A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)

Conditions

• Ovarian Cancer Recurrent

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Raludotatug Deruxtecan — BIOLOGICAL
  IV infusion on Day 1 of every 3-week cycle.
• Carboplatin — DRUG
  IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
• Paclitaxel — DRUG
  IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
• Bevacizumab — BIOLOGICAL
  IV infusion on Day 1 of every 3-week cycle.
• Rescue Medication — DRUG
  Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
• Pembrolizumab — BIOLOGICAL
  IV infusion on Day 1 of every 3-week cycle for a maximum of 35 cycles.
• Gemcitabine — DRUG
  IV injection on days 1 and 8 of each 3-week Cycle
• Pegylated liposomal doxorubicin — DRUG
  IV injection administered on Day 1 of each 4-week cycle

Study Details

Researchers are looking for other ways to treat relapsed high-grade serous ovarian cancer. Relapsed means the cancer came back after treatment. High-grade means the cancer cells grow and spread quickly. Serous means the cancer started in the cells that cover the ovaries, the lining of the belly, or in the fallopian tubes. Standard treatment (usual treatment) for people with relapsed high-grade serous ovarian cancer may include: * Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing * Targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread Raludotatug deruxtecan (R-DXd) is a study treatment that is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to know if R-DXd is safe to take with other treatments and if people tolerate them together. They also want to learn how many people have the cancer respond (gets smaller or goes away) to the treatments.

Key Dates

Start date

Apr 15, 2025

Status verified

Jun 2026

Primary completion

Mar 27, 2029

Completion

Mar 27, 2029

Study Design

Enrollment

460 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A-1 Arm 1 (R-DXd + Carboplatin Dose 1)
  Participants receive escalating doses of intravenous (IV) raludotatug deruxtecan (R-DXd) in combination with carboplatin at Dose 1. Participants can receive up to a maximum of six 3-week cycles of carboplatin (approximately 4 months) and will receive raludotatug deruxtecan until disease progression or discontinuation.
• Experimental: Cohort A-1 Arm 2 (R-DXd + Paclitaxel)
  Participants receive escalating doses of IV R-DXd in combination with paclitaxel. Participants can receive up to a maximum of six 3-week cycles of paclitaxel (approximately 4 months) and will receive R-DXd until disease progression or discontinuation.
• Experimental: Cohort A-1 Arm 3 (R-DXd + Carboplatin Dose 2)
  Participants receive escalating doses of intravenous (IV) R-DXd in combination with carboplatin at Dose 2. Participants can receive up to a maximum of six 3-week cycles of carboplatin (approximately 4 months) and will receive R-DXd until disease progression or discontinuation.
• Experimental: Cohort B-1 (R-DXd + Bevacizumab)
  Participants receive escalating doses of IV R-DXd in combination with bevacizumab until disease progression or discontinuation.
• Experimental: Cohort B-2 (R-DXd RP2D + Bevacizumab)
  Participants with platinum-resistant recurrent ovarian cancer (PRROC) receive recommended Phase 2 dose (RP2D) of IV R-DXd in combination with bevacizumab until disease progression or discontinuation.
• Experimental: Cohort C-1 (R-DXd + Pembrolizumab)
  Participants receive escalating doses of IV R-DXd in combination with pembrolizumab. Participants can receive up to a maximum of thirty-five 3-week cycles of pembrolizumab (approximately 2 years) and will receive R-DXd until disease progression or discontinuation.
• Experimental: Cohort D (R-DXd RP2D +/- Bevacizumab)
  Participants with platinum-sensitive recurrent ovarian cancer (PSROC) receive RP2D of IV R-DXd in combination with or without bevacizumab until disease progression or discontinuation.
• Experimental: Cohort A-2 Arm 1 (R-DXd RP2D + Carboplatin +/- Bevacizumab)
  Participants with PSROC will receive the RP2D of R-DXd in combination with a maximum of 6 cycles of carboplatin with or without bevacizumab, until disease progression or discontinuation.
• Experimental: Cohort A-2 Arm 2 (R-DXd RP2D + Paclitaxel +/- Bevacizumab)
  Participants with PSROC will receive the RP2D of R-DXd in combination with a maximum of 6 cycles of paclitaxel with or without bevacizumab, until disease progression or discontinuation.
• Active Comparator: Cohort A-2 Arm 3 (Platinum-Based Doublet Chemotherapy +/- Bevacizumab)
  Participants with PSROC will receive one of 3 regimens of investigator's choice of platinum-based doublet chemotherapy with or without bevacizumab. Platinum-based doublet chemotherapy will be administered for maximum of 8 cycles. Bevacizumab can be administered until disease progression or discontinuation.

Primary Outcome Measure

Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) Per Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0) [ Time Frame: Up to 21 days ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (8)

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