Clinical Trials /

Study of Atezolizumab in Combination With Cobimetinib in Participants With Locally Advanced or Metastatic Solid Tumors

NCT01988896

Description:

This is a Phase Ib, open-label, multicenter study designed to assess the safety, tolerability, and pharmacokinetics of coadministration of intravenous (IV) dosing of atezolizumab (an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody) and oral dosing of cobimetinib in participants with metastatic or locally advanced cancer for which no standard therapy exists.

Related Conditions:
  • Colorectal Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

A Phase 1b Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic Solid Tumors

Title

  • Brief Title: A Phase 1b Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic Solid Tumors
  • Official Title: A Phase 1b Study of the Safety and Pharmacology of MPDL3280A Administered With Cobimetinib in Patients With Locally Advanced or Metastatic Solid Tumors
  • Clinical Trial IDs

    NCT ID: NCT01988896

    ORG ID: GP28363

    Trial Conditions

    Neoplasms

    Trial Interventions

    Drug Synonyms Arms
    Cobimetinib Dose-expansion: cobimetinib + MPDL3280A
    Cobimetinib Dose-finding: cobimetinib + MPDL3280A
    MPDL3280A Dose-expansion: cobimetinib + MPDL3280A, Dose-finding: cobimetinib + MPDL3280A

    Trial Purpose

    A Phase Ib, open-label, multicenter study designed to assess the safety, tolerability, and
    pharmacokinetics of coadministration of MPDL3280A and of cobimetinib in patients with
    metastatic or locally advanced cancer for which no standard of care exists.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Dose-expansion: cobimetinib + MPDL3280A Experimental Cobimetinib, MPDL3280A
    Dose-finding: cobimetinib + MPDL3280A Experimental Cobimetinib, MPDL3280A

    Eligibility Criteria

    Inclusion Criteria:

    - Age >/= 18 years.

    - Solid tumor that is metastatic, locally advanced or recurrent.

    - ECOG performance status of 0 or 1.

    - Life expectancy >/= 12 weeks.

    - Measurable disease, as defined by RECIST v1.1.

    - Adequate blood and organ function.

    - Use of highly effective contraception.

    - Histological tumor tissue specimen.

    - Patients enrolling in the expansion cohorts in Stage 2 must consent to tumor biopsies
    and must have one of the following types of cancer:

    - KRAS-mutant metatastic colorectal cancer (mCRC)

    - Non-small cell lung cancer (NSCLC)

    - Melanoma

    Exclusion Criteria:

    - Pregnant and lactating women.

    - History of autoimmune disease.

    - Patients with prior stem cell or organ transplant.

    - History of idiopathic pulmonary fibrosis.

    - History of HIV or hepatitis C infection; history of hepatitis B is allowed if
    infection has resolved (absence of HBsAG).

    - Severe infections within 4 weeks prior to study start; signs or symptoms of infection
    within 2 weeks prior to study start.

    - Oral or IV antibiotic therapy within 2 weeks prior to study start.

    - Significant cardiovascular disease.

    - Administration of a live, attenuated vaccine within 4 weeks before study start or
    until the end of the study.

    Cancer-Specific Exclusions

    - Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within
    3 weeks prior to study start.

    - Active or untreated central nervous system (CNS) tumors.

    - Leptomeningeal disease.

    - Excess, uncontrolled calcium levels.

    - History of prior significant toxicity from another MEK pathway inhibitor requiring
    discontinuation of treatment.

    - Prior treatment with CD137 agonists or immune checkpoint blockade therapies.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Safety: Incidence of adverse events (AE)

    Safety: Incidence of dose-limiting toxicities (DLT)

    Secondary Outcome Measures

    Pharmacokinetics: Maximum concentration (Cmax) of MPDL3280A

    Pharmacokinetics: Plasma Cmax of Cobimetinib

    Trial Keywords