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

Completed · Phase 1

Conditions studied: Solid Cancers

In brief

This global, multicenter, open-label study will evaluate the safety and tolerability of atezolizumab in combination with other immune-modulating therapies in the treatment of selected advanced or metastatic malignancies. The atezolizumab plus ipilimumab arm (Arm A) will focus primarily on participants with advanced or metastatic non-small cell lung cancer (NSCLC). The atezolizumab plus interferon alfa-2b arm (Arm B), plus pegylated interferon alfa-2a (PEG-interferon alfa-2a, Arm C), and atezolizumab plus PEG-interferon Alfa-2a plus bevacizumab (Arm D) will enroll participants with advanced or metastatic renal cell carcinoma (RCC), metastatic NSCLC and melanoma. The atezolizumab plus obinutuzumab) (Arm E) will enroll participants with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Atezolizumab will be administered as intravenous (IV) infusion every 3 weeks (q3w).

Key facts

Study ID

NCT02174172

Run by

Hoffmann-La Roche

People needed

158

Starts

2014-08-18

Expected to finish

2019-11-25

Last updated by the study team

2020-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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
• Inclusion criteria specific to Arm A: Atezolizumab+ Ipilimumab
• Escalation stage: NSCLC participants
• Mandatory biopsy cohort: NSCLC or melanoma atezolizumab
• Prior atezolizumab-treated cohort: participants with NSCLC or melanoma previously treated with atezolizumab
• Inclusion criteria specific to Arm B: Atezolizumab+ Interferon alfa-2b
• 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)
• Inclusion Criteria Specific to Arm C (Atezolizumab plus PEG-Interferon Alafa-2a):
• Cohort 1: participants with RCC
• Inclusion Criteria Specific to Arm D (Atezolizumab plus PEG-Interferon Alfa-2a +Bevacizumab)
• 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
• Inclusion Criteria Specific to Arm E (Atezolizumab +Obinutuzumab)
• R/M HNSCC participants with at least one prior line of systemic therapy
• Inclusion Criteria Specific to prior Anti-PD-L1/PD-1 Treated Cohorts:
• 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 qualify 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
• Exclusion Criteria Related to Medications:
• 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)

Where it is running

• HonorHealth Research Institute - Bisgrove — Scottsdale, Arizona, United States
• Mayo Clinic- Scottsdale — Scottsdale, Arizona, United States
• UCLA — Los Angeles, California, United States
• Yale University — New Haven, Connecticut, United States
• Mayo Clinic-Jacksonville — Jacksonville, Florida, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Sarah Cannon Research Inst. — Nashville, Tennessee, United States
• Vanderbilt Medical Center — Nashville, Tennessee, United States
• The Netherlands Cancer Institute of Amsterdam — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.