A Phase 2 interventional study of Sacituzumab tirumotecan and Pembrolizumab in Ovarian Clear Cell Carcinoma, Metastatic Ovarian Cancer and Recurrent Ovarian Clear Cell Adenocarcinoma, sponsored by Tufts Medical Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Tufts Medical Center · Phase 2, Interventional, and Treatment
This is a phase II, two-arm, noncomparative screening 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. The regimens will be evaluated separately, and the study is not designed or powered to compare the regimens.
The treatment plan consists of Sacituzumab tirumotecan administered at 4 mg/kg on days 1, 15, and 29 as a single agent (Arm 1) or in combination with pembrolizumab 400mg on day 1 (Arm 2). Each cycle will be 42 days. Treatment is administered for a maximum duration of two years on both arms. The interventions are summarized in Table 1.
To avoid the possibility of inappropriate or excessive accrual, an exact Simon minimax two-stage design will guide each arm. Confirmed responses will be determined by investigator-assessed RECIST 1.1 imaging, with the first tumor assessment at Week 6, followed by assessments every 12 weeks and compared to baseline imaging. Based on the results of BrUOG 354 and given the lack of treatment options following immunotherapy for OCCC, an ORR of 15% or lower will be considered insufficiently active, whereas an ORR of 35% or higher will be considered sufficiently promising to warrant further investigation. Fourteen participants will be enrolled in each arm for the first stage; the anticipated duration of accrual is approximately eighteen months. Given this trial evaluates a rare tumor population where we are evaluating a new regimen, our intent is to minimize the trial duration as feasibly as possible. Consistent with the rare-disease trade-off proposed by Khan, Sarker, and Hackshaw, the design was selected using a maximum one-sided type I error of approximately 0.057 and minimum power of 77%.
Stage 1 While both arms are open and each arm has fewer than 14 treated participants, each eligible participant will receive the next concealed allocation from the 1:1 randomization sequence. A participant who receives any amount of assigned study treatment will count toward the applicable arm's Stage 1 treated-participant target. A participant who is assigned but receives no study treatment will not count toward the target and will be excluded from the treated efficacy population. The participant must nevertheless remain in the study disposition and CONSORT flow diagram.
Across both treatment arms and both stages combined, no more than 8 assigned participants who receive no study treatment may be excluded from the treated efficacy population.
If one arm reaches 14 treated participants before the other, that arm will be closed temporarily and the randomization sequence will be suspended. Subsequent eligible participants will then be assigned nonrandomly to the deficient arm until it reaches 14 treated participants. If a participant assigned during this top-up period receives no treatment, another participant will again be assigned nonrandomly to that arm.
Once both arms contain 14 treated participants, enrollment will pause until the Stage 1 responses have been ascertained and the interim decision has been made separately for each arm. An arm will stop for futility if there are no more than 2 responses among its 14 treated participants and will continue to Stage 2 if there are at least 3 responses.
Stage 2 if both arms continue: The concealed 1:1 randomization sequence will resume at the next unused allocation. Randomization will continue while both arms remain open and each contains fewer than 24 treated participants. If one arm reaches 24 treated participants before the other, that arm will close, the randomization sequence will again be suspended, and subsequent participants will be assigned nonrandomly to the deficient arm until it also contains 24 treated participants.
The final Simon decision will be based on the 24 treated participants in each arm. An arm will be considered promising if there are at least 7 responses and insufficiently active if there are no more than 6 responses.
Stage 2 if only one arm continues: The randomization sequence will not be resumed. All participants entering Stage 2 will be assigned nonrandomly to the continuing arm until 10 additional treated participants have been enrolled in that arm.
3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.
This study's planned enrollment of 50 is close to the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Tufts Medical Center is the lead sponsor of 200 studies on the registry; 28 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 16 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
An individual is eligible for inclusion in the study if the individual meets all of the following criteria:
Type of Participant and Disease Characteristics
Participant is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Agrees to use of a 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) beginning at the time of informed consent, during the study treatment, and for at least 210 days after the last dose of study drug. During this period, the participant agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during this period for the purpose of reproduction.
- 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.
- Medical history, menstrual history, and recent sexual activity have been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.
Informed Consent
-infected participants must have well-controlled HIV on ART, defined as:
a. Having a ≥350 cells/mm3 at the time of screening b. Having achieved and maintained virologic suppression, defined as confirmed HIV RNA level below 50 or the LLOQ using the locally available assay, at the time of screening and for at least 12 weeks before screening.
c. Absence of any AIDS-defining opportunistic infections within the past 12 months d. Being on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before randomization and agreeing to continue ART throughout the study Note: The ART regimen must not contain any antiretroviral medications that are strong inducers/inhibitors/substrates. Refer to 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/substrate of CYP3A4.
HIV testing at screening is not otherwise required.
Participants who are positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization.
Note: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.
Hepatitis B testing at screening is not required unless:
Note: Participants must have completed curative antiviral therapy at least 4 weeks before randomization.
Hepatitis C testing at screening is not required unless:
Exclusion Criteria
An individual must be excluded from the study if the individual meets any of the following criteria:
Medical Conditions 18. 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.
19. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.
20. Is receiving chronic systemic therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of therapy within 7 days prior to the first dose of study drug.
21. Has active disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) 22. History of stem cell/solid organ transplant. Prior/Concomitant Therapy 23. Received prior treatment with a TROP2-targeted ADC. 24. Received prior treatment with a topoisomerase 1 inhibitor-containing ADC. 25. Received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention.
26. 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.
27. Received a live or within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
28. Is currently receiving a strong inducer/inhibitor of that cannot be discontinued for the duration of treatment with study intervention. The required before starting study intervention is 2 weeks.
Prior/Concurrent Clinical Study Experience 29. 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.
30. Has received an agent or has used an investigational device within 4 weeks before the first dose of study intervention.
Diagnostic Assessments 31. Has a known additional that is progressing or has required active treatment within the past 3 years.
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of any organ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded.
Note: Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \<10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.
32. Has and/or carcinomatous meningitis. 33. Has an active infection requiring systemic therapy. 34. Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the individual's ability to cooperate with the requirements of the study, or interfere with the individual's participation for the full duration of the study, such that it is not in the best interest of the individual to participate, in the opinion of the treating investigator.
Other Exclusions 35. Severe (Grades ≥3) to study interventions, any of their , and/or to another biologic therapy.
36. Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary.
Note: Participants who underwent major surgery must have adequately recovered from toxicity and/or complications from the surgery before starting study intervention.
37. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
38. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
Sacituzumab tirumotecan
pembrolizumab
Objective response rate for sacituzumab tirumotecan alone and sacituzumab tirumotecan plus pembrolizumab, defined as the proportion of treated participants with a best overall response of complete response or partial response.
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. Response will be evaluated by the investigator using RECIST 1.1 criteria, confirmed by repeat imaging performed at least 4 weeks after the initial documentation of response. 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
Time frame: 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.
Clinical benefit rate (Response+Stable disease at 6 months)
Clinical benefit rate is determined by confirmed resopnse or stable disease maintained for at least 6 months. 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
Time frame: 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)
All AEs, SAEs, and other reportable safety events that occur after the participant provides documented informed consent, but before intervention randomization, must be reported by the investigator if the participant is receiving placebo run-in or other run-in treatment, if the event causes the participant to be excluded from the study, or is the result of a protocol-specified intervention, including, but not limited to washout or discontinuation of usual therapy, diet, or a procedure. * All AEs (including those meeting serious criteria) from the time of intervention randomization through 90 days after cessation of study intervention must be reported by the investigator. * Pregnancies (as described in protocol section 8.4.1) * Any SAE brought to the attention of an investigator at any time outside the time specified above must be reported immediately to the Sponsor/Principal Investigator if the event is considered related to study intervention.
Time frame: Safety information will be collected according to protocol guidelines from the time of patient signing of informed consent or treatment randomization (as applicable) through 90 days after cessation of study intervention or until resolution.
Progression-Free Survival (Time to progression of disease)
Disease progression event will be defined as progressive disease according to investigator RECIST 1.1 assessment or death. 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
Time frame: 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 from any cause)
Participant survival follow-up status will be assessed approximately every 12 weeks to assess for survival status until death, withdrawal of consent, or the end of the study, whichever occurs first. The first survival follow-up assessment should be scheduled as described below: * For participants who discontinue treatment intervention and who will not enter Efficacy Follow-up, the first survival follow-up contact will be scheduled 12 weeks after the Discontinuation Visit and/or Safety Follow-up Visit (whichever is last). * For participants who completed assessments in Efficacy Follow-up, the first survival follow-up contact will be scheduled 12 weeks after the last efficacy assessment follow-up visit has been performed.
Time frame: 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.
Started Sep 2026 (actual). Primary completion is estimated for Sep 2036, 120 months after the start.
Of 228 non-industry phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 80. This study's planned 120 months is above that.
Counting every sponsor, half of 344 studies reached it within 47 months; a quarter within 33 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Sacituzumab tirumotecan