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Checkpoint Inhibitor

Sacituzumab + Atezolizumab for Urologic Cancers

Phase 2

Recruiting

Led By Andrea B Apolo, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Age >= 18 years

Participants must have histologically confirmed diagnosis of a locally advanced unresectable or metastatic non-prostate genitourinary (GU) tumor of specific histologies

Must not have

Symptomatic or untreated brain/CNS metastases

Participants unwilling to accept blood products as medically indicated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1 and 8 of each cycle, at eot, at the safety visit, at follow-up, and every 90 days for up to a total of 5 years after the end of therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial tests 2 drugs to treat rare tumors in the kidney, bladder, ureters, and penis. Tests, scans, and exams will be done to track progress. Treatment may last up to 5 years.

Who is the study for?

Adults over 18 with rare genitourinary tumors like small cell carcinoma of the bladder, squamous cell carcinoma of the bladder or penis, primary adenocarcinoma of the bladder, and renal medullary carcinoma. They must have measurable disease progression if previously treated, good physical function (ECOG <=1), adequate organ/marrow function, may have had any number of prior treatments or be treatment-naive.

What is being tested?

The trial is testing Sacituzumab Govitecan (SG) alone or combined with Atezolizumab in treating rare GU cancers. Participants will receive SG on specific days within a 21-day cycle; some will also get Atezolizumab. The study includes regular blood/urine tests and scans for up to 5 years with an additional follow-up period.

What are the potential side effects?

Potential side effects include allergic reactions similar to those seen in other cancer treatments which could involve immune-related issues due to atezolizumab, infusion reactions from either drug, as well as general chemotherapy-associated risks such as fatigue and digestive problems.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have a confirmed diagnosis of an advanced or metastatic non-prostate GU cancer.

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My cancer cannot be surgically removed and is worsening despite previous treatments.

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I am mostly self-sufficient and can carry out daily activities.

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My organs and bone marrow are functioning well.

Exclusion Criteria

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

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I have brain metastases that are causing symptoms or have not been treated.

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I am unwilling to receive blood products even if needed for my treatment.

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I expect to undergo a major surgery during the study.

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I have had a stem cell or organ transplant in the past.

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I do not have severe heart disease, unmanaged illness, or high calcium levels.

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I have been treated with immune checkpoint inhibitors before.

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I haven't had any cancer except for treatable ones in the last 2 years.

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I have a history of lung conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1 and 8 of each cycle, at eot, at the safety visit, at follow-up, and every 90 days for up to a total of 5 years after the end of therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1 and 8 of each cycle, at eot, at the safety visit, at follow-up, and every 90 days for up to a total of 5 years after the end of therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1 and 8 of each cycle, at eot, at the safety visit, at follow-up, and every 90 days for up to a total of 5 years after the end of therapy for reporting.