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

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Status and phase

Completed
Phase 1

Conditions

Colorectal Carcinoma
Breast Cancer
Melanoma
Solid Tumors
Renal Cell Carcinoma
Ovarian Cancer
Non-small Cell Lung Carcinoma
Prostate Cancer
Pancreatic Carcinoma

Treatments

Drug: gemcitabine/nab-paclitaxel
Drug: Capecitabine
Drug: nivolumab
Drug: Gemcitabine/carboplatin
Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Drug: Paclitaxel
Drug: Pembrolizumab
Drug: Pazopanib
Drug: Pegilodecakin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02009449
J1L-AM-JZGA (Other Identifier)
AM0010-001 (Other Identifier)
17159

Details and patient eligibility

About

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.

Enrollment

353 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)
    • At least 18 years of age
    • Performance Status of 0 or 1
    • Adequate organ function

Exclusion criteria

  • 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
  • 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 design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

353 participants in 24 patient groups

Part A: Dose Escalation Cohort 1
Experimental group
Description:
Pegilodecakin (1 ug/kg) - Daily subcutaneous (SC) injections of pegilodecakin for up to 22 months
Treatment:
Drug: Pegilodecakin
Part A: Dose Escalation Cohort 2
Experimental group
Description:
Pegilodecakin (2.5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
Treatment:
Drug: Pegilodecakin
Part A: Dose Escalation Cohort 3
Experimental group
Description:
Pegilodecakin (5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
Treatment:
Drug: Pegilodecakin
Part A: Dose Escalation Cohort 4
Experimental group
Description:
Pegilodecakin (10 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
Treatment:
Drug: Pegilodecakin
Part A: Dose Escalation Cohort 5
Experimental group
Description:
Pegilodecakin (20 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
Treatment:
Drug: Pegilodecakin
Part A: Dose Escalation Cohort 6
Experimental group
Description:
Pegilodecakin (40 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
Treatment:
Drug: Pegilodecakin
Part A: Dose Expansion Cohort 1
Experimental group
Description:
at least 15 RCC participants will be dosed with pegilodecakin for up to 22 months
Treatment:
Drug: Pegilodecakin
Part B: Dose Escalation Cohort 1
Experimental group
Description:
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
Treatment:
Drug: Pegilodecakin
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Part B: Dose Escalation Cohort 2
Experimental group
Description:
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
Treatment:
Drug: Pegilodecakin
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Part B: Dose Escalation Cohort 3
Experimental group
Description:
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
Treatment:
Drug: Pegilodecakin
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Part B: Dose Expansion Cohort
Experimental group
Description:
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
Treatment:
Drug: Pegilodecakin
Drug: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Part C: Dose Escalation Cohort 1
Experimental group
Description:
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
Treatment:
Drug: Pegilodecakin
Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Part C: Dose Escalation Cohort 2
Experimental group
Description:
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
Treatment:
Drug: Pegilodecakin
Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Part C: Dose Escalation Cohort 3
Experimental group
Description:
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
Treatment:
Drug: Pegilodecakin
Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Part C: Dose Expansion Cohort 1
Experimental group
Description:
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
Treatment:
Drug: Pegilodecakin
Drug: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Part D: Dose Escalation Cohort 1
Experimental group
Description:
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.
Treatment:
Drug: Pegilodecakin
Drug: gemcitabine/nab-paclitaxel
Part E: Dose Escalation Cohort 1
Experimental group
Description:
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
Treatment:
Drug: Pegilodecakin
Drug: Capecitabine
Part F: Dose Escalation Cohort 1
Experimental group
Description:
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
Treatment:
Drug: Pegilodecakin
Drug: Paclitaxel
Part G: Dose Escalation Cohort 1
Experimental group
Description:
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
Treatment:
Drug: Pazopanib
Drug: Pegilodecakin
Part H: Dose Escalation Cohort 1
Experimental group
Description:
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
Treatment:
Drug: Pegilodecakin
Drug: Pembrolizumab
Part I: Dose Escalation Cohort 1
Experimental group
Description:
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
Treatment:
Drug: nivolumab
Part H: Dose Escalation Cohort 2
Experimental group
Description:
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
Treatment:
Drug: Pembrolizumab
Part H: Dose Escalation Cohort 3
Experimental group
Description:
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
Treatment:
Drug: Pembrolizumab
Part J: Dose Escalation Cohort 1
Experimental group
Description:
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
Treatment:
Drug: Gemcitabine/carboplatin

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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