A clinical study of sacituzumab tirumotecan for cervical cancer (MK-2870-036)

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

26 Jan 2026 → ongoing

Decision date (initial)

2026-01-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2025-521514-26-00

WHO UTN

U1111-1319-9926

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Pharmacokinetic, Safety

1. Part 1 (Safety Run-in) To evaluate the safety and tolerability of maintenance treatment with sac-TMT plus pembrolizumab with bevacizumab
2. Part 2 Maintenance Objective: To compare maintenance treatment with sac-TMT plus pembrolizumab, with or without bevacizumab to SoC with respect to PFS per RECIST 1.1 as assessed by BICR.
3. Part 2 Maintenance Objective: To compare maintenance treatment with sac-TMT plus pembrolizumab, with or without bevacizumab to SoC with respect to OS.

Secondary objectives 3

1. Part 2 Maintenance To evaluate maintenance treatment with sac-TMT plus pembrolizumab, with or without bevacizumab versus SoC with respect to PFS2 as assessed by the investigator.
2. Part 2 Maintenance To evaluate safety and tolerability of maintenance treatment with sac-TMT plus pembrolizumab, with or without bevacizumab.
3. Part 2 Maintenance To evaluate maintenance treatment with sac-TMT plus pembrolizumab, with or without bevacizumab versus SoC with respect to HRQoL outcome.

Conditions and MedDRA coding

Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix
2. Has persistent, recurrent, or newly diagnosed metastatic cervical cancer that is not amenable to curative treatment (surgery and/or radiation)
3. If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy
4. If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load
5. If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
6. Has an Eastern Cooperative Oncology Group performance status of 0 or 1
7. Has tumor programmed cell death ligand 1 expression of combined positive score ≥1

Exclusion criteria 13

1. Has HIV infection with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
2. 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
3. Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis, or chronic diarrhea)
4. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
5. Has received prior systemic anticancer therapy other than what is specified in this protocol
6. Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sacituzumab tirumotecan
7. Has a diagnosis of immunodeficiency
8. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
9. Has known active central nervous system metastases and/or carcinomatous meningitis
10. Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed
11. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
12. Has a history of stem cell/solid organ transplant
13. Has not adequately recovered from major surgery or has ongoing surgical complications

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Part 1 Safety Run-in: Number of Participants Who Experience One or More Adverse Events (AEs)
2. Part 1 Safety Run-in: Number of Participants Who Discontinue Study Treatment Due to an AE
3. Part 2 Maintenance Treatment: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Blinded Independent Central Review
4. Part 2 Maintenance Treatment: Overall Survival (OS)

Secondary endpoints 7

1. Part 2 Maintenance Treatment: Progression-free Survival 2 (PFS2) as Assessed by the Investigator
2. Part 2 Maintenance Treatment: Number of Participants Who Experience One or More AEs
3. Part 2 Maintenance Treatment: Number of Participants Who Discontinue Study Treatment Due to an AE
4. Part 2 Maintenance Treatment: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status and Quality of Life Combined Score
5. Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Physical Functioning Combined Score
6. Part 2 Maintenance Treatment: Change from Baseline in EORTC QLQ-C30 Role Functioning Combined Score
7. Part 2 Maintenance Treatment: Change from Baseline in EORTC Quality of Life Questionnaire-Cervical Cancer Module (QLQ-CX24) Combined Score

Investigational products

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

Test 6

Auxiliary 4

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

Ved Desai

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Ved Desai

Third parties 14

Locations

13 EU/EEA countries · 70 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 105 files

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

Application history

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