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Cytokine

Pegilodecakin for Solid Tumors (IVY Trial)

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
Part A Escalation Cohorts: 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group

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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I have a specific type of advanced cancer that does not respond to standard treatments.
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My tumor can be of any type or origin for the study.
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My previous cancer treatment didn’t work, I refused other treatments, or my current treatment is standard for my condition.
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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.
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My organs are working well.
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I have a specific type of advanced cancer that does not respond to standard treatments.
Select...
My prostate cancer can be measured or evaluated by specific criteria.
Select...
I am 18 years old or older.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

IVY Trial Timeline

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)

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Paclitaxel
FDA approved
Pegilodecakin
Not yet FDA approved
Pembrolizumab
FDA approved
Nivolumab
FDA approved
Pazopanib
FDA approved
Capecitabine
FDA approved

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,594 Previous Clinical Trials
3,184,457 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
1,330 Previous Clinical Trials
401,196 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 2, Part A: Dose Escalation Cohort 3, Part A: Dose Escalation Cohort 5, Part A: Dose Escalation Cohort 6, Part A: Dose Expansion Cohort 1, Part B: Dose Escalation Cohort 3, Part B: Dose Expansion Cohort, Part C: Dose Escalation Cohort 1, Part C: Dose Escalation Cohort 2, Part C: Dose Escalation Cohort 3, Part E: Dose Escalation Cohort 1, Part G: Dose Escalation Cohort 1, Part H: Dose Escalation Cohort 1, Part I: Dose Escalation Cohort 1, Part H: Dose Escalation Cohort 2, Part H: Dose Escalation Cohort 3, Part J: Dose Escalation Cohort 1, Part A: Dose Escalation Cohort 4, Part A: Dose Escalation Cohort 1, Part C: Dose Expansion Cohort 1, 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
~31 spots leftby Feb 2025