A Study of Selicrelumab (RO7009789) in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

This is an open-label, multicenter study designed to assess the safety, pharmacokinetics, pharmacodynamics and activity of Selicrelumab administered in combination with Atezolizumab (ATZ) in participants with metastatic or locally advanced solid tumors. The study will be conducted in two Parts (I and II), with Part I divided into Parts IA and IB. All participants will be followed up for survival until death or loss of follow-up after the last visit or withdrawal of consent.

Key facts

Study ID

NCT02304393

Run by

Hoffmann-La Roche

People needed

140

Starts

2014-12-12

Expected to finish

2019-11-07

Last updated by the study team

2019-12-13

Who can join

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

You may qualify if…

• Histologically confirmed diagnosis of locally advanced and/or metastatic solid tumors, which are not amenable to standard therapy
• Part I: histologically confirmed diagnosis of advanced/metastatic small and large bowel carcinomas (small bowel and CRC), CPI-experienced non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC)
• Part II: CPI-experienced NSCLC patients must have experienced documented disease progression on or after PD-L1 or PD-1 inhibitor therapy (investigational or approved): screening tumor assessment should confirm prior progression
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy greater than or equal to (>/=) 16 weeks
• Adequate hematologic and end organ function
• Measurable disease per RECIST Version 1.1
• Ability to comply with the protocol requirements
• Female participants of childbearing potential must have a negative pregnancy test (urine/serum) within seven days prior to the first study drug administration
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than (<) 1% per year during the treatment period and for at least 5 months after the last dose of study treatment
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for at least 28 days after the last dose of study treatment

You may not qualify if…

• If one of the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1 Day 1) are: soluble interleukin 2 receptor (sCD25) greater than (>) 2 × upper limit of normal (ULN); Serum ferritin >1000 nanograms per milliliter (ng/mL)
• Any approved anti-cancer therapy that includes chemotherapy, hormonal therapy, or radiotherapy within 2 weeks prior to the first dose of study treatment; the following is, however, allowed: Palliative radiotherapy for bone metastases less than or equal to (</=) 2 weeks prior to Cycle 1 Day 1
• Adverse events from prior anti-cancer therapy that have not resolved to Grade </= 1 except for any grade alopecia and </= Grade 2 peripheral neuropathy
• Bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other reasons (example: bone metastasis or osteoporosis) is allowed
• Uncontrolled pleural effusion, pericardial effusion, or ascites that require recurrent drainage procedures (one monthly or more frequently). Participants with indwelling catheters are allowed
• Known clinically significant liver disease which includes active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease
• History (within the previous year) of congestive heart failure, stroke, arrhythmia, or myocardial infarction
• History of peripheral venous thrombosis or thromboembolic event (within 12 months prior to Cycle 1 Day 1)
• Significant cardio- or cerebrovascular disease within 6 months prior to Cycle 1 Day 1
• Known hereditary or acquired coagulopathies
• Clinically meaningful proteinuria
• Requiring dialysis (peritoneal or hemodialysis)
• Known primary central nervous system (CNS) malignancy or symptomatic or untreated CNS metastases: participants with asymptomatic-treated CNS metastases may be enrolled after consultation with the Medical Monitor, provided they meet the following criteria:
• Radiographic demonstration of improvement upon completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
• No stereotactic radiation or whole-brain radiation within 28 days prior to Cycle 1 Day 1
• Pregnancy, lactation, or breastfeeding
• Allergy or hypersensitivity to components of the RO7009789 formulation or to components of atezolizumab formulation
• History of autoimmune diseases (participants with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible; participants with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study)
• History of idiopathic pulmonary fibrosis, pneumonitis (excluding infectious disease-induced), organizing pneumonia, or evidence of active pneumonitis
• History of radiation pneumonitis in the radiation field (fibrosis) is permitted
• Participants with human immunodeficiency virus (HIV) infection, active hepatitis B (chronic or acute), or hepatitis C infection
• Active tuberculosis
• Severe infections within 4 weeks prior to Cycle 1 Day 1
• Signs or symptoms of infection within 2 weeks prior to Cycle 1 Day 1
• Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University Health Network; Princess Margaret Hospital; Medical Oncology Dept — Toronto, Ontario, Canada
• Jewish General Hospital / McGill University — Montreal, Quebec, Canada
• Rigshospitalet; Onkologisk Klinik — København Ø, Denmark
• Aphm; Cpcet — Marseille, France
• Hopital Saint Louis, Service D Oncologie Medicale — Paris, France
• Institut Gustave Roussy; Sitep — Villejuif, France
• Antoni van Leeuwenhoek Ziekenhuis — Amsterdam, Netherlands
• Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed — Rotterdam, Netherlands
• Hospital Univ Vall d'Hebron; Servicio de Oncologia — Barcelona, Spain
• START Madrid. Centro Integral Oncologico Clara Campal; CIOCC — Madrid, Spain

Full record on ClinicalTrials.gov

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