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Active, Not Recruiting

NCT Number: NCT05165264

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0001

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A National, Prospective, Non-interventional Study (NIS) of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Patients With HER2 Negative Advanced or Metastatic Gastric, Gastro-oesophageal Junction or Oesophageal Adenocarcinoma Whose Tumours Express PD-L1 With a CPS ≥5

Acronym: INGA

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 21, 2021
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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