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NCT02009449 · REGISTRY CONDITION SEARCH

A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2026-07-09

This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

Who could take part
eligibility Criteria
Inclusion Criteria: Part A Escalation Cohorts: o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts: * Tumors with all histological diagnosis or tissue origin may be enrolled * Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease. * Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC) * At least 18 years of age * Performance Status of 0 or 1 * Adequate organ function Exclusion Criteria: * Hematologic malignancies * Pregnant or lactating * Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders * Myocardial infarction within the last 6 months * Unstable angina, or unstable cardiac arrhythmia requiring medication * Surgery within the last 28 days * Systemic fungal, bacterial, viral, or other infection * History of bleeding diathesis within the last 6 months * Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants received 0.08 or 0.1 mg of Pegilodecakin once daily (QD) administered subcutaneously (SC). Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
    intervention Names
    1. Drug: Pegilodecakin
    label
    Part A: Pegilodecakin 0.08/0.1 mg
    type
    EXPERIMENTAL
  2. description
    Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
    intervention Names
    1. Drug: Pegilodecakin
    label
    Part A: Pegilodecakin 0.2/0.25 mg
    type
    EXPERIMENTAL
  3. description
    Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
    intervention Names
    1. Drug: Pegilodecakin
    label
    Part A: Pegilodecakin 0.4/0.5 mg
    type
    EXPERIMENTAL
  4. description
    Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
    intervention Names
    1. Drug: Pegilodecakin
    label
    Part A: Pegilodecakin 0.8/1 mg
    type
    EXPERIMENTAL
  5. description
    Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
    intervention Names
    1. Drug: Pegilodecakin
    label
    Part A: Pegilodecakin 1.6/2 mg
    type
    EXPERIMENTAL
  6. description
    Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
    intervention Names
    1. Drug: Pegilodecakin
    label
    Part A: Pegilodecakin 3.2/4 mg
    type
    EXPERIMENTAL
  7. description
    Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
    intervention Names
    1. Drug: Pegilodecakin
    2. Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
    label
    Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane
    type
    EXPERIMENTAL
  8. description
    Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
    intervention Names
    1. Drug: Pegilodecakin
    2. Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
    label
    Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane
    type
    EXPERIMENTAL
  9. description
    Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
    intervention Names
    1. Drug: Pegilodecakin
    2. Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
    label
    Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane
    type
    EXPERIMENTAL
  10. description
    Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-Fluorouracil (FU) 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
    intervention Names
    1. Drug: Pegilodecakin
    2. Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
    label
    Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX
    type
    EXPERIMENTAL
  11. description
    Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
    intervention Names
    1. Drug: Pegilodecakin
    2. Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
    label
    Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX
    type
    EXPERIMENTAL
  12. description
    Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
    intervention Names
    1. Drug: Pegilodecakin
    2. Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
    label
    Part C: Pegilodecakin 0.8/1 mg + FOLFOX
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Part A: Pegilodecakin 0.08/0.1 mg
    2. Part A: Pegilodecakin 0.2/0.25 mg
    3. Part A: Pegilodecakin 0.4/0.5 mg
    4. Part A: Pegilodecakin 0.8/1 mg
    5. Part A: Pegilodecakin 1.6/2 mg
    6. Part A: Pegilodecakin 3.2/4 mg
    7. Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane
    8. Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane
    9. Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane
    10. Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX
    11. Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX
    12. Part C: Pegilodecakin 0.8/1 mg + FOLFOX
    description
    Daily subcutaneous injections of pegilodecakin up to 12 months
    name
    Pegilodecakin
    other Names
    1. LY3500518
    2. AM0010
    3. PEGylated recombinant human Interleukin-10
    4. PEG-rHuIL-10
    type
    DRUG
  2. arm Group Labels
    1. Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane
    2. Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane
    3. Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane
    description
    Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
    name
    Paclitaxel or Docetaxel and Carboplatin or Cisplatin
    other Names
    1. Taxol or taxotere and paraplatin or platinol
    type
    DRUG
  3. arm Group Labels
    1. Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX
    2. Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX
    3. Part C: Pegilodecakin 0.8/1 mg + FOLFOX
    description
    FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
    name
    FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
    other Names
    1. Eloxatin®/Leucovorin/5-FU
    type
    DRUG
  4. arm Group Labels
    1. Part D: Pegilodecakin 0.4/ 0.5 mg + Gemcitabine/Nab-Paclitaxel
    description
    Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle.
    name
    gemcitabine/nab-paclitaxel
    other Names
    1. Gemzar/Abraxane ABI-007
    type
    DRUG
  5. arm Group Labels
    1. Part E: Pegilodecakin 0.8/1 mg + Capecitabine
    description
    Capecitabine administered orally twice daily for 14 days out of every 21 days.
    name
    Capecitabine
    other Names
    1. Xeloda
    type
    DRUG
  6. arm Group Labels
    1. Part G: Pegilodecakin 0.8/1 mg + Pazopanib
    description
    Pazopanib administered orally daily continuously
    name
    Pazopanib
    other Names
    1. GW786034
    type
    DRUG
  7. arm Group Labels
    1. Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab
    2. Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab
    3. Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab
    description
    Pembrolizumab administered IV on Day 1 of every 21 day cycle.
    name
    Pembrolizumab
    other Names
    1. Keytruda, MK-3475
    type
    DRUG
  8. arm Group Labels
    1. Part F: Pegilodecakin 0.8/ 1 mg + Paclitaxel
    description
    Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle)
    name
    Paclitaxel
    type
    DRUG
  9. arm Group Labels
    1. Part I: Pegilodecakin 0.8/1 mg + Nivolumab
    2. Part I: Pegilodecakin 1.6/2 mg + Nivolumab
    description
    Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
    name
    nivolumab
    other Names
    1. Opdivo
    type
    DRUG
  10. arm Group Labels
    1. Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin
    2. Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin
    description
    Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
    name
    Gemcitabine/carboplatin
    other Names
    1. gemzar/paraplatin
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
353
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The number of participants who experienced treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study.
    measure
    Number of Participants With TEAEs and SAEs Observed During the Study of Pegilodecakin
    time Frame
    From first dose of study drug through 30 days after the last dose of study drug (Up to 63 Months)
  2. description
    Serum concentration of Pegilodecakin is reported.
    measure
    Pharmacokinetic (PK): Serum Concentration of Pegilodecakin
    time Frame
    Day 29
secondary Outcomes
  1. description
    Number of participants with treatment-emergent anti-Pegilodecakin antibodies, defined as participants with at least one postbaseline anti-drug antibody (ADA) titer ≥4-fold increase from baseline (treatment-boosted) or ADA present with titer ≥1:20 if baseline ADA was negative (treatment-induced), analyses were conducted in the TE ADA-evaluable population. A participant is TE ADA evaluable if at least one non-missing ADA result is available at both baseline and postbaseline.
    measure
    Number of Participants With Anti-Pegilodecakin Antibody Formation
    time Frame
    Up to 63 Months
  2. description
    Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of Immune-related Complete Response (irCR) or Immune-related Partial Response (irPR). irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis.
    measure
    Part A: Number of Participants With Overall Response Rate (ORR)
    time Frame
    From Date of First Dose of study drug until Disease Progression or Death (Up to 54 months)
  3. description
    Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis.
    measure
    Part B: Number of Participants With Overall Response Rate (ORR)
    time Frame
    From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
  4. description
    Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis.
    measure
    Part C: Number of Participants With Overall Response Rate (ORR)
    time Frame
    From Date of First Dose of Study drug until Disease Progression or Death (Upto 23 months)
  5. description
    Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis.
    measure
    Part D: Number of Participants With Overall Response Rate (ORR)
    time Frame
    From Date of First Dose of Study Drug until Disease Progression or Death (Up to 7 months)
  6. description
    Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis.
    measure
    Part E: Number of Participants With Overall Response Rate (ORR)
    time Frame
    From Date of First Dose of study drug until Disease Progression or Death (Upto 12 months)
  7. description
    Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis.
    measure
    Part F: Number of Participants With Overall Response Rate (ORR)
    time Frame
    From Date of First Dose of Study Drug until Disease Progression or Death (Up to 3 months)
  8. description
    Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis.
    measure
    Part G: Number of Participants With Overall Response Rate (ORR)
    time Frame
    From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
  9. description
    Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis.
    measure
    Part H: Number of Participants With Overall Response Rate (ORR)
    time Frame
    From Date of First Dose of Study Drug until Disease Progression or Death (Up to 48 months)
  10. description
    Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis.
    measure
    Part I: Number of Participants With Overall Response Rate (ORR)
    time Frame
    From Date of First Dose of Study Drug until Disease Progression or Death (Up to 50 months)
  11. description
    Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis.
    measure
    Part J: Number of Participants With Overall Response Rate (ORR)
    time Frame
    From Date of First Dose of Study Drug until Disease Progression or Death (Up to 8 months)
Full study description
brief Summary
This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.
Source references
references
  1. citation
    Naing A, Wong DJ, Infante JR, Korn WM, Aljumaily R, Papadopoulos KP, Autio KA, Pant S, Bauer TM, Drakaki A, Daver NG, Hung A, Ratti N, McCauley S, Van Vlasselaer P, Verma R, Ferry D, Oft M, Diab A, Garon EB, Tannir NM. Pegilodecakin combined with pembrolizumab or nivolumab for patients with advanced solid tumours (IVY): a multicentre, multicohort, open-label, phase 1b trial. Lancet Oncol. 2019 Nov;20(11):1544-1555. doi: 10.1016/S1470-2045(19)30514-5. Epub 2019 Sep 25.
    pmid
    31563517
    type
    DERIVED
  2. citation
    Naing A, Papadopoulos KP, Autio KA, Ott PA, Patel MR, Wong DJ, Falchook GS, Pant S, Whiteside M, Rasco DR, Mumm JB, Chan IH, Bendell JC, Bauer TM, Colen RR, Hong DS, Van Vlasselaer P, Tannir NM, Oft M, Infante JR. Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human Interleukin-10 (AM0010) in Patients With Advanced Solid Tumors. J Clin Oncol. 2016 Oct 10;34(29):3562-3569. doi: 10.1200/JCO.2016.68.1106.
    pmid
    27528724
    type
    DERIVED
Source notices and limitations
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    Preserved source evidence · Not medical advice