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Taking people in United KingdomPhase 3

Compares INCB123667 with standard chemotherapy in platinum-resistant ovarian cancer

Tests INCB123667 against chemotherapy in adults with ovarian cancer that stopped responding to platinum.

Key facts

Who runs it
Incyte Corporation
Where
Cambridge, Cardiff, Guildford, Leeds, Liverpool, London, Manchester Greater, Northampton, Northwood, Sutton, and Taunton, United KingdomSee the 13 sitesAlso in 15 other countries, 183 sites
Registry title
Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
Status
Recruiting
Phase
Phase 3
People taking part
466 people, planned
Started
9 Dec 2025
Expected to end
14 May 2029
Type of study
Interventional, 2 groups
Treatments tested
  • INCB123667
  • Investigator's choice of chemotherapy
Record updated
15 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18 or older with platinum-resistant high-grade serous ovarian, fallopian tube, or primary peritoneal cancer with cyclin E1 overexpression.

Age
18 years or older.
Sex
Women only.
Disease stage
High-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer that is platinum-resistant, with measurable disease per RECIST v1.1.
Earlier treatment
Must have had at least 1 and no more than 4 earlier lines of systemic therapy. With only 1 line of platinum therapy, at least 4 cycles are needed. With 2 to 4 lines, the cancer must have progressed on or within 6 months after the last platinum dose. Should have had bevacizumab unless it could not be used. Should have had mirvetuximab soravtansine if the tumor is FRα-positive, unless there is a medical reason not to.
Biomarker or test result
Cyclin E1 overexpression. Archival tumor tissue no older than 5 years is needed, or a new tumor biopsy before treatment.

Main reasons for not taking part

  • Endometrioid, clear cell, mucinous, or sarcomatous cancer, mixed tumors with these types, or low-grade/borderline ovarian cancer
  • Cancer that got worse on or within 3 months after the last dose of first-line platinum therapy
  • Clinically significant or uncontrolled heart disease within 6 months before the first dose
  • Known active brain or spinal cord spread of cancer, or carcinomatous meningitis
  • Another cancer that is getting worse or needs treatment, or another cancer within 3 years before the first dose

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • Have platinum-resistant disease; Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum containing regimen; Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum
  • Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy
  • Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent chemotherapy is considered an appropriate next therapeutic option
  • Should have received prior treatment with bevacizumab unless there was a contraindication for its use
  • Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FRα, unless there is an exception for its use on medical grounds
  • Measurable disease per RECIST v1.1

Who cannot take part

  • Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment
  • Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer
  • Have primary platinum-refractory disease, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy
  • Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years before the first dose of study treatment
  • Known active CNS metastases and/or carcinomatous meningitis
  • Clinically significant gastrointestinal abnormalities; Other protocol-defined Inclusion/Exclusion Criteria may apply

Where in United Kingdom

Also in 15 other countries, 183 sites

  • Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation TrustCambridge, United KingdomTaking people
  • Velindre NHS Trust, Velindre Cancer CentreCardiff, United KingdomNo longer taking part
  • Royal Surrey County Hospital - Royal Surrey County Hospital Nhs Foundation TrustGuildford, United KingdomTaking people
  • St James's University Hospital, Leeds Teaching Hospitals NHS TrustLeeds, United KingdomTaking people
  • Clatterbridge Cancer CenterLiverpool, United KingdomTaking people
  • Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation TrustLondon, United KingdomTaking people
  • Royal Marsden Hospital - LondonLondon, United KingdomTaking people
  • University College London Hospitals - University College London Hospitals Nhs Foundation TrustLondon, United KingdomTaking people
  • The Christie Nhs Foundation TrustManchester Greater, United KingdomTaking people
  • Northampton General Hospital - Northampton General Hospital Nhs TrustNorthampton, United KingdomTaking people
  • Mount Vernon Cancer CentreNorthwood, United KingdomNot yet recruiting
  • Royal Marsden Hospital (Sutton)Sutton, United KingdomTaking people
  • Musgrove Park Hospital - Somerset Nhs Foundation TrustTaunton, United KingdomTaking people

About the trial

What the trial wants to find out

The purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with cyclin E1 overexpression.

The 2 groups in the trial

  • Treatment Group A (TGA)Treatment being tested

    INCB123667 at the protocol-defined dose.

    Treatment: INCB123667

  • Treatment Group B (TGB)Treatment being tested

    Investigator's choice of chemotherapy at the protocol-defined dose as defined by the protocol.

    Treatment: Investigator's choice of chemotherapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
Plain-language title
Compares INCB123667 with standard chemotherapy in platinum-resistant ovarian cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
15 October 2026