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Recurrent Platinum Resistant Epithelial Ovarian CarcinomaPhase 2NCT06865677

Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

A Phase 2 study testing Sacituzumab Govitecan, EKG and Brain MRI in people with Recurrent Platinum Resistant Epithelial Ovarian Carcinoma and Recurrent Epithelial Endometrial Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Background: Cancers of the female reproductive organs often come back after treatment. A drug called sacituzumab govitecan (SG) has been approved for use in other types of cancers. Researchers want to see if SG can also help people with ovarian, endometrial, or cervical cancers. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
What is being tested?
Sacituzumab Govitecan, EKG and Brain MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
9 Jun 2025to 1 Jul 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cohort 1 (Ovarian Cancer)
  • Participants must have histologically or cytologically confirmed recurrent platinum-resistant (defined as less than six months of platinum-free interval) epithelial (i.e., high grade serous, endometrioid, low grade serous, or clear cell) ovarian carcinoma that is refractory to standard treatment.
  • Participants with known BReast CAncer gene (BRCA) mutated tumors should have received a poly(ADP-ribose) polymerase (PARP) inhibitor maintenance or treatment.
  • Participants without known BRCA mutation and platinum-resistant tumors must have had prior bevacizumab or not eligible for bevacizumab-based therapy (i.e., history of proteinuria).
  • Cohort 2 (Endometrial Cancer)
  • Participants must have histologically or cytologically confirmed recurrent epithelial (i.e., endometrioid or serous) endometrial carcinoma that is refractory to standard treatment.
Show all 36Show fewer
  • Participants must have received prior anti-programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1)-based therapy or not eligible for anti-PD-1/PD-L1-based therapy.
  • Cohort 3 (Cervical Cancer)
  • -Participants must have histologically or cytologically confirmed recurrent epithelial cervical (i.e. squamous or adeno) carcinoma that is refractory to standard treatment.
  • Note: Participants with a history of human papilloma virus infection (i.e., positive human papillomavirus (HPV deoxyribonucleic acid (DNA testing) are eligible.
  • -Participants must have received prior bevacizumab-based therapy or not eligible for bevacizumab-based therapy (i.e., history of proteinuria).
  • Note: Platinum chemotherapy administered concurrent with primary radiation (i.e., weekly cisplatin) is not counted as a systemic chemotherapeutic regimen for management of persistent or recurrent carcinoma of the cervix.
  • All Cohorts
  • Participants must have received at least two systemic therapies including at least one platinum-based therapy regimen.
  • Participants must have radiographically measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and safely biopsiable lesion.
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status <= 1
  • Adequate organ and marrow function as defined below:
  • Hemoglobin (Hgb) >= 9.0 g/dL
  • Absolute neutrophil count (ANC) >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • White Blood Cell count (WBC) >= 3,000/mcL
  • Total bilirubin <= 1.5 x upper limit of normal (ULN) (<= 3 x ULN in participants with known/suspected Gilbert's disease)
  • Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) <= 2.5 x ULN
  • Serum creatinine <= 1.5 x ULN or estimated glomerular filtration rate (GFR) >= 30 ml/min/1.73 m^2
  • Participants with suspicion or prior history of treated central nervous system (CNS) metastases with no evidence of active disease (assessed by magnetic resonance imaging (MRI) or contrast computed tomography (CT) scan of the brain and spinal column) are eligible if pretreatment brain MRI demonstrate no evidence of disease in the past 4 weeks prior to entry.
  • Major surgical procedure, other than for diagnosis, must not occur within 4 weeks prior to the first dose of study treatment. Participants must have recovered adequately from the toxicity and/or complications from the intervention prior to starting the study drug.
  • Participants with prior cancer-directed therapy must have a washout period of 3 weeks prior to the first dose of study treatment.
  • Participants with prior cancer-directed immunotherapy-based therapy must have a washout period of 4 weeks prior to the first dose of study treatment.
  • Human immunodeficiency virus (HIV)-infected participants are eligible if on stable dose of highly active antiretroviral therapy (HAART), a cluster of differentiation 4 (CD4) count >= 200 cells/mcL, and an undetectable viral load (VL).
  • Hepatitis B virus (HBV) positive participants are eligible if they have been treated or are on an appropriate course of antivirals at study entry.
  • Participants with a history of hepatitis C virus (HCV) infection (i.e., positive HCV antibody test) must have been treated and cured (undetectable HCV VL at screening). Participants with HCV infection who are currently on treatment are eligible if they have an undetectable HCV VL.
  • Individuals of child-bearing potential (IOCBP) must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) prior to study entry, for the duration of study participation, and for at least 6 months after the last dose of study drug.
  • IOCBP must undergo pregnancy testing at screening and must not be pregnant in order to take part. Note: In these cases, a negative Beta-human chorionic gonadotropin (Beta-human chorionic gonadotropin (hCG) (urine or blood) is required.
  • Nursing participants must discontinue nursing and/or not begin nursing until 1 month after the last dose of study drug.
  • Ability of participants to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Participants who are receiving any other investigational agents
  • Primary platinum-refractory ovarian cancer (defined as progression while on the upfront platinum-based therapy)
  • Participants with any other concomitant invasive malignancies
  • History of severe hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to sacituzumab govitecan (SG), Camptosar; irinotecan; 7-ethyl-10-{4-[1-piperidino]-1-piperidino}carbonyoxycamptothecin (SN-38), or irinotecan.
  • Prior treatment with trophoblast cell-surface marker (TROP2)-targeting antibody drug conjugates (ADC). Participants with prior use of other ADCs are eligible.
  • Prior treatment with topoisomerase 1 inhibitors i.e., topotecan
Show all 17Show fewer
  • Symptomatic or untreated brain/central nervous system (CNS) metastases
  • Participants who require treatment with uridine diphosphate glucuronosyltransferase (UGT1A1) inhibitors.
  • Participants with known homozygous UGT1A1*28 allele if tested during the previous treatment.
  • Participants with active infection requiring antibiotics.
  • Participants who have not recovered from toxicities or adverse events (AE) related to prior therapy to Grade <= 1 with the following exceptions.
  • Participants with platinum related hypomagnesemia (on replacement) are eligible.
  • Participants with auto-immune thyroid dysfunction on stable replacement therapy are eligible.
  • Participants with any grade alopecia or grade 1 or 2 neuropathy are eligible.
  • Participants with a history of gastrointestinal (GI) perforation or hemorrhage (> 30mL bleeding/episode) fistula or hemoptysis within 3 months prior to initiation of study therapy, intra-abdominal abscess in the 6 months prior to entry, history of ascites or pleural effusion requiring paracentesis or thoracentesis in the 4 weeks prior to initiation of study therapy or history of bowel obstruction within 3 months prior to initiation of study therapy.
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during SG treatment or within 5 months after the final dose of SG. Note: Seasonal flu vaccines that do not contain a live virus and locally authorized/approved Coronavirus disease 2019 (COVID-19) vaccines are permitted
  • Participants with severe uncontrolled intercurrent illness that would limit compliance with study requirements, evaluated by history, physical exam, and chemistry panel.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Phase II Pilot Study of Sacituzumab Govitecan for Relapsed Ovarian, Endometrial, and Cervical Carcinomas

Background:

Cancers of the female reproductive organs often come back after treatment. A drug called sacituzumab govitecan (SG) has been approved for use in other types of cancers. Researchers want to see if SG can also help people with ovarian, endometrial, or cervical cancers.

Read more

Objective:

To test SG in people with ovarian, endometrial, or cervical cancers.

Eligibility:

People aged 18 years and older with ovarian, endometrial, or cervical cancer. Their cancers must have returned after at least 2 rounds of standard treatments.

Design:

Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and a test of their heart function. They also will have biopsies to get new tissues samples taken from their tumors.

SG is infused through a tube attached to a needle inserted into a vein in the arm. Treatment will be given in 21-day cycles. Participants will receive SG on days 1 and 8 of each cycle. Each infusion takes 1 to 3 hours.

Participants may receive SG for up to 5 years. They can continue as long as the drug is helping them. Imaging scans and other tests will be repeated throughout the study period.

Participants will have an end-of-treatment visit within 2 weeks and a safety visit about 30 days after they stop treatment. Physical exams, blood tests, and imaging scans may be repeated.

Participants will then be contacted by phone every 6 months for up to 10 years after their first dose of SG.

Sponsoring Institution:

National Cancer Institute...

Read the detailed description

Background:

  • Human trophoblast cell-surface marker (TROP2) is a surface glycoprotein originally identified in human placental tissue and highly expressed in gynecologic malignancies. TROP2 overexpression in ovarian, endometrial, and cervical cancers is linked to tumorigenicity and poor overall survival.
  • Sacituzumab govitecan (SG) is an antibody-drug conjugate (ADC) of an Immunoglobulin G (IgG(kappa)1 monoclonal antibody targeting TROP2 with a chemotherapeutic payload of SN-38. SN-38 is an active metabolite of irinotecan and acts as a topoisomerase I inhibitor.
  • Preclinical data suggest that SG induces deoxyribonucleic acid (DNA) damage, replication stress, and tumor shrinkage in drug-resistant ovarian, endometrial, and cervical cancer in vitro and in vivo preclinical models.
  • Further clinical and translational studies are needed to better understand SGs clinical activity and biology in relapsed gynecologic cancer patients.

Objective:

-To determine the objective response rate (ORR) of sacituzumab govitecan (SG) in participants with recurrent gynecological malignancies, calculated for each individual tumor histology by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Eligibility:

  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status <= 1
  • Histologically documented, recurrent platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancer (referred to as ovarian cancer); recurrent endometrioid or serous endometrial cancer; or recurrent epithelial cervical cancer
  • At least two prior systemic therapeutic regimens
  • Measurable disease by RECIST v1.1 criteria with lesions that can be safely biopsied
  • No prior TROP2-targeting antibody drug conjugates (ADC)

Design:

  • This is an open label, non-randomized Phase II pilot study with one Arm.
  • SG will be administered intravenously (IV) at 10 mg/kg on Days 1 and 8 each 21-day cycle.
  • Tumor assessments will be time-based: every 9 weeks (+/- 1 week) for the first year and every 12 weeks (+/- 1 week) thereafter until disease progression. Pre-treatment biopsies and serial blood samples will be collected for the correlative studies.
  • Treatment will be given for a maximum of 5 years or until disease progression or unacceptable toxicities.
  • Up to 66 evaluable participants will be enrolled.
Being tested
Sacituzumab Govitecan, EKG, Brain MRI, CT scans, Tumor biopsy
Keywords
TROP2, ADC, Gynecologic Malignancies, Relapsed
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab GovitecanDrug

    Also called Trodelvy

    10mg/kg administered intravenous (IV) infusion on days 1 and 8 of each 21-day cycle.

  • EKGDiagnostic test

    Also called Electrocardiogram

    Screening.

  • Brain MRIDiagnostic test

    Also called Brain magnetic resonance imaging

    Screening. Baseline/Cycle 1 Day 1 (within 14 (+3) days.

  • CT scansDiagnostic test

    Also called Computed tomography scans

    Screening. Baseline/Cycle 1 Day 1 (within 14 (+3) days. Subsequent cycle 3 every 3 cycles ±7 days for the first year and then every 4 cycles ±7 days until progressive disease or up to 5 years. End of treatment assessments +14 days.

  • Tumor biopsyProcedure or surgery

    Also called Tumor bx

    Baseline/Cycle 1 Day 1≤10 days. End of treatment assessments +14 days (optional).

  • LoperamideDrug

    Also called Immodium

    For diarrhea. 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily.

  • OctreotideDrug

    Also called Sandostatin, Bynfezia, Mycapssa

    For diarrhea. 100-150 mcg subcutaneous (SC) three times a day if diarrhea persists.

  • Diphenoxylate/AtropineDrug

    Also called Lomotil

    For diarrhea. 20 mg of diphenoxylate/atropine (Lomotil) administered according to package insert guidelines.

  • AntiemeticsDrug

    For vomiting as clinically indicated.

Study groups in NCT06865677
Study groupRoleWhat they receive
Arm 1 -Treatment with Sacituzumab Govitecan (SG)ExperimentalTreatment with Sacituzumab Govitecan (SG).
Receives: Drug: Sacituzumab Govitecan; Diagnostic Test: EKG; Diagnostic Test: Brain MRI; Diagnostic Test: CT scans; Procedure: Tumor biopsy; Drug: Loperamide; Drug: Octreotide; Drug: Diphenoxylate/Atropine; Drug: Antiemetics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (Partial Response or Complete Response) of Sacituzumab Govitecan in Participants With Recurrent Gynecological Malignancies, Calculated for Each Individual Tumor Histology by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Overall Response Rate (the fraction of Partial Response (PR) or Complete Response (CR) will be calculated along with a 95% confidence interval for each cohort. The proportion of participants who achieve a response will be reported separately for each cohort, along with 95% confidence intervals (Clopper-Pearson). Response was assessed by the RECIST v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to 22 days.

Secondary outcomes (4)

  1. Median Duration of Response (DOR) of Sacituzumab Govitecan (SG)

    Duration of response (DOR) will be calculated by the Kaplan-Meier method, starting at date response was identified until progression or the response is declared to have ended, if the participants have a PR or CR. The median DOR will be reported along with a 95% confidence interval by cohort. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

    Measured: Up to 22 days.

  2. Overall Survival of Participants Receiving Sacituzumab Govitecan (SG)

    Overall Survival (OS) will be calculated from on-study date until date of 10-year follow-up, using the Kaplan-Meier method by cohort. The ten-year OS rate, which is the percentage of people in a study or treatment group who are alive ten years after their initiation of the study treatment. The median OS will be reported along with a 95% confidence interval by cohort.

    Measured: Up to 22 days.

  3. Progression Free Survival (PFS) of Participants Receiving Sacituzumab Govitecan (SG)

    Progression Free Survival (PFS) will be calculated from on-study date until date of progression or death without progression, using the Kaplan-Meier method by cohort. The median PFS will be reported along with a 95% confidence interval by cohort. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

    Measured: Up to 22 days.

  4. Adverse Events (AE) Per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, by Type and Grade of Toxicity

    Safety will be reported by describing adverse events (AE) per CTCAE v5.0, by type and grade of toxicity. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.

    Measured: Up to 22 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2025
  2. Study start9 Jun 2025
  3. Primary completion1 Jul 2025
  4. Study completion1 Jul 2025

Why it stopped: This protocol was terminated prematurely because the prior principal investigator departed the Institute without treating any participants.

Resources

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
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06865677
Sponsor's protocol ID
10002068
Other IDs
002068-C
Status last verified
Jan 2026
First submitted
7 Mar 2025
Last updated
21 Jan 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: This study will comply with the National Institutes of Health (NIH) Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the intramural research program (IRP), as of January 25, 2023, that is associated with an investigator-initiated intramural research program (ZIA), with a clinical protocol that undergoes scientific review and/or will involve genomic data sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab Govitecan, EKG and Brain MRI in people with Recurrent Platinum Resistant Epithelial Ovarian Carcinoma and Recurrent Epithelial Endometrial Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.

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 36 inclusion and 17 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: stopped early, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (Partial Response or Complete Response) of Sacituzumab Govitecan in Participants With Recurrent Gynecological Malignancies, Calculated for Each Individual Tumor Histology by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: Up to 22 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06865677.

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 21 Jan 2026.

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