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

Merck Sharp & Dohme (MSD)

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Ovarian Cancer Recurrent

Treatments

Biological: Bevacizumab

Drug: Carboplatin

Drug: Paclitaxel

Biological: Raludotatug Deruxtecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT06843447

2024-514674-47 (Registry Identifier)

MK-5909-003 (Other Identifier)

U1111-1308-2821 (Registry Identifier)

5909-003

Details and patient eligibility

About

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 standard treatment and if people tolerate them together.

Enrollment

78 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Has pathologically documented diagnosis of high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
Has measurable disease per Response Evaluation Criteria In Solid Tumors 1.1
Participants in Cohort A-1 Arm 1 and Arm 2: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease).
Participants in Cohort B-1: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression <6 months (<180 days) after the last dose of platinum-based therapy (ie, platinum-resistant disease).
Participants in Cohort B-1: Is a candidate for bevacizumab treatment
Has provided tumor tissue from a core or excisional biopsy of a tumor lesion not previously irradiated
Has an Eastern Cooperative Oncology Group performance status of 0 to 1 assessed within 7 days before allocation
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy
Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation
Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion criteria

Has any of the following within 6 months before allocation: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event
Has uncontrolled or significant cardiovascular disease
Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement, or prior pneumonectomy
Has ≥Grade 2 peripheral neuropathy
Has received prior treatment with cadherin-6-targeted agents
Has received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before allocation
Has received prior radiotherapy within 2 weeks of the start of study intervention, or has radiation-related toxicities, requiring corticosteroids
Receives chronic steroid treatment
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known active CNS metastases and/or carcinomatous meningitis
Has history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
Has active infection requiring systemic therapy
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

78 participants in 3 patient groups

Cohort A-1 Arm 1 (R-DXd + Carboplatin)

Experimental group

Description:

Participants receive escalating doses of intravenous (IV) raludotatug deruxtecan in combination with carboplatin. 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.

Treatment:

Biological: Raludotatug Deruxtecan

Drug: Carboplatin

Cohort A-1 Arm 2 (R-DXd + Paclitaxel)

Experimental group

Description:

Participants receive escalating doses of IV raludotatug deruxtecan in combination with paclitaxel. Participants can receive up to a maximum of six 3-week cycles of paclitaxel (approximately 4 months) and will receive raludotatug deruxtecan until disease progression or discontinuation.

Treatment:

Biological: Raludotatug Deruxtecan

Drug: Paclitaxel

Cohort B-1 (R-DXd + Bevacizumab)

Experimental group

Description:

Participants receive escalating doses of IV raludotatug deruxtecan in combination with bevacizumab until disease progression or discontinuation.

Treatment:

Biological: Raludotatug Deruxtecan

Biological: Bevacizumab