A Study to Assess the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab (Also Known as MPDL3280A or Anti-PD-L1) in Participants With Locally Advanced or Metastatic Solid Tumors
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/31/2019 |
Start Date: | April 24, 2015 |
End Date: | August 31, 2019 |
A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and
pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally
advanced, recurrent, or metastatic incurable solid malignancy that has progressed after
available standard therapy; or for which standard therapy has proven to be ineffective or
intolerable or is considered inappropriate; or for which a clinical trial of an
investigational agent is a recognized standard of care. Participants will be enrolled in two
stages: a dose-escalation stage and an expansion stage.
pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally
advanced, recurrent, or metastatic incurable solid malignancy that has progressed after
available standard therapy; or for which standard therapy has proven to be ineffective or
intolerable or is considered inappropriate; or for which a clinical trial of an
investigational agent is a recognized standard of care. Participants will be enrolled in two
stages: a dose-escalation stage and an expansion stage.
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 12 weeks
- Adequate hematologic and end organ function
- Histologic documentation of locally advanced, recurrent, or metastatic incurable solid
malignancy that has progressed after available standard therapy; or for which standard
therapy is ineffective, intolerable, or considered inappropriate; or for which a
clinical trial of an investigational agent is recognized standard of care
- Tumor specimen availability
- Measurable disease according to RECIST v1.1
Exclusion Criteria:
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy,
hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study
treatment
- Malignancies other than disease under study within 5 years prior to D1 of C1
- Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
- History of leptomeningeal disease
- History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced),
organizing pneumonia, or evidence of active pneumonitis on screening chest computed
tomography scan; history of radiation pneumonitis in the radiation field (fibrosis) is
permitted
- History of autoimmune disease
- Positive human immunodeficiency virus test result
- Active hepatitis B, hepatitis C, or tuberculosis
- Severe infection within 4 weeks prior to D1 of C1
- Prior allogeneic bone marrow or solid organ transplantation
- Significant cardiovascular disease
- Known clinically significant liver disease
We found this trial at
10
sites
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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