Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 2)

Incyte

Status and phase: Enrolling; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: INCB123667; Drug: Investigator's choice of chemotherapy

Study type: Interventional

Funder types: NETWORK; Industry; Other

Identifiers

NCT07214779

INCB123667-305

2025-522748-42-00 (Registry Identifier)

ENGOT-OV95 (Other Identifier)

GOG-3137 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 466 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment.
• Known active CNS metastases and/or carcinomatous meningitis.
• 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.
• Clinically significant gastrointestinal abnormalities.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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466 participants in 2 patient groups

Treatment Group A (TGA)

Experimental group

Description:

INCB123667 at the protocol-defined dose.

Treatment:

Drug: INCB123667

Treatment Group B (TGB)

Experimental group

Description:

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

Treatment:

Drug: Investigator's choice of chemotherapy