Resumen

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

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

biological

Pembrolizumab

Intravenous (IV) Infusion

biological

Sacituzumab Tirumotecan

IV Infusion

biological

Bevacizumab

IV Infusion

drug

Paclitaxel

IV Infusion

drug

Cisplatin

IV Infusion

drug

Carboplatin

IV Infusion

drug

Rescue Medications

Participants 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. Participants are also recommended to receive prophylactic steroid mouthwash (dexamethasone or equivalent).

Ubicaciones

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)

Mar del Plata, Buenos Aires, Argentina

Study Coordinator · +542234963224

RECRUITING

Fundación Respirar ( Site 0101)

Belgrano, Buenos Aires F.D., Argentina

Study Coordinator · +5491170781548

RECRUITING

Instituto de Oncologia de Rosario ( Site 0104)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +543414484830

RECRUITING

Hospital Provincial del Centenario ( Site 0106)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +5493414307185

RECRUITING

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0111)

La Rioja, Argentina

Study Coordinator · +543804436443X108

RECRUITING

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Pembrolizumab

Sacituzumab Tirumotecan

Bevacizumab

Paclitaxel

Cisplatin

Carboplatin

Rescue Medications

Ubicaciones

Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)

Fundación Respirar ( Site 0101)

Instituto de Oncologia de Rosario ( Site 0104)

Hospital Provincial del Centenario ( Site 0106)

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0111)

Patrocinadores

Contactos

Toll Free Number