A study to look at how safe different doses of MOXR0916 were for patients with cancer – when combined with one or two other medicines

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

Cancer
Tumor
Neoplasms
Solid Tumors

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Basic Details

Gender

All

Age

≥18 Years

Healthy Volunteers

Sponsor Genentech, Inc.

Phase Phase 1

Study Identifier NCT02410512, GO29674, 2015-000516-18

This clinical trial was done to study a new medicine called, “MOXR0916”, for the treatment of patients with cancer. This study was done to find out if MOXR0916 given with atezolizumab with and without bevacizumab – was safe for patients. Researchers also wanted to find out if the treatment had any effect on cancer. Two hundred and ninety-eight patients took part in this study at 25 study centers in 7 countries.

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

Basic Details

Sponsor Genentech, Inc.

Phase Phase 1

Trial Identifier NCT02410512, GO29674, 2015-000516-18

Condition Neoplasms

Official Title 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

Study Summary

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.

Eligibility Criteria

Gender

All

Age

≥18 Years

Healthy Volunteers

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

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

A study to look at how safe different doses of MOXR0916 were for patients with cancer – when combined with one or two other medicines

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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Find participating medical centers and current study status in each of them

A study to look at how safe different doses of MOXR0916 were for patients with cancer – when combined with one or two other medicines

Basic Details

What you can do next

Find participating medical centers and current study status in each of them

Explore related studies

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com