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 involved 444 people across two phases. The first phase (62 participants) tested different doses of a drug called epacadostat, given twice daily, to look at how participants responded to the treatment and what unwanted effects they experienced. The second phase (382 participants) tested a combination of epacadostat (100 mg twice daily) and another drug called pembrolizumab across several different cancer types, with the main goal of measuring how many participants' tumours shrank or disappeared. The reported data shows that in Phase 1, between 94% and 100% of participants across the dose groups experienced at least one treatment-emergent adverse event (an unwanted sign or symptom that appeared or worsened after starting the study drug). Serious adverse events — meaning events that were life-threatening, caused hospitalisation, or were otherwise considered medically significant — were reported in 40% of participants in the 50 mg group, 50% in the 100 mg group, and 45% in the 300 mg group, with none reported in the small 25 mg group (which had only 4 participants). For Phase 2, the reported data shows the proportion of participants whose tumours shrank enough to count as a response varied across cancer types, with figures ranging from approximately 8% to 61% depending on the cancer group. For time-related measures — how long responses lasted, how long before the disease progressed, and overall survival — the reported data shows results that also varied considerably by cancer type, with some figures not reported for certain 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 ↗
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 2 Breast Cancer Trial, Completed
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not 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 may be able to join
- People who have been diagnosed with certain cancers confirmed by laboratory testing, including non-small cell lung cancer, melanoma, bladder or urinary tract cancer, kidney cancer, triple negative breast cancer, uterine cancer, head and neck cancer (Phase 1), or ovarian cancer, bowel cancer with a specific genetic marker (MSI high), stomach cancer, liver cancer, or a type of lymphoma called DLBCL (Phase 2).
- People with a life expectancy of more than 12 weeks.
- People who are reasonably active and able to care for themselves, as measured by a standard health scoring system (a score of 0 or 1 on the ECOG scale — confirm with trial site).
- People whose cancer can be measured using standard imaging criteria.
- People whose blood test results and medical history fall within the ranges set out in the trial protocol (confirm with trial site).
- For Phase 1: People whose cancer has spread or is advanced, and who have already had at least one prior treatment, or whose cancer has no curative treatment available.
- For Phase 2 – Non-small cell lung cancer: People who have had at least one prior treatment containing platinum-based chemotherapy (or another regimen with approval from the trial medical monitor), and who have not previously received certain immune checkpoint therapies targeting PD-1 or CTLA-4.
- For Phase 2 – Melanoma: People whose BRAF mutation status has been documented, and who fall into one of three groups — those who have never received immune checkpoint therapy, those whose melanoma did not respond to prior anti-PD-1 or anti-PD-L1 treatment, or those whose melanoma responded but later came back; people in the last two groups must be willing to have tissue samples (biopsies) taken before and during treatment.
- For Phase 2 – Bladder or urinary tract cancer: People with advanced or spreading disease that has worsened during or after platinum-based chemotherapy (or an alternative if platinum was not appropriate), and who have not had prior PD-1 or CTLA-4 targeted therapy.
- For Phase 2 – Head and neck squamous cell cancer: People with confirmed advanced or returning cancer that cannot be treated with surgery or radiation to cure it, who have had at least one prior platinum-based chemotherapy regimen, and who have not received prior PD-1 or CTLA-4 targeted therapy.
- For Phase 2 – Ovarian cancer: People with confirmed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer at certain stages or that has returned or cannot be removed by surgery, who have had a platinum and taxane-based treatment as their first therapy, and who have not received prior PD-1 or CTLA-4 targeted therapy.
- For Phase 2 – DLBCL lymphoma: People who have had at least one prior treatment, are not suitable for a stem cell transplant or curative therapy, have not had a prior allogeneic (donor) stem cell transplant, and have not received prior PD-1 or CTLA-4 targeted therapy.
- For Phase 2 – Triple negative breast cancer: People with confirmed triple negative breast cancer that has spread or cannot be surgically removed, who have had at least one prior treatment for advanced disease, and who have not received prior PD-1 or CTLA-4 targeted therapy.
- For Phase 2 – Kidney cancer (RCC): People with confirmed clear cell kidney cancer that cannot be cured by surgery, who have had prior anti-angiogenic therapy, and who have not received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy.
- For Phase 2 – MSI high bowel cancer: People with confirmed locally advanced or spreading bowel cancer with a specific genetic marker (MSI high), who have had no more than two prior treatments for advanced disease.
- For Phase 2 – Stomach cancer: People with confirmed stomach or gastroesophageal junction cancer who have had disease progression on or after platinum/fluoropyrimidine-based treatment (or who declined standard therapy), and who have had no more than two prior treatments for advanced disease, and no prior PD-1 or CTLA-4 targeted therapy.
- For Phase 2 – Liver cancer (HCC): People with confirmed liver cancer of specific types and stages, who have progressed on, declined, or could not tolerate a drug called sorafenib, who have had no more than two prior treatments for advanced disease, and who have not received prior PD-1 or CTLA-4 targeted therapy.
- People who are able to provide a tumour tissue sample (biopsy); in some cancer types where this is difficult, enrolment with archived tissue may be considered with approval from the trial's medical monitor (confirm with trial site).
- Women who could become pregnant and men who agree to use adequate contraception for at least 120 days after the last dose.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have taken part in another clinical trial involving an experimental drug or device within the past 2 weeks or 5 half-lives of that drug, whichever is longer.
- People who have previously received certain immune checkpoint or T-cell targeting therapies, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies such as ipilimumab — except for melanoma patients who received anti-CTLA-4 as a preventative (adjuvant) treatment.
- People with currently active cancer that has spread to the brain or the lining of the brain; however, people with previously treated and stable brain metastases may be considered (confirm with trial site).
- People with an active autoimmune disease.
- People who have had, or currently have, inflammation of the lungs (pneumonitis) not caused by infection, particularly if it required steroid treatment.
- People who have received a live vaccine within 30 days before the first dose of the study drug.
- People who are taking a type of medication called monoamine oxidase inhibitors (MAOIs).
- For Phase 2 – Melanoma: People with a type of melanoma that originates in the eye (ocular melanoma).
- For Phase 2 – Ovarian cancer: People whose tumour has been identified as a borderline or low-malignant-potential type.
- For Phase 2 – Liver cancer (HCC): People who have had a liver transplant, have cancer invading the main bile duct or main blood vessels of the liver, have a condition called hepatorenal syndrome, or have had a procedure to treat bleeding in the oesophagus within 28 days before starting the study.
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events; Phase 2: Objective Response Rate (ORR)
Other options
Data last synced from ClinicalTrials.gov: 13 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.