A Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RO6870810 and Atezolizumab (PD-L1 Antibody) in Participants With Advanced Ovarian Cancer or Triple Negative Breast Cancer

Stopped early · Phase 1

Conditions studied: Advanced Ovarian Cancer, Triple Negative Breast Cancer

In brief

This is Phase IB, open label, non-randomized study designed to investigate the dose, safety, pharmacokinetics and anti-tumor activity of RO6870810 in combination with a fixed dose of atezolizumab. The study consists of four groups, Group 1 (Dose Escalation Group) and Group 2 (Sequential Dose Group), and Groups 3 and 4 (Expansion Groups), which will further evaluate the safety, pharmacokinetic, pharmacodynamic and preliminary clinical activity in patients with triple negaive breast cancer and/or ovarian cancer.

Key facts

Study ID

NCT03292172

Run by

Hoffmann-La Roche

People needed

36

Starts

2017-11-08

Expected to finish

2019-02-26

Last updated by the study team

2020-11-06

Who can join

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

You may not qualify if…

• Participants with history of prior malignancy except solid tumor treated curatively more than 3 years ago without evidence of recurrence
• Asymptomatic or symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• History of leptomeningeal disease
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. Participants with indwelling catheters are allowed.
• Uncontrolled or symptomatic hypercalcemia
• New York Heart Association Class III or IV cardiac disease, pericarditis, myocardial infarction within the past 6 months, unstable arrhythmia
• Fredericia-corrected QT interval (QTcF) > 470 milli seconds (msec) (female) or > 450 msec (male), or history of congenital long QT syndrome. Any electrocardiogram (ECG) abnormality, including pericarditis, which in the opinion of the Investigator would preclude safe participation in the study.
• Active, uncontrolled bacterial, viral, or fungal infections within 7 days of study entry requiring systemic therapy. Participants with active TB infection are excluded from the study.
• Known clinically important respiratory impairment
• History of major organ transplant
• History of an autologous or allogeneic bone marrow transplant
• Serious non-malignant disease that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor
• Pregnant or nursing women
• Any systemic anticancer therapy within 3 weeks prior to Cycle 1 Day 1
• Any radiation treatment to metastatic site within <= 14 days of Cycle 1 Day 1
• Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1 Day 1 or anticipation of need for major surgical procedure during the course of the study
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human or humanized antibodies or fusion proteins
• Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
• Active or history of autoimmune disease
• History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
• Positive test for Human immunodeficiency virus (HIV)
• Active hepatitis B or hepatitis C
• Receipt of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live, attenuated vaccine will be required during the study
• Treatment with investigational therapy within 28 days prior to initiation of study treatment

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Oklahoma University Health Sciences Center — Oklahoma City, Oklahoma, United States
• Sarah Cannon Res Inst; TN Onc — Nashville, Tennessee, United States
• St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia
• Peter MacCallum Cancer Centre; Medical Oncology — Melbourne, Victoria, Australia
• University Health Network; Princess Margaret Hospital; Medical Oncology Dept — Toronto, Ontario, Canada
• Rigshospitalet; Onkologisk Klinik — København Ø, Denmark
• Western General Hospital — Edinburgh, United Kingdom
• Guys and St Thomas NHS Foundation Trust, Guys Hospital — London, United Kingdom
• The Christie — Manchester, United Kingdom
• Churchill Hospital — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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