Study on Sacituzumab Tirumotecan and Pembrolizumab for First-line Maintenance Treatment of Cervical Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT07216703
This clinical trial is exploring a new treatment combination for women with cervical cancer that has spread to other parts of the body. The study aims to find out if the combination of sacituzumab tirumotecan and pembrolizumab, with or without bevacizumab, is safe and effective in helping patients live longer or prevent the cancer from worsening compared to standard treatments.
Patient Parameters
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Program Overview
Researchers are testing a new treatment for cervical cancer that has spread beyond the cervix. This study involves using a medicine called sacituzumab tirumotecan (also known as sac-TMT or MK-2870) along with pembrolizumab and possibly bevacizumab. Sac-TMT is a special type of drug that targets cancer cells and helps destroy them. The study's main goals are to see if this combination is safe, if patients can tolerate it well, and if it helps patients live longer or keep their cancer from getting worse compared to standard treatments.
Description
This study is divided into two parts:
In Part 1, called the Safety Run-in, participants who qualify will receive a combination of sac-TMT, pembrolizumab, and bevacizumab to see if this combination is safe and well-tolerated.
In Part 2, all participants will first receive the standard initial treatment for cervical cancer. If their cancer does not get worse, they will then start maintenance treatment. During this phase, participants will be randomly assigned to receive either pembrolizumab alone or a combination of sac-TMT and pembrolizumab. Additionally, participants may also receive bevacizumab based on the doctor's decision.
Eligibility Criteria
The main inclusion criteria include but are not limited to the following:
- Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix
- Has persistent, recurrent, or newly diagnosed metastatic cervical cancer that is not amenable to curative treatment (surgery and/or radiation)
- If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy
- If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load
- If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
- Has an Eastern Cooperative Oncology Group performance status of 0 or 1
- Has tumor programmed cell death ligand 1 expression of combined positive score ≥1
The main exclusion criteria include but are not limited to the following:
- Has HIV infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has received prior systemic anticancer therapy other than what is specified in this protocol
- Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT
- Has a diagnosis of immunodeficiency
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system metastases and/or carcinomatous meningitis
- Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has a history of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| TRIALS 365 ( Site 6008) | 71103 | Shreveport | Louisiana |
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