MelanomaPhase 1IVYNCT02009449
A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors
A Phase 1 study testing Pegilodecakin, Paclitaxel or Docetaxel and Carboplatin or Cisplatin and FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) in people with Melanoma and Prostate Cancer, run by Eli Lilly and Company at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Prostate Cancer, Ovarian Cancer
- What is being tested?
- Pegilodecakin, Paclitaxel or Docetaxel and Carboplatin or Cisplatin and FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 10 sitesUnited States
- Study dates
- 15 Nov 2013to 22 Jul 2023
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- At least 18 years of age
- Performance Status of 0 or 1
- Adequate organ function
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
UCLA Medical Hematology & Oncology
Los Angeles, California, 90024
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program
Oklahoma City, Oklahoma, 73104
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
UCSF
San Francisco, California
Florida Cancer Specialists & Research Institute
Sarasota, Florida, 34232
About this study
Official 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
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.
- Conditions
- Melanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma, Colorectal Carcinoma, Pancreatic Carcinoma
- Being tested
- Pegilodecakin, Paclitaxel or Docetaxel and Carboplatin or Cisplatin, FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil), gemcitabine/nab-paclitaxel, Capecitabine
- Keywords
- Phase 1/Phase 1b, Oncology, Cancer, Solid Tumors
- Medical subject headings
- Melanoma, Prostatic Neoplasms, Ovarian Neoplasms, Carcinoma, Renal Cell, Colorectal Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegilodecakinDrug
Also called LY3500518, AM0010, PEGylated recombinant human Interleukin-10, PEG-rHuIL-10
Daily subcutaneous injections of pegilodecakin up to 12 months
Paclitaxel or Docetaxel and Carboplatin or CisplatinDrug
Also called Taxol or taxotere and paraplatin or platinol
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)Drug
Also called Eloxatin®/Leucovorin/5-FU
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
gemcitabine/nab-paclitaxelDrug
Also called Gemzar/Abraxane ABI-007
Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle.
CapecitabineDrug
Also called Xeloda
Capecitabine administered orally twice daily for 14 days out of every 21 days.
PazopanibDrug
Also called GW786034
Pazopanib administered orally daily continuously
PembrolizumabDrug
Also called Keytruda, MK-3475
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
PaclitaxelDrug
Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle)
nivolumabDrug
Also called Opdivo
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
Gemcitabine/carboplatinDrug
Also called gemzar/paraplatin
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
| Study group | Role | What they receive |
|---|---|---|
| Part A: Pegilodecakin 0.08/0.1 mg | Experimental | 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. Receives: Drug: Pegilodecakin |
| Part A: Pegilodecakin 0.2/0.25 mg | Experimental | 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. Receives: Drug: Pegilodecakin |
| Part A: Pegilodecakin 0.4/0.5 mg | Experimental | 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. Receives: Drug: Pegilodecakin |
| Part A: Pegilodecakin 0.8/1 mg | Experimental | 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. Receives: Drug: Pegilodecakin |
| Part A: Pegilodecakin 1.6/2 mg | Experimental | 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. Receives: Drug: Pegilodecakin |
| Part A: Pegilodecakin 3.2/4 mg | Experimental | 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. Receives: Drug: Pegilodecakin |
| Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin |
| Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin |
| Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin |
| Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) |
| Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) |
| Part C: Pegilodecakin 0.8/1 mg + FOLFOX | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil) |
| Part D: Pegilodecakin 0.4/ 0.5 mg + Gemcitabine/Nab-Paclitaxel | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: gemcitabine/nab-paclitaxel |
| Part E: Pegilodecakin 0.8/1 mg + Capecitabine | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: Capecitabine |
| Part F: Pegilodecakin 0.8/ 1 mg + Paclitaxel | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: Paclitaxel |
| Part G: Pegilodecakin 0.8/1 mg + Pazopanib | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: Pazopanib |
| Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: Pembrolizumab |
| Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: Pembrolizumab |
| Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: Pembrolizumab |
| Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: Gemcitabine/carboplatin |
| Part I: Pegilodecakin 1.6/2 mg + Nivolumab | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: nivolumab |
| Part I: Pegilodecakin 0.8/1 mg + Nivolumab | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: nivolumab |
| Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin | Experimental | 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. Receives: Drug: Pegilodecakin; Drug: Gemcitabine/carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With TEAEs and SAEs Observed During the Study of Pegilodecakin
The number of participants who experienced treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study.
Measured: 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
Serum concentration of Pegilodecakin is reported.
Measured: Day 29
Secondary outcomes (11)
Number of Participants With Anti-Pegilodecakin Antibody Formation
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.
Measured: Up to 63 Months
Part A: Number of Participants With Overall Response Rate (ORR)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: From Date of First Dose of Study Drug until Disease Progression or Death (Up to 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study start15 Nov 2013
- Primary completion19 Feb 2019
- Study completion22 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ARMO BioSciences
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009449
- Sponsor's protocol ID
- 17159
- Other IDs
- J1L-AM-JZGA, AM0010-001
- Acronym
- IVY
- Status last verified
- Jun 2026
- First submitted
- 2 Dec 2013
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31563517Naing 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.
PubMed 27528724