A clinical study of sacituzumab tirumotecan in people with ovarian cancer (MK-2870-021)

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

30 Apr 2026 → ongoing

Decision date (initial)

2026-04-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2023-508047-40-00

WHO UTN

U1111-1297-5158

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To compare sac-TMT maintenance treatment with or without bevacizumab to SoC, with respect to PFS per RECIST 1.1 as assessed by BICR

Secondary objectives 4

1. To compare sac-TMT maintenance treatment with or without bevacizumab to SoC with respect to OS
2. To evaluate PFS2 as determined by the investigator
3. To evaluate the safety and tolerability of sac-TMT maintenance treatment with or without bevacizumab
4. To evaluate sac-TMT maintenance treatment with or without bevacizumab versus SoC with respect to the mean change from baseline of GHS/QoL score using the EORTC QLQ-C30 and abdominal/GI symptoms using the EORTC QLQ-OV28 abdominal/GI symptom scale

Conditions and MedDRA coding

Ovarian cancer

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Has histologically confirmed FIGO Stage III or Stage IV epithelial ovarian, primary peritoneal, or fallopian tube cancer.
2. Has completed primary debulking surgery or interval debulking surgery.
3. Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, or complete response per protocol.
4. Has provided tumor tissue that is not previously irradiated.
5. Has well-controlled human immunodeficiency virus (HIV) with antiretroviral therapy if HIV-infected.
6. Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
7. Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection.

Exclusion criteria 13

1. Has nonepithelial cancers, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma.
2. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
3. Has a history of severe eye disease.
4. Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease.
5. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
6. Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, or has current pneumonitis/ILD.
7. Had prior systemic anticancer therapy.
8. Had a live or live-attenuated vaccine within 30 days of randomization.
9. Has a known additional malignancy that is progressing or required active treatment within the past 3 years.
10. Has active infection requiring systemic therapy.
11. Has concurrent and active HBV and HCV infections.
12. Has HIV infection and a history of Kaposi’s sarcoma and/or multicentric Castleman’s disease.
13. Has not recovered from major surgery or has ongoing surgical complications.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression-Free Survival (PFS)

Secondary endpoints 8

1. Overall Survival (OS)
2. Second Progression-Free Survival (PFS2)
3. Number of Participants Who Experience an Adverse Event (AE)
4. Number of Participants Who Discontinue Study Treatment Due to an AE
5. Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) Combined Score (Items 29 and 30) Using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)
6. Change From Baseline in Physical Functioning Combined Score (Items 1 to 5) Using EORTC QLQ-C30
7. Change From Baseline in Role Functioning Combined Score (Items 6 and 7) Using EORTC QLQ-C30
8. Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Combined Score (Items 31 to 36) Using the EORTC QLQ-Ovarian Cancer Module 28 (OV28)

Investigational products

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

Test 5

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Jacob Rotmensch

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Jacob Rotmensch

Third parties 8

Locations

15 EU/EEA countries · 84 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 117 files

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

Application history

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