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Cytokine

Pegilodecakin for Solid Tumors (IVY Trial)

Q: What conditions is Pembrolizumab usually prescribed to treat?

<p>Pembrolizumab offers patients with <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, macrocytic anemia, and metastasized neoplasm a potential therapy.</p>

Phase 1

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

IVY Trial Summary

This trial is testing a new cancer treatment to see if it is safe and effective.

Who is the study for?

This trial is for adults with advanced solid tumors like melanoma, prostate, ovarian, kidney, colorectal, pancreatic or lung cancer who have not responded to standard treatments or refuse them. They must be in good physical condition with a performance status of 0 or 1 and have proper organ function.Check my eligibility

What is being tested?

The study tests Pegilodecakin alone or combined with various chemotherapies (like Paclitaxel) or immunotherapies (like Pembrolizumab). It's an early-phase trial to see how safe it is and what doses are tolerable when given as a daily subcutaneous injection.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, fatigue, nausea, immune-related issues such as inflammation in organs due to immunotherapy drugs like Pembrolizumab and Nivolumab, and typical chemotherapy side effects like hair loss and low blood cell counts.

IVY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer can be measured or evaluated by specific criteria.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

IVY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pharmacokinetic (PK) parameters

Safety and tolerability as measured by incidence of adverse events

Secondary outcome measures

Anti-Pegilodecakin antibody formation

Change in tumor burden measured by volumetric Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) according to immune-related response criteria (irRC)

Progression in bone by bone scintigraphy according to Prostate Cancer Working Group 2 (PCWG2) for participants with metastatic castration resistant prostate cancer (CRPC)

IVY Trial Design

24Treatment groups

Experimental Treatment

Group I: Part J: Dose Escalation Cohort 1Experimental Treatment1 Intervention

Pegilodecakin (10 ug/kg) daily subcutaneous injections with gemcitabine and carbolplatin on Days 1,8 of each cycle (21 days=1 cycle) until disease progression gemcitabine 1000mg/m2 IV over 30 minutes followed by carboplatin AUC2 over 60 minutes

Group II: Part I: Dose Escalation Cohort 1Experimental Treatment1 Intervention

Pegilodecakin (20 ug/kg) daily subcutaneous injections with nivolumab on Day 1 of each cycle (14 days= 1 cycle). • Nivolumab 3 mg/kg IV over 60 min

Group III: Part H: Dose Escalation Cohort 3Experimental Treatment1 Intervention

Pegilodecakin (40 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min

Group IV: Part H: Dose Escalation Cohort 2Experimental Treatment1 Intervention

Pegilodecakin (20 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min

Group V: Part H: Dose Escalation Cohort 1Experimental Treatment2 Interventions

Pegilodecakin (10 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min

Group VI: Part G: Dose Escalation Cohort 1Experimental Treatment2 Interventions

Pegilodecakin (10 ug/kg) daily subcutaneous injections with pazopanib orally given daily for 14 days of each cycle (21 days= 1 cycle) • Pazopanib 800 mg po QD

Group VII: Part F: Dose Escalation Cohort 1Experimental Treatment2 Interventions

Pegilodecakin (10 ug/kg) daily subcutaneous injections with paclitaxel on Days 1, 8, 15 of each cycle (28 days= 1 cycle) • Paclitaxel 80 mg/ m2 IV

Group VIII: Part E: Dose Escalation Cohort 1Experimental Treatment2 Interventions

Pegilodecakin (10 ug/kg) daily subcutaneous injections with capecitabine BID daily for 14 days of each cycle (21 days= 1 cycle). • Capecitabine 1000 mg/m2 po BID

Group IX: Part D: Dose Escalation Cohort 1Experimental Treatment2 Interventions

Pegilodecakin (5 ug/kg) daily subcutaneous injections with Gemcitabine and nab-paclitaxel on Days 1, 8, 15 of each cycle (28 days = 1 cycle). Nab-paclitaxel 125 mg/m2 IV over 30 minutes followed by • Gemcitabine 1000 mg/m2 IV.

Group X: Part C: Dose Expansion Cohort 1Experimental Treatment2 Interventions

Daily SC injection with pegilodecakin with FOLFOX4 Every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours

Group XI: Part C: Dose Escalation Cohort 3Experimental Treatment2 Interventions

Pegilodecakin (10 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours

Group XII: Part C: Dose Escalation Cohort 2Experimental Treatment2 Interventions

Pegilodecakin (5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours

Group XIII: Part C: Dose Escalation Cohort 1Experimental Treatment2 Interventions

Pegilodecakin (2.5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours

Group XIV: Part B: Dose Expansion CohortExperimental Treatment2 Interventions

Daily SC injection with pegilodecakin with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV

Group XV: Part B: Dose Escalation Cohort 3Experimental Treatment2 Interventions

Pegilodecakin (10 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV

Group XVI: Part B: Dose Escalation Cohort 2Experimental Treatment2 Interventions

Pegilodecakin (5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV

Group XVII: Part B: Dose Escalation Cohort 1Experimental Treatment2 Interventions

Pegilodecakin (2.5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV

Group XVIII: Part A: Dose Expansion Cohort 1Experimental Treatment1 Intervention

at least 15 RCC participants will be dosed with pegilodecakin for up to 22 months

Group XIX: Part A: Dose Escalation Cohort 6Experimental Treatment1 Intervention

Pegilodecakin (40 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months

Group XX: Part A: Dose Escalation Cohort 5Experimental Treatment1 Intervention

Pegilodecakin (20 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months

Group XXI: Part A: Dose Escalation Cohort 4Experimental Treatment1 Intervention

Pegilodecakin (10 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months

Group XXII: Part A: Dose Escalation Cohort 3Experimental Treatment1 Intervention

Pegilodecakin (5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months

Group XXIII: Part A: Dose Escalation Cohort 2Experimental Treatment1 Intervention

Pegilodecakin (2.5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months

Group XXIV: Part A: Dose Escalation Cohort 1Experimental Treatment1 Intervention

Pegilodecakin (1 ug/kg) - Daily subcutaneous (SC) injections of pegilodecakin for up to 22 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

FDA approved

Pazopanib

FDA approved

Pegilodecakin

Not yet FDA approved

Pembrolizumab

FDA approved

Paclitaxel

FDA approved

Capecitabine

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,613 Previous Clinical Trials

3,200,579 Total Patients Enrolled

9 Trials studying Melanoma

848 Patients Enrolled for Melanoma

ARMO BioSciencesIndustry Sponsor

7 Previous Clinical Trials

768 Total Patients Enrolled

1 Trials studying Melanoma

Study DirectorEli Lilly and Company

1,344 Previous Clinical Trials

404,902 Total Patients Enrolled

3 Trials studying Melanoma

572 Patients Enrolled for Melanoma

Media Library

Pegilodecakin (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT02009449 — Phase 1

Melanoma Research Study Groups: Part A: Dose Escalation Cohort 3, Part A: Dose Escalation Cohort 4, Part A: Dose Escalation Cohort 5, Part A: Dose Escalation Cohort 6, Part A: Dose Expansion Cohort 1, Part B: Dose Expansion Cohort, Part G: Dose Escalation Cohort 1, Part I: Dose Escalation Cohort 1, Part H: Dose Escalation Cohort 3, Part J: Dose Escalation Cohort 1, Part H: Dose Escalation Cohort 1, Part A: Dose Escalation Cohort 1, Part H: Dose Escalation Cohort 2, Part E: Dose Escalation Cohort 1, Part C: Dose Expansion Cohort 1, Part C: Dose Escalation Cohort 3, Part A: Dose Escalation Cohort 2, Part B: Dose Escalation Cohort 3, Part C: Dose Escalation Cohort 1, Part C: Dose Escalation Cohort 2, Part D: Dose Escalation Cohort 1, Part B: Dose Escalation Cohort 1, Part B: Dose Escalation Cohort 2, Part F: Dose Escalation Cohort 1

Melanoma Clinical Trial 2023: Pegilodecakin Highlights & Side Effects. Trial Name: NCT02009449 — Phase 1

Pegilodecakin (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02009449 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on participants for this clinical research?

"This trial has since closed for recruitment. It was initially posted on November 15th 2013 and updated for the final time on November 15th 2022. For those searching other trials, there are 8352 studies seeking patients with prostate cancer and 3627 recruiting participants to test Pembrolizumab's efficacy."

Answered by AI

What conditions is Pembrolizumab usually prescribed to treat?

"Pembrolizumab offers patients with melanoma, macrocytic anemia, and metastasized neoplasm a potential therapy."

Answered by AI

Can you provide an overview of the research conducted on Pembrolizumab?

"Currently, 819 trials are in the third phase of development for Pembrolizumab and a total of 3627 studies dedicated to this drug are ongoing. Additionally, 159446 locations across the globe run clinical trials involving Pembrolizumab with several based out Guangzhou, Guangdong."

Answered by AI

How does Pembrolizumab fare in terms of patient risk?

"Data from this phase 1 trial suggests limited safety and efficacy, so Power gave Pembrolizumab a score of one."

Answered by AI

How widespread is the implementation of this experiment?

"This study is actively recruiting patients at Sarah Cannon Research Institute (HealthONE, Denver), Dana Farber Cancer Institute (Boston), and Stephenson Cancer Center (Oklahoma University TSET Phase 1 Program; Oklahoma City). Additionally, there are 8 other clinical trial sites."

Answered by AI

Are enrollment opportunities for this experiment presently accessible to participants?

"According to the clinicaltrials.gov database, this study is not actively seeking new participants at this time. While it was initially posted in 2013 and last edited in 2022, there are 11979 other trials currently recruiting patients."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Pegilodecakin Combined with Pembrolizumab or Nivolumab for Patients with Advanced Solid Tumours (IVY): A Multicentre, Multicohort, Open-label, Phase 1b Trial

Naing, Aung, Deborah J Wong, Jeffrey R Infante, W Michael Korn, Raid Aljumaily, Kyriakos P Papadopoulos, Karen A Autio, et al.. 2019. “Pegilodecakin Combined with Pembrolizumab or Nivolumab for Patients with Advanced Solid Tumours (IVY): A Multicentre, Multicohort, Open-label, Phase 1b Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(19)30514-5.

Journal of Clinical OncologyJournal

Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human Interleukin-10 (AM0010) in Patients with Advanced Solid Tumors

Naing, Aung, Kyriakos P. Papadopoulos, Karen A. Autio, Patrick A. Ott, Manish R. Patel, Deborah J. Wong, Gerald S. Falchook, et al.. 2016. “Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human Interleukin-10 (AM0010) in Patients with Advanced Solid Tumors”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2016.68.1106.

clinicaltrials.govStudy

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

2013. "A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02009449.

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