Actively Recruiting
A Phase 2 Trial of Atezolizumab and Cabozantinib in Adolescents and Young Adults With Recurrent/Metastatic Osteosarcoma (TACOS)
Led by M.D. Anderson Cancer Center · Updated on 2026-04-17
40
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of atezolizumab and cabozantinib in adolescents and young adults with osteosarcoma that has returned or spread to other parts of the body. This phase II trial aims to assess how well this treatment works by measuring progression-free survival, objective response rate, overall survival, and safety. The study also explores biomarkers and immune system changes to understand treatment effects better. Participants receive atezolizumab through an intravenous infusion on day 1 and take cabozantinib orally every day from days 1 to 21 in repeating 21-day cycles, continuing until the disease worsens or side effects become unacceptable. After treatment ends, patients have follow-up visits within 30 days and then every three months for two years to monitor their health and response. During the study, patients undergo regular assessments including tumor biopsies for biomarker research, blood tests to track immune changes, and scans to evaluate disease progression using standard criteria. Safety is monitored through reported side effects and laboratory tests. The main goal is to see how long patients live without disease progression, with monitoring extending up to two years after starting treatment.
CONDITIONS
Brief Title
Atezolizumab and Cabozantinib for the Treatment of Adolescents and Young Adults With Recurrent or Metastatic Osteosarcoma, TACOS Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 12 years or older at time of consent
- Ability to follow the study protocol
- Histologically confirmed osteosarcoma
- Metastatic or unresectable locally advanced disease
- Relapsed or refractory to conventional therapy including cisplatin, doxorubicin, methotrexate, and/or ifosfamide
- Measurable disease by RECIST v1.1 criteria
- Availability of tumor specimen for biomarker research
- ECOG performance status 0, 1, or 2; Karnofsky 60; 50 for patients >16 years; Lansky 60; 50 for patients 4 16 years
- Body surface area 60; 1 m2
- Life expectancy of at least 6 months
- Recovery to baseline or 4 grade 1 CTCAE v5 from prior treatment toxicities
- Adequate blood counts and organ function within 14 days prior to treatment
- Negative HIV and hepatitis B tests at screening
- Women of childbearing potential must not be pregnant and agree to contraception or abstinence
- Men must agree to abstinence or condom use and refrain from sperm donation during and for 5 months after treatment
You will not qualify if you...
- Inability to swallow tablets
- Prior treatment with cabozantinib
- Prior treatment with immune checkpoint inhibitors combined with VEGF-targeted kinase inhibitors
- Use of kinase inhibitors within 2 weeks before treatment
- Recent cytotoxic or biologic cancer therapy within 4 weeks before treatment
- Recent radiation therapy within 2 to 6 weeks before treatment
- Active or untreated brain metastases or leptomeningeal disease
- Uncontrolled tumor-related pain or symptomatic lesions requiring treatment
- Uncontrolled pleural, pericardial effusion, or ascites needing frequent drainage
- Use of certain anticoagulants except specified allowed agents
- Uncontrolled or symptomatic hypercalcemia
- Active or history of autoimmune disease except specified controlled conditions
- History or signs of certain lung diseases or active pneumonitis
- Active tuberculosis
- Significant cardiovascular disease or uncontrolled hypertension
- Recent stroke, myocardial infarction, or thromboembolic events
- Gastrointestinal disorders with risk of perforation or fistula
- Moderate to severe liver impairment
- Uncompensated hypothyroidism
- Significant bleeding or pulmonary lesions
- Major surgery within 4 weeks prior to treatment or incomplete wound healing
- Prolonged QT interval on ECG
- History of malignancy other than osteosarcoma unless specified otherwise
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Repeated 21-day cycles until disease progression or unacceptable toxicity
Participants receive atezolizumab intravenously over 60 minutes on day 1 and take cabozantinib orally once daily on days 1-21. Treatment cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Visits every 21 days during treatment cycles
Duration - Up to 2 years with visits within 30 days after treatment ends, then every 3 months
After completion of study treatment, participants are followed up to monitor safety and overall survival.
1 visit within 30 days after treatment, then visits every 3 months for 2 years
Trial Site Locations
Total: 2 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
John A Livingston, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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