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

June 11, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

353

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • UCLA Medical Hematology & Oncology
      • San Francisco, California, United States
        • UCSF
    • Colorado
      • Denver, Colorado, United States, 80218
        • Sarah Cannon Research Institute at HealthONE
    • Florida
      • Sarasota, Florida, United States, 34232
        • Florida Cancer Specialists & Research Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas M.D. Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Pegilodecakin 0.08/0.1 mg

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.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Pegilodecakin 0.2/0.25 mg
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.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Pegilodecakin 0.4/0.5 mg
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.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Pegilodecakin 0.8/1 mg
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.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Pegilodecakin 1.6/2 mg
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.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part A: Pegilodecakin 3.2/4 mg
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.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Experimental: Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane

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.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Other Names:
  • Taxol or taxotere and paraplatin or platinol
Experimental: Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane

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.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Other Names:
  • Taxol or taxotere and paraplatin or platinol
Experimental: Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane

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.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Other Names:
  • Taxol or taxotere and paraplatin or platinol
Experimental: Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX

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.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Other Names:
  • Eloxatin®/Leucovorin/5-FU
Experimental: Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX

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.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Other Names:
  • Eloxatin®/Leucovorin/5-FU
Experimental: Part C: Pegilodecakin 0.8/1 mg + FOLFOX

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.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Other Names:
  • Eloxatin®/Leucovorin/5-FU
Experimental: Part D: Pegilodecakin 0.4/ 0.5 mg + Gemcitabine/Nab-Paclitaxel

Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with Gemcitabine 1000 mg/m2 IV over 30 minutes plus nab-paclitaxel 125 mg/m2 IV over 30 to 40 minutes on Days 1, 8, and 15 of every 28-day cycle.

Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: gemcitabine/nab-paclitaxel
Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle.
Other Names:
  • Gemzar/Abraxane ABI-007
Experimental: Part E: Pegilodecakin 0.8/1 mg + Capecitabine

Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Capecitabine 1000 mg/m² orally twice daily (BID) on Days 1 through 14 of each 21-day cycle.

Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Capecitabine
Capecitabine administered orally twice daily for 14 days out of every 21 days.
Other Names:
  • Xeloda
Experimental: Part F: Pegilodecakin 0.8/ 1 mg + Paclitaxel

Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Paclitaxel 80 mg/m2 IV over 3 hours on Days 1, 8, and 15 of every 28-day cycle.

Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Paclitaxel
Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle)
Experimental: Part G: Pegilodecakin 0.8/1 mg + Pazopanib

Participants received a 0.8 or 1 mg of Pegilodecakin QD administered SC with Pazopanib 800 mg orally QD.

Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Pazopanib
Pazopanib administered orally daily continuously
Other Names:
  • GW786034
Experimental: Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab

Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle.

Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Pembrolizumab
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Other Names:
  • Keytruda, MK-3475
Experimental: Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab

Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle.

Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Pembrolizumab
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Other Names:
  • Keytruda, MK-3475
Experimental: Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab

Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle.

Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Pembrolizumab
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Other Names:
  • Keytruda, MK-3475
Experimental: Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin

Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an Area Under the Curve of 2 mg/mL x min (AUC2) IV over 60 minutes on Days 1 and 8 of each 21-day cycle.

Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Gemcitabine/carboplatin
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
Other Names:
  • gemzar/paraplatin
Experimental: Part I: Pegilodecakin 1.6/2 mg + Nivolumab

Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle.

Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: nivolumab
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
Other Names:
  • Opdivo
Experimental: Part I: Pegilodecakin 0.8/1 mg + Nivolumab

Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle.

Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: nivolumab
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
Other Names:
  • Opdivo
Experimental: Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin

Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an AUC2 IV over 60 minutes on Days 1 and 8 of each 21-day cycle.

Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
Drug: Pegilodecakin
Daily subcutaneous injections of pegilodecakin up to 12 months
Other Names:
  • LY3500518
  • AM0010
  • PEGylated recombinant human Interleukin-10
  • PEG-rHuIL-10
Drug: Gemcitabine/carboplatin
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
Other Names:
  • gemzar/paraplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From first dose of study drug through 30 days after the last dose of study drug (Up to 63 Months)
Pharmacokinetic (PK): Serum Concentration of Pegilodecakin
Time Frame: Day 29
Serum concentration of Pegilodecakin is reported.
Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 63 Months
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.
From Date of First Dose of study drug until Disease Progression or Death (Up to 54 months)
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.
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
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.
From Date of First Dose of Study drug until Disease Progression or Death (Upto 23 months)
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.
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 7 months)
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.
From Date of First Dose of study drug until Disease Progression or Death (Upto 12 months)
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.
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 3 months)
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.
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
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.
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 48 months)
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.
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 50 months)
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.
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 8 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

ARMO BioSciences

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2013

Primary Completion (Actual)

February 19, 2019

Study Completion (Actual)

July 22, 2023

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

December 9, 2013

First Posted (Estimated)

December 12, 2013

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17159
  • J1L-AM-JZGA (Other Identifier: Eli Lilly and Company)
  • AM0010-001 (Other Identifier: ARMO BioSciences)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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