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NCT04205227

NCT04205227
Active, Not Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

For all participants:

  • You must be at least 18 years old and willing to sign a consent form.
  • You must have a life expectancy of more than 3 months.
  • You must have tumor tissue samples (either a fresh biopsy or stored tissue taken within the last 24 months) available before starting treatment.
  • You must be generally well enough to carry out light activity — scored 0 or 1 on a standard health scale used by doctors (confirm with trial site).
  • You must have at least one tumor that can be measured by CT scan or MRI, at least 10mm in size.
  • Your blood, kidney, and liver test results must meet certain healthy ranges (confirm specific values with trial site).
  • If you are a woman who could become pregnant, you must agree to use reliable contraception from the time you sign the consent form until at least 150 days after your last dose of treatment, and must not be pregnant or breastfeeding.
  • If you are a man, you must agree to use contraception and not donate sperm from the time you sign the consent form until at least 120 days after your last dose of treatment.

For melanoma (skin cancer):

  • You must have been confirmed by a lab test to have advanced, inoperable, or metastatic melanoma.
  • You must have had no more than 3 previous cancer treatments for advanced disease.
  • You must have previously received a type of immunotherapy called an anti-PD-1/PD-L1 drug (for at least 6 weeks) and your cancer must have grown or not responded well within 6 months of starting that treatment.

For ovarian, fallopian tube, or primary peritoneal cancer:

  • You must have a lab-confirmed diagnosis of a specific type of ovarian, fallopian tube, or peritoneal cancer (high grade serous, high grade endometrioid, or clear cell).
  • Your cancer must have stopped responding to or grown during or within 6 months of a platinum-based chemotherapy treatment.
  • You must have had no more than 3 previous cancer treatments for advanced disease.
  • You must have been tested for a specific genetic marker (MSI); if your result is high (MSI-H) or shows a repair problem (dMMR), you must also have previously received an anti-PD-1 treatment that did not work well (confirm details with trial site).

For pancreatic cancer:

  • You must have a lab-confirmed diagnosis of advanced or metastatic pancreatic cancer, or pancreatic cancer that has come back after surgery.
  • You must have previously been treated with specific chemotherapy regimens (FOLFIRINOX or a gemcitabine-based treatment) and your cancer must have grown after that treatment.
  • You must have had no more than 2 previous treatments for advanced or metastatic disease.
  • You must have been tested for a specific genetic marker (MSI); if your result is high (MSI-H) or shows a repair problem (dMMR), you must also have previously received an anti-PD-1 treatment that did not work well (confirm details with trial site).

For head and neck squamous cell cancer (a type of mouth, throat, or neck cancer):

  • You must have a lab-confirmed diagnosis of metastatic squamous cell cancer of the head and neck.
  • You must have previously received an anti-PD-1/PD-L1 immunotherapy drug (for at least 6 weeks) and your cancer must have grown or not responded well within 6 months of starting that treatment.

For triple negative breast cancer (TNBC):

  • You must have a lab-confirmed diagnosis of metastatic triple negative breast cancer.
  • You must be tested for a protein called PD-L1; if your score is above 10, you must have previously received an anti-PD-1/PD-L1 immunotherapy drug (for at least 6 weeks) that did not work well within 6 months (confirm details with trial site).

Who may not be able to join:

  • You are pregnant, breastfeeding, or planning to have a child during the study period or shortly after it ends.
  • You previously had a serious (Grade 3 or higher) immune-related side effect that caused you to stop taking immunotherapy (such as an

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
ENB Therapeutics, Inc
Registry
clinicaltrials_gov
Start date
18 February 2020
Est. completion
1 January 2026

Where this trial is recruiting

🇦🇺 Australia 🇺🇸 United States

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

Primary endpoints

Part A: Incidence of Treatment-Emergent Adverse Events of ENB003 in combination with pembrolizumab, as assessed by NCI CTCAE Version 5; Part B: Efficacy of ENB003 in combination with pembrolizumab; Part B: Efficacy of ENB003 in combination with pembrolizumab

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