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NCT03190174 · FLOW

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Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers · Source last updated 2025-02-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    The study will employ the standard "cohort of three" design. Three patients are treated at each dose level with expansion to six patients per cohort if DLT is observed in one of the three initially enrolled patients at each dose level. If no DLT occurs after 2 doses, escalation to the next dose level will be permitted. The maximum tolerated dose is defined as the highest safely tolerated dose, where not more than one patient experienced DLT, with the next higher dose level having at least two patients who experienced DLT. Patients in the dose escalation study may continue treatment at their designated dose levels up to eighteen 3-week cycles or until significant disease progression or unacceptable toxicity occurs. No intra-patient dose escalation will take place.
    id
    FG000
    title
    Dose Escalation Phase 1 Dose Level I
  2. description
    The study will employ the standard "cohort of three" design. Three patients are treated at each dose level with expansion to six patients per cohort if DLT is observed in one of the three initially enrolled patients at each dose level. If no DLT occurs after 2 doses, escalation to the next dose level will be permitted. The maximum tolerated dose is defined as the highest safely tolerated dose, where not more than one patient experienced DLT, with the next higher dose level having at least two patients who experienced DLT. Patients in the dose escalation study may continue treatment at their designated dose levels up to eighteen 3-week cycles or until significant disease progression or unacceptable toxicity occurs. No intra-patient dose escalation will take place.
    id
    FG001
    title
    Dose Escalation Phase 1 Dose Level II
  3. description
    The study will employ the standard "cohort of three" design. Three patients are treated at each dose level with expansion to six patients per cohort if DLT is observed in one of the three initially enrolled patients at each dose level. If no DLT occurs after 2 doses, escalation to the next dose level will be permitted. The maximum tolerated dose is defined as the highest safely tolerated dose, where not more than one patient experienced DLT, with the next higher dose level having at least two patients who experienced DLT. Patients in the dose escalation study may continue treatment at their designated dose levels up to eighteen 3-week cycles or until significant disease progression or unacceptable toxicity occurs. No intra-patient dose escalation will take place.
    id
    FG002
    title
    Dose Escalation Phase 1 Dose Level III
  4. description
    Following dose escalation, an additional 22-28 patients will receive ABI-009 at the MTD and defined doses of nivolumab to assess overall safety and potential efficacy in a greater number of patients. Patients in the expansion phase of the study may continue treatment up to 18 3-week treatment cycles or until significant disease progression or unacceptable toxicity occurs.
    id
    FG003
    title
    Expansion Phase 1b Part
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        25
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This was an open-label, single-center, dose-finding phase IB study using a fixed dose of nivolumab and escalating doses of nab-sirolimus given intravenously. Patients were enrolled from August 2017 to July 2021 at the Sarcoma Oncology Center, Santa Monica CA 90403. The study was conducted in accordance with the Declaration of Helsinki and approved by the Western Institutional Review Board (Protocol Code 20151429 on September 8, 2017) for studies involving humans.
Complete source fields
groups
  1. description
    The study will employ the standard "cohort of three" design. Three patients are treated at each dose level with expansion to six patients per cohort if DLT is observed in one of the three initially enrolled patients at each dose level. If no DLT occurs after 2 doses, escalation to the next dose level will be permitted. The maximum tolerated dose is defined as the highest safely tolerated dose, where not more than one patient experienced DLT, with the next higher dose level having at least two patients who experienced DLT. Patients in the dose escalation study may continue treatment at their designated dose levels up to eighteen 3-week cycles or until significant disease progression or unacceptable toxicity occurs. No intra-patient dose escalation will take place.
    id
    FG000
    title
    Dose Escalation Phase 1 Dose Level I
  2. description
    The study will employ the standard "cohort of three" design. Three patients are treated at each dose level with expansion to six patients per cohort if DLT is observed in one of the three initially enrolled patients at each dose level. If no DLT occurs after 2 doses, escalation to the next dose level will be permitted. The maximum tolerated dose is defined as the highest safely tolerated dose, where not more than one patient experienced DLT, with the next higher dose level having at least two patients who experienced DLT. Patients in the dose escalation study may continue treatment at their designated dose levels up to eighteen 3-week cycles or until significant disease progression or unacceptable toxicity occurs. No intra-patient dose escalation will take place.
    id
    FG001
    title
    Dose Escalation Phase 1 Dose Level II
  3. description
    The study will employ the standard "cohort of three" design. Three patients are treated at each dose level with expansion to six patients per cohort if DLT is observed in one of the three initially enrolled patients at each dose level. If no DLT occurs after 2 doses, escalation to the next dose level will be permitted. The maximum tolerated dose is defined as the highest safely tolerated dose, where not more than one patient experienced DLT, with the next higher dose level having at least two patients who experienced DLT. Patients in the dose escalation study may continue treatment at their designated dose levels up to eighteen 3-week cycles or until significant disease progression or unacceptable toxicity occurs. No intra-patient dose escalation will take place.
    id
    FG002
    title
    Dose Escalation Phase 1 Dose Level III
  4. description
    Following dose escalation, an additional 22-28 patients will receive ABI-009 at the MTD and defined doses of nivolumab to assess overall safety and potential efficacy in a greater number of patients. Patients in the expansion phase of the study may continue treatment up to 18 3-week treatment cycles or until significant disease progression or unacceptable toxicity occurs.
    id
    FG003
    title
    Expansion Phase 1b Part
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        25
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This was an open-label, single-center, dose-finding phase IB study using a fixed dose of nivolumab and escalating doses of nab-sirolimus given intravenously. Patients were enrolled from August 2017 to July 2021 at the Sarcoma Oncology Center, Santa Monica CA 90403. The study was conducted in accordance with the Declaration of Helsinki and approved by the Western Institutional Review Board (Protocol Code 20151429 on September 8, 2017) for studies involving humans.

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Preserved source evidence · Not medical advice