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Monoclonal Antibodies

Sacituzumab Tirumotecan for Cervical Cancer

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent

Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 51 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial will have two parts: a safety evaluation phase and a Phase 3 part. The purpose is to compare the effectiveness and safety of sacituzumab tirumotecan with another treatment

Who is the study for?

This trial is for adults assigned female at birth with recurrent or metastatic cervical cancer, including squamous cell carcinoma and adenocarcinoma. Participants must have measurable disease, controlled HIV on ART if applicable, undetectable HBV or HCV viral load if previously infected, adequate organ function, and an ECOG performance status of 0 or 1.

What is being tested?

The study tests Sacituzumab Tirumotecan against treatments chosen by physicians (like Topotecan) as a second-line therapy for cervical cancer. It has two phases: an initial safety check followed by a Phase 3 to compare overall survival rates between the new drug and standard options in patients with high TROP2 expression levels.

What are the potential side effects?

Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, low blood counts leading to increased infection risk or bleeding tendencies. Specific side effects related to Sacituzumab Tirumotecan will be further identified during the safety run-in phase.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 18 or older.

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My cervical cancer is confirmed as squamous, adenosquamous, or adenocarcinoma.

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My cervical cancer has returned or spread.

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I have provided a recent biopsy sample from a tumor that has not been treated with radiation.

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I am HIV positive and my HIV is well controlled with medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 51 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 51 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 51 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Discontinuing Study Treatment Due to an AE in Sacituzumab Tirumotecan Run-in

Number of Participants Experiencing One or More Adverse Events (AEs) in Sacituzumab Tirumotecan Run-in

Objective Response Rate (ORR) in Sacituzumab Tirumotecan Run-in

+1 more

Secondary study objectives

Change from Baseline in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score in Phase 3 Portion

Change from Baseline in EORTC QLQ-C30 Physical Functioning Score in Phase 3 Portion

Change from Baseline in EORTC QLQ-C30 Role Functioning Score in Phase 3 Portion

+6 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sacituzumab TirumotecanExperimental Treatment1 Intervention

Participants will receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.

Group II: Treatment of Physician's Choice (TPC)Active Control6 Interventions

At the physician's discretion, participants will receive 2 mg/m\^2 of pemetrexed on day 1 of every 3-week cycle via IV infusion OR 2 mg/kg of tisotumab vedotin on day 1 of every 3-week cycle via IV infusion OR 1 mg/m\^2 (or 1.25 mg/m\^2 if tolerating well) topotecan on days 1, 2, 3, 4, and 5 of every 3-week cycle via IV infusion OR 30 mg/m\^2 of vinorelbine on days 1 and 8 of every 3-week cycle via IV infusion OR 1000 mg/m\^2 of gemcitabine on day 1 and 8 of every 3-week cycle via IV infusion OR 100 mg/m\^2 (or 125 mg/m\^2 if tolerating well) of irinotecan on days 1, 8, 15, and 22 of every 6 week cycle via IV infusion, until progressive disease or discontinuation.

0 / 5Eligibility criteria met