AzTrials
AzTrials

Solid CancersPhase 1NCT02323191

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

A Phase 1 study testing Atezolizumab and Emactuzumab in people with Solid Cancers, run by Hoffmann-La Roche at 12 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Cancers
What is being tested?
Atezolizumab and Emactuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
221 participants
Where
12 sitesin 4 countries
Study dates
19 Jan 2015to 21 Aug 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Participants must have histologically confirmed diagnosis of locally advanced and/or metastatic triple negative breast cancer, ovarian cancer, bladder cancer, gastric cancer, or soft tissue sarcoma, with exceptions defined in the 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

12 sites in 4 countries.

12 sites in 4 countries

United States5 sites

  • Massachusetts General Hospital.

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber - Harvard

    Boston, Massachusetts

  • Yale Cancer Center; Medical Oncology

    New Haven, Connecticut, 06520

  • Memorial Sloan-Kettering Cancer Center Breast & Imaging Center

    New York, New York, 10065

Other trials in United States

France3 sites

  • Centre Leon Berard; Departement Oncologie Medicale

    Lyon, 69373

  • Institut Claudius Regaud; Departement Oncologie Medicale

    Toulouse, 31059

  • Institut Gustave Roussy; Departement Oncologie Medicale

    Villejuif, 94805

Other trials in France

Spain3 sites

  • Hospital del Mar; Servicio de Oncologia

    Barcelona, 08003

  • Centro Integral Oncológico Clara Campal Ensayos Clínicos START

    Madrid, 28050

  • Clinica Universitaria de Navarra; Servicio de Oncologia

    Pamplona, Navarre, 31008

Other trials in Spain

Belgium1 site

  • Cliniques Universitaires St-Luc

    Brussels, 1200

Other trials in Belgium

About this study

Official title: Open-Label, Multicenter, Dose Escalation Phase Ib Study With Expansion Phase to Evaluate the Safety, Pharmacokinetics, and Activity of RO5509554 (Emactuzumab) and MPDL3280A (Atezolizumab) Administered in Combination in Patients With Advanced Solid Tumors

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
Being tested
Atezolizumab, Emactuzumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called MPDL3280A, TECENTRIQ

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

  • EmactuzumabDrug

    Also called RO5509554

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

Study groups in NCT02323191
Study groupRoleWhat they receive
Part 1 (Dose-finding): Emactuzumab + AtezolizumabExperimentalParticipants will receive escalating doses of emactuzumab along with atezolizumab every 3 weeks (q3w).
Receives: Drug: Atezolizumab; Drug: Emactuzumab
Part 2 (Expansion): Emactuzumab + AtezolizumabExperimentalParticipants will receive emactuzumab at or below the MTDs for the combination treatments that are determined during Part 1 along with atezolizumab.
Receives: Drug: Atezolizumab; Drug: Emactuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Dose Limiting Toxicities (DLTs)

    Measured: 21 days

  2. Maximum Tolerated Dose (MTD) of Emactuzumab

    Measured: 21 days

  3. Percentage of Participants With Adverse Events (AEs)

    Measured: Baseline up to 3 years

Secondary outcomes (21)

  1. Maximum Observed Plasma Concentration (Cmax) of Emactuzumab

    predose (-4 hours [h]) and 0.5h post end of infusion (90 minutes infusion) on Days (D) 1 of Cycle (C) 1, 2, 3, 4, 5, 6, all subsequent cycles (Cycle Length=21 days) until disease progression (up to approximately 3 years); 5h postdose on D1 of C1; postdose on D2, D4 or D5, D8, D15 of C1, C2, C4; D12, D19 of C1, C4; 44 and 120 days post last infusion; 28 day follow-up visit (up to approximately 3 years)

    Measured: predose (-4 h) on Day 1 of Cycle 1 up to approximately 3 years (detailed timeframe provided in measure description)

  2. Maximum Observed Plasma Concentration (Cmax) of Atezolizumab

    Measured: predose (-4 h) on D1 of C1, C2, C3, C4, C6, then every 8 cycles (Cycle Length=21 days); 0.5h post end of infusion (60 minutes infusion) on D1 of C1; 120 days post last infusion (up to approximately 3 years)

  3. Minimum Observed Plasma Trough Concentration (Cmin) of Emactuzumab

    Measured: predose (-4 h) on D1 of C2, C3, C4, C5, C6, all subsequent cycles (Cycle Length=21 days) until disease progression (up to approximately 3 years)

  4. Minimum Observed Plasma Trough Concentration (Cmin) of Atezolizumab

    Measured: predose (-4 h) on D1 of C1, C2, C3, C4, C6, then every 8 cycles (Cycle Length=21 days)

  5. Area under the Concentration-Time Curve (AUC) of Emactuzumab

    predose (-4 h) and 0.5h post end of infusion (90 minutes infusion) on D1 of C1, C2, C3, C4, C5, C6, all subsequent cycles (Cycle Length=21 days) until disease progression (up to approximately 3 years); 5h postdose on D1 of C1; postdose on D2, D4 or D5, D8, D15 of C1, C2, C4; D12, D19 of C1, C4; 44 and 120 days post last infusion; 28 day follow-up visit (up to approximately 3 years)

    Measured: predose (-4 h) on Day 1 of Cycle 1 up to approximately 3 years (detailed timeframe provided in measure description)

  6. Total Clearance (CL) of Emactuzumab

    Measured: predose (-4 h) and 0.5h post end of infusion (90 minutes infusion) on D1 of C1, C4 (Cycle Length=21 days); 5h postdose on D1 of C1; postdose on D2, D4 or D5, D8, D12, D15, D19 of C1, C4

  7. Volume of Distribution at Steady State (Vss) of Emactuzumab

    Measured: predose (-4 h) and 0.5h post end of infusion (90 minutes infusion) on D1 of C1, C4 (Cycle Length=21 days); 5h postdose on D1 of C1; postdose on D2, D4 or D5, D8, D12, D15, D19 of C1, C4

  8. Accumulation Ratio (Rac) of Emactuzumab

    Measured: predose (-4 h) and 0.5h post end of infusion (90 minutes infusion) on D1 of C1, C4 (Cycle Length=21 days); 5h postdose on D1 of C1; postdose on D2, D4 or D5, D8, D12, D15, D19 of C1, C4

  9. Terminal Elimination Half-life (t1/2) of Emactuzumab

    Measured: predose (-4 h) and 0.5h post end of infusion (90 minutes infusion) on D1 of C1, C4 (Cycle Length=21 days); 5h postdose on D1 of C1; postdose on D2, D4 or D5, D8, D12, D15, D19 of C1, C4

  10. Emactuzumab Concentration at the time of Tumor Progression (Cprog)

    predose (-4 h) and 0.5h post end of infusion (90 minutes infusion) on D1 of C1, C2, C3, C4, C5, C6, all subsequent cycles (Cycle Length=21 days) until disease progression (up to approximately 3 years); 5h postdose on D1 of C1; postdose on D2, D4 or D5, D8, D15 of C1, C2, C4; D12, D19 of C1, C4; 44 and 120 days post last infusion; 28 day follow-up visit (up to approximately 3 years)

    Measured: predose (-4 h) on Day 1 of Cycle 1 up to approximately 3 years (detailed timeframe provided in measure description)

  11. Emactuzumab Concentration at the Time of Tumor Response (Complete Response/Partial Response)

    predose (-4 h) and 0.5h post end of infusion (90 minutes infusion) on D1 of C1, C2, C3, C4, C5, C6, all subsequent cycles (Cycle Length=21 days) until disease progression (up to approximately 3 years); 5h postdose on D1 of C1; postdose on D2, D4 or D5, D8, D15 of C1, C2, C4; D12, D19 of C1, C4; 44 and 120 days post last infusion; 28 day follow-up visit (up to approximately 3 years)

    Measured: predose (-4 h) on Day 1 of Cycle 1 up to approximately 3 years (detailed timeframe provided in measure description)

  12. Emactuzumab Concentration at the Time of Infusion-related Reaction (IRR) or Hypersensitivity Reaction

    predose (-4 h) and 0.5h post end of infusion (90 minutes infusion) on D1 of C1, C2, C3, C4, C5, C6, all subsequent cycles (Cycle Length=21 days) until disease progression (up to approximately 3 years); 5h postdose on D1 of C1; postdose on D2, D4 or D5, D8, D15 of C1, C2, C4; D12, D19 of C1, C4; 44 and 120 days post last infusion; 28 day follow-up visit (up to approximately 3 years)

    Measured: predose (-4 h) on Day 1 of Cycle 1 up to approximately 3 years (detailed timeframe provided in measure description)

  13. Change From Baseline in Tumor-Associated Macrophages (TAMs) Levels in Paired-Tumor Biopsies at Specified Timepoints

    Measured: Baseline (predose [-4 h] on D1 of C2; Cycle Length=21 days), at disease progression (up to approximately 3 years)

  14. Change From Baseline in Dermal Macrophages Levels in Paired Skin Biopsies at Specified Timepoints

    Measured: Baseline, D15 of C1 (Cycle Length=21 days)

  15. Change From Baseline in Circulating Cluster of Differentiation (CD) 14DimCD16high Monocytes Levels in Peripheral Blood at Specified Timepoints

    Baseline (predose [-4 h] on D1 of C1), predose [-4 h] on D1 of C2, C3, C5, then every other cycle (Cycle Length=21 days) until disease progression (up to approximately 3 years); postdose on D2, D8, D15 of C1, C2; D4 or D5 of C1; 44 days post last infusion (up to approximately 3 years)

    Measured: Baseline up to approximately 3 years (detailed timeframe provided in measure description)

  16. Percentage of Participants With Anti-therapeutic Antibodies to Emactuzumab

    Measured: predose (-4 h) on D1 of C1, C2, C3, C4, C6, all subsequent cycles (Cycle Length=21 days) until disease progression (up to approximately 3 years), 44 and 120 days post last infusion, 28 day follow-up visit (up to approximately 3 years)

  17. Percentage of Participants With Anti-therapeutic Antibodies to Atezolizumab

    Measured: predose (-4 h) on D1 of C1, C2, C3, C4, C6, then every 8 cycles (Cycle Length=21 days; up to approximately 3 years), 120 days post last infusion (up to approximately 3 years)

  18. Percentage of Participants With Best Overall Response as Determined Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: Baseline up to disease progression or death, whichever occurs first (assessed up to approximately 3 years)

  19. Percentage of Participants With Best Overall Response as Determined Using Modified RECIST

    Measured: Baseline up to disease progression or death, whichever occurs first (assessed up to approximately 3 years)

  20. Percentage of Participants With Objective Response as Determined Using RECIST v1.1

    Measured: Baseline up to disease progression or death, whichever occurs first (assessed up to approximately 3 years)

  21. Percentage of Participants With Objective Response as Determined Using Modified RECIST

    Measured: Baseline up to disease progression or death, whichever occurs first (assessed up to approximately 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2014 (estimated)
  2. Study start19 Jan 2015
  3. Primary completion21 Aug 2020
  4. Study completion21 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02323191
Sponsor's protocol ID
BP29428
Other IDs
2014-002428-29, RG7155, 2014
Status last verified
Aug 2020
First submitted
5 Dec 2014
Last updated
27 Aug 2020
Results posted
No

Publications

  • 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.

    PubMed 35577503

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atezolizumab and Emactuzumab in people with Solid Cancers, run by Hoffmann-La Roche at 12 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, France, Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Dose Limiting Toxicities (DLTs) (time frame: 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02323191, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in