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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT03358472

NCT03358472
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • Your cancer must be measurable using standard imaging scans (based on specific medical guidelines called RECIST v1.1).
  • You must be fairly active and able to carry out normal daily activities with little or no limitation (a doctor will assess this using a standard scale).
  • Your heart, liver, kidneys, and other organs must be working well enough to meet the trial's health requirements.
  • If you have cancer of the oropharynx (the back of the throat/mouth area), you must have been tested for a virus called HPV and have those results available.
  • You must either have a stored tumor tissue sample available, or be willing to have a small piece of tumor tissue removed before treatment starts (from a tumor that has not been previously treated with radiation).

Who may not be able to join:

  • Your cancer cannot be a type that started in the nasopharynx, salivary glands, or is of unknown origin, or is not a squamous cell type of head and neck cancer.
  • You cannot join if your cancer got worse within 6 months of finishing a previous treatment that was intended to cure your head and neck cancer.
  • You cannot have received certain prior or ongoing treatments that are not allowed under the trial's rules (confirm with trial site).
  • You cannot have another cancer that is currently growing or has needed active treatment in the past 3 years.
  • You cannot have active cancer that has spread to the brain or the lining around the brain or spinal cord.
  • You cannot have an active autoimmune disease (where your immune system attacks your own body) that needed medical treatment in the past 2 years.
  • You cannot have a known history of HIV infection.
  • You cannot have an active hepatitis B or hepatitis C infection, confirmed by specific blood tests.

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.

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.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
Incyte Corporation
Registry
clinicaltrials_gov
Start date
1 December 2017
Est. completion
19 July 2018

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇨🇦 Canada 🇭🇺 Hungary 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇵🇹 Portugal 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov