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Monoclonal Antibodies

Sacituzumab Govitecan + Enfortumab Vedotin for Bladder Cancer

Phase 1

Waitlist Available

Led By Guru P Sonpavde, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have received prior treatment with platinum containing therapy defined as within the adjuvant/neoadjuvant setting with recurrent or progressive disease within 12 months or receiving treatment with platinum in locally advanced or metastatic setting.

ECOG performance status 0-1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 days

Awards & highlights

Study Summary

This trial will study what doses of these drugs can be safely combined and given to people with mUC.

Who is the study for?

Adults with advanced urothelial carcinoma who've had platinum-based therapy and a checkpoint inhibitor treatment can join. They must have good organ function, no active infections or serious heart conditions, not be pregnant or breastfeeding, and agree to use contraception.Check my eligibility

What is being tested?

The trial is testing the safe combination doses of two drugs: Sacituzumab Govitecan (SG) and Enfortumab Vedotin (EV), for treating metastatic urothelial carcinoma. It aims to find out how these drugs work together.See study design

What are the potential side effects?

Potential side effects include allergic reactions to drug components, liver issues reflected in blood tests, possible impact on fertility and pregnancy outcomes, fatigue from anemia due to low red blood cells count.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had platinum-based treatment for cancer that came back or worsened within a year.

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I am fully active or can carry out light work.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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My cancer can be measured on scans and has grown in previously treated areas.

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I am using two birth control methods or am not having sex if I can have children.

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My cancer is mainly urothelial carcinoma but may have other cell types, except small-cell carcinoma.

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My cancer cannot be removed with surgery.

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My blood and organ functions are within the required ranges for the trial.

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I am 18 years old or older.

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My hepatitis B virus load is undetectable with treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting toxicity (DLT) of Sacituzumab Govitecan (SG) and Enfortumab Vedotin in combination

Maximum Tolerated Dose (MTD) of Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) in Combination

Secondary outcome measures

Objective response rate (ORR)

Overall survival (OS) Rate

Rate of Complete Responses (CR)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV),Experimental Treatment2 Interventions

Participants will be given the study drugs Enfortumab Vedotin and then Sacituzumab Govitecan on Days 1 and 8 of a 21-day study cycle. Dose escalation and de-escalation for the Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) combination will be guided using the Bayesian optimal interval (BOIN) design with up to 4 dose level escalations.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor

1,082 Previous Clinical Trials

842,817 Total Patients Enrolled

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,848 Total Patients Enrolled

Guru P Sonpavde, MDPrincipal InvestigatorDana-Farber Cancer Institute

1 Previous Clinical Trials

12 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on the number of participants in this medical trial?

"Affirmative. Data available on clinicaltrials.gov proves that the trial, which was first posted on May 20th 2021, is recruiting participants at this time. 24 patients will be accepted from one medical facility for enrolment into the study."

Answered by AI

What indications is Sacituzumab Govitecan (SG) typically used for?

"Sacituzumab Govitecan (SG) is typically utilized to treat locally advanced urothelial cancer. In addition, this drug can be prescribed following a platinum based therapy or therapeutic procedure and it may also assist patients with metastatic urothelial cancer."

Answered by AI

Has a similar research experiment been conducted in the past?

"At present, Sacituzumab Govitecan (SG) is being investigated in 49 live studies across 689 cities and 46 nations. Seagen Inc. began trialling SG back in 2014 with a cohort of 213 patients; the Phase 1 drug approval was successfully completed at that time. In the 6 years since then, 4 more trials have been realised to completion."

Answered by AI

Is Sacituzumab Govitecan (SG) a risk-free therapy for humans?

"The team at Power judged the safety of Sacituzumab Govitecan (SG) to be 1 out of 3 due to its Phase 1 status, indicating limited clinical data supporting both efficacy and security."

Answered by AI

What aims is this research endeavor attempting to accomplish?

"This clinical study, which will be overseen for a period of 21 days, aims to determine the dose-limiting toxicity (DLT) associated with Sacituzumab Govitecan (SG) and Enfortumab Vedotin in combination. The secondary objectives include assessing objective response rate using Response Evaluation Criteria in Solid Tumors Version 1.1, measuring complete responses through Response Evaluation Criteria in Solid Tumors Version 1.1, and ascertaining the proportion of patients displaying signs of progressive disease as per Response Evaluation Criteria in Solid Tumors Version 1.1 criteria."

Answered by AI

Are there any vacancies for enrolment in this research study?

"Affirmative. According to clinicaltrials.gov, the trial initially posted on May 20th 2021 is currently searching for 24 participants from a single centre of care. The details were last modified September 28th 2022."

Answered by AI

Are there any precedential experiments involving Sacituzumab Govitecan (SG)?

"At present, 49 clinical trials are underway to assess the efficacy of Sacituzumab Govitecan (SG). Of those studies, 11 are in Phase 3. Generally speaking, most research is taking place in Boston; however, 2709 sites across the US have opened their doors for these investigations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sacituzumab Govitecan Plus EV in Metastatic UC

Bradley A. McGregor, MD 2021. "Sacituzumab Govitecan Plus EV in Metastatic UC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04724018.

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