Raludotatug Deruxtecan for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment option for individuals with relapsed high-grade serous ovarian cancer, where the cancer returns after treatment and grows rapidly. Researchers are testing Raludotatug Deruxtecan, a drug that targets and destroys cancer cells, in combination with other cancer treatments. The aim is to determine if this combination is safe and effective in shrinking or eliminating the cancer. This trial may suit those whose cancer has returned and spread quickly, especially if previous treatments were short-lived. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that raludotatug deruxtecan (R-DXd) is safe for people with ovarian cancer. Research indicates that patients tolerated R-DXd well, with manageable side effects. In one study, about half of the patients experienced tumor shrinkage, suggesting the treatment's effectiveness while maintaining safety.
In this trial, R-DXd is combined with other treatments such as paclitaxel, carboplatin, bevacizumab, and pembrolizumab. The goal is to assess how well patients tolerate these combinations. While each drug is known to be safe individually, the trial aims to confirm their safety when used with R-DXd.
As this trial is in its early stages, the primary focus is on ensuring the treatment's safety for participants. So far, evidence supports that R-DXd can be safely administered, especially considering previous patient responses.12345Why are researchers excited about this trial's treatments?
Raludotatug deruxtecan is unique because it combines a powerful antibody-drug conjugate with various cancer-fighting agents, aiming for a more targeted approach against ovarian cancer. Unlike traditional treatments like carboplatin or paclitaxel that broadly attack cells, raludotatug deruxtecan specifically targets cancer cells by delivering a cytotoxic payload directly to them, potentially reducing side effects and increasing effectiveness. Researchers are particularly excited about its flexibility in combination with other agents like bevacizumab and pembrolizumab, which might enhance its ability to overcome both platinum-resistant and platinum-sensitive ovarian cancer. This tailored mechanism of action represents a promising advancement over current options, which typically involve more generalized chemotherapy.
What evidence suggests that this trial's treatments could be effective for relapsed high-grade serous ovarian cancer?
Research shows that raludotatug deruxtecan (R-DXd) offers promising results for treating relapsed high-grade serous ovarian cancer. Studies found that about 50.5% of patients experienced tumor reduction or disappearance, with results appearing on average in about 7.1 weeks. This trial will explore various combinations of R-DXd with other treatments, such as paclitaxel, bevacizumab, carboplatin, and pembrolizumab, to assess their effectiveness and manageability. While some patients experienced side effects, most managed them effectively. Overall, early evidence suggests that R-DXd could be a strong option against this aggressive cancer type.12346
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive escalating doses of raludotatug deruxtecan in combination with other agents until disease progression or discontinuation
Dose-limiting Toxicity Evaluation
Participants are monitored for dose-limiting toxicities to assess safety of the treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Raludotatug Deruxtecan
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
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
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD