802 Participants NeededMy employer runs this trial

R-DXd + Bevacizumab for Ovarian Cancer

Recruiting at 12 trial locations
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Overseen ByToll Free Number
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: Merck Sharp & Dohme LLC
Must be taking: Antiretroviral therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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

I finished first-line platinum chemotherapy and my cancer responded or stayed stable.
I have recovered from side effects of past cancer treatments, except for hair or skin changes.
My HIV is well-controlled with antiretroviral therapy.
See 3 more

Exclusion Criteria

I have HIV and a history of Kaposi's sarcoma or multicentric Castleman disease.
I am still healing or have complications from major surgery.
My ovarian cancer is not high-grade serous or endometrioid type.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive R-DXd with or without bevacizumab or standard care (bevacizumab or observation) for up to 2 years

Up to 2 years
Every 3 weeks

Follow-up

Participants are monitored for progression-free survival and overall survival

Up to approximately 5.5 years

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

Group I: Arm 1: R-DXd with or without bevacizumabExperimental Treatment2 Interventions
Group II: Arm 2: Standard of care (bevacizumab or observation only)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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 profile image

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe profile image

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Citations

Raludotatug 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- ...

A 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.

REJOICE-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, ...

A 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.

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40769277/

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 ...