Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 738 participants in total. The global part of the trial included 350 people who received pembrolizumab (an immunotherapy medicine) added to standard chemotherapy, and 348 people who received standard chemotherapy alone. A separate smaller group based in Japan included 20 people in each of two similar treatment arms. The trial was measuring how long participants lived without their cancer growing (called progression-free survival), how long they lived overall (overall survival), how many had their tumours shrink or disappear (objective response rate), and how long those responses lasted. The reported data shows that, in the global group, participants receiving pembrolizumab plus standard chemotherapy had a median progression-free survival — meaning half of participants reached this point without their disease worsening — of 10.0 months, compared with 8.1 months in the standard chemotherapy group. Median overall survival was reported as 20.0 months for the pembrolizumab group and 16.8 months for the standard chemotherapy group. For the secondary outcomes, the reported data shows that 72.6% of participants in the pembrolizumab group had their tumours shrink or disappear, compared with 60.1% in the standard chemotherapy group. Among those who responded, the response lasted a median of 11.13 months in the pembrolizumab group and 9.5 months in the standard chemotherapy group. The Japan-specific group was not included in these outcome calculations, as specified in the trial's analysis plan. Regarding reported adverse events (unwanted medical occurrences during the study), 348 out of 350 participants in the global pembrolizumab group and 346 out of 346 treated participants in the global standard chemotherapy group experienced at least one adverse event. All 20 participants in each of the Japan groups also experienced at least one adverse event. Treatment was stopped due to an adverse event in 150 participants in the global pembrolizumab group, 136 in the global standard chemotherapy group, and 11 in each of the Japan groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 37871604) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Stomach Cancer Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with stomach cancer or cancer of the junction between the stomach and food pipe (gastroesophageal junction) that has spread or cannot be removed by surgery, and you have not yet received treatment for it
- Your cancer has been confirmed by a lab test (biopsy or cell sample) to be HER2-positive, a specific protein found on some cancer cells
- Your cancer can be measured on a scan, according to standard medical guidelines
- Male participants must agree to use an approved form of contraception during the trial
- Female participants must not be pregnant or breastfeeding, and must either not be able to become pregnant, or agree to use an approved form of contraception
- You are in good enough general health to carry out everyday activities, as measured by a standard medical scale (ECOG score of 0 or 1), confirmed within 3 days before starting treatment
- You are expected to live for more than 6 months
- Your liver, kidneys, and other organs are working well enough (confirm with trial site)
Who may not be able to join:
- You have already received treatment specifically for your advanced or metastatic stomach/gastroesophageal junction cancer
- You have had major surgery, an open biopsy, or a serious injury within the past 28 days, or are likely to need major surgery during the trial
- You have had radiation therapy within the past 14 days
- You have another cancer that is still growing or has needed active treatment within the last 5 years
- You have cancer that has spread to your brain or the lining around your brain and spinal cord
- You have an active autoimmune disease (where your immune system attacks your own body) that needed treatment in the past 2 years
- You have been diagnosed with an immune system deficiency, or are currently taking long-term steroid medicines
- You have had or currently have lung inflammation (pneumonitis) that required steroid treatment
- You have a known history of active tuberculosis (TB)
- You currently have an active infection that requires medicine to treat it
- You have diarrhea that is difficult to control
- You have a build-up of fluid around your lungs, abdomen, or heart that has needed draining or water tablets (diuretics) within the past 2 weeks (unless diuretics are being taken for a different reason)
- You have a condition, previous treatment, or abnormal test result that could affect the trial results or make it unsafe for you to participate, in the doctor's opinion
- You have significant nerve damage or tingling/numbness in your hands or feet beyond a mild level (confirm with trial site)
- You have a mental health condition or substance use disorder that would make it difficult to take part in the trial
- You are a woman who could become pregnant and have a positive pregnancy test within 24 hours before starting treatment
- You have a significant or active heart condition
- You have a known history of HIV
- You have a known history of active Hepatitis B or Hepatitis C infection
- You have had a severe allergic reaction (grade 3 or higher) to any of the medicines used in this trial, including pembrolizumab, trastuzumab, platinum-based chemotherapy, or related substances
- You have had an organ or tissue transplant from another person
- You have previously been treated with certain immunotherapy medicines that work on the immune system's "checkpoint" pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar drugs)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Medical Director, Merck Sharp & Dohme LLC
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Progression Free Survival (PFS) Per RECIST 1.1 Assessed by BICR; Overall Survival (OS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.