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

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 (International Federation of Gynecology and Obstetrics [FIGO]-2028 Stage IVB) 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 (eg, 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 (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed - Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments - 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

ArmDescriptionAssigned 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 20 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.
  • Biological: Pembrolizumab
    Intravenous (IV) Infusion
    Other names:
    • Keytruda®
    • MK-3475
    • SCH 900475
  • Biological: Sacituzumab Tirumotecan
    IV Infusion
    Other names:
    • sac-TMT
    • MK-2870
    • SKB264
  • Biological: Bevacizumab
    IV Infusion
    Other names:
    • Avastin®
    • MVASI®
  • Drug: Rescue Medications
    Participants will receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent, prophylactic steroid mouthwash (dexamethasone or equivalent), and granulocyte colony-stimulating factor (G-CSF).
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 20 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.
  • Biological: Pembrolizumab
    Intravenous (IV) Infusion
    Other names:
    • Keytruda®
    • MK-3475
    • SCH 900475
  • Biological: Sacituzumab Tirumotecan
    IV Infusion
    Other names:
    • sac-TMT
    • MK-2870
    • SKB264
  • Biological: Bevacizumab
    IV Infusion
    Other names:
    • Avastin®
    • MVASI®
  • Drug: Paclitaxel
    IV Infusion
    Other names:
    • Taxol
    • Onxol
  • Drug: Cisplatin
    IV Infusion
    Other names:
    • Platinol®
  • Drug: Carboplatin
    IV Infusion
    Other names:
    • Paraplatin®
  • Drug: Rescue Medications
    Participants will receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent, prophylactic steroid mouthwash (dexamethasone or equivalent), and granulocyte colony-stimulating factor (G-CSF).
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 20 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.
  • Biological: Pembrolizumab
    Intravenous (IV) Infusion
    Other names:
    • Keytruda®
    • MK-3475
    • SCH 900475
  • Biological: Bevacizumab
    IV Infusion
    Other names:
    • Avastin®
    • MVASI®
  • Drug: Paclitaxel
    IV Infusion
    Other names:
    • Taxol
    • Onxol
  • Drug: Cisplatin
    IV Infusion
    Other names:
    • Platinol®
  • Drug: Carboplatin
    IV Infusion
    Other names:
    • Paraplatin®

Recruiting Locations

Mount Sinai Comprehensive Cancer Center ( Site 6000)
Miami Beach, Florida 33140
Contact:
Study Coordinator
305-674-2625

Florida Cancer Specialists - East ( Site 7000)
West Palm Beach, Florida 33401
Contact:
Study Coordinator
561-366-4100

TRIALS 365 ( Site 6008)
Shreveport, Louisiana 71103
Contact:
Study Coordinator
318-408-1198

Women's Cancer Center of Nevada ( Site 6011)
Las Vegas, Nevada 89106
Contact:
Study Coordinator
702-851-4672

Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)
New York, New York 10016
Contact:
Study Coordinator
212-404-4434

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
Eugene, Oregon 97401
Contact:
Study Coordinator
541-683-5001

University of Tennessee Medical Center ( Site 6012)
Knoxville, Tennessee 37920
Contact:
Study Coordinator
865-305-4893

Texas Oncology - DFW ( Site 8005)
Fort Worth, Texas 76104
Contact:
Study Coordinator
817-413-1500

Texas Oncology-The Woodlands ( Site 8000)
The Woodlands, Texas 77380
Contact:
Study Coordinator
281-296-0365

Texas Oncology - Northeast Texas ( Site 8002)
Tyler, Texas 75702
Contact:
Study Coordinator
903-579-9800

University of Virginia Cancer Center ( Site 6014)
Charlottesville, Virginia 22908
Contact:
Study Coordinator
434-243-8109

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.