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Pegilodecakin

BIOLOGICAL7 trials

Sponsors

Eli Lilly and Company

Conditions

Breast CancerColorectal CarcinomaHealthy Adult SubjectsMelanomaNon Small Cell Lung CancerNon-small Cell Lung CarcinomaOvarian CancerPancreatic Cancer

Phase 1

A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors
CompletedNCT02009449
Eli Lilly and CompanyBreast Cancer, Colorectal Carcinoma, Melanoma +6
Start: 2013-11-15End: 2023-07-22Updated: 2026-07-09
A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)
CompletedNCT03267732
Eli Lilly and CompanyHealthy Adult Subjects
Start: 2017-09-05End: 2017-10-30Updated: 2019-04-05
A 3-Way Crossover Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)
CompletedNCT03381547
Eli Lilly and CompanyHealthy Adult Subjects
Start: 2017-12-18End: 2018-02-13Updated: 2026-07-07
A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants
CompletedNCT04194892
Eli Lilly and CompanyHealthy Adult Subjects
Start: 2018-01-19End: 2018-03-14Updated: 2026-07-13

Phase 2

Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
TerminatedNCT03382899
Eli Lilly and CompanyNon Small Cell Lung Cancer
Start: 2018-03-19End: 2020-03-05Updated: 2021-01-20
Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
TerminatedNCT03382912
Eli Lilly and CompanyNon Small Cell Lung Cancer
Start: 2018-03-22End: 2020-03-03Updated: 2020-09-11

Phase 3

Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer
CompletedNCT02923921
Eli Lilly and CompanyPancreatic Cancer
Start: 2017-03-01End: 2020-03-05Updated: 2020-10-19

Related Papers

Immunologic and tumor responses of pegilodecakin with 5-FU/LV and oxaliplatin (FOLFOX) in pancreatic ductal adenocarcinoma (PDAC)
Investigational New Drugs2020-09-1014 citations
Relationship of Hypothyroidism and Immune Response to Pegylated IL-10/nivolumab
Immunotherapy2020-08-182 citations
Randomized phase II study of pembrolizumab (P) alone versus pegilodecakin (PEG) in combination with P as first-line (1L) therapy in patients (pts) with stage IV non-small cell lung cancer (NSCLC) with high PD-L1 expression (CYPRESS 1).
Journal of Clinical Oncology2020-05-202 citations
Randomized phase II study of nivolumab (N) alone versus with pegilodecakin (PEG) in combination with N in patients (pts) with post-platinum immunotherapy-naive stage IV non-small cell lung cancer (NSCLC) and no or low PD-L1 expression (CYPRESS 2).
Journal of Clinical Oncology2020-05-201 citations
Pegilodecakin as monotherapy or in combination with anti-PD-1 or tyrosine kinase inhibitor in heavily pretreated patients with advanced renal cell carcinoma (RCC): Updated results from phase I/Ib IVY study.
Journal of Clinical Oncology2020-02-191 citations
Randomized Phase III Study of FOLFOX Alone and with Pegilodecakin as Second-line Therapy in Patients with Metastatic Pancreatic Cancer (SEQUOIA).
Journal of Clinical Oncology2020-02-0125 citations
Pegilodecakin combined with pembrolizumab or nivolumab for patients with advanced solid tumours (IVY): a multicentre, multicohort, open-label, phase 1b trial.
2019-09-25100 citations
Abstract A016: PEGylated IL-10 (pegilodecakin) induces systemic immune activation, CD8+ T-cell invigoration and polyclonal T-cell expansion in cancer patients
Cancer Immunology Research2019-02-011 citations
Responses and durability of clinical benefit in non-small cell lung cancer treated with pegilodecakin in combination with anti-PD-1 inhibitors
Annals of Oncology2018-10-013 citations
Durability of clinical benefit in metastatic epithelial ovarian cancer patients treated with pegilodecakin monotherapy or in combination with platinum plus taxane-based chemotherapy
Annals of Oncology2018-10-012 citations
Responses and durability of clinical benefit in pancreatic ductal adenocarcinoma (PDAC) patients treated with pegilodecakin (AM0010) in combination with 5-FU/LV and oxaliplatin (FOLFOX)
Annals of Oncology2018-10-011 citations
Responses and durability of clinical benefit in renal cell carcinoma treated with pegilodecakin in combination with anti-PD-1 inhibitors
Annals of Oncology2018-10-01
Responses and durability of clinical benefit in triple negative breast cancer patients treated with pegilodecakin monotherapy or in combination with platinum plus taxane-based chemotherapy
Annals of Oncology2018-10-01
Pegilodecakin with nivolumab (nivo) or pembrolizumab (pembro) in patients (pts) with metastatic renal cell carcinoma (RCC).
Journal of Clinical Oncology2018-05-2010 citations
Overall survival of PEGylated pegilodecakin with 5-FU/LV and oxaliplatin (FOLFOX) in metastatic pancreatic adenocarcinoma (PDAC).
Journal of Clinical Oncology2018-05-207 citations
Responses and durability in NSCLC treated with pegilodecakin and anti-PD-1.
Journal of Clinical Oncology2018-05-203 citations
Overall survival of PEGylated human IL-10 (AM0010) with 5-FU/LV and oxaliplatin (FOLFOX) in metastatic pancreatic adenocarcinoma (PDAC).
Journal of Clinical Oncology2018-02-0113 citations
PEGylated human IL-10 (AM0010) in combination with pembrolizumab in anti-PD1 and CTLA-4 refractory melanoma.
Journal of Clinical Oncology2017-05-204 citations
Efficacy, safety, and immune activation with pegylated human IL-10 (AM0010) plus FOLFOX in metastatic pancreatic adenocarcinoma (PDAC).
Journal of Clinical Oncology2017-05-202 citations
Efficacy and safety of pegylated human IL-10 (AM0010) in combination with an anti-PD-1 in renal cell cancer.
Journal of Clinical Oncology2017-05-201 citations

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