Sacituzumab Tirumotecan +/- Pembrolizumab in I/O Exposed Metastatic or Recurrent Ovarian Clear Cell Cancer

NCT07718854 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Sacituzumab-OCCC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II randomized study of Sacituzumab tirumotecan, an intravenous antibody-drug conjugate (ADC) that targets Trop-1, administered alone or in combination with pembrolizumab, a monoclonal antibody to PD-1 in patients with relapsed clear cell cancers that originated in the ovary, fallopian tube or peritoneal cavity, inclusive of endometriosis (collectively referred to as OCCC throughout the protocol) after previous treatment with anti-PD1 therapy.

Conditions

Ovarian Clear Cell Carcinoma; Metastatic Ovarian Cancer; Recurrent Ovarian Clear Cell Adenocarcinoma

Keywords

clear cell carcinoma; ovarian; Sacituzumab; MK2870; pembrolizumab

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR).

  Responses will be confirmed by serial imaging (CT or MRI), conducted at least 4 weeks apart. Initial tumor scans at Screening must be performed within 28 days before randomization. The first on-study scan should be performed 6 weeks (42 days+7 days) from the date of randomization. Subsequent tumor scans should be performed every 12 weeks (84 days±7 days) or more frequently if clinically indicated for the first two years of treatment (Week 104). After Week 104 (±7 days), tumor scans should be performed every 16 weeks (112 days±7 days) until documentation of disease progression. Scans are to be performed until disease progression is identified by the investigator or until any of these conditions are met: * start of a new anticancer therapy * pregnancy * death * withdrawal of consent * the end of the study

  First scan collected within 28 days prior to randomization, then according to the schedule above until disease progression, new anticancer therapy, pregnancy, death, withdrawal of consent, or the end of the study, whichever occurs first, up to ten years.

Secondary Outcomes (4)

• Clinical benefit rate (Response+Stable disease at 6 months)

  Baseline imaging assessment will be collected within 28 days before randomization. All scans obtained thereafter through the first six months after randomization.

• Toxicity of Treatment (Adverse Events)

  Safety information will be collected according to protocol guidellines from the time of patient signing of informed consent through 90 days after cessation of study intervention or until resolution.

• Progression-Free Survival (Time to progression of disease)

  First scan collected within 28 days prior to randomization, then according to the schedule above until disease progression, new anticancer therapy, pregnancy, death, withdrawal of consent, or the end of the study, whichever occurs first, up to ten years.

• Overall Survival (Time to Death)

  Survival status will be assessed beginning after the discontinuation, safety follow-up or final efficacy follow-up visit, approximately every 12 weeks until death, withdrawal of consent, or the end of the study, whichever occurs first, up to 10 years.

Study Arms (2)

Sacituzumab tirumotecan + Pembrolizumab

EXPERIMENTAL

Sacituzumab tirumotecan will be administered at a dose of 4 mg/kg by IV infusion on Days 1, 15, and 29 of each 42-day (6 week) cycle. Pembrolizumab is administered at a dose of 400 mg by IV infusion on Day 1 of each 42-Day cycle. Pembrolizumab is administered prior to premedications for - and infusion of - Sacituzumab.

Drug: Sacituzumab tirumotecan; Drug: Pembrolizumab

Sacituzumab tirumotecan

EXPERIMENTAL

Sacituzumab tirumotecan will be administered at a dose of 4 mg/kg by IV infusion on Days 1, 15, and 29 of each 42-day (6 week) cycle.

Drug: Sacituzumab tirumotecan

Interventions

Sacituzumab tirumotecan DRUG

Sacituzumab tirumotecan

Sacituzumab tirumotecan; Sacituzumab tirumotecan + Pembrolizumab

Pembrolizumab DRUG

pembrolizumab

Sacituzumab tirumotecan + Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type of Participant and Disease Characteristics
• Has a histologically-confirmed diagnosis of pure OCCC. Patients with mixed histologies that include a clear cell component will not be eligible for this trial.
• Has measurable disease per RECIST 1.1 as assessed by the local site investigator/ radiology. Lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions.
• Patients must have received at least one prior platinum and taxane based chemotherapy regimen. Radiation therapy (including the use of chemotherapy as a radiosensitizer) will not count as a prior systemic regimen.
• Participants with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• ECOG performance status 0-1
• Is an individual of assigned female sex at birth and is at least 18 years of age at the time of providing the informed consent.
• Participant is not pregnant or breastfeeding, and at least one of the following conditions applies:
• Is not a Person of Child-Bearing Potential (POCBP) OR
• Is a POCBP and:
• \- Agrees to use of 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 5 during the intervention period 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 Sacituzumab tirumotecan is 210 days.
• ◦ sacituzumab tirumotecan: 210 days
• \- The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.
• Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are in Section 8.3.5.
• Abstains from breastfeeding during the study intervention period and for at least 10 days after study intervention.

You may not qualify if:

• Medical Conditions
• 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.
• 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 first dose of study drug.
• Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)
• History of stem cell/solid organ transplant. Prior/Concomitant Therapy
• Received prior treatment with a TROP2-targeted ADC.
• Received prior treatment with a topoisomerase 1 inhibitor-containing ADC.
• Received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention.
• Received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and/or has radiation pneumonitis.
• Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
• Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
• Refer to Section 6.2 for information on COVID-19 vaccines.
• 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 study intervention is 2 weeks.
• Note: A list of strong inducers/inhibitors of CYP3A4 can be found at the following website: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally-approved label for all concomitant therapy to ensure it is not a strong inducer/inhibitor of CYP3A4.

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Adenocarcinoma, Clear Cell

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Neely Center for Clinical Cancer Research

CONTACT

617-636-5000; TMNCCCR@tuftsmedicine.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: July 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): March 1, 2032
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

US (1)