A clinical study of sacituzumab tirumotecan and pembrolizumab in people with endometrial cancer (MK-2870-033)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

22 Aug 2025 → ongoing

Decision date (initial)

2025-06-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-519331-42-00

WHO UTN

U1111-1315-0794

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Therapy

1. To compare maintenance treatment with sacituzumab tirumotecan plus pembrolizumab to pembrolizumab alone with respect to PFS per RECIST 1.1 as assessed by BICR in participants with pMMR primary advanced or recurrent endometrial carcinoma
2. To compare maintenance treatment with sacituzumab tirumotecan plus pembrolizumab to pembrolizumab alone with respect to OS in participants with pMMR primary advanced or recurrent endometrial carcinoma

Secondary objectives 4

1. To evaluate maintenance treatment with sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab alone with respect to PFS2, as assessed by investigator, in participants with pMMR primary advanced or recurrent endometrial carcinoma
2. To evaluate the safety and tolerability of maintenance treatment with sacituzumab tirumotecan plus pembrolizumab in participants with pMMR primary advanced or recurrent endometrial carcinoma
3. To compare maintenance treatment with sacituzumab tirumotecan plus pembrolizumab to pembrolizumab alone with respect to mean change from baseline in HRQoL using the EORTC QLQ-C30 in participants with pMMR primary advanced or recurrent endometrial carcinoma
4. To compare maintenance treatment with sacituzumab tirumotecan plus pembrolizumab to pembrolizumab alone with respect to mean change from baseline in HRQoL using the EORTC QLQ-EN24 in participants with pMMR primary advanced or recurrent endometrial carcinoma

Conditions and MedDRA coding

pMMR endometrial carcinoma

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

EMA paediatric investigation plan (PIP)

EMEA-003461-PIP01-23

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR)
2. Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator.
3. Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment

Exclusion criteria 8

1. Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas
2. Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR)
3. Is a candidate for curative-intent surgery or curative-intent radiotherapy at the time of enrollment
4. 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
5. Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
6. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
7. Human Immunodeficiency Virus-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
8. Received prior therapy in any setting with any of the following: anti-programmed cell death 1 protein, anti-programmed cell death ligand 1, anti-programmed cell death ligand 2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor; trophoblast cell surface antigen 2-targeted antibody drug conjugate; or topoisomerase I inhibitor-containing antibody drug conjugate

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Maintenance Treatment: Progression Free Survival (PFS)
2. Maintenance Treatment: Overall Survival (OS)

Secondary endpoints 7

1. Maintenance Treatment: Progression-Free Survival 2 (PFS2) as Assessed by Investigator
2. Maintenance Treatment: Number of Participants Who Experience One or More Adverse Events (AEs)
3. Maintenance Treatment: Number of Participants Who Discontinue Study Intervention Due to an AE
4. Maintenance Treatment: Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Item Mean Score
5. Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
6. Maintenance Treatment: Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
7. Maintenance Treatment: Change from baseline in EORTC QLQ Endometrial Cancer Symptom Score (QLQ-EN24)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 8

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Stephan Kruger

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Stephan Kruger

Third parties 9

Locations

16 EU/EEA countries · 91 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 121 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications