Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
- Conditions
- Endometrial Cancer
- Interventions
- Registration Number
- NCT06132958
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Researchers are looking for new ways to treat people with endometrial cancer (EC) who have previously received treatment with platinum based therapy (a type of chemotherapy) and immunotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. This clinical study will compare sacituzumab tirumotecan to chemotherapy. The goal of the study is to learn if people who receive sacituzumab tirumotecan live longer overall and without the cancer getting worse compared to people who receive chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 710
- Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
- Has radiographically evaluable disease, either measurable or nonmeasurable per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR).
- Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.
- Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas
- 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
- Has had a recurrence of endometrial carcinoma or carcinosarcoma more than >12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. Note: 1) If Immunotherapy-based treatment is administered in the recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from time of adjuvant therapy 2) For Stage IVb disease, treatment that includes gynecological surgery followed by a platinum-based regimen is NOT considered curative-intent per protocol and does not require platinum rechallenge in the recurrent setting, regardless of the duration of the platinum-free interval
- Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma
- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has received prior treatment with single-agent nonplatinum based chemotherapy in the third-line setting
- Has received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) (eg, sacituzumab govitecan)
- Has received prior treatment with a topoisomerase I inhibitor-containing ADC (eg, sacituzumab govitecan or fam-trastuzumab deruxtecan-nxki)
- Has previously received both single-agent paclitaxel and single-agent doxorubicin in any setting for prior treatment of endometrial cancer
- Requires recurrent drainage of effusions (e.g., pleural, ascitic, etc.) within 6 weeks before randomization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sacituzumab tirumotecan Sacituzumab tirumotecan Participants will receive 4 mg/kg of sacituzumab tirumotecan via intravenous (IV) infusion on Day 1 of each 14-day cycle. Additionally, participants receive diphenhydramine (or equivalent), a Histamine (H2 antagonist) of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator. Chemotherapy Doxorubicin Participants will receive 60 mg/m\^2 of doxorubicin by IV infusion on Day 1 of each 21-day cycle; or 80 mg/m\^2 of paclitaxel by IV infusion on Days 1, 8, and 15 of each 28-day cycle. Participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive Nab-paclitaxel. Chemotherapy Paclitaxel Participants will receive 60 mg/m\^2 of doxorubicin by IV infusion on Day 1 of each 21-day cycle; or 80 mg/m\^2 of paclitaxel by IV infusion on Days 1, 8, and 15 of each 28-day cycle. Participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive Nab-paclitaxel. Chemotherapy Nab-paclitaxel Participants will receive 60 mg/m\^2 of doxorubicin by IV infusion on Day 1 of each 21-day cycle; or 80 mg/m\^2 of paclitaxel by IV infusion on Days 1, 8, and 15 of each 28-day cycle. Participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive Nab-paclitaxel.
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) Up to approximately 4 years PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
Overall Survival (OS) Up to approximately 4 years OS is defined as the time from randomization to death due to any cause.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Discontinue Study Intervention Due to an AE Up to approximately 4 years An AE is defined as 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.
Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR Up to approximately 4 years ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. based on BICR.
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR Up to approximately 4 years For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Number of Participants Who Experience One or More Adverse Events (AEs) Up to approximately 4 years An AE is defined as 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.
Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30]) Baseline, up to approximately 4 years The EORTC QLQ-C30 is a questionnaire to assess the overall health status and quality of life of cancer patients. Participant responses to the questions, "How would you rate your overall health during the past week (Item 29)?" and "How would you rate your overall quality of life during the past week (Item 30)?" are 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 score indicates a better overall health status and quality of life. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Trial Locations
- Locations (242)
USA Mitchell Cancer Institute ( Site 4142)
🇺🇸Mobile, Alabama, United States
Alaska Womens Cancer Care ( Site 4122)
🇺🇸Anchorage, Alaska, United States
HonorHealth (HH) ( Site 8000)
🇺🇸Phoenix, Arizona, United States
Arizona Oncology Associates - HOPE ( Site 8002)
🇺🇸Tucson, Arizona, United States
UCLA Hematology/Oncology - Westwood (Building 100)-Department of OBGYN, Division of Gynecologic Onc ( Site 4131)
🇺🇸Los Angeles, California, United States
California Pacific Medical Center - Van Ness Campus ( Site 4129)
🇺🇸San Francisco, California, United States
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 4114)
🇺🇸New Haven, Connecticut, United States
MedStar Washington Hospital Center ( Site 4108)
🇺🇸Washington, District of Columbia, United States
Mount Sinai Cancer Center ( Site 4117)
🇺🇸Miami Beach, Florida, United States
AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 4113)
🇺🇸Orlando, Florida, United States
Scroll for more (232 remaining)USA Mitchell Cancer Institute ( Site 4142)🇺🇸Mobile, Alabama, United StatesStudy CoordinatorContact888-577-8839