Sacituzumab Govitecan for Cervical Cancer

Overseen By Lisa Baker, RN

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Yale University

Must not be taking: UGT1A1 inhibitors

Disqualifiers: Pregnancy, Cardiac disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Until progression or adverse effects

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called sacituzumab govitecan for individuals with cervical cancer that has returned or persists. The main goal is to determine if this drug can manage symptoms and improve conditions for those who have already undergone other chemotherapy treatments. This trial may suit someone whose cervical cancer did not respond to previous chemotherapy and who has at least one measurable tumor. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you must be at least 2 weeks beyond prior treatments like chemotherapy, investigational drugs, or high-dose corticosteroids, and a 4-week washout period is required after prior immunotherapy.

Is there any evidence suggesting that sacituzumab govitecan is likely to be safe for humans?

Studies have shown that sacituzumab govitecan is generally well-tolerated by patients with recurring cervical cancer. One study found that patients experienced manageable side effects during treatment. Another study reported that while some patients had side effects, these were not severe enough to discontinue treatment for most. The FDA has also approved sacituzumab govitecan for another type of cancer, indicating a well-understood safety profile. Overall, early research suggests the treatment is safe, though patients may experience some side effects, as with any medication. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Sacituzumab govitecan is unique because it combines an antibody with a chemotherapy drug, targeting cancer cells more precisely. Most treatments for cervical cancer, like chemotherapy and radiation, broadly attack both healthy and cancerous cells, leading to significant side effects. Researchers are excited because sacituzumab govitecan aims directly at the cancer cells, potentially reducing collateral damage to healthy cells and offering a more targeted approach. This could mean fewer side effects and a more efficient attack on the cancer itself.

What evidence suggests that sacituzumab govitecan might be an effective treatment for cervical cancer?

Research has shown that sacituzumab govitecan, the treatment under study in this trial, effectively treats patients with recurring cervical cancer. It delivers chemotherapy directly to the tumor, helping to kill cancer cells. In studies, many patients experienced tumor shrinkage, and some saw their cancer stop growing. Most people manage the treatment's side effects without major issues. These positive results make sacituzumab govitecan a promising option for those with ongoing cervical cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Alessandro Santin

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults with recurrent or persistent cervical cancer who have had at least one chemotherapy regimen. They must not be pregnant, breastfeeding, or have other invasive cancers in the last 5 years. Participants need functioning major organs and controlled health conditions without significant heart disease, infections, or uncontrolled hypertension.

Inclusion Criteria

I have had at most 2 chemotherapy treatments for my cervical cancer.

I can provide a sample of my tumor for testing.

My cervical cancer has returned or persisted after at least one chemotherapy treatment.

Exclusion Criteria

Patients with Gilbert's disease

I have not had an intestinal blockage in the last 6 months.

I have been treated with topoisomerase I inhibitors before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sacituzumab govitecan, 10 mg/kg for the first 2 weeks of a 21-day cycle until progression or adverse effects prohibit further treatment

Until progression or adverse effects

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 years

What Are the Treatments Tested in This Trial?

Interventions

• Sacituzumab Govitecan

Trial Overview The study tests Sacituzumab Govitecan (IMMU-132) on patients with cervical cancer that has come back or hasn't gone away after treatment. It's a Phase 2 trial where all participants receive the drug; there's no comparison group.

How Is the Trial Designed?

Group I: Sacituzumab Govitecan Experimental Treatment 1 Intervention

Sacituzumab govitecan, 10 mg/kg for the first 2 weeks of 21-day cycle until progression or adverse effects prohibit further treatment.

Sacituzumab Govitecan is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Trodelvy for:

• Metastatic triple-negative breast cancer
• Locally advanced or metastatic urothelial cancer (withdrawn)
• Metastatic HR+/HER2- breast cancer

Approved in European Union as Trodelvy for:

• Metastatic triple-negative breast cancer

Approved in Canada as Trodelvy for:

• Metastatic triple-negative breast cancer

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Alessandro Santin

Lead Sponsor

Trials

4

Recruited

140+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Published Research Related to This Trial

Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2 and has shown a 33.3% overall response rate in patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies, based on a phase I/II study with 108 participants.

The treatment has a median duration of response of 7.7 months, and while it is generally well-tolerated, common side effects include nausea, neutropenia, and fatigue, indicating a need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. Seligson, JM., Patron, AM., Berger, MJ., et al.[2021]

Sacituzumab govitecan (TRODELVY) is an effective treatment for metastatic triple-negative breast cancer, showing promising results in a phase I/II study and receiving accelerated FDA approval for patients who have undergone at least two prior therapies.

The drug has a well-defined and manageable toxicity profile, and proactive management of adverse events is crucial for optimizing treatment duration and maintaining patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan for Metastatic Triple-Negative Breast Cancer: Clinical Overview and Management of Potential Toxicities. Spring, LM., Nakajima, E., Hutchinson, J., et al.[2021]

Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2 and delivers a topoisomerase I inhibitor, showing promise in treating metastatic triple-negative breast cancer (mTNBC) after at least two prior therapies.

In April 2020, it received accelerated approval in the USA for mTNBC, and it is currently undergoing further clinical trials for various cancers, indicating its potential as a versatile treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacituzumab Govitecan: First Approval. Syed, YY.[2021]

Sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2, showed promising therapeutic activity in a phase I trial with 25 patients suffering from various metastatic solid cancers, achieving partial responses in two patients and stable disease in 16 others.

The maximum tolerated dose was determined to be 12 mg/kg for the first cycle, with lower doses (8 and 10 mg/kg) being safer for extended treatment, leading to acceptable toxicity levels and disease control for up to 36 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. Starodub, AN., Ocean, AJ., Shah, MA., et al.[2022]

Sacituzumab govitecan (SG) demonstrated effectiveness in treating relapsed or refractory metastatic triple-negative breast cancer (RM-TNBC), with a median overall survival of 12.9 months and an objective response rate of 34% based on an analysis of 412 patients across three trials.

The treatment was associated with significant adverse effects, particularly myelosuppression, with 46% of patients experiencing grade ≥3 neutropenia, and there were four treatment-related deaths reported, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrated analysis of Sacituzumab govitecan in relapsed or refractory metastatic triple-negative breast cancer. Cheng, SX., Chen, QC., Lin, GH., et al.[2023]

Sacituzumab govitecan (SG) is an effective treatment for locally advanced and metastatic urothelial cancer, showing a 27% objective response rate in the TROPHY-U-01 phase II trial.

While SG has common side effects like diarrhea and neutropenia, these can be managed with supportive care, and it has received accelerated approval for patients who have previously undergone platinum-based chemotherapy and PD-1 or PD-L1 inhibitor treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and emerging role of sacituzumab govitecan in the management of urothelial carcinoma. Mathew Thomas, V., Tripathi, N., Agarwal, N., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05838521

NCT05838521 | A Study of Sacituzumab Govitecan (IMMU- ... 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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01631552

Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults ... The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day ...

3. targetedonc.com targetedonc.com/view/sacituzumab-govitecan-shows-antitumor-activity-in-metastatic-cervical-cancer

Sacituzumab Govitecan Shows Antitumor Activity in ... New trial results reveal sacituzumab govitecan shows significant antitumor activity in recurrent cervical cancer, especially in heavily ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0923753421008838

Sacituzumab govitecan, a Trop-2-directed antibody-drug ... This report summarizes the safety data from the overall safety population (OSP) and efficacy data, including additional disease cohorts not published previously ...

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2020/761115Orig1s000MultidisciplineR.pdf

761115Orig1s000 - accessdata.fda.gov evidence of effectiveness. The effectiveness of sacituzumab govitecan (IMMU-132) was demonstrated in study IMMU-132-01, single-arm trial. An overall response ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825825009965

Sacituzumab govitecan in Chinese patients with recurrent ... In the interim analysis of 18 patients, SG showed promising efficacy and manageable safety in patients with recurrent/metastatic cervical cancer who had ...