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

PHASE1CompletedINTERVENTIONAL
Enrollment

353

Participants

Timeline

Start Date

November 15, 2013

Primary Completion Date

February 19, 2019

Study Completion Date

July 22, 2023

Conditions
MelanomaProstate CancerOvarian CancerRenal Cell CarcinomaColorectal CarcinomaPancreatic CarcinomaNon-small Cell Lung CarcinomaSolid TumorsBreast Cancer
Interventions
DRUG

Pegilodecakin

Daily subcutaneous injections of pegilodecakin up to 12 months

DRUG

Paclitaxel or Docetaxel and Carboplatin or Cisplatin

Day 1 of every 21 day cycle

DRUG

FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)

Intravenous administration on Day 1 and 2 of every 14 day cycle

DRUG

gemcitabine/nab-paclitaxel

Intravenous administration of the gemcitabine/nab-paclitaxel regimen on Day 1, 8 and 15 of each 28 day treatment cycle.

DRUG

Capecitabine

Capecitabine will be administered orally twice daily for 14 days out of every 21 days.

DRUG

Pazopanib

Pazopanib will be administered orally daily continuously

DRUG

Pembrolizumab

Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.

DRUG

Paclitaxel

"Paclitaxel will be administered intravenously on Days 1, 8, 15 of each cycle (28 days= 1 cycle)~• Paclitaxel 80 mg/ m2 IV"

DRUG

nivolumab

Nivolumab on Day 1 of each cycle (14 days = 1 cycle)

DRUG

Gemcitabine/carboplatin

gemcitabine and carboplatin on Days 1, 8 of each cycle (21 days = 1 cycle)

Trial Locations (10)

10065

Memorial Sloan Kettering Cancer Center, New York

34232

Florida Cancer Specialists & Research Institute, Sarasota

37203

Sarah Cannon Research Institute, Nashville

73104

Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program, Oklahoma City

77030

The University of Texas M.D. Anderson Cancer Center, Houston

78229

South Texas Accelerated Research Therapeutics, San Antonio

80218

Sarah Cannon Research Institute at HealthONE, Denver

90024

UCLA Medical Hematology & Oncology, Los Angeles

Unknown

UCSF, San Francisco

02215

Dana Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ARMO BioSciences

INDUSTRY

lead

Eli Lilly and Company

INDUSTRY