A clinical study of sacituzumab tirumotecan in people with ovarian cancer (MK-2870-022)

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

11 Apr 2025 → ongoing

Decision date (initial)

2026-03-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2023-508015-23-00

WHO UTN

U1111-1297-4489

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacogenetic, Pharmacogenomic, Efficacy, Safety, Therapy, Pharmacoeconomic, Pharmacodynamic

1. Part 1: To evaluate the safety and tolerability of sacituzumab tirumotecan maintenance treatment with bevacizumab

2. Part 2: To compare sacituzumab tirumotecan maintenance treatment with or without bevacizumab to SoC (observation with or without bevacizumab) with respect to PFS per RECIST 1.1 as assessed by BICR

Secondary objectives 3

1. Part 2: To compare sacituzumab tirumotecan maintenance treatment with or without bevacizumab to SoC with respect to OS
2. Part 2: To evaluate the safety and tolerability of sacituzumab tirumotecan maintenance treatment with or without bevacizumab
3. Part 2: To evaluate sacituzumab tirumotecan maintenance treatment with or without bevacizumab versus SoC with respect to the mean change from baseline of global health status/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 recurrent

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 8

1. Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
2. Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC)
3. Has platinum-sensitive epithelial OC
4. Has provided tissue of a tumor lesion that was not previously irradiated
5. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
6. Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2)
7. Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
8. Has an ECOG performance status of 0 to 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)

Exclusion criteria 13

1. Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner’s tumor and undifferentiated carcinoma
2. Has platinum-resistant OC or platinum-refractory OC
3. Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
4. Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea)
5. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
6. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
7. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
8. Has received more than 2 prior lines of systemic therapy for OC
9. Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2)
10. Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids
11. Has an additional malignancy that is progressing or has required active treatment within the past 3 years
12. Has active CNS metastases and/or carcinomatous meningitis
13. Has an active infection requiring systemic therapy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Part 1: Number of Participants with One or More Adverse Events (AE)
2. Part 1: Number of Participants who Discontinue Study Intervention Due to an AE
3. Part 2: Progression-free Survival (PFS)

Secondary endpoints 7

1. Part 2: Overall Survival (OS)
2. Part 2: Number of Participants with One or More AEs
3. Part 2: Number of Participants who Discontinue Study Intervention Due to an AE
4. Part 2: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score
5. Part 2: Change from Baseline in EORTC QLQ-C30 Physical Functioning Score
6. Part 2: Change from Baseline in EORTC QLQ-C30 Role Functioning Score
7. Part 2: Change from Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 Abdominal/Gastrointestinal Symptom Scale

Investigational products

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

Test 4

Auxiliary 5

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

​Matt Horn​

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

​Matt Horn​

Third parties 9

Locations

14 EU/EEA countries · 82 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 113 files

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

Application history

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