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SG + Radiation Therapy for Bladder Cancer

Phase 1

Recruiting

Led By Omar Mian, MD, PhD

Research Sponsored by Omar Mian

Eligibility Criteria Checklist

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

Must have

Performance status: ECOG Performance status ≤ 2

Participants must have histologically or cytologically confirmed muscle-invasive bladder cancer (MIBC) (T2-T4aN0M0). Participants with mixed urothelial carcinoma will be eligible for the trial, except for small cell or neuroendocrine component

Must not have

Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Has limited bladder function as noted by a provider, with frequency of small amounts of urine, urinary incontinence including stress/urge, requires self-catheterization or a permanent indwelling catheter.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial explores the safety and tolerability of a drug (SG) combined with radiation therapy to help treat localized bladder cancer. Patients receive SG for 3 cycles during 8 weeks of treatment, then monitored for up to 5 years.

Who is the study for?

This trial is for adults with muscle-invasive bladder cancer (MIBC) that's not spread beyond the bladder. They should have had a tumor removal surgery recently and no prior systemic chemotherapy for MIBC. Participants must be in good health otherwise, with normal organ function, and not pregnant or breastfeeding. Those who've received other recent investigational treatments or have certain medical conditions are excluded.

What is being tested?

The study tests combining Sacituzumab Govitecan (SG), an IV drug given on specific days of a treatment cycle, with adaptive radiation therapy to see if it's safe and can help preserve the bladder. The trial includes initial SG treatment before starting radiation therapy, followed by two more cycles during radiation.

What are the potential side effects?

Potential side effects include reactions related to infusion of SG such as nausea, fatigue, hair loss; plus typical risks from radiation like skin irritation and discomfort near the treated area. Organ-specific inflammation might also occur due to either treatment.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but might not be able to do heavy physical work.

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My bladder cancer is invasive but hasn't spread beyond my pelvis.

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My blood tests show normal liver, kidney, and bone marrow function.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled illnesses that could interfere with the study.

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I have issues controlling my bladder, including needing help to urinate.

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I am not pregnant or breastfeeding.

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I have had radiation therapy in the pelvic area for bladder cancer or another type of cancer.

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I have been diagnosed with swelling in both kidneys.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of acute-dose limiting toxicities

Secondary study objectives

Determine the bladder intact event-free survival (BI-EFS)

Other study objectives

Characterize imaging changes

Characterize immune repertoire editing

Characterize tumor clonal dynamics

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SG + Adaptive radiotherapyExperimental Treatment2 Interventions

Sacituzumab Govitecan, IV, 8 mg/kg, 21-day cycles for 1 loading cycle prior to radiation and two subsequent cycles with concurrent adaptive radiotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Adaptive Radiotherapy

2007

Completed Phase 2

~160

Sacituzumab govitecan

2017

Completed Phase 3

~530