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NCT04931342

NCT04931342
Active, Not Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with a specific type of ovarian, fallopian tube, or peritoneal cancer that has come back or not gone away — including low-grade serous, clear cell, mucinous, carcinosarcoma, and several other types (but NOT high-grade serous or high-grade endometrioid types)
  • Your cancer cannot be fully removed by surgery
  • At least one area of your cancer can be measured on a scan
  • You have already received between one and four previous cancer treatments, and at least one of those included a platinum-based chemotherapy (note: hormone therapy does not count as a treatment line for this purpose)
  • Your cancer got worse during or within 6 months after your most recent platinum-based chemotherapy
  • You are able to provide a tumour tissue sample suitable for laboratory testing, to help determine which treatment group you would be placed in
  • You are also able to provide your local pathology report and, if available, any related tissue slides from your diagnosis
  • You are generally well enough to carry out daily activities with little or no limitation (confirm with trial site what this means for you specifically)
  • Your blood counts and organ function (such as liver and kidneys) are within acceptable ranges
  • If you could become pregnant, you agree to use reliable contraception or remain abstinent during the study, and agree not to donate eggs

Who may not be able to join:

  • You are currently pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
  • Your cancer did not respond to your very first platinum-based chemotherapy and got worse during treatment or within 4 weeks of finishing it
  • Your cancer has been identified as high-grade serous or high-grade endometrioid ovarian, fallopian tube, or peritoneal cancer
  • Your only current diagnosis is a "borderline" ovarian tumour (a low-risk, slow-growing type)
  • Your ovarian tumour is a non-epithelial type (confirm with trial site)
  • You currently also have endometrial (womb) cancer at the same time
  • You have a previous history of endometrial cancer, unless it was caught very early, was a lower-grade type, had no spread into blood or lymph vessels, and was not a high-grade subtype (confirm with trial site)
  • You have uncontrolled fluid build-up around your lungs, heart, or abdomen that regularly needs to be drained
  • You have brain metastases (cancer that has spread to the brain) that are causing symptoms, have not been treated, or are getting worse
  • You had a serious infection within the 4 weeks before starting the study treatment
  • You received chemotherapy, radiation, immunotherapy, gene therapy, a vaccine therapy, or another experimental treatment within 28 days before starting the study treatment
  • You received hormone therapy within 14 days before starting the study treatment

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
Hoffmann-La Roche
Registry
clinicaltrials_gov
Start date
7 October 2021
Est. completion
28 February 2028

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Confirmed Objective Response Rate (ORR)

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