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Active not recruitingPHASE3INTERVENTIONAL

A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)

This study is investigating a new treatment named Sacituzumab Tirumotecan for women in the UK with cervical cancer that has come back or spread after initial treatments. The main goal is to see if this new medication can help patients live longer compared to existing treatment options. Researchers will also look at safety and how well the new drug works. The study includes women whose cancer has progressed after at least one previous course of platinum-based chemotherapy and who have also received specific immunotherapy. This is a Phase 3 study, meaning it's in the later stages of testing new treatments, comparing them directly with current standards of care. It aims to find better options for those facing this challenging diagnosis.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
686
Start
24 Jul 2024
Estimated completion
15 Jun 2028

What is this study about?

This important study is looking into a new medication called Sacituzumab Tirumotecan. It's designed for women in the UK who have cervical cancer that has either returned after previous treatment or has spread to other parts of the body (known as metastatic cancer). These women would have already undergone at least one course of chemotherapy and a type of immunotherapy.

The main aim of this research is to see if Sacituzumab Tirumotecan is more effective than the treatments doctors currently choose for this condition. Specifically, the study wants to find out if taking Sacituzumab Tirumotecan can help people live longer compared to standard care. Researchers will also be carefully monitoring any side effects to understand the safety of the new treatment.

This study is structured in two parts. First, a small group will receive Sacituzumab Tirumotecan to confirm the best and safest dose. After this, a larger group will take part in the main Phase 3 study, where participants will be randomly assigned to either receive Sacituzumab Tirumotecan or one of the standard treatments currently used for this type of cervical cancer. The overall goal is to potentially offer a new, more effective option for women living with recurrent or metastatic cervical cancer.

Key takeaways

  • This study evaluates a new treatment for advanced cervical cancer.
  • It aims to see if Sacituzumab Tirumotecan improves survival compared to current treatments.
  • Participants must have recurrent or metastatic cervical cancer that has progressed after chemotherapy and immunotherapy.
  • The study involves detailed health checks and regular monitoring.
  • You have the right to withdraw from the study at any time.
  • This is a Phase 3 study, comparing new treatment to standard care.

Who may be eligible?

To be considered for this study, you would need to be a woman, aged 18 or over, who has been diagnosed with cervical cancer that has either come back or spread to other parts of your body. Importantly, your cancer would need to have progressed after you've already had at least one course of chemotherapy (which might have included a drug called bevacizumab) and also a specific type of immunotherapy.

Doctors would also need to be able to measure your cancer to track how it responds to treatment. You would need to be generally well enough to take part, as assessed by your doctor. The study also requires a recent tissue sample of your cancer. There are specific health requirements regarding HIV, hepatitis B, and hepatitis C, requiring these conditions to be well-managed if present. You should not have severe nerve damage (neuropathy) or certain severe eye conditions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a woman, aged 18 or older?
  2. Do you have cervical cancer that has come back or spread?
  3. Has your cancer progressed after prior chemotherapy and immunotherapy?
  4. Do you feel generally well enough to participate?
  5. Do you have a recent tissue sample of your cancer available?
  6. Have you been diagnosed with any severe nerve damage (neuropathy) or serious eye conditions?
Answer every question to see your result.

What does participation involve?

As a participant in this study, you would first undergo a series of health checks to confirm your eligibility. If you meet the criteria, you would either be part of a small safety group or enter the main study where you would be randomly assigned to receive either the new treatment (Sacituzumab Tirumotecan) or a standard treatment chosen by your doctor. These standard treatments could include medications like Pemetrexed, Tisotumab Vedotin, Topotecan, Vinorelbine, Gemcitabine, or Irinotecan. The specific medication would depend on what your doctor feels is most appropriate for you.

Throughout the study, you would attend regular appointments for assessments, blood tests, and scans to monitor your health and how your cancer is responding. The exact number and frequency of visits would be explained to you by the study team. You would receive your assigned medication as part of these visits. The study would continue for as long as the treatment is helping you, or until unacceptable side effects occur, with regular follow-up appointments even after treatment stops to track your long-term health. The total duration of your participation would vary depending on your individual response to treatment.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and close medical monitoring. While the new treatment may be more effective than current options, there are also potential risks, including side effects from the medication, which will be carefully explained to you. Standard treatments also carry known risks and side effects. The research team will discuss all potential benefits and risks thoroughly before you decide to take part. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (240)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • USA Mitchell Cancer Institute-Clinical Trials ( Site 4126)
    Verified postcode
    Mobile, United States
  • Providence Alaska Medical Center ( Site 4137)
    Verified postcode
    Anchorage, United States
  • HonorHealth (HH) ( Site 8002)
    Verified postcode
    Phoenix, United States
  • Arizona Oncology Associates - HOPE ( Site 8001)
    Verified postcode
    Tucson, United States
  • Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 4125)
    Verified postcode
    La Jolla, United States
  • UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4105)
    Verified postcode
    Los Angeles, United States
  • Hoag Memorial Hospital Presbyterian ( Site 4104)
    Verified postcode
    Newport Beach, United States
  • Mount Sinai Braman Comprehensive Cancer Center ( Site 4143)
    Verified postcode
    Miami Beach, United States
  • Advent Health ( Site 4140)
    Verified postcode
    Orlando, United States
  • Florida Cancer Specialists East ( Site 7001)
    Verified postcode
    West Palm Beach, United States
  • Northside Hospital ( Site 4127)
    Verified postcode
    Atlanta, United States
  • Georgia Cancer Center at Augusta University ( Site 4112)
    Verified postcode
    Augusta, United States

Common questions

What is the new treatment being tested?

The new treatment is called Sacituzumab Tirumotecan (MK-2870).

What type of cancer is this study for?

This study is for recurrent or metastatic cervical cancer.

What does 'recurrent or metastatic' mean?

It means the cancer has either come back after previous treatment or has spread to other parts of the body.

Will I definitely get the new treatment?

Not necessarily. In the main part of the study, you would be randomly assigned to either receive the new treatment or one of the standard treatments.

What are some of the existing treatments used in the study?

Existing treatments could include medications like Pemetrexed, Tisotumab Vedotin, Topotecan, Vinorelbine, Gemcitabine, or Irinotecan, chosen by your doctor.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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