Status:
ACTIVE_NOT_RECRUITING
Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
European Network for Gynaecological Oncological Trial groups(ENGOT)
GOG Foundation
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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. Immunot...
Eligibility Criteria
Inclusion
- The main inclusion and exclusion criteria include but are not limited to the following:
- 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
- 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
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 10 2028
Estimated Enrollment :
710 Patients enrolled
Trial Details
Trial ID
NCT06132958
Start Date
December 6 2023
End Date
January 10 2028
Last Update
January 9 2026
Active Locations (241)
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1
USA Mitchell Cancer Institute ( Site 4142)
Mobile, Alabama, United States, 36604
2
Alaska Womens Cancer Care ( Site 4122)
Anchorage, Alaska, United States, 99508
3
HonorHealth (HH) ( Site 8000)
Phoenix, Arizona, United States, 85016
4
Arizona Oncology Associates - HOPE ( Site 8002)
Tucson, Arizona, United States, 85711