Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Adenocarcinoma
Esophageal Neoplasms
Gastric Cancer Third Line
Stomach Neoplasms
Unresectable, Recurrent, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02625623
Study type	Interventional
Source	EMD Serono
Contact
Status	Completed
Phase	Phase 3
Start date	December 28, 2015
Completion date	November 13, 2019

Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms