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JOURNAL ONKOLOGIE – STUDIE

Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)

Rekrutierend

NCT-Nummer:
NCT06132958

Studienbeginn:
Dezember 2023

Letztes Update:
22.04.2024

Wirkstoff:
Sacituzumab tirumotecan, Doxorubicin, Paclitaxel

Indikation (Clinical Trials):
Endometrial Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Merck Sharp & Dohme LLC

Collaborator:
European Network for Gynaecological Oncological Trial groups(ENGOT), GOG Foundation,

Studienleiter

Medical Director
Study Director
Merck Sharp & Dohme LLC

Kontakt

Studienlocations
(3 von 43)

Seoul National University Bundang Hospital-Obstetrics and Gynecology ( Site 3505)
13620 Seongnam
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 82317877253» Ansprechpartner anzeigen
Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 3503)
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 82222282230» Ansprechpartner anzeigen
Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3501)
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 82230103640» Ansprechpartner anzeigen
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit
02-781 Warszawa
PolandRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 48225462295» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

The primary objectives of this study are to compare sacituzumab tirumotecan to Treatment of

Physician's Choice (TPC) with respect to progression-free survival (PFS) per response

evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central

review (BICR), and overall survival (OS). The primary hypotheses are that sacituzumab

tirumotecan is superior to TPC with respect to PFS per RECIST 1.1, as assessed by BICR, and

that sacituzumab tirumotecan is superior to TPC with respect to OS.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

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.

Studien-Arme

  • 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.

Geprüfte Regime

  • 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


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