646 Participants NeededMy employer runs this trial

Raludotatug Deruxtecan + Bevacizumab for Ovarian Cancer

Recruiting at 5 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: Platinum-based chemotherapy
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 examines a new treatment called raludotatug deruxtecan (R-DXd) for advanced, high-grade ovarian cancer that spreads quickly and may not be surgically removable. Researchers aim to determine if R-DXd, with or without another treatment called bevacizumab (a type of targeted therapy), helps patients live longer without cancer progression. The trial compares this new approach to standard treatments, which often include chemotherapy and bevacizumab. Suitable candidates have ovarian, peritoneal, or fallopian tube cancer that has returned after initial platinum-based therapy and maintenance treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients access to potentially groundbreaking treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that raludotatug deruxtecan (R-DXd) is generally well-tolerated. In one study, 89% of patients experienced treatment-related side effects, but only 50% were severe (Grade 3 or higher), and just 2 patients discontinued treatment due to these effects. Another study found that R-DXd offered more benefits than risks, with side effects that most patients could manage.

When combined with bevacizumab, R-DXd demonstrated a manageable safety profile. While side effects occur, they are not too severe for most people. The data suggest that patients can handle this combination therapy well.

Overall, these findings indicate that the treatment is relatively safe, though it can have side effects. These effects appear manageable for doctors and patients, considering the potential benefits of the treatment.12345

Why are researchers excited about this trial's treatments?

Raludotatug Deruxtecan (R-DXd) is unique because it combines a novel drug conjugate with bevacizumab, which targets blood vessel growth in tumors. This approach is different from the standard platinum-based chemotherapies typically used for ovarian cancer. R-DXd works by delivering a targeted payload directly to cancer cells, potentially increasing effectiveness while minimizing damage to healthy cells. Researchers are excited about its ability to precisely target and destroy cancer cells, offering hope for better outcomes and fewer side effects compared to existing treatments.

What evidence suggests that this trial's treatments could be effective for ovarian cancer?

Research has shown that the drug raludotatug deruxtecan (R-DXd) yields promising results for treating ovarian cancer. Studies found that nearly half of the patients responded to the treatment, and over 97% experienced disease control, meaning the cancer did not worsen. In this trial, participants may receive R-DXd with or without bevacizumab. Combining R-DXd with bevacizumab also shows significant benefits for patients with recurring ovarian cancer that doesn't respond to standard treatments. This combination has a response rate of 46%, indicating it could be a strong option for managing advanced ovarian cancer.678910

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with advanced, fast-growing ovarian, peritoneal, or fallopian tube cancer that has spread and got worse during or soon after PARP inhibitor maintenance treatment. Participants must be in good physical condition (ECOG 0-1), have recovered from past treatments, and had at least one round of platinum-based chemo.

Inclusion Criteria

I am fully active or restricted in strenuous activity but can do light work.
I have had at least 4 cycles of platinum-based chemotherapy and my cancer is platinum-sensitive.
I have advanced high-grade serous or endometrioid ovarian, peritoneal, or fallopian tube cancer.
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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-of-care platinum-based chemotherapy with or without bevacizumab

6 to 8 cycles for chemotherapy; up to 2 years for R-DXd

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 4 years

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • Raludotatug Deruxtecan (R-DXd)

Trial Overview

The study compares a new drug called R-DXd (raludotatug deruxtecan), given alone or with bevacizumab, to standard chemotherapy options like paclitaxel, carboplatin, PLD, or gemcitabine. The goal is to see which approach helps patients live longer without their cancer worsening.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: R-DXd +/- BevacizumabExperimental Treatment2 Interventions
Group II: Standard of CareActive Control5 Interventions

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

LBA42 Raludotatug deruxtecan (R-DXd) in patients (pts) ...

Raludotatug deruxtecan. Median treatment duration was 23.9 weeks (range, 3.0—42.1) Conclusions: R-DXd 5.6 mg/kg is considered the optimal dose. R-DXd ...

"Raludotatug Deruxtecan Granted Breakthrough Therapy ...

The study will evaluate safety endpoints, including dose-limiting toxicities and adverse events and efficacy endpoints, including objective ...

745MO Raludotatug deruxtecan (R-DXd; DS-6000) ...

The confirmed overall response rate (RECIST patients with measurable disease was 38% (13 of 34): 67% R-DXd demonstrated acceptable safety and encouraging ...

Press Release - Raludotatug Deruxtecan ...

disease control rate of 98% with a median duration of response of 11.2 months seen with raludotatug deruxtecan. One complete response (CR), 22 ...

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 ...

The two-part, multicenter, open-label, first-in-human phase 1 trial is evaluating the safety and efficacy of investigational raludotatug ...

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 ...

77MO Raludotatug deruxtecan (R-DXd) monotherapy in ...

Treatment-emergent treatment-related adverse events (AEs) were reported in 16 pts (88.9%; Grade ≥3 in 9 pts [50.0%]) and led to R-DXd discontinuation in 2 pts ...

Press Release - Raludotatug Deruxtecan ...

The phase 1 trial is the first-in-human, open-label study evaluating the safety and efficacy of raludotatug deruxtecan in patients with advanced ...

FDA Grants Breakthrough Therapy Designation to R-DXd ...

In a subgroup of 50 patients with measurable ovarian cancer receiving R-DXd, the confirmed overall response rate (ORR) was 46% (95% CI, 32 ...