Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
This phase I/II trial tests the safety and side effects of atezolizumab in combination with cabozantinib and whether they work to shrink tumors in patients with glioblastoma that has come back (recurrent). 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 control the disease in patients with recurrent glioblastoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent form (ICF)
Ability and willingness to comply with the requirements of the study protocol
Age >= 18 years
Have histologically confirmed World Health Organization grade IV glioma (glioblastoma or gliosarcoma). Archival tissue will be required for diagnosis confirmation. Receipt of archival tissue is not required for the start of treatment
Disqualifiers
Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery. Prior treatment with Gliadel wafers will be excluded. Active treatment with the Optune device will be excluded
Has received radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment, or systemic treatment with radionuclides within 6 weeks before first dose of study treatment
Has clinically relevant ongoing complications from prior radiation therapy
Is currently participating in any other recurrent therapeutic trial after completion of chemoradiation
Trial design
Design model
Single group
Treatments tested in this trial
Atezolizumab
Biological/VaccineGiven IV
Cabozantinib
DrugGiven PO
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: Treatment (atezolizumab, cabozantinib)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS)
Will estimate the 6 months PFS distribution using the Kaplan-Meier method.
Time frame
At 6 momths2
Objective response rate
Will be estimated with exact binomial 95% confidence intervals. Logistic regression will be used to explore the correlations between response rates and correlative markers.
Time frame
Up to 3 years3
Incidence of adverse events
Will be estimated with exact binomial 95% confidence intervals. Adverse events will be tabulated by grade and by their relationship to the treatment.
Time frame
Up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov