Phase 3 Oesophageal Cancer Trial, Completed NCT02872116 Sponsor: Bristol-Myers Squibb Condition: Oesophageal Cancer
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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 (NCT02872116) enrolled a total of 2,031 participants across three treatment groups: one group received nivolumab (an immunotherapy medicine) combined with chemotherapy (789 people), one group received chemotherapy alone (833 people), and one group received nivolumab combined with another immunotherapy called ipilimumab (409 people). The trial was studying treatments for gastric (stomach) and related cancers. The main things being measured were how long participants lived overall (called "overall survival"), and how long they went before their cancer got worse or they died (called "progression-free survival"). Some of these measurements were focused on participants whose tumours showed a particular protein marker, called PD-L1 CPS, at certain levels. The reported data shows that, among participants whose tumours had a PD-L1 CPS score of 5 or higher, the median overall survival — that is, the midpoint time at which half the participants in each group had died — was reported as approximately 14.4 months in the nivolumab-plus-chemotherapy group, compared with approximately 11.1 months in the chemotherapy-alone group. For progression-free survival in that same group, the reported median was approximately 7.7 months for nivolumab plus chemotherapy, compared with approximately 6.1 months for chemotherapy alone. When looking at all participants regardless of their PD-L1 marker level, overall survival medians ranged from around 13.7 to 15.0 months for the nivolumab-plus-chemotherapy group and around 10.9 to 11.6 months for chemotherapy alone across the different subgroups reported. The reported data shows that the proportion of participants whose tumours shrank (the "objective response rate") was approximately 47–50% in the nivolumab-plus-chemotherapy group, compared with approximately 37–38% in the chemotherapy-alone group, depending on the subgroup. For time to worsening of stomach cancer symptoms, the data was not reported for the nivolumab-plus-chemotherapy group, while the chemotherapy-alone group had a reported median of approximately 21 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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 Oesophageal Cancer Trial, Completed

NCT02872116
Completed Phase 3 🇦🇺 Australian site

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 must be at least 18 years old (male or female)
  • You must have stomach cancer or cancer where the stomach meets the food pipe (esophagus) that cannot be removed by surgery and has spread or is at an advanced stage
  • You must not have received chemotherapy, radiotherapy, or both as a pre- or post-surgery treatment for this cancer in the last 6 months
  • You must be fully active, or if your activity is somewhat limited, you should still be able to walk and do light tasks such as light housework or office work
  • You must agree to provide a tumor tissue sample — either from a previous surgery or biopsy done within the last 6 months, or a new sample — before starting treatment in this study

Who may not be able to join:

  • You may not be eligible if cancer cells have spread to the brain or spinal cord and have not been treated
  • You may not be eligible if you have an active autoimmune disease (a condition where your immune system attacks your own body), either confirmed or suspected
  • You may not be eligible if you have a serious or uncontrolled medical condition or an active infection
  • You may not be eligible if you have a known history of HIV (the virus that causes AIDS) or have been diagnosed with AIDS
  • You may not be eligible if you have tested positive for hepatitis B or C, showing a current or ongoing infection

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb

Australian sites

Local Institution - 0202, Blacktown, New South Wales
Local Institution - 0100, Gosford, New South Wales
Local Institution - 0190, Southport, Queensland
Local Institution - 0101, Adelaide, South Australia
Local Institution - 0103, Ballarat, Victoria
Local Institution - 0102, Shepparton, Victoria
Local Institution - 0214, St Albans, Victoria
Local Institution - 0099, Perth, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
12 October 2016
Est. completion
27 May 2020

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇴 Colombia 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇵🇪 Peru 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇺 Russia 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

8 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5; Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov