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Completed

NCT Number: NCT02009449

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

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.

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Key information

Conditions

Melanoma Adenocarcinoma Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-small Cell Lung Carcinoma Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Carcinoma Pancreatic Diseases Pancreatic Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Solid Tumors Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCLA Medical Hematology & Oncology, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegilodecakin

Drug

Daily subcutaneous injections of pegilodecakin up to 12 months

Other names: LY3500518, AM0010, PEGylated recombinant human Interleukin-10, PEG-rHuIL-10

Paclitaxel or Docetaxel and Carboplatin or Cisplatin

Drug

Platinum/ Taxane administered IV on Day 1 of every 21 day cycle

Other names: Taxol or taxotere and paraplatin or platinol

FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)

Drug

FOLFOX administered IV on Day 1 and 2 of every 14 day cycle

Other names: Eloxatin®/Leucovorin/5-FU

Gemcitabine/nab-paclitaxel

Drug

Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle.

Other names: Gemzar/Abraxane ABI-007

Capecitabine

Drug

Capecitabine administered orally twice daily for 14 days out of every 21 days.

Other names: Xeloda

Pazopanib

Drug

Pazopanib administered orally daily continuously

Other names: GW786034

Pembrolizumab

Drug

Pembrolizumab administered IV on Day 1 of every 21 day cycle.

Other names: Keytruda, MK-3475

paclitaxel

Drug

Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle)

Nivolumab

Drug

Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)

Other names: Opdivo

gemcitabine/carboplatin

Drug

Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)

Other names: gemzar/paraplatin

Primary outcomes

  1. 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)

    The number of participants who experienced treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study.

  2. Pharmacokinetic (PK): Serum Concentration of Pegilodecakin

    Time frame: Day 29

    Serum concentration of Pegilodecakin is reported.

Secondary outcomes

  1. Number of Participants With Anti-Pegilodecakin Antibody Formation

    Time frame: Up to 63 Months

    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.

  2. 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)

    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.

  3. 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)

    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.

  4. 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)

    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.

  5. 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)

    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.

  6. 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)

    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.

  7. 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)

    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.

  8. 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)

    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.

  9. 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)

    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.

  10. 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)

    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.

  11. 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)

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • ARMO BioSciences

Registry information

Official study title

A Phase 1, Open-Label Dose Escalation First-in-Human Study to Evaluate the Tolerability, Safety, Maximum Tolerated Dose, Preliminary Clinical Activity and Pharmacokinetics of AM0010 in Patients With Advanced Solid Tumors

Acronym: IVY

Important dates

Study start
2013
Primary completion
2019
Study completion
2023
First posted
Dec 12, 2013
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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