A Study to Test Combination Treatments in People With Advanced Gastric Cancer
- Conditions
- Advanced Gastric CancerMedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-002807-24-DE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 300
For the master protocol:
-Advanced Gastric Cancer
-Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
-Must have at least 1 lesion with measurable disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
For the master protocol:
-Patients/subjects with HER2 positive tumor that have not been treated with trastuzumab prior to enrollment
-Must not have suspected or known central nervous system metastases unless adequately treated
-Patients/subjects with autoimmune disease
-Patients/subjects who need daily oxygen therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of this study is to determine whether nivolumab in combination with other therapies is more effective than nivolumab in combination with ipilimumab in treating patients/subjects with advanced gastric cancer.;Secondary Objective: Safety and tolerability of Nivolumab in combination with other therapies based on incidence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths;Primary end point(s): 1. Objective Response Rate (ORR)<br>2. Duration of Response (DOR)<br>3. Progression-free Survival Rate (PFSR)<br>4.Incidence of Adverse Events (AEs) in Part 1<br>5.Incidence of Serious Adverse Events (SAEs) in Part 1<br>6.Incidence of AEs leading to Discontinuation in Part 1<br>7.Incidence of Deaths in Part 1<br>5.Incidence of Clinical Laboratory Abnormalities in Part 1;Timepoint(s) of evaluation of this end point: 1 to 3. Up to 24 months<br>4 to 7. Approximately 28 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1.Incidence of Adverse Events (AEs)<br>2.Incidence of Serious Adverse Events (SAEs)<br>3.Incidence of AEs leading to Discontinuation<br>4.Incidence of Deaths<br>5. Incidence of Clinical laboratory test abnormalities;Timepoint(s) of evaluation of this end point: 1 to 5. Approximately 28 months