Raludotatug Deruxtecan for Ovarian Cancer

Recruiting at 3 trial locations

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Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Steroids, Cadherin-6 agents

Disqualifiers: Cardiovascular disease, Pulmonary compromise, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 4 months for combination with carboplatin or paclitaxel; until disease progression for combination with bevacizumab

78 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received prior systemic anticancer therapy within 4 weeks before starting the study treatment.

What data supports the effectiveness of the drug Raludotatug Deruxtecan for ovarian cancer?

While there is no direct data on Raludotatug Deruxtecan, similar drugs like topotecan have shown effectiveness in treating ovarian cancer, especially in cases where the cancer is resistant to other treatments. Topotecan has been effective in achieving tumor response and improving survival, suggesting that drugs with similar mechanisms might also be beneficial. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for people with high-grade serous ovarian cancer that has returned after treatment. Participants must have had 1-3 prior treatments, show measurable disease progression, and be fit enough for chemotherapy. They should not have been heavily pre-treated or have conditions that exclude them from receiving bevacizumab.

Inclusion Criteria

My cancer can be measured by scans.

I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.

I had hepatitis C but my current tests show no virus.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of raludotatug deruxtecan in combination with other agents until disease progression or discontinuation

Up to 4 months for combination with carboplatin or paclitaxel; until disease progression for combination with bevacizumab

Dose-limiting Toxicity Evaluation

Participants are monitored for dose-limiting toxicities to assess safety of the treatment

Up to 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 3 years

Treatment Details

Interventions

• Raludotatug Deruxtecan

Trial Overview The study tests Raludotatug Deruxtecan (R-DXd), an antibody drug conjugate, combined with standard therapies like Carboplatin, Paclitaxel, and Bevacizumab. It aims to see if R-DXd is safe and tolerable when used alongside these established treatments.

Participant Groups

Group I: Cohort B-1 (R-DXd + Bevacizumab) Experimental Treatment 2 Interventions

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

Group II: Cohort A-1 Arm 2 (R-DXd + Paclitaxel) Experimental Treatment 2 Interventions

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.

Group III: Cohort A-1 Arm 1 (R-DXd + Carboplatin) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Daiichi Sankyo

Industry Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Findings from Research

In a phase II study involving 41 patients with ovarian cancer resistant to platinum and taxane treatments, the combination of docetaxel and irinotecan showed a low overall response rate of 6.3%, indicating limited efficacy for this patient group.

The treatment was generally well tolerated, with neutropenia being the most common severe side effect (56.1% of patients), but the combination did not significantly improve survival outcomes, with a median overall survival of only 45.3 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel/irinotecan combination chemotherapy in platinum/taxane-refractory and -resistant ovarian cancer: JGOG/WJGOG Intergroup Study. Ushijima, K., Kamura, T., Tamura, K., et al.[2021]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Docetaxel/irinotecan combination chemotherapy in platinum/taxane-refractory and -resistant ovarian cancer: JGOG/WJGOG Intergroup Study. [2021]

2. Japan pubmed.ncbi.nlm.nih.gov

Weekly docetaxel for patients with platinum/paclitaxel/irinotecan-resistant relapsed ovarian cancer: a phase I study. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

A multicenter phase II study of cisplatin and docetaxel (Taxotere) in the first-line treatment of advanced ovarian cancer: a GINECO study. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Topotecan in platinum-resistant epithelial ovarian cancer. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical experience with topotecan in relapsed ovarian cancer. [2019]