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RECRUITINGPhase 3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.

Who May Be Eligible (Plain English)

Who May Qualify: - Has diagnosed by tissue sample (biopsy-confirmed) Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies - Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC) - Has platinum-sensitive epithelial OC - Has provided tissue of a tumor lesion that was not previously irradiated - Human weakened immune system virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy - Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2) - Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening - Has an You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2) Who Should NOT Join This Trial: - Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid tumors, borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma - Has platinum-resistant OC or platinum-refractory OC - Has 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Has histologically confirmed Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies * Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC) * Has platinum-sensitive epithelial OC * Has provided tissue of a tumor lesion that was not previously irradiated * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy * Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2) * Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening * Has an ECOG performance status of 0 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2) Exclusion Criteria: * Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid tumors, borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma * Has platinum-resistant OC or platinum-refractory OC * Has 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 a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received more than 2 prior lines of systemic therapy for OC * Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2) * Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids * Has an additional malignancy that is progressing or has required active treatment within the past 3 years * Has active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has an active infection requiring systemic therapy * Has active or ongoing stomatitis

Treatments Being Tested

BIOLOGICAL

Sacituzumab tirumotecan

IV Infusion

BIOLOGICAL

Bevacizumab

IV Infusion

DRUG

H1 receptor antagonist

Rescue medication taken per approved product label before sacituzumab tirumotecan

DRUG

H2 receptor antagonist

Rescue medication taken per approved product label before sacituzumab tirumotecan

DRUG

Acetaminophen (or equivalent)

Rescue medication taken per approved product label before sacituzumab tirumotecan

DRUG

Dexamethasone (or equivalent)

Rescue medication taken per approved product label before sacituzumab tirumotecan

DRUG

Steroid mouthwash (dexamethasone or equivalent)

Rescue medication taken orally 2-4 times daily

Locations (20)

University of Alabama at Birmingham ( Site 0006)
Birmingham, Alabama, United States
Alaska Women's Cancer Care ( Site 0096)
Anchorage, Alaska, United States
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001)
New Haven, Connecticut, United States
Mount Sinai Cancer Center ( Site 0078)
Miami Beach, Florida, United States
Sarasota Memorial Hospital ( Site 0075)
Sarasota, Florida, United States
Florida Cancer Specialists East ( Site 7000)
West Palm Beach, Florida, United States
Winship Cancer Institute of Emory University ( Site 0086)
Atlanta, Georgia, United States
Augusta University - Georgia Cancer Center ( Site 0066)
Augusta, Georgia, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0003)
Fort Wayne, Indiana, United States
Women's Cancer Care ( Site 0067)
Covington, Louisiana, United States
Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0008)
Scarborough, Maine, United States
St. Dominic's Hospital ( Site 0064)
Jackson, Mississippi, United States
Nebraska Methodist Hospital ( Site 0053)
Omaha, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0081)
Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey ( Site 0071)
New Brunswick, New Jersey, United States
University of New Mexico Comprehensive Cancer Center ( Site 0055)
Albuquerque, New Mexico, United States
NYU Langone Hospital - Long Island ( Site 0015)
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center ( Site 0076)
New York, New York, United States
FirstHealth Cancer Center ( Site 0079)
Pinehurst, North Carolina, United States
University of Cincinnati Medical Center ( Site 0090)
Cincinnati, Ohio, United States