Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-29 @ 5:21 AM
Study NCT ID:
NCT05019703
Status:
RECRUITING
Last Update Posted:
2025-10-09
First Post:
2021-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atezolizumab and Cabozantinib for the Treatment of Adolescents and Young Adults With Recurrent or Metastatic Osteosarcoma, TACOS Study
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase 2 Trial of Atezolizumab and Cabozantinib in Adolescents and Young Adults With Recurrent/Metastatic Osteosarcoma (TACOS)
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
PRIMARY OBJECTIVE:
I. To assess the efficacy of cabozantinib in combination with atezolizumab in recurrent/metastatic osteosarcoma as determined by the progression-free survival (PFS) defined as the time from treatment onset to either disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause, whichever occurs first.
SECONDARY OBJECTIVES:
I. To estimate the objective response rate (ORR) by RECIST 1.1 criteria, immune-based (i)RECIST, and immune-modified (im)RECIST.
II. To estimate the progression-free survival (PFS) rates at 4 months and 6 months.
III. To estimate the overall survival (OS) in patients with recurrent/metastatic osteosarcoma receiving cabozantinib + atezolizumab.
IV. To evaluate the safety and tolerability of the combination as assessed by toxicity rates according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
EXPLORATORY OBJECTIVES:
I. To determine the expression of selected biomarkers including PD-1/PD-L1, MET, and VEGFR in pre-treatment and on-treatment tumor biopsy specimens.
II. To assess the immunologic response by change in immune infiltrate in tumors from baseline and on-treatment biopsy specimens and correlate findings with clinical benefit/response to therapy.
III. To characterize and quantify immunologic changes in peripheral blood and correlate with clinical benefit/treatment response.
OUTLINE:
Patients receive atezolizumab intravenously (IV) over 60 minutes on day 1 and cabozantinib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up within 30 days, then every 3 months for 2 years.
I. To assess the efficacy of cabozantinib in combination with atezolizumab in recurrent/metastatic osteosarcoma as determined by the progression-free survival (PFS) defined as the time from treatment onset to either disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause, whichever occurs first.
SECONDARY OBJECTIVES:
I. To estimate the objective response rate (ORR) by RECIST 1.1 criteria, immune-based (i)RECIST, and immune-modified (im)RECIST.
II. To estimate the progression-free survival (PFS) rates at 4 months and 6 months.
III. To estimate the overall survival (OS) in patients with recurrent/metastatic osteosarcoma receiving cabozantinib + atezolizumab.
IV. To evaluate the safety and tolerability of the combination as assessed by toxicity rates according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
EXPLORATORY OBJECTIVES:
I. To determine the expression of selected biomarkers including PD-1/PD-L1, MET, and VEGFR in pre-treatment and on-treatment tumor biopsy specimens.
II. To assess the immunologic response by change in immune infiltrate in tumors from baseline and on-treatment biopsy specimens and correlate findings with clinical benefit/response to therapy.
III. To characterize and quantify immunologic changes in peripheral blood and correlate with clinical benefit/treatment response.
OUTLINE:
Patients receive atezolizumab intravenously (IV) over 60 minutes on day 1 and cabozantinib orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up within 30 days, then every 3 months for 2 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: