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NCT02644369

NCT02644369
Active, Not Recruiting Phase 2

Who may be able to join

Who might be able to join this trial:

  • You must be willing and able to sign a consent form agreeing to take part in the trial.
  • You must be 18 years old or older at the time of signing the consent form.
  • You must have a solid tumour cancer that has been confirmed by a lab test, cannot be cured, and has either stopped responding to standard treatments, has no standard treatment available, or you and your doctor have agreed that standard treatment is not the right option for you.
  • Your cancer must be one of the following types: squamous cell cancer of the head and neck, triple negative breast cancer, epithelial ovarian cancer, malignant melanoma, or certain other advanced solid tumours.
  • Your cancer must be measurable using standard medical imaging criteria (confirm with trial site).
  • You must be willing to have a fresh tissue sample (biopsy) taken from your tumour before the trial begins — samples that already exist cannot be used instead.
  • You must be reasonably active and able to care for yourself, as measured by a standard medical scoring system (called ECOG score 0 or 1 — confirm with trial site).
  • Your liver, kidneys, and other organs must be working well enough as shown by blood tests.
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before starting.
  • You must be willing to use approved contraception during the trial and for 120 days after your last dose of the study drug.

Who may not be able to join:

  • You are currently taking part in another clinical trial or have received an experimental treatment within the last 4 weeks.
  • You have been diagnosed with a condition that weakens your immune system, or you have been taking steroid or other immune-suppressing medicines within the last 7 days.
  • You have a known history of active tuberculosis (TB).
  • You have had an allergic reaction to pembrolizumab or any of its ingredients.
  • You have received a type of cancer treatment called a monoclonal antibody within the last 4 weeks, or you are still experiencing side effects from one given more than 4 weeks ago.
  • You have received chemotherapy, targeted therapy, or radiation therapy within the last 2 weeks, or you are still experiencing side effects from a previous treatment.
  • You have another separate cancer that is growing or currently being treated.
  • You have cancer that has spread to your brain or the lining around your brain and spinal cord (confirm with trial site).
  • You have an autoimmune disease (where your immune system attacks your own body) that has needed medical treatment in the past 2 years.
  • You have a known history of, or currently have, a non-infectious lung condition called pneumonitis.
  • You currently have an active infection that requires medical treatment.
  • You have any condition, ongoing treatment, or abnormal test result that your doctor believes could affect the trial results or make participation unsafe for you.
  • You have a known mental health condition or substance use problem that would make it difficult to follow the trial's requirements.
  • You are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial or within 120 days after the last dose.
  • You have previously been treated with certain types of immunotherapy drugs that target PD-1, PD-L1, or PD-L2 (confirm with trial site).
  • You have a known history of HIV.
  • You have active Hepatitis B or Hepatitis C infection.
  • You have received a live vaccine (such as certain flu or travel vaccines) within the last 30 days before starting the trial.

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 2: approximately ~30% 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
Active, Not Recruiting
Phase
Phase 2
Sponsor
University Health Network, Toronto
Registry
clinicaltrials_gov
Start date
21 March 2016
Est. completion
1 December 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Changes in genomic and immune biomarkers that will be measured in blood and tumor pre-treatment, on-treatment and at progression (progression biopsies only done for those who have complete or partial responses, or stable disease for more than 4 months)

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