A clinical trial of sacituzumab tirumotecan to treat urothelial cancer (MK-2870-031)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

22 Apr 2026 → ongoing

Decision date (initial)

2026-04-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-520014-22-00

WHO UTN

U1111-1316-4390

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic, Pharmacodynamic, Therapy

1. To compare sacituzumab tirumotecan to investigator’s choice nonplatinum chemotherapy with respect to OS

Secondary objectives 5

1. To compare sacituzumab tirumotecan to investigator’s choice nonplatinum chemotherapy with respect to PFS per RECIST 1.1 as assessed by investigator
2. To compare sacituzumab tirumotecan to investigator’s choice nonplatinum chemotherapy with respect to ORR per RECIST 1.1 as assessed by investigator
3. To evaluate the DOR of both treatment arms per RECIST 1.1 as assessed by investigator
4. To evaluate the safety and tolerability of sacituzumab tirumotecan
5. To evaluate change from baseline in HRQoL and disease-related symptoms using the EORTC QLQ-C30

Conditions and MedDRA coding

Locally advanced/metastatic urothelial carcinoma

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 13

1. Has histologically documented locally advanced/metastatic urothelial cancer. Locally advanced disease must not be amenable to resection or radiation with curative intent per investigator assessment.
2. Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator.
3. Has received treatment with anti-programmed cell death [ligand] 1 (anti-PD-[L]1) therapy, platinum-based chemotherapy, and enfortumab vedotin (EV).
4. Prior therapy with disitamab vedotin (DV) is allowed but will not meet the requirement for prior treatment with EV, except in China, where participants may have received DV instead of EV before study entry.
5. Has received a maximum of 3 prior lines of therapy.
6. Has experienced radiographic disease progression on or after the immediate prior line of therapy before study entry.
7. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization.
8. Is eligible to receive at least one of the control arm nonplatinum chemotherapy options (paclitaxel, docetaxel, or vinflunine).
9. Is able to provide archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated.
10. If human immunodeficiency virus (HIV) positive, has well-controlled HIV on antiretroviral therapy (ART).
11. If hepatitis B surface antigen (HBsAg) positive, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load.
12. If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
13. Has adequate organ function.

Exclusion criteria 17

1. Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
2. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
3. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
4. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
5. Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from adverse event (AE) associated with anticancer therapy.
6. Has received prior therapy with trophoblast cell-surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC).
7. Has received prior therapy with a topoisomerase 1 inhibitor-containing ADC.
8. Has completed prior external radiotherapy within 6 weeks or stereotactic radiotherapy within 4 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids.
9. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
10. Has received prior chemotherapy for urothelial cancer with any of the study therapies in the control arm (paclitaxel, docetaxel, and vinflunine).
11. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
12. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
13. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
14. Has a current or past history of central nervous system (CNS) metastases and/or carcinomatous meningitis.
15. Has an active infection requiring systemic therapy other than those permitted per protocol.
16. Has a history of stem cell/solid organ transplant.
17. Has not adequately recovered from major surgery, or has ongoing surgical complications.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall Survival (OS)

Secondary endpoints 11

1. Progression-Free Survival (PFS)
2. Objective Response Rate (ORR)
3. Duration of Response (DOR)
4. Number of Participants Who Experience an Adverse Event (AE)
5. Number of Participants Who Discontinue Study Treatment Due to an AE
6. 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 (Items 29 and 30) Combined Score
7. Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
8. Change From Baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
9. Change From Baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score
10. Change From Baseline in EORTC QLQ-C30 Nausea/Vomiting (Items 14 and 15) Combined Score
11. Change From Baseline in EORTC QLQ-C30 Diarrhea (Item 17) Score

Investigational products

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

Test 2

Comparator 3

Auxiliary 2

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

Abhishek Bavle

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Abhishek Bavle

Third parties 8

Locations

8 EU/EEA countries · 59 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 46 files

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

Application history

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