Une étude de phase 1 sur la pegilodecakine (LY3500518) chez des participants atteints de tumeurs solides avancées (IVY)
Une première étude ouverte de phase 1 avec escalade de dose chez l'homme pour évaluer la tolérance, l'innocuité, la dose maximale tolérée, l'activité clinique préliminaire et la pharmacocinétique de l'AM0010 chez les patients atteints de tumeurs solides avancées
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Médicament: Pegilodecakin
- Médicament: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
- Médicament: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
- Médicament: gemcitabine/nab-paclitaxel
- Médicament: Capecitabine
- Médicament: Paclitaxel
- Médicament: Pazopanib
- Médicament: Pembrolizumab
- Médicament: Gemcitabine/carboplatin
- Médicament: nivolumab
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90024
- UCLA Medical Hematology & Oncology
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San Francisco, California, États-Unis
- UCSF
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Colorado
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Denver, Colorado, États-Unis, 80218
- Sarah Cannon Research Institute at HealthONE
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Florida
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Sarasota, Florida, États-Unis, 34232
- Florida Cancer Specialists & Research Institute
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Dana Farber Cancer Institute
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New York
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New York, New York, États-Unis, 10065
- Memorial Sloan Kettering Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73104
- Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program
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Tennessee
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Nashville, Tennessee, États-Unis, 37203
- Sarah Cannon Research Institute
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Texas
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Houston, Texas, États-Unis, 77030
- The University of Texas M.D. Anderson Cancer Center
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San Antonio, Texas, États-Unis, 78229
- South Texas Accelerated Research Therapeutics
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
La description
Critère d'intégration:
Cohortes d'escalade de la partie A :
o Tumeur solide maligne avancée confirmée histologiquement ou cytologiquement, limitée au mélanome, au cancer de la prostate résistant à la castration (CRPC), au cancer de l'ovaire (OVCA), au carcinome à cellules rénales, au carcinome colorectal (CRC), au carcinome pancréatique ou au carcinome pulmonaire non à petites cellules (NSCLC) qui est réfractaire, intolérant, pour lequel aucune norme thérapeutique n'est disponible ou pour laquelle le participant refuse les thérapies existantes
Cohortes d'expansion de la partie A, cohortes d'escalade et d'expansion des parties B et C :
- Les tumeurs avec tout diagnostic histologique ou origine tissulaire peuvent être inscrites
Les participants doivent avoir échoué à une chimiothérapie curative standard antérieure pour leur maladie, refuser les thérapies existantes OU le régime de chimiothérapie proposé auquel la pegilodecakin est ajoutée représente un traitement standard acceptable pour leur maladie.
- Maladie mesurable ou évaluable selon l'irRC ou maladie métastatique osseuse évaluable selon les critères du groupe de travail sur le cancer de la prostate 2 (PCWG2) pour le cancer de la prostate résistant à la castration (CRPC)
- Au moins 18 ans
- Statut de performance de 0 ou 1
- Fonction organique adéquate
Critère d'exclusion:
- Hémopathies malignes
- Enceinte ou allaitante
- Présent ou antécédents de troubles neurologiques tels que la sclérose en plaques et Guillain Barre ou des troubles inflammatoires du système nerveux central/système nerveux périphérique (SNC/SNP)
- Infarctus du myocarde au cours des 6 derniers mois
- Angor instable ou arythmie cardiaque instable nécessitant des médicaments
- Chirurgie dans les 28 derniers jours
- Infection systémique fongique, bactérienne, virale ou autre
- Antécédents de diathèse hémorragique au cours des 6 derniers mois
- Positif pour le virus de l'immunodéficience humaine (VIH), l'hépatite C ou l'hépatite B
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
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Expérimental: 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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Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
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Expérimental: 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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Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
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Expérimental: 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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Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
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Expérimental: 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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Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
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Expérimental: 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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Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle.
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
Capecitabine administered orally twice daily for 14 days out of every 21 days.
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle)
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
Pazopanib administered orally daily continuously
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
Autres noms:
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Expérimental: 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. |
Injections sous-cutanées quotidiennes de pegilodecakin jusqu'à 12 mois
Autres noms:
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Participants With TEAEs and SAEs Observed During the Study of Pegilodecakin
Délai: 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
Délai: Day 29
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Serum concentration of Pegilodecakin is reported.
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Day 29
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Participants With Anti-Pegilodecakin Antibody Formation
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: 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
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Maladies du système endocrinien
- Tumeurs génitales, homme
- Tumeurs urogénitales
- Tumeurs par site
- Maladies génitales, sexe masculin
- Maladies de la prostate
- Maladies urogénitales masculines
- Maladies rénales
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies intestinales
- Maladies des voies respiratoires
- Tumeurs par type histologique
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies gastro-intestinales
- Tumeurs intestinales
- Maladies rectales
- Maladies génitales, femme
- Maladies pulmonaires
- Tumeurs des glandes endocrines
- Maladies pancréatiques
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Maladies du côlon
- Tumeurs pulmonaires
- Maladies ovariennes
- Maladies annexielles
- Tumeurs génitales, femme
- Troubles gonadiques
- Maladies de la peau
- Maladies du sein
- Tumeurs urologiques
- Carcinome
- Tumeurs neuroectodermiques
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs, tissu nerveux
- Tumeurs rénales
- Carcinome bronchique
- Tumeurs bronchiques
- Tumeurs neuroendocrines
- Nevi et mélanomes
- Tumeurs cutanées
- Maladies de la peau et du tissu conjonctif
- Tumeurs
- Tumeurs prostatiques
- Tumeurs colorectales
- Tumeurs ovariennes
- Tumeurs mammaires
- Tumeurs pancréatiques
- Carcinome à cellules rénales
- Carcinome pulmonaire non à petites cellules
- Mélanome
- Acides aminés, peptides et protéines
- Protéines
- Produits chimiques organiques
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Acides nucléiques, nucléotides et nucléosides
- Hydrocarbures
- Cycloparaffines
- Hydrocarbures, alicyclique
- Hydrocarbures, cyclique
- Terpènes
- Anticorps, monoclonal, humanisé
- Anticorps, monoclonal
- Anticorps
- Immunoglobulines
- Immunoprotéines
- Protéines sanguines
- Globulines sériques
- Globulines
- Produits chimiques inorganiques
- Composés de chlore
- Composés d'azote
- Complexes de coordination
- Taxes
- Cyclodécanes
- Diterpènes
- Désoxycytidine
- Cytidine
- Nucléosides pyrimidine
- Pyrimidines
- Nucléosides
- Uracile
- Pyrimidinones
- Composés en platine
- Désoxyribonucléosides
- Fluorouracile
- Docétaxel
- Capécitabine
- Oxaliplatine
- Nivolumab
- Gemcitabine
- Carboplatine
- Paclitaxel
- Cisplatine
- pembrolizumab
- Protocole Folfox
- pazopanib
- pegilodecakin
- AM0010
Autres numéros d'identification d'étude
- 17159
- J1L-AM-JZGA (Autre identifiant: Eli Lilly and Company)
- AM0010-001 (Autre identifiant: ARMO BioSciences)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .