En fase 1-studie av Pegilodecakin (LY3500518) hos deltakere med avanserte solide svulster (IVY)
En fase 1, åpen doseeskalering første-i-menneske-studie for å evaluere tolerabilitet, sikkerhet, maksimal tolerert dose, foreløpig klinisk aktivitet og farmakokinetikk av AM0010 hos pasienter med avanserte solide svulster
Studieoversikt
Status
Forhold
Intervensjon / Behandling
- Legemiddel: Pegilodecakin
- Legemiddel: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
- Legemiddel: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
- Legemiddel: gemcitabine/nab-paclitaxel
- Legemiddel: Capecitabine
- Legemiddel: Paclitaxel
- Legemiddel: Pazopanib
- Legemiddel: Pembrolizumab
- Legemiddel: Gemcitabine/carboplatin
- Legemiddel: nivolumab
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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California
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Los Angeles, California, Forente stater, 90024
- UCLA Medical Hematology & Oncology
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San Francisco, California, Forente stater
- UCSF
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Colorado
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Denver, Colorado, Forente stater, 80218
- Sarah Cannon Research Institute at HealthONE
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Florida
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Sarasota, Florida, Forente stater, 34232
- Florida Cancer Specialists & Research Institute
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Dana Farber Cancer Institute
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New York
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New York, New York, Forente stater, 10065
- Memorial Sloan Kettering Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- Sarah Cannon Research Institute
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Texas
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Houston, Texas, Forente stater, 77030
- The University of Texas M.D. Anderson Cancer Center
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San Antonio, Texas, Forente stater, 78229
- South Texas Accelerated Research Therapeutics
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
Del A-eskaleringskohorter:
o Histologisk eller cytologisk bekreftet avansert malign solid svulst, begrenset til melanom, kastratresistent prostatakreft (CRPC), eggstokkreft (OVCA), nyrecellekarsinom, kolorektalt karsinom (CRC), pankreaskarsinom eller ikke-småcellet lungekarsinom (NSCLC) som er refraktær overfor, intolerant overfor, som det ikke finnes noen standard for terapi for, eller hvor deltakeren nekter eksisterende terapier
Del A utvidelseskohorter, del B og C Eskalering og utvidelseskohorter:
- Tumorer med alle histologiske diagnoser eller vevsopprinnelse kan bli registrert
Deltakerne må ha mislyktes tidligere standard kurativ kjemoterapi for sin sykdom, nekte eksisterende terapier ELLER det foreslåtte kjemoterapiregimet som pegilodecakin tilsettes representerer en akseptabel standardbehandling for sykdommen deres.
- Målbar eller evaluerbar sykdom i henhold til irRC eller benmetastatisk sykdom som kan evalueres av Prostate Cancer Working Group 2-kriterier (PCWG2) for kastrasjonsresistent prostatakreft (CRPC)
- Minst 18 år
- Ytelsesstatus på 0 eller 1
- Tilstrekkelig organfunksjon
Ekskluderingskriterier:
- Hematologiske maligniteter
- Gravid eller ammende
- Nåværende eller historie med nevrologiske lidelser som multippel sklerose og Guillain Barre eller inflammatoriske forstyrrelser i sentralnervesystemet/perifert nervesystem (CNS/PNS)
- Hjerteinfarkt de siste 6 månedene
- Ustabil angina, eller ustabil hjertearytmi som krever medisinering
- Kirurgi i løpet av de siste 28 dagene
- Systemisk sopp, bakteriell, viral eller annen infeksjon
- Anamnese med blødende diatese i løpet av de siste 6 månedene
- Positiv for humant immunsviktvirus (HIV), hepatitt C eller hepatitt B
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Part A: Pegilodecakin 0.08/0.1 mg
Participants received 0.08 or 0.1 mg of Pegilodecakin once daily (QD) administered subcutaneously (SC). Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
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Eksperimentell: Part A: Pegilodecakin 0.2/0.25 mg
Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC.
Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
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Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
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Eksperimentell: Part A: Pegilodecakin 0.4/0.5 mg
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC.
Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
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Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
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Eksperimentell: Part A: Pegilodecakin 0.8/1 mg
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC.
Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
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Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
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Eksperimentell: Part A: Pegilodecakin 1.6/2 mg
Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC.
Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
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Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
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Eksperimentell: Part A: Pegilodecakin 3.2/4 mg
Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC.
Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial.
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Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
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Eksperimentell: Part B: Pegilodecakin 0.2/0.25 mg + Platinum/Taxane
Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Andre navn:
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Eksperimentell: Part B: Pegilodecakin 0.4/0.5 mg + Platinum/Taxane
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Andre navn:
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Eksperimentell: Part B: Pegilodecakin 0.8/1 mg + Platinum/Taxane
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC along with Platinum/Taxane combination on Day 1 of each 21-day cycle for a maximum of 5 or 6 cycles. Participants received: Paclitaxel 200 or 175 mg/m² intravenously (IV) over 3 hours, or docetaxel 75 or 65 mg/m² IV over 1 hour, followed by carboplatin (AUC 6/5/4; max 6 × 150 mg) IV over 30 minutes or cisplatin 75 mg/m² IV over 6-8 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Andre navn:
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Eksperimentell: Part C: Pegilodecakin 0.2/0.25 mg + FOLFOX
Participants received 0.2 or 0.25 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-Fluorouracil (FU) 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Andre navn:
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Eksperimentell: Part C: Pegilodecakin 0.4/0.5 mg + FOLFOX
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Andre navn:
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Eksperimentell: Part C: Pegilodecakin 0.8/1 mg + FOLFOX
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC and FOLFOX treatment on Day 1 of each 14-day cycle for a maximum of 12 cycles. Participants received: oxaliplatin 85 mg/m2 IV over 2 hours, and leucovorin 200 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, 5-FU 600 mg/m2/day IV over 22 hours, and leucovorin 200 mg/m2 over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus over 2-4 minutes, and 5-FU 600 mg/m2/day IV over 22 hours. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Andre navn:
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Eksperimentell: Part D: Pegilodecakin 0.4/ 0.5 mg + Gemcitabine/Nab-Paclitaxel
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with Gemcitabine 1000 mg/m2 IV over 30 minutes plus nab-paclitaxel 125 mg/m2 IV over 30 to 40 minutes on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle.
Andre navn:
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Eksperimentell: Part E: Pegilodecakin 0.8/1 mg + Capecitabine
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Capecitabine 1000 mg/m² orally twice daily (BID) on Days 1 through 14 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
Capecitabine administered orally twice daily for 14 days out of every 21 days.
Andre navn:
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Eksperimentell: Part F: Pegilodecakin 0.8/ 1 mg + Paclitaxel
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Paclitaxel 80 mg/m2 IV over 3 hours on Days 1, 8, and 15 of every 28-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle)
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Eksperimentell: Part G: Pegilodecakin 0.8/1 mg + Pazopanib
Participants received a 0.8 or 1 mg of Pegilodecakin QD administered SC with Pazopanib 800 mg orally QD. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
Pazopanib administered orally daily continuously
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Eksperimentell: Part H: Pegilodecakin 0.8/1 mg + Pembrolizumab
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Andre navn:
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Eksperimentell: Part H: Pegilodecakin 1.6/2 mg + Pembrolizumab
Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Andre navn:
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Eksperimentell: Part H: Pegilodecakin 3.2/4 mg + Pembrolizumab
Participants received 3.2 or 4 mg of Pegilodecakin QD administered SC with Pembrolizumab 2 mg/kg bolus IV infusion over 30 minutes on Day 1 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Andre navn:
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Eksperimentell: Part J: Pegilodecakin 0.8/1 mg + Gemcitabine/Carboplatin
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an Area Under the Curve of 2 mg/mL x min (AUC2) IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
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Eksperimentell: Part I: Pegilodecakin 1.6/2 mg + Nivolumab
Participants received 1.6 or 2 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
Andre navn:
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Eksperimentell: Part I: Pegilodecakin 0.8/1 mg + Nivolumab
Participants received 0.8 or 1 mg of Pegilodecakin QD administered SC with Nivolumab 3 mg/kg IV infusion over 60 minutes on Day 1 of each 14-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
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Eksperimentell: Part J: Pegilodecakin 0.4/0.5 mg + Gemcitabine/Carboplatin
Participants received 0.4 or 0.5 mg of Pegilodecakin QD administered SC with gemcitabine 500 mg/m2 IV over 30 minutes followed by carboplatin targeting an AUC2 IV over 60 minutes on Days 1 and 8 of each 21-day cycle. Study treatment continued until disease progression, death, unacceptable toxicity, or end of trial. |
Daglige subkutane injeksjoner av pegilodecakin opptil 12 måneder
Andre navn:
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With TEAEs and SAEs Observed During the Study of Pegilodecakin
Tidsramme: From first dose of study drug through 30 days after the last dose of study drug (Up to 63 Months)
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The number of participants who experienced treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study.
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From first dose of study drug through 30 days after the last dose of study drug (Up to 63 Months)
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Pharmacokinetic (PK): Serum Concentration of Pegilodecakin
Tidsramme: Day 29
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Serum concentration of Pegilodecakin is reported.
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Day 29
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Number of Participants With Anti-Pegilodecakin Antibody Formation
Tidsramme: Up to 63 Months
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Number of participants with treatment-emergent anti-Pegilodecakin antibodies, defined as participants with at least one postbaseline anti-drug antibody (ADA) titer ≥4-fold increase from baseline (treatment-boosted) or ADA present with titer ≥1:20 if baseline ADA was negative (treatment-induced), analyses were conducted in the TE ADA-evaluable population.
A participant is TE ADA evaluable if at least one non-missing ADA result is available at both baseline and postbaseline.
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Up to 63 Months
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Part A: Number of Participants With Overall Response Rate (ORR)
Tidsramme: From Date of First Dose of study drug until Disease Progression or Death (Up to 54 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of Immune-related Complete Response (irCR) or Immune-related Partial Response (irPR). irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of study drug until Disease Progression or Death (Up to 54 months)
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Part B: Number of Participants With Overall Response Rate (ORR)
Tidsramme: From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
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Part C: Number of Participants With Overall Response Rate (ORR)
Tidsramme: From Date of First Dose of Study drug until Disease Progression or Death (Upto 23 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study drug until Disease Progression or Death (Upto 23 months)
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Part D: Number of Participants With Overall Response Rate (ORR)
Tidsramme: From Date of First Dose of Study Drug until Disease Progression or Death (Up to 7 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 7 months)
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Part E: Number of Participants With Overall Response Rate (ORR)
Tidsramme: From Date of First Dose of study drug until Disease Progression or Death (Upto 12 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of study drug until Disease Progression or Death (Upto 12 months)
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Part F: Number of Participants With Overall Response Rate (ORR)
Tidsramme: From Date of First Dose of Study Drug until Disease Progression or Death (Up to 3 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 3 months)
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Part G: Number of Participants With Overall Response Rate (ORR)
Tidsramme: From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
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Part H: Number of Participants With Overall Response Rate (ORR)
Tidsramme: From Date of First Dose of Study Drug until Disease Progression or Death (Up to 48 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 48 months)
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Part I: Number of Participants With Overall Response Rate (ORR)
Tidsramme: From Date of First Dose of Study Drug until Disease Progression or Death (Up to 50 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 50 months)
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Part J: Number of Participants With Overall Response Rate (ORR)
Tidsramme: From Date of First Dose of Study Drug until Disease Progression or Death (Up to 8 months)
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Overall response rate was assessed according to Immune-related Response Criteria (irRC) (Wolchok, Hoos et al. 2009). ORR is the number of participants with a best overall response of irCR or irPR. irCR is defined as complete disappearance of all lesions with no new lesions; irPR as a ≥50% decrease in tumor burden from baseline; both are confirmed ≥4 weeks after initial documentation. Only participants with adequate irRC tumor assessments (baseline and ≥1 post-baseline) and without major protocol deviations, were included in the analysis. |
From Date of First Dose of Study Drug until Disease Progression or Death (Up to 8 months)
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Naing A, Papadopoulos KP, Autio KA, Ott PA, Patel MR, Wong DJ, Falchook GS, Pant S, Whiteside M, Rasco DR, Mumm JB, Chan IH, Bendell JC, Bauer TM, Colen RR, Hong DS, Van Vlasselaer P, Tannir NM, Oft M, Infante JR. Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human Interleukin-10 (AM0010) in Patients With Advanced Solid Tumors. J Clin Oncol. 2016 Oct 10;34(29):3562-3569. doi: 10.1200/JCO.2016.68.1106.
- Naing A, Wong DJ, Infante JR, Korn WM, Aljumaily R, Papadopoulos KP, Autio KA, Pant S, Bauer TM, Drakaki A, Daver NG, Hung A, Ratti N, McCauley S, Van Vlasselaer P, Verma R, Ferry D, Oft M, Diab A, Garon EB, Tannir NM. Pegilodecakin combined with pembrolizumab or nivolumab for patients with advanced solid tumours (IVY): a multicentre, multicohort, open-label, phase 1b trial. Lancet Oncol. 2019 Nov;20(11):1544-1555. doi: 10.1016/S1470-2045(19)30514-5. Epub 2019 Sep 25.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Antatt)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Sykdommer i det endokrine systemet
- Genitale neoplasmer, hanner
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Kjønnssykdommer, mannlige
- Prostata sykdommer
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Tarmsykdommer
- Sykdommer i luftveiene
- Neoplasmer etter histologisk type
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Kjønnssykdommer, kvinner
- Lungesykdommer
- Neoplasmer i endokrine kjertel
- Pankreassykdommer
- Neoplasmer, kjertel og epitel
- Adenokarsinom
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Kolonsykdommer
- Lungeneoplasmer
- Sykdommer i eggstokkene
- Adnexal sykdommer
- Genitale neoplasmer, kvinnelige
- Gonadal lidelser
- Hudsykdommer
- Bryst sykdommer
- Urologiske neoplasmer
- Karsinom
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Nyre-neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Nevroendokrine svulster
- Nevi og melanomer
- Neoplasmer i huden
- Hud- og bindevevssykdommer
- Neoplasmer
- Prostatiske neoplasmer
- Kolorektale neoplasmer
- Neoplasmer i eggstokkene
- Brystneoplasmer
- Neoplasmer i bukspyttkjertelen
- Karsinom, nyrecelle
- Karsinom, ikke-småcellet lunge
- Melanom
- Aminosyrer, peptider og proteiner
- Proteiner
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Nukleinsyrer, nukleotider og nukleosider
- Hydrokarboner
- Cycloparaffins
- Hydrokarboner, alicyklisk
- Hydrokarboner, syklisk
- Terpener
- Antistoffer, monoklonalt, humanisert
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Uorganiske kjemikalier
- Klorforbindelser
- Nitrogenforbindelser
- Koordinasjonskomplekser
- Taxoider
- Cyclodecanes
- Diterpenes
- Deoxycytidine
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- Nukleosider
- Uracil
- Pyrimidinoner
- Platinumforbindelser
- Deoxyribonucleosides
- Fluorouracil
- Docetaxel
- Capecitabin
- Oksaliplatin
- Nivolumab
- Gemcitabin
- Karboplatin
- Paclitaxel
- Cisplatin
- pembrolizumab
- FOLFOX -protokoll
- Pazopanib
- pegilodecakin
- AM0010
Andre studie-ID-numre
- 17159
- J1L-AM-JZGA (Annen identifikator: Eli Lilly and Company)
- AM0010-001 (Annen identifikator: ARMO BioSciences)
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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