Actively Recruiting
Atezolizumab and Cabozantinib for the Treatment of Adolescents and Young Adults With Recurrent or Metastatic Osteosarcoma, TACOS Study
Led by M.D. Anderson Cancer Center · Updated on 2026-04-17
40
Participants Needed
2
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial studies the effect of atezolizumab and cabozantinib in treating adolescents and young adults with osteosarcoma that has come back (recurrent) or has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab and cabozantinib may help to control the osteosarcoma.
CONDITIONS
Official 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 signing informed consent
- Ability to follow study protocol as judged by investigator
- Histologically confirmed osteosarcoma diagnosis
- Metastatic or unresectable locally advanced osteosarcoma
- Relapsed or refractory after conventional therapies including cisplatin, doxorubicin, methotrexate, and/or ifosfamide
- Measurable disease by RECIST version 1.1
- Availability of recent tumor specimen for biomarker research
- ECOG performance status 0, 1, or 2; Karnofsky score ≥50 for patients over 16 years; Lansky score ≥50 for patients 16 years or younger
- Body surface area ≥1 m²
- Life expectancy of at least 6 months
- Recovery to baseline or grade ≤1 from previous treatment toxicities
- Absolute neutrophil count ≥1.0 x 10⁹/L without growth factor support
- Lymphocyte count ≥0.5 x 10⁹/L
- Platelet count ≥100 x 10⁹/L without transfusion
- Hemoglobin ≥90 g/L; transfusions allowed to meet this
- Liver enzymes AST and ALT ≤3 times upper limit of normal for age
- Alkaline phosphatase ≤3 times upper limit normal or ≤5 times if bone metastases
- Serum bilirubin ≤1.5 times upper limit normal (≤3 if Gilbert disease)
- Creatinine clearance ≥50 mL/min (adults) or ≥50 mL/min/1.73m² (pediatrics)
- Urine protein/creatinine ratio ≤1 mg/mg or 24-hour urine protein ≤1 g
- Serum albumin ≥20 g/L
- INR or aPTT ≤1.5 times upper limit normal if not on anticoagulation
- Negative HIV and hepatitis B tests
- Women of childbearing potential must not be pregnant and agree to abstinence or effective contraception during and for 5 months after treatment
- Men must agree to abstain or use condoms and refrain from sperm donation during and for 5 months after treatment
You will not qualify if you...
- Unable to swallow tablets
- Prior treatment with cabozantinib
- Prior immune checkpoint blockade with anti-CTLA-4, anti-PD-1, or anti-PD-L1 combined with VEGF-targeted tyrosine kinase inhibitors
- Small molecule kinase inhibitors within 2 weeks before study treatment
- Cytotoxic, biologic, or systemic anticancer therapy within 4 weeks before study treatment
- Radiation therapy for bone metastasis within 2 weeks or other radiation within 4 weeks before study treatment
- Ongoing complications from prior radiation or recent brain metastases not stable for 4 weeks
- History of leptomeningeal disease
- Uncontrolled tumor-related pain or unstable lesions without prior treatment
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Use of certain anticoagulants; some anticoagulation allowed under specific conditions
- Uncontrolled or symptomatic hypercalcemia
- Active or history of autoimmune diseases except certain controlled exceptions
- History of pneumonitis or active pneumonitis on screening
- Active tuberculosis
- Significant cardiovascular disease within 3 months prior to treatment
- Uncontrolled hypertension despite treatment
- Recent stroke, myocardial infarction, or thromboembolic events within 6 months
- Gastrointestinal disorders with high risk of perforation or fistula, or recent abdominal fistula or abscess
- Moderate to severe liver impairment
- Uncompensated or symptomatic hypothyroidism
- Significant bleeding or hematuria within 12 weeks before treatment
- Cavitating pulmonary lesions or airway disease
- Lesions invading major blood vessels
- Major surgery within 4 weeks or minor surgery within 10 days before treatment
- Prolonged QT interval on ECG (>500 ms) within 14 days before treatment
- History of malignancy not specified in detail
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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