What side effects are associated with this type of intervention?

Common treatments for melanoma, particularly immunotherapies like pembrolizumab and nivolumab, often result in side effects such as fatigue, fever, chills, nausea, joint pain, and headache. Severe side effects can include immune-related adverse events like pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Combination therapies, such as those involving ipilimumab, can increase the incidence of severe toxicities, including gastrointestinal and hepatic toxicities. These side effects are generally manageable with appropriate medical intervention.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of melanoma. Notable among these are checkpoint inhibitors like nivolumab and pembrolizumab, which target PD-1, and ipilimumab, which targets CTLA-4. These drugs enhance the immune system's ability to fight cancer. Additionally, high-dose interleukin-2 (IL-2) has been approved for metastatic melanoma, leveraging its ability to stimulate immune cell activity. These treatments share a common goal with Pegilodecakin in modulating the immune system to enhance anti-tumor activity.

What other types of research exist?

Promising novel alternatives to Pegilodecakin for melanoma patients include: 1) Pembrolizumab (Keytruda), a PD-1 inhibitor, which has shown significant improvements in survival and quality of life in various trials. 2) Nivolumab (Opdivo) combined with Ipilimumab (Yervoy), which has demonstrated prolonged survival in metastatic melanoma. 3) Talimogene laherparepvec (T-VEC) combined with Pembrolizumab, which has shown promising results in advanced melanoma. 4) Experimental therapies such as CAR-T cell therapies and genetically modified tumor vaccines, which are currently being tested in clinical trials.

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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

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

Must not have

Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders

Unstable angina, or unstable cardiac arrhythmia requiring medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had a neurological disorder like Multiple Sclerosis.

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I have unstable heart conditions that need medication.

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I have a blood cancer.

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I have not had a heart attack in the last 6 months.

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I have not had a bleeding disorder in the past 6 months.

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I do not have any ongoing serious infections.

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)

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

Pembrolizumab

FDA approved

Pazopanib

FDA approved

Pegilodecakin

Not yet FDA approved

Nivolumab

FDA approved

Paclitaxel

FDA approved

Capecitabine

FDA approved

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for melanoma, particularly immunotherapies, work by enhancing the body's immune response to target and destroy cancer cells. Checkpoint inhibitors like nivolumab and pembrolizumab block proteins (PD-1/PD-L1) that prevent T-cells from attacking cancer cells, thereby boosting the immune response. Ipilimumab, another checkpoint inhibitor, blocks CTLA-4, a protein that downregulates immune activity, thus enhancing T-cell function. Pegilodecakin (Pegylated Interleukin-10) modulates the immune system by enhancing anti-tumor activity, similar to these immunotherapies. These treatments are crucial for melanoma patients as they offer a targeted approach to combat the cancer by leveraging the body's own immune system, potentially leading to better outcomes and prolonged survival.