Study on Sacituzumab Govitecan with or without Atezolizumab for Rare Genitourinary Tumors

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06161532

Provider View

This clinical trial is exploring the use of sacituzumab govitecan, alone or with atezolizumab, to treat rare cancers in the urinary system, including bladder, kidney, and penile cancers. The study aims to see if these drugs can help control these rare tumors.

Patient Parameters

Program Overview

This study focuses on rare cancers in the urinary system, such as those in the bladder, kidney, and penis. These cancers are hard to study because they are uncommon, making it difficult to conduct large trials. Researchers are testing two drugs, sacituzumab govitecan and atezolizumab, which are already used for other cancers, to see if they can help treat these rare tumors. The goal is to determine if using these drugs together or separately can effectively manage these cancers.

Description

This study involves two drugs: sacituzumab govitecan (SG) and atezolizumab. SG is a drug that targets cancer cells and delivers chemotherapy directly to them. Atezolizumab is an immunotherapy drug that helps the immune system fight cancer. Both drugs are given through an IV in the arm.

Participants will receive SG on days 1 and 8 of a 21-day cycle. Some participants will also receive atezolizumab on day 1 of each cycle. The treatment can continue for up to 5 years, depending on how well it works and if there are any side effects.

Participants will have regular check-ups, including blood and urine tests, scans, and possibly biopsies, to monitor their health and the treatment's effectiveness. After the treatment phase, follow-up visits will continue for another 5 years to ensure long-term safety and effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years and older.
  • Diagnosed with rare urinary system cancers, such as:
    • Small cell carcinoma of the bladder or urinary tract
    • Squamous cell carcinoma of the bladder or urinary tract
    • Primary adenocarcinoma of the bladder or urinary tract
    • Renal medullary carcinoma
    • Squamous cell carcinoma of the penis
  • Cancer must be advanced or have spread and cannot be removed by surgery.
  • Must have measurable disease on scans.
  • Good overall health with a performance status of 0 or 1.
  • Adequate organ and blood function based on specific medical tests.
  • May have had previous cancer treatments, except for certain conditions.
  • Must provide a tumor sample for study purposes.
  • Women of childbearing potential must use effective contraception during and after the study.
  • Men must use effective contraception and refrain from donating sperm during and after the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Severe allergies to similar drugs or components.
  • Untreated or symptomatic brain metastases.
  • Positive pregnancy test.
  • Refusal to accept blood products if needed.
  • Active autoimmune diseases requiring treatment.
  • History of lung diseases like pneumonitis.
  • Need for major surgery during the study.
  • Recent live vaccinations.
  • Uncontrolled fluid buildup in the body.
  • Uncontrolled high calcium levels.
  • Recent severe heart problems.
  • Previous treatment with certain immune therapies (for some participants).
  • Recent other cancers, except for certain low-risk types.
  • Severe uncontrolled illnesses that would interfere with the study.

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