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 MK-2870 sacituzumab tirumotecan to chemotherapy.
The goal of the study is to learn if people who receive MK-2870 sacituzumab tirumotecan
live longer overall and without the cancer getting worse compared to people who receive
chemotherapy.
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 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 180 days
after completing platinum-based therapy administered in the curative-intent or
adjuvant setting without any additional platinum-based therapy received in the
metastatic or recurrent setting.
- Has received more than 3 prior lines of therapy for endometrial carcinoma or
carcinosarcoma.
Primary outcome:
1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) (Time Frame - 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.
2. Overall Survival (OS) (Time Frame - Up to approximately 4 years):
OS is defined as the time from randomization to death due to any cause.
Secondary outcome:
1. Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR (Time Frame - 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.
2. Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR (Time Frame - 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.
3. Number of Participants Who Experience One or More Adverse Events (AEs) (Time Frame - 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.
4. Number of Participants Who Discontinue Study Intervention Due to an AE (Time Frame - 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.
5. 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]) (Time Frame - 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.
- Experimental: 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. - Active Comparator: Chemotherapy
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.
- Sacituzumab tirumotecan (SKB264 MK-2870):
4 mg/kg of sacituzumab tirumotecan by IV infusion - Doxorubicin (ADRIAMYCIN®):
60 mg/m^2 of doxorubicin by IV Infusion - Paclitaxel (TAXOL®):
80 mg/m^2 of paclitaxel by IV infusion
Quelle: ClinicalTrials.gov
