R-DXd + Bevacizumab for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new ways to treat ovarian cancer by testing a combination of treatments. It compares the use of a new drug, Raludotatug Deruxtecan (R-DXd), with or without bevacizumab, against standard care, which may include bevacizumab or just observation. The main goal is to determine if this new approach can help patients live longer without their cancer worsening. This trial may suit those diagnosed with advanced ovarian cancer who have completed initial chemotherapy and undergone surgery to remove cancer. As a Phase 3 trial, it represents the final step before FDA approval, offering patients a chance to access potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have HIV, you must have it well-controlled on antiretroviral therapy. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that raludotatug deruxtecan (R-DXd) holds promise in treating cancers. In earlier studies, patients taking R-DXd experienced some side effects, with nausea (feeling sick), anemia (low red blood cell count), and weakness being the most common. About 69%, 57%, and 47% of patients reported these side effects, respectively.
R-DXd belongs to a group of drugs called ADCs (antibody-drug conjugates), which have already received approval for treating other cancers, such as breast and lung cancer. This indicates a certain level of safety, but it's crucial to remember that every drug can affect people differently. Discuss potential risks with a healthcare professional before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Raludotatug Deruxtecan (R-DXd) for ovarian cancer because it offers a novel approach compared to current treatments. Unlike standard options like bevacizumab, which primarily work by inhibiting blood vessel growth in tumors, R-DXd is an antibody-drug conjugate that delivers a potent chemotherapy agent directly to cancer cells. This targeted delivery system aims to increase the treatment's effectiveness while potentially minimizing side effects. Additionally, the combination of R-DXd with or without bevacizumab provides flexibility in treatment strategies, which could improve outcomes for patients with different needs.
What evidence suggests that this trial's treatments could be effective for ovarian cancer?
Research has shown that Raludotatug Deruxtecan (R-DXd) holds promise for treating ovarian cancer. In this trial, one group of participants will receive R-DXd with or without bevacizumab. Studies have found that R-DXd is generally safe and well-tolerated in patients with advanced ovarian cancer. It targets specific proteins on cancer cells to halt their growth. Early results suggest this treatment could be crucial for patients whose cancer does not respond to standard treatments. Additionally, R-DXd may benefit those with cancers that express a protein called CDH6.678910
Are You a Good Fit for This Trial?
This trial is for adults with newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer who have had surgery and finished their first round of platinum-based chemotherapy. Participants must be in stable condition after treatment and able to provide a tumor sample.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive R-DXd with or without bevacizumab or standard care (bevacizumab or observation) for up to 2 years
Follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Raludotatug Deruxtecan (R-DXd)
Trial Overview
The study compares maintenance treatment using the new drug R-DXd alone or combined with bevacizumab (a standard targeted therapy) versus usual care. The goal is to see if these treatments help people live longer without their cancer getting worse.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive intravenous (IV) raludotatug deruxtecan (R-DXd)with or without IV bevacizumab for up to 2 years until progressive disease (PD), unacceptable toxicity, or other protocol-specified reason for discontinuation.
Participants will receive bevacizumab 15 mg/kg IV q3w for up to 22 cycles (each cycle=21 days) until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention or will be observed and actively followed if not receiving bevacizumab.
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
Citations
1.
datasourcebydaiichisankyo.com
datasourcebydaiichisankyo.com/documents/d/datahub/ray-coquard_r-dxd-rejoice-ov01-primary-analysis_esmo-2025-19-octRaludotatug deruxtecan (R-DXd) in patients with platinum
5 events were hepatic failure, ovarian cancer, and malignant neoplasm progression. bGrade 5 events were ovarian cancer and aspiration. cGrade ...
Raludotatug Deruxtecan Granted Breakthrough Therapy ...
“Raludotatug deruxtecan has the potential to one day become an important option for the treatment of patients with CDH6 expressing platinum- ...
3.
yalemedicine.org
yalemedicine.org/clinical-trials/a-study-of-raludotatug-deruxtecan-r-dxd-in-subjects-with-platinum-resistant-high-grade-ovarian-pA Phase 2/3, Multicenter, Randomized Study of ...
This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.
4.
daiichisankyo.us
daiichisankyo.us/documents/36782/37817/US+R-DXd+REJOICE-Ovarian01+Trial+Initiation+Press+Release+FINAL.pdf/543d4817-4834-3fc0-e6f6-0c1d95601f7a?t=1712090309046REJOICE-Ovarian01 Phase 2/3 Trial of Raludotatug ...
Cancer. “Raludotatug deruxtecan has shown promising activity in a phase 1 trial of patients with advanced ovarian cancer,” said Mark Rutstein, ...
5.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-raludotatug-deruxtecan-r-dxd-in-subjects-with-platinum-resistant-high-grade-ovarian-pA Study of Raludotatug Deruxtecan (R-DXd) in Subjects With ...
This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.
Raludotatug Deruxtecan Granted Breakthrough Therapy ...
The two-part, multicenter, open-label, first-in-human phase 1 trial is evaluating the safety and efficacy of investigational raludotatug ...
Trastuzumab deruxtecan
It is licensed for the treatment of breast cancer, non-small cell lung cancer (NSCLC), gastric or gastroesophageal adenocarcinoma.
Pooled analysis of trastuzumab deruxtecan retreatment ...
This first large-scale pooled analysis demonstrates the safety of T-DXd retreatment after recovery from grade 1 ILD. ILD recurred in one-third of patients; ...
LBA42 Raludotatug deruxtecan (R-DXd) in patients (pts) ...
Most frequent any-grade treatment-emergent adverse events (TEAEs) were nausea (69.2%), anemia (57.0%), and asthenia (46.7%).
Ifinatamab Deruxtecan Granted Priority Review in ...
The phase 2 part of the trial (dose expansion) is evaluating the safety and efficacy of ifinatamab deruxtecan at the RDE of 12 mg/kg in patients with squamous ...
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