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NCT02983045 · OUTCOME

Part 3 Schedule Finding: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window

A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors · Source last updated 2023-03-13

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Dose-limiting toxicities (DLTs) were assessed during a 3-week (21-day) DLT evaluation period beginning with the first dose of ipilimumab.

What was measured

Part 3 of the study was a schedule finding phase to establish the recommended phase 2 dosing schedules for Part 4 and assess the safety and tolerability for the NKTR-214/nivolumab/ipilimumab triplet combination. The results presented are for the DLT Population.

Analysis population: The DLT population included all Part 3 patients who received at least 1 cycle of study treatment and stayed in study for at least 21 days after first dose of ipilimumab or discontinued from study treatment due to DLT.

Groups in this outcome

Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab

In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 1, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 360 mg flat dose q3w + ipilimumab at 1 mg/kg q6w.

Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab

In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 2, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 1 mg/kg q3w + ipilimumab at 3 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.

Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab

In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 3, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 3 mg/kg q3w + ipilimumab at 1 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab10
Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab8
Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab6

Reported measurements

Patients with at least one event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Endocrine disorders: Adrenal insufficiency
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab0Not reportedNot reportedNot reportedNot reported
Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab0Not reportedNot reportedNot reportedNot reported
Endocrine disorders: Hyperthyroidism
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab0Not reportedNot reportedNot reportedNot reported
Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab0Not reportedNot reportedNot reportedNot reported
Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Metabolism and nutrition disorders: Hyponatraemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab1Not reportedNot reportedNot reportedNot reported
Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab0Not reportedNot reportedNot reportedNot reported
Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
    title
    Patients with at least one event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Endocrine disorders: Adrenal insufficiency
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Endocrine disorders: Hyperthyroidism
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Metabolism and nutrition disorders: Hyponatraemia
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      6
    units
    Participants
description
Part 3 of the study was a schedule finding phase to establish the recommended phase 2 dosing schedules for Part 4 and assess the safety and tolerability for the NKTR-214/nivolumab/ipilimumab triplet combination. The results presented are for the DLT Population.
groups
  1. description
    In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 1, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 360 mg flat dose q3w + ipilimumab at 1 mg/kg q6w.
    id
    OG000
    title
    Schedule Finding (Schedule 1): NKTR-214 + Nivolumab + Ipilimumab
  2. description
    In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 2, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 1 mg/kg q3w + ipilimumab at 3 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.
    id
    OG001
    title
    Schedule Finding (Schedule 2): NKTR-214 + Nivolumab + Ipilimumab
  3. description
    In this Part 3 of the study, patients will receive a combination of NKTR-214 at 0.006 mg/kg q3w with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that proceed into Part 4. In Schedule 3, patients received NKTR-214 at 0.006 mg/kg q3w + nivolumab at 3 mg/kg q3w + ipilimumab at 1 mg/kg q3w for four cycles, followed by the maintenance dose of NKTR-214 0.006 mg/kg and nivolumab 360 mg q3w.
    id
    OG002
    title
    Schedule Finding (Schedule 3): NKTR-214 + Nivolumab + Ipilimumab
param Type
COUNT_OF_PARTICIPANTS
population Description
The DLT population included all Part 3 patients who received at least 1 cycle of study treatment and stayed in study for at least 21 days after first dose of ipilimumab or discontinued from study treatment due to DLT.
reporting Status
POSTED
time Frame
Dose-limiting toxicities (DLTs) were assessed during a 3-week (21-day) DLT evaluation period beginning with the first dose of ipilimumab.
title
Part 3 Schedule Finding: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice