Atezolizumab and Cabozantinib for the Treatment of Adolescents and Young Adults With Recurrent or Metastatic Osteosarcoma, TACOS Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05019703
Phase
PHASE2
Status
Recruiting

Conditions

  • Locally Advanced Osteosarcoma
  • Metastatic Osteosarcoma
  • Recurrent Osteosarcoma
  • Refractory Osteosarcoma
  • Unresectable Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 25, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (atezolizumab, cabozantinib)
    Patients receive atezolizumab IV over 60 minutes on day 1 and cabozantinib PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: From treatment onset to either disease progression or death from any cause, whichever occurs first, assessed up to 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Katherine Janeway, MD
617-632-4994
Katherine Janeway, MD (PRINCIPAL_INVESTIGATOR)
M D Anderson Cancer CenterHoustonTexas77030
John A. Livingston, MD
713-792-3626
John A. Livingston, MD (PRINCIPAL_INVESTIGATOR)

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