Study on Atezolizumab and Cabozantinib for Treating Recurrent or Metastatic Osteosarcoma in Adolescents and Young Adults

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT05019703

Provider View

This clinical trial is exploring the effects of combining two drugs, atezolizumab and cabozantinib, to treat osteosarcoma that has returned or spread in adolescents and young adults. The study aims to see if this combination can help control the cancer by boosting the immune system and blocking cancer cell growth.

Patient Parameters

Program Overview

This study is testing a combination of two drugs, atezolizumab and cabozantinib, to treat osteosarcoma in young people whose cancer has come back or spread. Atezolizumab is an immunotherapy drug that helps the immune system attack cancer cells, while cabozantinib blocks certain enzymes that cancer cells need to grow. The goal is to see if these drugs can work together to control the cancer more effectively.

Description

The main goal of this study is to see how well the combination of cabozantinib and atezolizumab works in stopping the progression of osteosarcoma that has returned or spread. Researchers will measure how long patients live without the cancer getting worse. They will also look at how many patients respond to the treatment and how long they survive overall. The safety of the drug combination will be monitored by checking for side effects.

Patients in the study will receive atezolizumab through an IV once every 21 days and take cabozantinib pills daily. This cycle will repeat every 21 days as long as the treatment is working and side effects are manageable. After finishing the treatment, patients will have follow-up visits to monitor their health.

The study will also explore how the drugs affect certain markers in the cancer cells and the immune system, which could help understand why the treatment works or doesn't work for some patients.

Eligibility Criteria

Inclusion Criteria

  • Must be 12 years or older and able to understand and agree to the study.
  • Have a confirmed diagnosis of osteosarcoma that has spread or cannot be removed by surgery.
  • Cancer must have returned or not responded to standard treatments like cisplatin, doxorubicin, methotrexate, or ifosfamide.
  • Have measurable cancer that can be tracked using standard criteria.
  • Provide a tumor sample for research, either from a recent biopsy or an older sample if no new treatment has been given since.
  • Be in good overall health with a performance status score of 0, 1, or 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a body surface area of at least 1 square meter.
  • Have a life expectancy of at least 6 months.
  • Have recovered from any side effects of previous treatments to a mild level.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Women of childbearing potential must not be pregnant and agree to use effective contraception during and for 5 months after treatment.
  • Men must agree to use condoms or abstain from intercourse and refrain from donating sperm during and for 5 months after treatment.

Exclusion Criteria

  • Cannot swallow tablets.
  • Have had previous treatment with cabozantinib or certain immune therapies combined with VEGF-targeted drugs.
  • Have taken certain cancer drugs or had radiation therapy too close to the start of the study.
  • Have untreated or unstable brain metastases.
  • Have uncontrolled pain or fluid buildup in the body that requires frequent drainage.
  • Are taking certain blood thinners that are not allowed in the study.
  • Have uncontrolled high calcium levels or certain autoimmune diseases.
  • Have significant heart or lung conditions, recent heart attacks, or strokes.
  • Have gastrointestinal disorders that increase the risk of complications.
  • Have severe liver problems or significant bleeding issues.
  • Have had major surgery recently or need major surgery during the study.
  • Have a prolonged QT interval on an ECG, which can indicate heart rhythm problems.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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