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Cervical CancerPhase 2NCT05838521

A Study of Sacituzumab Govitecan (IMMU-132) in Patients With Recurrent or Persistent Cervical Cancer

A Phase 2 study testing Sacituzumab govitecan in people with Cervical Cancer, run by Yale University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132) in subjects with recurrent or persistent cervical cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Sacituzumab govitecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
2 Jun 2023to 1 Dec 2028
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

  • Patients must have radiologically confirmed (i.e., CAT scan and/or MRI) persistent or recurrent histologically confirmed cervical cancer of epithelial origin who have progressed following at least one prior chemotherapy treatment regimen.
  • Must have availability of archival tumor tissue FFPE block for TROP-2 testing
  • 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 patients must have measurable disease.
  • Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST v1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence following completion of radiation therapy.
  • Patients with measurable recurrent disease of any previous substage (I-IV) are eligible to enrollment.
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  • Patients must have adequate bone marrow function: WBC greater than or equal to 3,000/ul, Platelets greater than or equal to 75,000/ul, Granulocytes greater than or equal to 1500/ul.
  • Patients must have adequate renal function: creatinine less than or equal to 2.0 mg/dL.
  • Patients must have adequate hepatic function: bilirubin ≤ 1.5 institutional upper limit of normal, aspartate aminotransferase [AST], and alanine aminotransferase [ALT] ≤ 2.5 × IULN or ≤ 5 × IULN if known liver metastases
  • Patients must have an ECOG performance status of 0 or 1.
  • Patients must have signed an approved informed consent.
  • Patients must be at least 2 weeks beyond prior treatment (chemotherapy, investigational drugs including small molecular inhibitors, endocrine therapy, immunotherapy and/or radiation therapy) or major surgery.
  • Patients must be at least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < or equal to 20 mg prednisone or equivalent daily are permitted)
  • Patients must have recovered from all acute toxicities to Grade 1 or less from adverse events due to a previously administered agent Note: Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study Note: If patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
  • Patients with recurrent disease may have received no more than 2 prior chemotherapies for treatment of their cervical cancer.
  • Patients may have received prior immunotherapy therapy alone or in combination with chemotherapy. A 4-week washout period is required between prior immunotherapy treatment and first dose of sacituzumab govitecan.
  • Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the study entry and be practicing an effective form of contraception during the study and until conclusion of 12-week post-treatment evaluation period.
  • Patients must be at least 18 years of age.

Who cannot join

  • Patients with a positive serum pregnancy test or women who are breastfeeding.
  • Patients with known hypersensitivity to the study drug, its metabolites, or formulation excipient.
  • Patients who require ongoing therapy with or prior use of any prohibited medication(s) such as UGT1A1 inhibitors.
  • Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
  • Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the patient's participation in the study.
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancers or carcinoma in situ of the cervix, are excluded if there is any evidence of other malignancy being present within the last 5 years.
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  • Patients with a significant history of cardiac disease within 6 months, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure (NYHA classification III-IV) or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring antiarrhythmia therapy.
  • Patients with known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months
  • Patients with any unstable medical issue (including cardiac issues as above, active treatment for symptomatic pulmonary embolism, CVA, renal or hepatic insufficiency, and active infection/sepsis requiring IV antibiotics).
  • Have known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤20 mg/day of prednisone or its equivalent. All patients with carcinomatous meningitis are excluded regardless of clinical stability
  • Patients who have an uncontrolled seizure disorder, or active neurological disease.
  • Have known history of HIV-1 or 2 (or positive HIV-1/2 antibody) with detectable viral load OR taking medications that may interfere with SN-38 metabolism
  • Have active HBV or HCV. In subjects with a history of HBV or HCV, subjects with a detectable viral load will be excluded.
  • Known hemorrhagic diathesis or active bleeding disorder.
  • Patients with Gilbert's disease
  • Presence of bulky disease (defined as any single mass >7 cm in its greatest dimension). Patients with a mass over 7 cm, but otherwise eligible, may be considered for enrollment after discussion and approval with the study PI.
  • Patients with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
  • Prior history of intestinal obstruction within 6 months of initiation of study treatment.
  • Patients with a history of an anaphylactic reaction to irinotecan or ≥ Grade 3 toxicity to prior irinotecan.
  • Have previously received topoisomerase I inhibitors

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alessandro D. Santin, MD contact

203-737-4450

alessandro.santin@yale.edu

Lisa Baker, RN contact

203-785-6398

lisa.baker@yale.edu

United States2 sites, 2 recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Emilie Slanoc, RN, 216-318-8858, SLANOCE@ccf.org

    Recruiting

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut, 06520

    Alessandro D. Santin, M.D, 203-737-4450, alessandro.santin@yale.edu

    Lisa Baker, R.N, 203-785-6398, lisa.baker@yale.edu

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Evaluation of Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2-SN-38 Antibody-drug Conjugate in Patients With Recurrent or Persistent Cervical Cancer

This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132) in subjects with recurrent or persistent cervical cancer.

Read the detailed description

This is an open-label, Phase 2 study designed to assess the clinical activity of sacituzumab govitecan in subjects with recurrent or persistent cervical cancer.

Conditions
Cervical Cancer
Being tested
Sacituzumab govitecan
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • Sacituzumab govitecanDrug

    Also called Trodelvy

    This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132).

Study groups in NCT05838521
Study groupRoleWhat they receive
Sacituzumab GovitecanExperimentalSacituzumab govitecan, 10 mg/kg for the first 2 weeks of 21-day cycle until progression or adverse effects prohibit further treatment.
Receives: Drug: Sacituzumab govitecan

What is being measured

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

  1. Objective Response Rate (ORR)

    Objective response rate (complete response and partial response rates) by RECIST1.1 criteria in patients with recurrent or persistent cervical cancer.

    Measured: 4 Years

Secondary outcomes (4)

  1. Duration of overall survival (OS)

    Overall survival is defined as the duration of time from study entry to death or the date of last contact.

    Measured: 6 Years

  2. Duration of progression free survival (PFS)

    Progression free survival is defined as the duration of time from study entry to time of progression, death, or is censored at date of last disease assessment.

    Measured: 6 Years

  3. Durable disease control rate (DDCR)

    The percentage of patients who have achieved complete response, partial response, and stable disease.

    Measured: 6 Years

  4. Assess the safety profile of sacituzumab govitecan in cervical cancer patients (adverse events as assessed by CTCAE v5.0)

    Incidence of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Measured: 6 Years

Timeline

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

  1. First posted1 May 2023
  2. Study start2 Jun 2023
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2028 (estimated)

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05838521
Sponsor's protocol ID
2000023639
Status last verified
Jul 2026
First submitted
18 Apr 2023
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab govitecan in people with Cervical Cancer, run by Yale University at 2 sites 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 18 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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 Alessandro D. Santin, MD (203-737-4450, alessandro.santin@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 4 Years). 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 NCT05838521.

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 27 Jul 2026.

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