Sacituzumab Tirumotecan for Ovarian Cancer

Recruiting at 36 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Antiretrovirals, HBV antivirals

Disqualifiers: Platinum-resistant OC, Cardiovascular disease, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

770 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for ovarian cancer to determine if it extends the time patients live without their cancer worsening. Researchers are examining sacituzumab tirumotecan, used alone or with bevacizumab, and comparing it to standard care. The goal is to assess the safety of these treatments and how well patients tolerate them. This trial may suit individuals with ovarian cancer who have previously responded to platinum-based chemotherapy and do not have other major health issues. As a Phase 3 trial, it represents the final step before FDA approval, offering participants access to potentially groundbreaking treatment.

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

The trial does not specify if you need to stop taking your current medications, but you should not have received any systemic anticancer therapy within 3 weeks before joining. 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 shows that sacituzumab tirumotecan, when used alone, can help fight tumors and generally has manageable side effects. While some side effects may occur, they are usually not severe. Previous studies with patients treated for other cancers, such as endometrial cancer, found this treatment to be well-tolerated.

When combined with bevacizumab, safety remains a priority. Patients have tolerated this combination in the past, but researchers continue to study specific side effects and patient tolerance. The current phase of this trial indicates that earlier trials have already demonstrated some safety, but ongoing research aims to confirm this and learn more about any potential side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about sacituzumab tirumotecan for ovarian cancer because it offers a novel approach compared to the standard treatments like chemotherapy and targeted therapies such as bevacizumab alone. Unlike traditional treatments, sacituzumab tirumotecan is an antibody-drug conjugate that specifically targets and delivers a potent chemotherapy directly to cancer cells, potentially reducing side effects on healthy cells. Additionally, when combined with bevacizumab, it might enhance the effectiveness by simultaneously attacking the cancer through multiple mechanisms, offering hope for improved outcomes in patients with advanced ovarian cancer.

What evidence suggests that sacituzumab tirumotecan might be an effective treatment for ovarian cancer?

Research has shown that sacituzumab tirumotecan may help treat certain cancers, such as ovarian cancer. Previous studies found that it can shrink tumors. In patients who had been treated before, about one-third experienced tumor reduction with this treatment. On average, these patients lived for about eight months without their cancer worsening and had a total survival time of 14 months. In this trial, participants may receive sacituzumab tirumotecan alone or with bevacizumab, while others will receive the standard of care. This suggests that sacituzumab tirumotecan could be a viable option for those with advanced cancer. ^{1 2 3 4 5}

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 individuals with platinum-sensitive recurrent ovarian cancer who've had specific chemotherapy treatments. They must have confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma and provide a tumor tissue sample. Participants with well-controlled HIV, hepatitis B or C are eligible if they meet certain conditions.

Inclusion Criteria

I've had 4+ cycles of first-line and 6 cycles of second-line platinum-based chemo for ovarian cancer.

My ovarian cancer responds well to platinum-based chemotherapy.

I have HIV and it is well controlled with medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sacituzumab tirumotecan with or without bevacizumab or standard of care treatment

6 weeks

Every 2-3 weeks (in-person)

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
• Sacituzumab Tirumotecan

Trial Overview The study tests the safety and effectiveness of Sacituzumab Tirumotecan alone or combined with Bevacizumab versus standard care. It aims to see if these treatments can extend the time patients live without their cancer worsening compared to current treatments.

How Is the Trial Designed?

Group I: Part 2: Sacituzumab tirumotecan Experimental Treatment 7 Interventions

Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.

Group II: Part 1: Sacituzumab tirumotecan + Bevacizumab Experimental Treatment 7 Interventions

Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) plus 15 mg/kg of bevacizumab once every 3 weeks (Q3W) via intravenous (IV) infusion over 6 weeks

Group III: Part 2: Standard of care (SOC) Active Control 1 Intervention

Participants receive local standard of care until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease 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

GOG Foundation

Collaborator

Trials

48

Recruited

18,500+

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Collaborator

Trials

41

Recruited

19,200+

Citations

1. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02296-8/fulltext

715MO Safety and efficacy of sacituzumab tirumotecan ... Results. As of March 5, 2024, 44 EC pts were enrolled and median follow-up time was 7.2 mo. 52.3% of pts had received ≥ 2 prior lines of therapy.

2. onclive.com onclive.com/view/sacituzumab-tirumotecan-shows-antitumor-activity-in-previously-treated-endometrial-ovarian-cancers

Sacituzumab Tirumotecan Shows Antitumor Activity in ... Sacituzumab tirumotecan monotherapy demonstrated antitumor activity with a manageable safety profile in previously treated endometrial and ovarian cancers.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06824467

NCT06824467 | A Study to Evaluate the Efficacy and ... The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and If people who take ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12142944/

Results of a phase 1/2 study of sacituzumab tirumotecan in ... Sac-TMT demonstrated manageable safety profile in patients with unresectable locally advanced/metastatic solid tumors and promising antitumor ...

5. jhoonline.biomedcentral.com jhoonline.biomedcentral.com/articles/10.1186/s13045-025-01705-2

Results of a phase 1/2 study of sacituzumab tirumotecan in ... Our study also demonstrated an ORR of 32%, median PFS of 8 months, and median OS of 14 months with sac-TMT in patients with previously treated ...