Vaiheen 1 tutkimus pegilodekakinista (LY3500518) osallistujilla, joilla on edennyt kiinteitä kasvaimia (IVY)
Vaihe 1, avoin annoksen eskalointi, ensimmäinen ihmistutkimus, jossa arvioidaan AM0010:n siedettävyyttä, turvallisuutta, suurinta siedettyä annosta, alustavaa kliinistä aktiivisuutta ja farmakokinetiikkaa potilailla, joilla on edennyt kiinteitä kasvaimia
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Opiskelupaikat
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California
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Los Angeles, California, Yhdysvallat, 90024
- UCLA Medical Hematology & Oncology
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San Francisco, California, Yhdysvallat
- UCSF
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Colorado
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Denver, Colorado, Yhdysvallat, 80218
- Sarah Cannon Research Institute at HealthONE
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Florida
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Sarasota, Florida, Yhdysvallat, 34232
- Florida Cancer Specialists & Research Institute
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02215
- Dana Farber Cancer Institute
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New York
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New York, New York, Yhdysvallat, 10065
- Memorial Sloan Kettering Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Yhdysvallat, 73104
- Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program
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Tennessee
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Nashville, Tennessee, Yhdysvallat, 37203
- Sarah Cannon Research Institute
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Texas
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Houston, Texas, Yhdysvallat, 77030
- The University of Texas M.D. Anderson Cancer Center
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San Antonio, Texas, Yhdysvallat, 78229
- South Texas Accelerated Research Therapeutics
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Sisällyttämiskriteerit:
Osa A Eskalointikohortit:
o Histologisesti tai sytologisesti vahvistettu pitkälle edennyt pahanlaatuinen kiinteä kasvain, joka rajoittuu melanoomaan, kastraattiresistenttiin eturauhassyöpään (CRPC), munasarjasyöpään (OVCA), munuaissolusyöpään, kolorektaalisyöpään (CRC), haimasyöpään tai ei-pienisoluiseen keuhkosyöpään (NSCLC) joka on tulenkestävä, ei siedä sitä, jolle ei ole saatavilla standardihoitoa tai jos osallistuja kieltäytyy olemassa olevista hoidoista
Osan A laajennuskohortit, osan B ja C eskalaatio- ja laajennuskohortit:
- Kasvaimia, joilla on kaikki histologinen diagnoosi tai kudosalkuperä, voidaan ottaa mukaan
Osallistujien on täytynyt epäonnistua sairautensa aiemmassa parantavassa kemoterapiassa, kieltäytyä olemassa olevista hoidoista TAI ehdotettu kemoterapia-ohjelma, johon lisätään pegilodekakiinia, edustaa heidän sairautensa hyväksyttävää standardihoitoa.
- Mitattavissa oleva tai arvioitava sairaus irRC:n mukaan tai luumetastaattinen sairaus, joka voidaan arvioida eturauhassyövän työryhmän 2 kriteereillä (PCWG2) kastraatioresistentille eturauhassyövälle (CRPC)
- Vähintään 18-vuotias
- Suorituskyvyn tila 0 tai 1
- Riittävä elinten toiminta
Poissulkemiskriteerit:
- Hematologiset pahanlaatuiset kasvaimet
- Raskaana oleva tai imettävä
- Neurologiset sairaudet, kuten multippeliskleroosi ja Guillain Barre tai tulehdukselliset keskushermoston/ääreishermoston (CNS/PNS) häiriöt
- Sydäninfarkti viimeisen 6 kuukauden aikana
- Epästabiili angina pectoris tai epästabiili sydämen rytmihäiriö, joka vaatii lääkitystä
- Leikkaus viimeisen 28 päivän aikana
- Systeeminen sieni-, bakteeri-, virus- tai muu infektio
- Aiempi verenvuotodiateesi viimeisen 6 kuukauden aikana
- Positiivinen ihmisen immuunikatovirukselle (HIV), hepatiitti C:lle tai hepatiitti B:lle
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
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Kokeellinen: 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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Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
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Kokeellinen: 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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Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
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Kokeellinen: 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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Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
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Kokeellinen: 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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Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
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Kokeellinen: 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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Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle.
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
Capecitabine administered orally twice daily for 14 days out of every 21 days.
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle)
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
Pazopanib administered orally daily continuously
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
Muut nimet:
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Kokeellinen: 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. |
Päivittäiset pegilodekakiiniinjektiot ihon alle 12 kuukauden ajan
Muut nimet:
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of Participants With TEAEs and SAEs Observed During the Study of Pegilodecakin
Aikaikkuna: 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
Aikaikkuna: Day 29
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Serum concentration of Pegilodecakin is reported.
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Day 29
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of Participants With Anti-Pegilodecakin Antibody Formation
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Opintojohtaja: 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
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
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Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvioitu)
Tutkimustietojen päivitykset
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Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
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Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Urogenitaaliset sairaudet
- Sukuelinten sairaudet
- Endokriinisen järjestelmän sairaudet
- Sukuelinten kasvaimet, mies
- Urogenitaaliset kasvaimet
- Neoplasmat sivustoittain
- Sukuelinten sairaudet, mies
- Eturauhasen sairaudet
- Miesten urogenitaaliset sairaudet
- Munuaissairaudet
- Urologiset sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet ja raskauden komplikaatiot
- Suoliston sairaudet
- Hengityselinten sairaudet
- Neoplasmat histologisen tyypin mukaan
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan sairaudet
- Ruoansulatuskanavan sairaudet
- Suoliston kasvaimet
- Peräsuolen sairaudet
- Sukuelinten sairaudet, naiset
- Keuhkosairaudet
- Endokriinisten rauhasten kasvaimet
- Haiman sairaudet
- Kasvaimet, rauhas- ja epiteelikasvaimet
- Adenokarsinooma
- Hengitysteiden kasvaimet
- Rintakehän kasvaimet
- Paksusuolen sairaudet
- Keuhkojen kasvaimet
- Munasarjan sairaudet
- Adnexaaliset sairaudet
- Sukuelinten kasvaimet, naiset
- Sukurauhasten häiriöt
- Ihosairaudet
- Rintojen sairaudet
- Urologiset kasvaimet
- Karsinooma
- Neuroektodermaaliset kasvaimet
- Neoplasmat, sukusolut ja alkiot
- Kasvaimet, hermokudos
- Munuaisten kasvaimet
- Syöpä, bronkogeeninen
- Keuhkoputkien kasvaimet
- Neuroendokriiniset kasvaimet
- Nevi ja melanoomat
- Ihon kasvaimet
- Iho- ja sidekudostaudit
- Neoplasmat
- Eturauhasen kasvaimet
- Kolorektaaliset kasvaimet
- Munasarjan kasvaimet
- Rintojen kasvaimet
- Haiman kasvaimet
- Karsinooma, munuaissolut
- Karsinooma, ei-pienisoluinen keuhko
- Melanooma
- Aminohapot, peptidit ja proteiinit
- Proteiinit
- Orgaaniset kemikaalit
- Heterosykliset yhdisteet, 1-rengas
- Heterosykliset yhdisteet
- Nukleiinihapot, nukleotidit ja nukleosidit
- Hiilivety
- Sykloparaffiinit
- Hiilivedyt, aliisykliset
- Hiilivedyt, sykliset
- Terpeenit
- Vasta -aineet, monoklonaalinen, humanisoitu
- Vasta -aineet, monoklonaalinen
- Vasta -aineet
- Immunoglobuliinit
- Immunoproteiinit
- Veriproteiinit
- Seerumin globuliinit
- Globuliinit
- Epäorgaaniset kemikaalit
- Klooriyhdisteet
- Typpiyhdisteet
- Koordinointikompleksit
- Taksoidit
- Syklodekaanit
- Diterpeenit
- Deoksisytidiini
- Syytidiini
- Pyrimidiininnukleosidit
- Pyrimidiinit
- Nukleosidit
- Urasiili
- Pyrimidinonit
- Platinayhdisteet
- Deoksihiobonukleosidit
- Fluorourasiili
- Doketakseli
- Kapesitabiini
- Oksaliplatiini
- Nivolumabi
- Gemsitabiini
- Karboplatiini
- Paklitakseli
- Sisplatiini
- pembrolitsumabi
- Folfox -protokolla
- pazopanibi
- pegilodecakin
- AM0010
Muut tutkimustunnusnumerot
- 17159
- J1L-AM-JZGA (Muu tunniste: Eli Lilly and Company)
- AM0010-001 (Muu tunniste: ARMO BioSciences)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
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Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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