A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Purpose
Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body. Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: - About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and - If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment
Condition
- Cervical Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants in Part 1 Safety Run-in are allocated to a single treatment arm. Participants in study Part 2 complete induction treatment and are then randomized to 1 of 2 maintenance treatment arms.
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1 Safety Run-in: Sac-TMT + Pembrolizumab + Bevacizumab |
Participants will receive sac-TMT 4 mg/kg every 2 weeks (q2w) and pembrolizumab 400 mg every 6 weeks (q6w) for up to 14 cycles (up to approximately 19 months). Bevacizumab 15 mg/kg every 3 weeks (q3w) will be administered until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long. |
|
|
Experimental Part 2: Sac-TMT + Pembrolizumab +/- Bevacizumab |
During induction treatment, participants will receive pembrolizumab 200 mg q3w, paclitaxel 175 mg/m^2 q3w, and cisplatin 50 mg/m^2 q3w (or carboplatin area under the curve [AUC]5 mg/mL/min q3w). Participants may also receive bevacizumab 15 mg/kg q3w at the investigator's discretion. Each cycle will be 3 weeks long and treatment will continue for up to 6 cycles (up to approximately 4 months). During maintenance treatment, participants will receive sac-TMT 4 mg/kg q2w and pembrolizumab 400 mg q6w for up to 14 cycles (up to approximately 19 months). Participants may also receive bevacizumab 15 mg/kg q3w, at the investigator's discretion, until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long. |
|
|
Active Comparator Part 2: Pembrolizumab +/- Bevacizumab |
During induction treatment, participants will receive pembrolizumab 200 mg q3w, paclitaxel 175 mg/m^2 q3w, and cisplatin 50 mg/m^2 q3w (or carboplatin AUC5 mg/mL/min q3w). Participants may also receive bevacizumab 15 mg/kg q3w at the investigator's discretion. Each cycle will be 3 weeks long and treatment will continue for up to 6 cycles (up to approximately 4 months). During maintenance treatment, participants will receive pembrolizumab 400 mg q6w for up to 14 cycles (up to approximately 19 months). Participants may also receive bevacizumab 15 mg/kg q3w, at the investigator's discretion, until a treatment discontinuation criterion is met. Each cycle will be 6 weeks long. |
|
Recruiting Locations
Miami Beach 4164143, Florida 4155751 33140
Study Coordinator
305-674-2625
Shreveport 4341513, Louisiana 4331987 71103
Study Coordinator
318-408-1198
Las Vegas 5506956, Nevada 5509151 89106
Study Coordinator
702-851-4672
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC
Detailed Description
This is a 2-part study. In Part 1 Safety Run-in, eligible participants will be allocated to treatment with sac-TMT + pembrolizumab + bevacizumab. In Part 2, all participants receive standard of care induction treatment. Eligible participants whose cancer does not progress then begin maintenance treatment and are randomized to receive pembrolizumab or sac-TMT + pembrolizumab. All participants in Part 2 maintenance treatment may also receive bevacizumab at the investigator's discretion.