A Study to Assess the Safety and Tolerability of Atezolizumab in Combination With Other Immune-Modulating Therapies in Participants With Locally Advanced or Metastatic Solid Tumors
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Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically documented locally advanced or metastatic solid tumors meeting the following study drug-specific criteria:
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Life expectancy greater than or equal to (\>/=) 12 weeks
Measurable disease, as defined by RECIST v1.1
Adequate hematologic and end organ function as confirmed by laboratory results within 14 days prior to the first study treatment
Escalation stage: NSCLC participants
Mandatory biopsy cohort: NSCLC or melanoma atezolizumab
Prior atezolizumab-treated cohort: participants with NSCLC or melanoma previously treated with atezolizumab
Escalation stage: RCC or melanoma participants
Expansion stage: RCC or melanoma participants
Mandatory biopsy cohort: RCC or melanoma participants
Prior immunotherapy-treated cohort: participants with RCC, NSCLC, or melanoma previously treated with programmed death-ligand 1 (PD-L1)/ Programmed death 1 (PD-1)
\- Cohort 1: participants with RCC
Cohort 1: participants with metastatic RCC with no prior line of systemic therapy for metastatic disease
Cohorts 2-3: disease progression during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic non-squamous solid tumors; participants with sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements must have failed or are intolerant to prior treatment with EGFR or ALK inhibitors; participants with melanoma with actionable BRAF mutations (e.g., V600) must have failed or are intolerant to prior treatment with BRAF inhibitors
\- R/M HNSCC participants with at least one prior line of systemic therapy
No permanent discontinuation of atezolizumab or other immunotherapies due to a treatment-related adverse event
Recovery from all immunotherapy-related adverse events to Grade less than or equal to (≤) 1 or baseline at the time of consent
You may not be if
General Medical Exclusions:
Pregnant and lactating women
Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment, with the following exception: (1) hormone-replacement therapy or oral contraceptives; (2) tyrosine kinase inhibitors (TKIs) that have been discontinued greater than (\>) 7 days prior to Cycle 1, Day 1, baseline scans must be obtained after discontinuation of prior TKIs
Investigational therapy within 28 days prior to initiation of study treatment
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of the atezolizumab formulation
History of or active autoimmune disease
History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, risk of pulmonary toxicity, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Prior allogeneic bone marrow transplantation or prior solid organ transplantation
History of human immunodeficiency virus (HIV)
Participants with active hepatitis B
Participants with active hepatitis C
Participants with active tuberculosis
Participants with a history of confirmed progressive multifocal leukoencephalopathy
Any serious medical condition, physical examination finding, or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study
Cancer-Specific Exclusions:
Active or untreated central nervous system (CNS) metastases, as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \>/= 2 weeks prior to screening
Leptomeningeal disease
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently); participants with indwelling catheters are allowed.
Uncontrolled tumor-related pain
Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
History of other malignancy within 2 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, localized prostate cancer treated with curative intent, ductal carcinoma in situ treated surgically with curative intent, or other cancers with a similar outcome
Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies (Note: Participants enrolled in the prior anti-PD-L1/PD-1 treated cohorts with melanoma may have received prior anti-cytotoxic T-lymphocyte-associated protein 4 treatment or other immunotherapies)
Treatment with systemic immunostimulatory agents within four weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1
Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1 (the use of inhaled corticosteroids and mineralocorticoids is allowed)
History of depression, suicidal ideation or behavior, bipolar disorder, or psychosis
Hypersensitivity to interferon alpha or any component of the product
Inadequately controlled hypertension
Prior history of hypertensive crisis or hypertensive encephalopathy
Significant vascular disease within 6 months prior to Day 1
History of hemoptysis
Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
History of tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
Clinical signs or symptoms of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure
Proteinuria, as demonstrated by urine dipstick or \> 1.0 gram of protein in a 24-hour urine collection
Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses of large volume
Hypersensitivity to obinutuzumab
Prior treatment with obinutuzumab
Clareo Health | A Study to Assess the Safety and Tolerability of Atezolizumab in Combination With Other Immune-Modulating Therapies in Participants With Locally Advanced or Metastatic Solid Tumors
