RecruitingNCT06824467ClinicalTrials.gov record

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)

Ovarian Cancer · Fallopian Tube Cancer · Primary Peritoneal Cancer

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 3
Age range: 18 years - Not specified
Sex eligible: Female
Healthy volunteers: Not accepted
Participants: 770 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

Has locally advanced or metastatic, histologically confirmed 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 to 8 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, has current pneumonitis/ILD, or has suspected pneumonitis or ILD that cannot be ruled out by standard diagnostic assessments at Screening
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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

Part 1: Sacituzumab tirumotecan + Bevacizumab

Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) plus 15 mg/kg of bevacizumab once every 3 weeks (Q3W) via intravenous (IV) infusion over 6 weeks

Biological: Sacituzumab tirumotecan · Biological: Bevacizumab · Drug: H1 receptor antagonist · Drug: H2 receptor antagonist · Drug: Acetaminophen (or equivalent) · Drug: Dexamethasone (or equivalent) · Drug: Steroid mouthwash (dexamethasone or equivalent)

Part 2: Sacituzumab tirumotecan

Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion for up to approximately 2 years or until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.

Part 2: Standard of care (SOC)

Participants receive local standard of care until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.

Biological: Bevacizumab

Sacituzumab tirumotecan BIOLOGICAL

IV Infusion

Bevacizumab BIOLOGICAL

IV Infusion

H1 receptor antagonist DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

H2 receptor antagonist DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

Acetaminophen (or equivalent) DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

Dexamethasone (or equivalent) DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

Steroid mouthwash (dexamethasone or equivalent) DRUG

Rescue medication taken orally 2-4 times daily

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Part 1: Number of Participants With One or More Adverse Events (AEs)

Time frame: Up to 6 weeks

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Part 1: Number of Participants Who Discontinue Study Intervention Due to an AE

Time frame: Up to 6 weeks

Part 2: Progression-Free Survival (PFS)

Time frame: Up to approximately 4 years

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.

Secondary measures

Part 2: Overall Survival (OS)

Time frame: Up to approximately 6 years

OS is defined as the time from randomization to death due to any cause.

Part 2: Number of Participants With One or More AEs

Time frame: Up to approximately 4 years

Part 2: Number of Participants Who Discontinue Study Intervention Due to an AE

Time frame: Up to approximately 4 years

Part 2: Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score

Time frame: Baseline and up to approximately 4 years

The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to Item 30 (""How would you rate your overall quality of life during the past week?") is scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher value indicates a better level of function. The change from baseline in EORTC QLQ-C30 Item 30 score will be reported.

Part 2: Change From Baseline in EORTC QLQ-C30 Physical Functioning Score

Time frame: Baseline and up to approximately 4 years

The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of physical functioning.

Part 2: Change From Baseline in EORTC QLQ-C30 Role Functioning Score

Time frame: Baseline and up to approximately 4 years

The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate a more impaired level of role functioning. Change from baseline in the role functioning score will be presented.

Part 2: Change From Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 (QLQ-OV28) abdominal/gastrointestinal (GI) symptom scale

Time frame: Baseline and up to approximately 4 years

The EORTC QLQ-OV28 is an OC-specific, and psychometrically and clinically validated module to supplement the EORTC QLQ-C30. The EORTC QLQ-OV28 abdominal/GI symptom scale is scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much).

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

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Research locations (202)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

Find a location in this study

202 locations

University of Alabama at Birmingham ( Site 0006)Birmingham, Alabama, United StatesRecruiting

Study CoordinatorCONTACT(205) 934-7442

What this study involves

About the research

Who may be able to participate?

Treatment, groups and participation

What researchers are measuring

Primary measures

Secondary measures

Research locations (202)

Study team and timeline

Official study contacts

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