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NCT03190174 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
3.8 years
Other-event reporting threshold
0%

The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from that of the clinicaltrials.gov.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Escalation Phase 1 Part I

The study will employ the standard "cohort of three" design. Patients receive ABI-009 in level I dose - 56 mg/m\^2 and defined dose of nivolumab - 240 mg IV 30 min. q 3 weeks.

0 / 30 / 33 / 3
Dose Escalation Phase 1 Part II

The study will employ the standard "cohort of three" design. Patients receive ABI-009 in level II dose - 75 mg/m\^2 and defined dose of nivolumab - 240 mg IV 30 min. q 3 weeks.

0 / 30 / 33 / 3
Dose Escalation Phase 1 Part III

The study will employ the standard "cohort of three" design. Patients receive ABI-009 in level III dose - 100 mg/m\^2 and defined dose of nivolumab - 240 mg IV 30 min. q 3 weeks.

0 / 30 / 33 / 3
Expansion Phase 1b

Following dose escalation, an additional 25 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 three-week cycles or until significant disease progression or unacceptable toxicity occurs.

3 / 252 / 2521 / 25

Group identifiers: EG000: Dose Escalation Phase 1 Part I · EG001: Dose Escalation Phase 1 Part II · EG002: Dose Escalation Phase 1 Part III · EG003: Expansion Phase 1b

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One (3.2%) had acute dehydration.
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Dehydration
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Three (9.7%) patients had thrombocytopenia.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      25
      num Events
      3
    term
    Thrombocytopenia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Two patients developed Grade 2 oral mucositis.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Oral mucositis
Complete source fields
description
The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from that of the clinicaltrials.gov.
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    The study will employ the standard "cohort of three" design. Patients receive ABI-009 in level I dose - 56 mg/m\^2 and defined dose of nivolumab - 240 mg IV 30 min. q 3 weeks.
    id
    EG000
    other Num Affected
    0
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose Escalation Phase 1 Part I
  2. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    The study will employ the standard "cohort of three" design. Patients receive ABI-009 in level II dose - 75 mg/m\^2 and defined dose of nivolumab - 240 mg IV 30 min. q 3 weeks.
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose Escalation Phase 1 Part II
  3. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    The study will employ the standard "cohort of three" design. Patients receive ABI-009 in level III dose - 100 mg/m\^2 and defined dose of nivolumab - 240 mg IV 30 min. q 3 weeks.
    id
    EG002
    other Num Affected
    0
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose Escalation Phase 1 Part III
  4. deaths Num Affected
    21
    deaths Num At Risk
    25
    description
    Following dose escalation, an additional 25 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 three-week cycles or until significant disease progression or unacceptable toxicity occurs.
    id
    EG003
    other Num Affected
    2
    other Num At Risk
    25
    serious Num Affected
    3
    serious Num At Risk
    25
    title
    Expansion Phase 1b
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Two patients developed Grade 2 oral mucositis.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Oral mucositis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One (3.2%) had acute dehydration.
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Dehydration
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Three (9.7%) patients had thrombocytopenia.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      25
      num Events
      3
    term
    Thrombocytopenia
time Frame
3.8 years

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Preserved source evidence · Not medical advice