A Study of Emactuzumab and Atezolizumab Administered in Combination in Participants With Advanced Solid Tumors

NCT ID: NCT02323191

Last Updated: 2020-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-19
• Study Completion Date: 2020-08-21

Brief Summary

This Phase 1, open-label, multicenter, global study will evaluate the safety, pharmacokinetics, and activity of emactuzumab and atezolizumab administered in combination in participants with selected locally advanced or metastatic solid tumors that are not amenable to standard treatment.

Participants who receive emactuzumab and atezolizumab will continue to receive study drug as long as they experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data, biopsy results (if available), and clinical status, or withdrawal of consent.

Conditions

Solid Cancers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1 (Dose-finding): Emactuzumab + Atezolizumab

Participants will receive escalating doses of emactuzumab along with atezolizumab every 3 weeks (q3w).

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Participants will receive atezolizumab intravenously at a fixed dose of 1200 milligram (mg) q3w.

Emactuzumab

Intervention Type: DRUG

Participants will receive emactuzumab intravenously in ascending dose levels with a starting dose of 500 mg.

Part 2 (Expansion): Emactuzumab + Atezolizumab

Participants will receive emactuzumab at or below the MTDs for the combination treatments that are determined during Part 1 along with atezolizumab.

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Participants will receive atezolizumab intravenously at a fixed dose of 1200 milligram (mg) q3w.

Emactuzumab

Intervention Type: DRUG

Participants will receive emactuzumab intravenously in ascending dose levels with a starting dose of 500 mg.

Interventions

Atezolizumab

Participants will receive atezolizumab intravenously at a fixed dose of 1200 milligram (mg) q3w.

Intervention Type: DRUG

Emactuzumab

Participants will receive emactuzumab intravenously in ascending dose levels with a starting dose of 500 mg.

Intervention Type: DRUG

Other Intervention Names

MPDL3280A, TECENTRIQ; RO5509554

Eligibility Criteria

Inclusion Criteria

• Eastern Cooperative Oncology Group performance status 0 or 1

Exclusion Criteria

• Measurable disease at baseline as per RECIST version 1.1
• Life expectancy of greater than or equal to (>=) 16 weeks
• Adequate bone marrow, liver, cardiac, and renal function
• Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women less than or equal to (<=) 12 months post-menopause. Postmenopausal state is defined as amenorrhea for greater than (>) 12 months.

• Allergy or hypersensitivity to components of the emactuzumab formulation or to components of the atezolizumab formulation
• Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging evaluation during screening (within 28 days before C1D1) and prior radiographic assessments. Participants with radiographically stable, asymptomatic previously irradiated lesions are eligible provided participant is >= 4 weeks beyond completion of cranial irradiation and >= 3 weeks off of corticosteroid therapy. Participants with metastases to the brain stem, midbrain, pons, medulla, or within 10 millimeter (mm) of the optic apparatus (optic nerves and chiasm) are completely excluded
• Leptomeningeal disease
• History of or active autoimmune disease
• Evidence of significant, uncontrolled concomitant diseases, which could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of symptomatic bronchospasm)
• Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment, with the exceptions provided in the protocol
• Prior corticosteroids as anti-cancer therapy within a minimum of 14 days of first receipt of study drug
• Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade <=1 severity (Common Terminology Criteria for Adverse Events [CTCAE] v4.03, or later versions)
• History of human immunodeficiency virus (HIV)
• Participants with active hepatitis B, active hepatitis C, or active tuberculosis
• Participant has had pulmonary embolism or any other thrombo-embolic event within 6 months prior to study entry
• Participants has a history of hematological malignancy within the last 5 years prior to study entry
• Treatment with systemic immunosuppressive medications - Pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Yale Cancer Center; Medical Oncology

New Haven, Connecticut, United States

Massachusetts General Hospital.

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber - Harvard

Boston, Massachusetts, United States

Memorial Sloan-Kettering Cancer Center Breast & Imaging Center

New York, New York, United States

Cliniques Universitaires St-Luc

Brussels, , Belgium

Centre Leon Berard; Departement Oncologie Medicale

Lyon, , France

Institut Claudius Regaud; Departement Oncologie Medicale

Toulouse, , France

Institut Gustave Roussy; Departement Oncologie Medicale

Villejuif, , France

Clinica Universitaria de Navarra; Servicio de Oncologia

Pamplona, Navarre, Spain

Hospital del Mar; Servicio de Oncologia

Barcelona, , Spain

Centro Integral Oncológico Clara Campal Ensayos Clínicos START

Madrid, , Spain

Countries

United States; Belgium; France; Spain

References

Gomez-Roca C, Cassier P, Zamarin D, Machiels JP, Perez Gracia JL, Stephen Hodi F, Taus A, Martinez Garcia M, Boni V, Eder JP, Hafez N, Sullivan R, Mcdermott D, Champiat S, Aspeslagh S, Terret C, Jegg AM, Jacob W, Cannarile MA, Ries C, Korski K, Michielin F, Christen R, Babitzki G, Watson C, Meneses-Lorente G, Weisser M, Ruttinger D, Delord JP, Marabelle A. Anti-CSF-1R emactuzumab in combination with anti-PD-L1 atezolizumab in advanced solid tumor patients naive or experienced for immune checkpoint blockade. J Immunother Cancer. 2022 May;10(5):e004076. doi: 10.1136/jitc-2021-004076.

Reference Type: DERIVED

PMID: 35577503 (View on PubMed)

Other Identifiers

2014-002428-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RG7155

Identifier Type: OTHER

Identifier Source: secondary_id

BP29428

Identifier Type: -

Identifier Source: org_study_id