Sacituzumab Tirumotecan for Ovarian Cancer

(TroFuse-021 Trial)

Recruiting at 40 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Nonepithelial cancers, CNS metastases, severe eye disease, 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: 1

Duration: Up to 132 weeks (22 cycles)

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called sacituzumab tirumotecan (sac-TMT) to determine if it can help people with ovarian cancer live longer without disease progression. Sac-TMT is a targeted therapy that controls cancer cell growth and spread. Participants will receive sac-TMT, possibly with an additional drug called bevacizumab, and researchers will compare the results to standard care options. Suitable candidates for this trial include those who have completed surgery and initial chemotherapy for certain types of ovarian cancer. As a Phase 3 trial, this research represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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

Research has shown that sacituzumab tirumotecan (sac-TMT) is generally safe. In past studies, individuals with advanced or hard-to-treat solid tumors, such as ovarian cancer, tolerated sac-TMT well. Most side effects were mild and did not necessitate stopping the treatment. This suggests that sac-TMT is usually well-tolerated, though individual reactions can vary. It is important to discuss potential risks and benefits with a healthcare professional before joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Unlike standard treatments for ovarian cancer, which often involve chemotherapy and targeted therapies like bevacizumab, sacituzumab tirumotecan (Sac-TMT) introduces a novel approach by combining an antibody-drug conjugate with a topoisomerase inhibitor. This unique mechanism allows Sac-TMT to specifically target and deliver its powerful cancer-killing agent directly to the cancer cells, potentially increasing its effectiveness and reducing harm to healthy cells. Researchers are excited about this treatment because it offers a targeted attack on cancer cells, which could lead to improved outcomes and fewer side effects compared to traditional therapies.

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

Studies have shown promising results for sacituzumab tirumotecan (sac-TMT) in treating ovarian cancer. In this trial, participants may receive sac-TMT, with or without bevacizumab, as part of the experimental treatment arm. Research indicates that patients receiving sac-TMT experienced significant antitumor activity, meaning the treatment helped shrink or control tumors. Specifically, one study found that patients lived for a median of 20.9 months without their cancer worsening, known as progression-free survival (PFS). Additionally, sac-TMT has a manageable safety profile, meaning most patients can handle the treatment's side effects. Overall, these findings suggest sac-TMT could be an effective option for those with ovarian cancer. ^{1 3 4 5 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

I finished first-line platinum chemotherapy and responded well to it.

I have given a tumor sample that was not treated with radiation.

I have HIV that is well-controlled with medication.

Exclusion Criteria

My tumor is a rare or low-grade type, not the common epithelial kind.

I currently have an infection that needs prescription medication.

Has concurrent and active HBV and HCV infections

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sacituzumab tirumotecan (sac-TMT) with or without bevacizumab in 6-week cycles until disease progression or prohibitive toxicity

Up to 132 weeks (22 cycles)

Visits on Days 1, 15, and 29 for sac-TMT; optional bevacizumab on Days 1 and 22

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 78 months

Observation

Participants are observed to see if cancer grows or worsens if not receiving bevacizumab

Up to 132 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sacituzumab tirumotecan

How Is the Trial Designed?

Group I: Sac-TMT +/- Bevacizumab Experimental Treatment 3 Interventions

Participants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses.

Group II: Standard of Care Active Control 1 Intervention

Participants will either receive bevacizumab q3w of every 6-week cycle for up to 22 courses until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention, or will be observed only and actively followed if not receiving bevacizumab.

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

Citations

1.

annalsofoncology.org

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

715MO Safety and efficacy of sacituzumab tirumotecan ...

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. The ORR was 34.1% (15/ ...

2.

biospace.com

biospace.com/press-releases/kelun-biotech-announces-results-from-the-skb264-ii-06-mk-2870-002-study-of-sacituzumab-tirumotecan-sac-tmt-in-gynecologic-oncology-presented-at-2026-sgo

Kelun-Biotech Announces Results from the SKB264-II-06/ ...

The data showed that median progression-free survival (PFS) in the overall population was 20.9 months; median overall survival (OS) was not ...

3.

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 ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07318558

Study Details | NCT07318558 | A Clinical Trial of Sac-TMT ...

The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer ...

5.

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.

6.

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 ...