local Institution
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Site 0001» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

The purpose of this observational study is to assess the effectiveness and safety of

nivolumab in participants with previously untreated advanced or metastatic Gastric Cancer

(GC), Gastro-oesophageal Junction (GEJ) Adenocarcinoma, or Oesophageal Adenocarcinoma (EAC).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Diagnosis of HER2 negative advanced or metastatic HER2-negative GC, GEJ adenocarcinoma

or EAC whose tumours express PD-L1 with a CPS ≥ 5

- Whose physician has decided to start a treatment with nivolumab (according to the

German marketing authorization) for the treatment of GC, GEJ adenocarcinoma or EAC and

prior to study participation

Exclusion Criteria:

- Previous malignancy within 3 years or concomitant malignancy, except: those with a

5-year overall survival rate of more than 90%, e.g. non-melanomatous skin cancer or

adequately treated in situ cervical cancer.

- Participants currently included in an interventional clinical trial for their advanced

or metastatic GC, GEJ adenocarcinoma or EAC. Participants who have completed their

participation in an interventional trial or who are not receiving any study drug

anymore and who are only in the follow-up Phase for OS can be enrolled. For blinded

studies, the study drug administered needs to be known at the time of enrolment.

Studien-Rationale

Primary outcome:

1. Overall Survival (OS) (Time Frame - From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months)

Secondary outcome:

1. Progression-free survival (PFS) (Time Frame - From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months):
Defined as time since initial diagnosis and treatment with nivolumab to either the first disease progression date or last known tumour assessment date, or death due to any cause, whichever occurs first.

2. Overall response rate (ORR) (Time Frame - From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months):
Defined as investigator assessed complete response, partial response, stable disease, or progressive disease.

3. Duration of response (Time Frame - From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months):
Defined as time from response to progression

4. Incidence of Adverse Events (AEs) (Time Frame - From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months)

5. Overall Survival (OS) (Time Frame - From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months):
Defined as time since initial diagnosis and treatment with nivolumab until date of death due to any cause.

6. OS measured by Programmed Death-Ligand 1 (PD-L1) combined positive score (CPS) (Time Frame - From initial diagnosis and treatment with nivolumab until date of death due to any cause, assessed up to 36 months)

Quelle: ClinicalTrials.gov

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