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

NCT02323191

Description:

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.

Related Conditions:
  • Bladder Carcinoma
  • Breast Carcinoma
  • Gastric Carcinoma
  • Ovarian Carcinoma
  • Soft Tissue Sarcoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

A Study of RO5509554 and <span class="go-doc-concept go-doc-intervention">MPDL3280A</span> Administered in Combination in Patients With Advanced Solid Tumors

Title

  • Brief Title: A Study of RO5509554 and MPDL3280A Administered in Combination in Patients With Advanced Solid Tumors
  • Official Title: OPEN-LABEL, MULTICENTER, DOSE ESCALATION PHASE IB STUDY WITH EXPANSION PHASE TO EVALUATE THE SAFETY, PHARMACOKINETICS AND ACTIVITY OF RO5509554 AND MPDL3280A ADMINISTERED IN COMBINATION IN PATIENTS WITH ADVANCED SOLID TUMORS
  • Clinical Trial IDs

    NCT ID: NCT02323191

    ORG ID: BP29428

    NCI ID: 2014-002428-29

    Trial Conditions

    Solid Cancers

    Trial Interventions

    Drug Synonyms Arms
    MPDL3280A Part 1, Part 2
    RO5509554 Part 1, Part 2

    Trial Purpose

    This Phase 1, open-label, multicenter, global study will evaluate the safety,
    pharmacokinetics, and activity of RO5509554 and MPDL3280A administered in combination in
    patients with selected locally advanced or metastatic solid tumors that are not amenable to
    standard treatment.

    Patients who receive MPDL3280A and RO5509554 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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Part 1 Experimental Dose-escalation stage MPDL3280A, RO5509554
    Part 2 Experimental Expansion stage MPDL3280A, RO5509554

    Eligibility Criteria

    Inclusion Criteria:

    - Age >/= 18 years

    - Eastern Cooperative Oncology Group performance status 0 or 1

    - Patients 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 protocol

    - Radiologically measurable and clinically evaluable disease (as per Response
    Evaluation Criteria in Solid Tumors [RECIST] version 1.1)

    - Life expectancy of >/= 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 </= 2 years post-menopause. Menopause is defined as amenorrhea for >
    2 years.

    - For women who are not postmenopausal or surgically sterile and for men with partners
    of childbearing potential, agreement to use highly effective contraceptive method(s)
    during the study period and for at least 6 months after the last dose of study drug

    Exclusion Criteria:

    - Allergy or hypersensitivity to components of either study drug 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 Cycle 1 Day 1) and prior radiographic assessments. Patients with
    radiographically stable, asymptomatic previously irradiated lesions are eligible
    provided patient is >/= 4 weeks beyond completion of cranial irradiation and >/= 3
    weeks off of corticosteroid therapy. Patients with metastases to the brain stem,
    midbrain, pons, medulla, or within 10 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 or radiotherapy that have not regressed to
    Grade</= 1 severity (CTCAE v4.03, or later versions)

    - History of HIV

    - Patients with active hepatitis B, active hepatitis C, or active tuberculosis

    - Patient has had pulmonary embolism or any other thrombo-embolic event within 6 months
    prior to study entry

    - Patient 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

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Safety: Nature and frequency of dose-limiting toxicities

    Safety (composite outcome measure): Incidence, nature and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03

    Safety (composite outcome measure): Changes in vital signs, physical findings, and clinical laboratory results during and following study drugs administration

    Secondary Outcome Measures

    Pharmacokinetics (PK): Profile parameters of MPDL3280A - maximum serum concentration (Cmax), minimum serum concentration(Cmin); additional PK parameters as appropriate

    Pharmacokinetics (PK): Profile parameters of RO5509554 - maximum serum concentration (Cmax), trough concentration (Ctrough), area under the concentration-time curve (AUC), total clearance (CL); additional PK parameters as appropriate

    Trial Keywords