Ovarian Clear Cell CarcinomaPhase 2TsubomiNCT07913568
A Phase II Investigator-initiated Trial of Sacituzumab Tirumotecan Plus Pembrolizumab in Patients With Recurrent ovarIan Clear Cell Carcinoma Previously Treated With Platinum-based Chemotherapy（NCCH2407/MK014）
A Phase 2 study testing Sacituzumab tirumotecan, Pembrolizumab in people with Ovarian Clear Cell Carcinoma, run by National Cancer Center, Japan at 4 sites in Japan.
Trial summary
Ovarian clear cell carcinoma is relatively more common in East Asian populations, and effective treatment options remain limited after recurrence. This study is designed to evaluate a novel combination treatment for patients with recurrent ovarian clear cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Clear Cell Carcinoma
- What is being tested?
- Sacituzumab tirumotecan, Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesJapan
- Study dates
- 1 Feb 2027to 31 Jan 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically diagnosed (histological or cytological examination) as clear cell carcinoma of the ovary, fallopian tube, and peritoneum.
- The tumor should be negative for expression of WT-1 antigen and Estrogen Receptor (ER) antigen by immunohistochemistry.
- Tumors with mixed histology will be eligible if > 50% consists of clear cell carcinoma.
- If diagnosed prior to registration, the timing is not restricted. However, if histological examination was conducted at another institution, the pathological diagnosis must generally be obtained by a pathologist at the study site, e.g., by requesting the pathological specimen.
- Have received prior systemic therapy that included at least one platinum-containing combination chemotherapy regimen..
- No active central nervous system (CNS) metastases-including brain metastases, carcinomatous (leptomeningeal) meningitis, or symptomatic spinal metastases that require radiotherapy or surgical intervention.
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- No clinically significant pericardial effusion, pleural effusion, or ascites requiring treatment.
- Age ≥18 years at the time of enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- No prior treatment with trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugates (ADC) or ADC containing anti-topoisomerase I agents.
- At least one target lesion※ identified on contrast-enhanced CT/MRI (head, neck, chest, abdomen, pelvis with ≤5 mm slice thickness) performed within 28 days prior to enrollment (same day of the week is acceptable; this applies similarly to other time-based criteria below) as defined by RECIST 1.1.
- No administration of anticancer therapies (e.g., chemotherapy, targeted therapy, immunotherapy) within 28 days prior to enrollment.
- No major surgery under general anesthesia within 28 days prior to enrollment.
- No radiotherapy (including Gamma Knife or CyberKnife) within 14 days prior to enrollment.
- Laboratory values within the following criteria based on testing within 14 days prior to enrollment. However, no administration of granulocyte colony-stimulating factor (G-CSF) or blood transfusion within 14 days prior to the blood draw date i) Neutrophil count≧1,500/mm3 ii) Platelet count≧10x104/mm3 iii) Hemoglobin≧9.0 g/dL iv) Albumin≧3.0 g/dL Must meet the specified albumin criterion without receiving albumin supplementation within 72 hours prior to blood sampling.
- AST≦100 U/L vi) ALT≦100 U/L vii) Total bilirubin≦1.5 mg/dL viii) Creatinine≦1.2 mg/dL Patients with serum creatinine >1.2 mg/dL are eligible only if Cockcroft-Gault eCCr or 24-hour urine CCr is ≥30 mL/min.
- PT-INR ≦1.5
- Peripheral oxygen saturation (SpO₂) ≥92% on room air within 14 days prior to enrollment.
- Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or pre-treatment baseline level (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible. Participants with Grade ≤2 peripheral neuropathy are eligible.
- Must not be pregnant or breastfeeding and must meet one of the following conditions:
- Not of childbearing potential (POCBP; see Appendix 19.2.1) ii) If of childbearing potential:
- Has a negative pregnancy test (high-sensitivity serum or urine β-hCG test) within 14 days before enrollment. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. Additional requirements for pregnancy testing during and after study intervention are in Section 8.2.6.
- Uses a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 19.2.2 during the protocol treatment and for at least the time needed to eliminate the study intervention after the last dose of study intervention. The participant agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during this period for the purpose of reproduction. The length of time required to continue contraception for protocol treatment and, with the last administration of the study-drug designated as Day0, until the periods specified below:
- Sacituzumab tirumotecan:210 days pembrolizumab: 120 days
- The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive methods for POCBP include the use of condoms, pessaries, oral contraceptives, and intrauterine devices.
- Abstains from breastfeeding during the below period after the last dose of study intervention.
- Sacituzumab tirumotecan:10 days pembrolizumab: 120 days Note: Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.
- Available to submit tumor tissue specimens for biomarker evaluation, consisting of either archived formalin-fixed, paraffin-embedded (FFPE) tissue blocks or unstained consecutive sections on slides prepared from FFPE block. Whenever possible, tumor tissue obtained from sites of recurrence or metastasis is preferred; however, archival tumor tissue from the primary tumor is acceptable if it was collected recently or is judged to be the most suitable for the study. Refer to the "Specimen Collection, Processing, and Shipping Manual" for detailed procedures.
- Written informed consent obtained from the patient.
Who cannot join
- 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.
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.
- Received a live or live-attenuated vaccine within 30 days before enrollment. Administration of killed vaccines are allowed.
- Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting protocol treatment is 2 weeks.
- Note: A list of strong inhibitors or inducers of CYP3A4 can be found at the Table 19.3.
- Please note that this list is not exhaustive, and investigators should review the locally approved label for all concomitant therapies to ensure they are not strong inducers or inhibitors of CYP3A4.
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- Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited.
- Has received an investigational agent or has used an investigational device within 28 days before enrollment.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Note: The following cancers that have been completely resected are not considered exclusionary. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder).
- Has severe hypersensitivity (≥Grade 3) to sacituzumab tirumotecan, pembrolizumab and/or any of their excipients or to another biologic therapy.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. ,or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening.
- Received prior therapy in any setting with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor※ (eg, CTLA-4, OX-40, CD137).
- ※ The term "agents targeting PD-1, PD-L1, PD-L2, or other coinhibitory T-cell receptors" refers to the following:
- Anti-PD-1 / Anti-PD-L1 / Anti-PD-L2 agents: pembrolizumab; nivolumab; cemiplimab; atezolizumab; avelumab; durvalumab; and similar agents.
- Agents targeting other coinhibitory T-cell receptors: ipilimumab; rocatinlimab; and similar agents.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the enrollment.
- Active autoimmune disease that has required systemic treatment in the past 2 years. Or with a history of chronic or recurrent occurrence of the same disease (however, patients with type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, dermatologic disorders not requiring systemic treatment, or conditions expected not to recur in the absence of external triggers will not be excluded).
- History of stem cell/solid organ transplant.
- Has an infectious disease requiring systemic treatment.
- Positive for HBs antigen, or negative for HBs antigen but positive for either HBs antibody or HBc antibody and positive for HBV DNA quantification. Patients are eligible if HBV DNA is below the lower limit of quantification; however, they will be excluded if they have not received at least 4 weeks of antiviral therapy prior to enrollment.
- Positive for HIV antibody and HCV RNA, or, if HCV RNA is negative, has not completed curative antiviral therapy at least 28 days prior to enrollment. HCV RNA testing is required only for patients who test positive for HCV antibodies.
- Patients with psychiatric disorders or symptoms that substantially impair daily functioning and who are deemed unsuitable for participation in the study
- Patients with active gastrointestinal ulcers
- Has an ongoing or not cured stomatitis
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan4 sites
Hyogo Cancer Center
Hyōgo
Kasumi Yamamoto, ＋81-78-929-1151, kasumi_5758@hyogo-cc.jp
Saitama Medical University International Medical Center
Saitama
Akira Yabuno, +81-42-984-4111, yakira@saitama-med.ac.jp
Cancer Institute Hospital Of JFCR
Tokyo
Mayu Yunokawa, +81-3-3520-0111, mayu.yunokawa@jfcr.or.jp
National Cancer Center Hospital
Tokyo
Kan Yonemori, +81-3-3542-251, kyonemor@ncc.go.jp
About this study
Ovarian clear cell carcinoma is relatively more common in East Asian populations, and effective treatment options remain limited after recurrence. This study is designed to evaluate a novel combination treatment for patients with recurrent ovarian clear cell carcinoma.
This phase II, open-label, single-arm study evaluates the efficacy and safety of sacituzumab tirumotecan in combination with pembrolizumab in participants with recurrent ovarian clear cell carcinoma. Sacituzumab tirumotecan is an antibody-drug conjugate, and pembrolizumab is an immune checkpoint inhibitor targeting programmed death-1 (PD-1).
The primary objective is to evaluate the objective response rate assessed by central review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary objectives include evaluation of progression-free survival, overall survival, duration of response, time to response, safety, and quality of life.
Read the detailed description
Background and Rationale Ovarian clear cell carcinoma (OCCC) is relatively more common in East Asian populations and accounts for a substantial proportion of epithelial ovarian cancers in Japan. Recurrent OCCC has limited effective treatment options, particularly after platinum-containing chemotherapy, highlighting the need for novel therapeutic strategies.
Sacituzumab tirumotecan is a TROP2-directed antibody-drug conjugate, and pembrolizumab is an immune checkpoint inhibitor targeting programmed death-1 (PD-1). The combination of sacituzumab tirumotecan and pembrolizumab is currently under clinical development in multiple solid tumors, although its efficacy and safety in OCCC have not been established.
In our retrospective study of 125 patients with OCCC, TROP2 expression was detected in 72.0% (90/125) of tumors using an H-score cutoff greater than 10. In addition, TROP2 H-score showed a modest positive correlation with PD-L1 tumor proportion score (ρ = 0.20, p = 0.02). The frequent expression of TROP2 in OCCC, together with the potential activity of immune checkpoint inhibition in this disease, provides a rationale for evaluating sacituzumab tirumotecan in combination with pembrolizumab in patients with recurrent OCCC.
Study Objectives The Tsubomi study aims to evaluate the efficacy and safety of sacituzumab tirumotecan in combination with pembrolizumab therapy in patients with recurrent ovarian clear cell carcinoma with a history of platinum-containing chemotherapy.
The primary endpoint of this study is the objective response rate (ORR) as assessed by the independent imaging review committee. Secondary endpoints include ORR as assessed by the investigator (site assessment), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), the incidence of adverse events, adverse reactions, and serious adverse events/adverse reactions, as well as measures of treatment feasibility, efficacy outcomes such as duration of response (DoR) and time to response (TTR) and QOL score.
Study Design The Tsubomi trial is a multicenter, single-arm, phase II investigator-initiated trial
Study Treatment
All participants will receive sacituzumab tirumotecan at a dose of 4 mg/kg, administered by intravenous infusion every 2 weeks (on Days 1, 15, and 29 of each 6-week cycle), and pembrolizumab at a dose of 400 mg, administered by intravenous infusion every 6 weeks. Treatment is initiated within 7 days of registration and is continued until one or more of the following occur:
- Radiographic or clinical disease progression
- Unacceptable toxicity
- Withdrawal of consent
- Investigator or Steering Committee decision based on participant safety or protocol-defined criteria
Efficacy Assessments Tumor scans with contrast-enhanced CT (brain,neck, chest, abdomen, and pelvis) will be performed every 8 weeks up to week 24 and every 12 weeks thereafter to evaluate the response of the sacituzumab tirumotecan and pembrolizumab. Tumor response and disease progression are evaluated according to RECIST version 1.1.
" Endpoints Primary Endpoint： Objective Response Rate (ORR) as assessed by the Independent Imaging Review Committee Secondary Endpoints： Objective Response Rate (ORR) as assessed by the investigator (site assessment).
Progression-Free Survival (PFS) Overall Survival (OS) Disease Control Rate (DCR) Incidence and severity of adverse events and adverse drug reactions (CTCAE v5.0) Duration of Response(DoR), Time to Response (TTR) Quality of life（QOL） score
Study Oversight and Funding National Cancer Center Hospital, Japan, is the coordinating sponsor and is responsible for overall trial coordination, data management, monitoring, and analysis.
Merck Sharp \& Dohme LLC provides the investigational product and research funding for the study.
Prespecified translational research program A prespecified translational research program is embedded in the trial. Archival tumor tissue or a pretreatment biopsy is required for enrollment whenever feasible.
Tumor TROP2 and PD-L1 expression will be evaluated centrally by immunohistochemistry. Prespecified subgroup analyses will be conducted according to TROP2 expression status (positive vs. negative) and PD-L1 expression status (positive vs. negative) to explore their associations with clinical outcomes following treatment with sacituzumab tirumotecan.
- Conditions
- Ovarian Clear Cell Carcinoma
- Being tested
- Sacituzumab tirumotecan, Pembrolizumab
- Keywords
- Sacituzumab tirumotecan, Pembrolizumab, ovarIan clear cell carcinoma, advanced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab tirumotecan, PembrolizumabDrug
Sacituzumab tirumotecan 4mg/kg will be administered by intravenous infusion every 2 weeks (at 6-week intervals, day1, day15, day29), and pembrolizumab 400mg will be administered by intravenous infusion every 6 weeks and continued until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab tirumotecan, Pembrolizumab | Experimental | Not described Receives: Drug: Sacituzumab tirumotecan, Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) assessed by the central review
Measured: Baseline up to 3 years. Overall Response is assessed every 8 weeks until 24 weeks after initiation of protocol treatment, and every 12 weeks after 25 weeks and after termination. It continues until PD confirmation or post-study treatment initiation.
Secondary outcomes (10)
Objective Response Rate (ORR) as assessed by the investigator (site assessment)
Measured: Baseline up to 3 years. Overall Response is assessed every 8 weeks until 24 weeks after initiation of protocol treatment, and every 12 weeks after 25 weeks and after termination. It continues until PD confirmation or post-study treatment initiation.
Progression-Free Survival (PFS)
Measured: From baseline up to 3 years
Overall Survival (OS)
Measured: From baseline up to 3 years
Disease Control Rate (DCR)
Measured: From baseline up to 3 years
Incidence of adverse events
Measured: From baseline up to 3 years
Incidence of Adverse Reactions
Measured: From baseline up to 3 years
Incidence of Serious Adverse Events/ Adverse Reactions
Measured: From baseline up to 3 years
Duration of Response (DoR)
Measured: From baseline up to 3 years
Time to Response (TTR)
Measured: From baseline up to 3 years
Quality of life（QOL） score
Measured: From baseline up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Feb 2027 (estimated)
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Clear Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Japan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07913568
- Sponsor's protocol ID
- NCCH2407/MK014
- Acronym
- Tsubomi
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Investigator-initiated Trial of Sacituzumab Tirumotecan Plus Pembrolizumab in Patients With Recurrent ovarIan Clear Cell Carcinoma Previously Treated With Platinum-based Chemotherapy（NCCH2407/MK014）
- ClinicalTrials.gov ID
- NCT07913568
- Acronym / sponsor ID
- Tsubomi / NCCH2407/MK014
- Conditions
- Ovarian Clear Cell Carcinoma
- Keywords
- Sacituzumab tirumotecan, Pembrolizumab, ovarIan clear cell carcinoma, advanced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National Cancer Center, JapanOther government
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ovarian clear cell carcinoma is relatively more common in East Asian populations, and effective treatment options remain limited after recurrence. This study is designed to evaluate a novel combination treatment for patients with recurrent ovarian clear cell carcinoma.
This phase II, open-label, single-arm study evaluates the efficacy and safety of sacituzumab tirumotecan in combination with pembrolizumab in participants with recurrent ovarian clear cell carcinoma. Sacituzumab tirumotecan is an antibody-drug conjugate, and pembrolizumab is an immune checkpoint inhibitor targeting programmed death-1 (PD-1).
The primary objective is to evaluate the objective response rate assessed by central review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary objectives include evaluation of progression-free survival, overall survival, duration of response, time to response, safety, and quality of life.
Detailed description
Background and Rationale Ovarian clear cell carcinoma (OCCC) is relatively more common in East Asian populations and accounts for a substantial proportion of epithelial ovarian cancers in Japan. Recurrent OCCC has limited effective treatment options, particularly after platinum-containing chemotherapy, highlighting the need for novel therapeutic strategies.
Sacituzumab tirumotecan is a TROP2-directed antibody-drug conjugate, and pembrolizumab is an immune checkpoint inhibitor targeting programmed death-1 (PD-1). The combination of sacituzumab tirumotecan and pembrolizumab is currently under clinical development in multiple solid tumors, although its efficacy and safety in OCCC have not been established.
In our retrospective study of 125 patients with OCCC, TROP2 expression was detected in 72.0% (90/125) of tumors using an H-score cutoff greater than 10. In addition, TROP2 H-score showed a modest positive correlation with PD-L1 tumor proportion score (ρ = 0.20, p = 0.02). The frequent expression of TROP2 in OCCC, together with the potential activity of immune checkpoint inhibition in this disease, provides a rationale for evaluating sacituzumab tirumotecan in combination with pembrolizumab in patients with recurrent OCCC.
Study Objectives The Tsubomi study aims to evaluate the efficacy and safety of sacituzumab tirumotecan in combination with pembrolizumab therapy in patients with recurrent ovarian clear cell carcinoma with a history of platinum-containing chemotherapy.
The primary endpoint of this study is the objective response rate (ORR) as assessed by the independent imaging review committee. Secondary endpoints include ORR as assessed by the investigator (site assessment), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), the incidence of adverse events, adverse reactions, and serious adverse events/adverse reactions, as well as measures of treatment feasibility, efficacy outcomes such as duration of response (DoR) and time to response (TTR) and QOL score.
Study Design The Tsubomi trial is a multicenter, single-arm, phase II investigator-initiated trial
Study Treatment
All participants will receive sacituzumab tirumotecan at a dose of 4 mg/kg, administered by intravenous infusion every 2 weeks (on Days 1, 15, and 29 of each 6-week cycle), and pembrolizumab at a dose of 400 mg, administered by intravenous infusion every 6 weeks. Treatment is initiated within 7 days of registration and is continued until one or more of the following occur:
- Radiographic or clinical disease progression
- Unacceptable toxicity
- Withdrawal of consent
- Investigator or Steering Committee decision based on participant safety or protocol-defined criteria
Efficacy Assessments Tumor scans with contrast-enhanced CT (brain,neck, chest, abdomen, and pelvis) will be performed every 8 weeks up to week 24 and every 12 weeks thereafter to evaluate the response of the sacituzumab tirumotecan and pembrolizumab. Tumor response and disease progression are evaluated according to RECIST version 1.1.
" Endpoints Primary Endpoint： Objective Response Rate (ORR) as assessed by the Independent Imaging Review Committee Secondary Endpoints： Objective Response Rate (ORR) as assessed by the investigator (site assessment).
Progression-Free Survival (PFS) Overall Survival (OS) Disease Control Rate (DCR) Incidence and severity of adverse events and adverse drug reactions (CTCAE v5.0) Duration of Response(DoR), Time to Response (TTR) Quality of life（QOL） score
Study Oversight and Funding National Cancer Center Hospital, Japan, is the coordinating sponsor and is responsible for overall trial coordination, data management, monitoring, and analysis.
Merck Sharp \& Dohme LLC provides the investigational product and research funding for the study.
Prespecified translational research program A prespecified translational research program is embedded in the trial. Archival tumor tissue or a pretreatment biopsy is required for enrollment whenever feasible.
Tumor TROP2 and PD-L1 expression will be evaluated centrally by immunohistochemistry. Prespecified subgroup analyses will be conducted according to TROP2 expression status (positive vs. negative) and PD-L1 expression status (positive vs. negative) to explore their associations with clinical outcomes following treatment with sacituzumab tirumotecan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab tirumotecan, Pembrolizumab | Experimental | Drug: Sacituzumab tirumotecan, Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Pathologically diagnosed (histological or cytological examination) as clear cell carcinoma of the ovary, fallopian tube, and peritoneum.
- Have received prior systemic therapy that included at least one platinum-containing combination chemotherapy regimen..
- No active central nervous system (CNS) metastases-including brain metastases, carcinomatous (leptomeningeal) meningitis, or symptomatic spinal metastases that require radiotherapy or surgical intervention.
- No clinically significant pericardial effusion, pleural effusion, or ascites requiring treatment.
- Age ≥18 years at the time of enrollment
Key exclusion criteria (25 listed)
- 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.
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.
- Received a live or live-attenuated vaccine within 30 days before enrollment. Administration of killed vaccines are allowed.
- Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting protocol treatment is 2 weeks.
- Note: A list of strong inhibitors or inducers of CYP3A4 can be found at the Table 19.3.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab tirumotecan, PembrolizumabSacituzumab tirumotecan 4mg/kg will be administered by intravenous infusion every 2 weeks (at 6-week intervals, day1, day15, day29), and pembrolizumab 400mg will be administered by intravenous infusion every 6 weeks and continued until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria are met. | Drug | Sacituzumab tirumotecan, Pembrolizumab |
Primary outcome
Objective Response Rate (ORR) assessed by the central review
Time frame: Baseline up to 3 years. Overall Response is assessed every 8 weeks until 24 weeks after initiation of protocol treatment, and every 12 weeks after 25 weeks and after termination. It continues until PD confirmation or post-study treatment initiation.
10 secondary outcomes
Objective Response Rate (ORR) as assessed by the investigator (site assessment)
Time frame: Baseline up to 3 years. Overall Response is assessed every 8 weeks until 24 weeks after initiation of protocol treatment, and every 12 weeks after 25 weeks and after termination. It continues until PD confirmation or post-study treatment initiation.
Progression-Free Survival (PFS)
Time frame: From baseline up to 3 years
Overall Survival (OS)
Time frame: From baseline up to 3 years
Disease Control Rate (DCR)
Time frame: From baseline up to 3 years
Incidence of adverse events
Time frame: From baseline up to 3 years
Incidence of Adverse Reactions
Time frame: From baseline up to 3 years
Incidence of Serious Adverse Events/ Adverse Reactions
Time frame: From baseline up to 3 years
Duration of Response (DoR)
Time frame: From baseline up to 3 years
Time to Response (TTR)
Time frame: From baseline up to 3 years
Quality of life（QOL） score
Time frame: From baseline up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab tirumotecan, Pembrolizumab in people with Ovarian Clear Cell Carcinoma, run by National Cancer Center, Japan at 4 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kan Yonemori, M.D., Ph.D. (+81-3-3542-2511, kyonemor@ncc.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) assessed by the central review (time frame: Baseline up to 3 years. Overall Response is assessed every 8 weeks until 24 weeks after initiation of protocol treatment, and every 12 weeks after 25 weeks and after termination. It continues until PD confirmation or post-study treatment initiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.