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Study of Sacituzumab Tirumotecan with or without Pembrolizumab for Ovarian Clear Cell Cancer

This study is for women aged 18 and older with ovarian clear cell cancer that has spread (metastatic) or come back (recurrent), and who have already received anti-PD1 therapy. It tests Sacituzumab tirumotecan, a drug that targets cancer cells, either alone or combined with pembrolizumab, a drug that helps your immune system fight cancer. The study aims to see how many patients respond to these treatments (Overall Response Rate). You must have a confirmed diagnosis of pure ovarian clear cell cancer and measurable disease to join. The study is currently recruiting 50 participants.

Study design
This is a randomized study, meaning participants will be assigned by chance to receive either Sacituzumab tirumotecan alone or Sacituzumab tirumotecan with pembrolizumab. It plans to enroll 50 participants.
What's involved
Treatment involves Sacituzumab tirumotecan given on days 1, 15, and 29, and pembrolizumab (if in that arm) on day 1, every 42 days. Treatment can last up to two years, and scans will be done regularly to check for changes.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be monitored until your disease gets worse, you start new cancer treatment, become pregnant, pass away, withdraw from the study, or the study ends, for up to ten years.

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NCT07718854

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

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Tufts Medical Center
~50 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Sacituzumab tirumotecanPembrolizumab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (ORR).
Measured over 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.

Conditions

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

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Ovarian Clear Cell AdenocarcinomaProgrammed Cell Death Protein 1

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Neely Center for Clinical Cancer Research
[email protected]
617-636-5000
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Is not a Person of Child-Bearing Potential (POCBP) OR
Is a POCBP and:
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.
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.
There is a known history of HBV infection
Mandated by local guidelines 16. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
There is a known history of HCV infection
Mandated by local guidelines

What this trial measures

  • Overall Response Rate (ORR).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.

    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