Uno studio di fase 1 di Pegilodecakin (LY3500518) in partecipanti con tumori solidi avanzati (IVY)
Uno studio di fase 1, in aperto, di escalation della dose, il primo nell'uomo per valutare la tollerabilità, la sicurezza, la dose massima tollerata, l'attività clinica preliminare e la farmacocinetica di AM0010 in pazienti con tumori solidi avanzati
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
California
-
Los Angeles, California, Stati Uniti, 90024
- UCLA Medical Hematology & Oncology
-
San Francisco, California, Stati Uniti
- UCSF
-
-
Colorado
-
Denver, Colorado, Stati Uniti, 80218
- Sarah Cannon Research Institute at HealthONE
-
-
Florida
-
Sarasota, Florida, Stati Uniti, 34232
- Florida Cancer Specialists & Research Institute
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02215
- Dana Farber Cancer Institute
-
-
New York
-
New York, New York, Stati Uniti, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Stati Uniti, 73104
- Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program
-
-
Tennessee
-
Nashville, Tennessee, Stati Uniti, 37203
- Sarah Cannon Research Institute
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- The University of Texas M.D. Anderson Cancer Center
-
San Antonio, Texas, Stati Uniti, 78229
- South Texas Accelerated Research Therapeutics
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Descrizione
Criterio di inclusione:
Parte A Escalation Coorti:
o Tumore solido maligno avanzato confermato istologicamente o citologicamente, limitato a melanoma, carcinoma prostatico resistente alla castrazione (CRPC), carcinoma ovarico (OVCA), carcinoma a cellule renali, carcinoma colorettale (CRC), carcinoma pancreatico o carcinoma polmonare non a piccole cellule (NSCLC) che è refrattario a, intollerante a, per il quale non è disponibile uno standard di terapia o in cui il partecipante rifiuta le terapie esistenti
Coorti di espansione della parte A, coorti di escalation ed espansione della parte B e C:
- Possono essere arruolati tumori con tutte le diagnosi istologiche o di origine tissutale
I partecipanti devono aver fallito la precedente chemioterapia curativa standard per la loro malattia, rifiutare le terapie esistenti OPPURE il regime chemioterapico proposto a cui viene aggiunta la pegilodecachina rappresenta un trattamento standard accettabile per la loro malattia.
- Malattia misurabile o valutabile secondo irRC o malattia metastatica ossea valutabile secondo i criteri del gruppo di lavoro 2 sul cancro alla prostata (PCWG2) per il cancro alla prostata resistente alla castrazione (CRPC)
- Almeno 18 anni di età
- Stato delle prestazioni di 0 o 1
- Adeguata funzionalità degli organi
Criteri di esclusione:
- Neoplasie ematologiche
- Incinta o in allattamento
- Presenza o anamnesi di disturbi neurologici come la sclerosi multipla e Guillain Barre o disturbi infiammatori del sistema nervoso centrale/del sistema nervoso periferico (SNC/SNP)
- Infarto del miocardio negli ultimi 6 mesi
- Angina instabile o aritmia cardiaca instabile che richiede farmaci
- Chirurgia negli ultimi 28 giorni
- Infezione sistemica fungina, batterica, virale o di altro tipo
- Storia di diatesi emorragica negli ultimi 6 mesi
- Positivo per virus dell'immunodeficienza umana (HIV), epatite C o epatite B
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
|
|
Sperimentale: 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.
|
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
|
|
Sperimentale: 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.
|
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
|
|
Sperimentale: 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.
|
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
|
|
Sperimentale: 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.
|
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
|
|
Sperimentale: 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.
|
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle.
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
Capecitabine administered orally twice daily for 14 days out of every 21 days.
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle)
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
Pazopanib administered orally daily continuously
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
Altri nomi:
|
|
Sperimentale: 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. |
Iniezioni sottocutanee giornaliere di pegilodecakin fino a 12 mesi
Altri nomi:
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants With TEAEs and SAEs Observed During the Study of Pegilodecakin
Lasso di tempo: From first dose of study drug through 30 days after the last dose of study drug (Up to 63 Months)
|
The number of participants who experienced treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the study.
|
From first dose of study drug through 30 days after the last dose of study drug (Up to 63 Months)
|
|
Pharmacokinetic (PK): Serum Concentration of Pegilodecakin
Lasso di tempo: Day 29
|
Serum concentration of Pegilodecakin is reported.
|
Day 29
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants With Anti-Pegilodecakin Antibody Formation
Lasso di tempo: Up to 63 Months
|
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.
|
Up to 63 Months
|
|
Part A: Number of Participants With Overall Response Rate (ORR)
Lasso di tempo: From Date of First Dose of study drug until Disease Progression or Death (Up to 54 months)
|
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)
|
|
Part B: Number of Participants With Overall Response Rate (ORR)
Lasso di tempo: From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
|
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)
|
|
Part C: Number of Participants With Overall Response Rate (ORR)
Lasso di tempo: From Date of First Dose of Study drug until Disease Progression or Death (Upto 23 months)
|
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)
|
|
Part D: Number of Participants With Overall Response Rate (ORR)
Lasso di tempo: From Date of First Dose of Study Drug until Disease Progression or Death (Up to 7 months)
|
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)
|
|
Part E: Number of Participants With Overall Response Rate (ORR)
Lasso di tempo: From Date of First Dose of study drug until Disease Progression or Death (Upto 12 months)
|
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)
|
|
Part F: Number of Participants With Overall Response Rate (ORR)
Lasso di tempo: From Date of First Dose of Study Drug until Disease Progression or Death (Up to 3 months)
|
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)
|
|
Part G: Number of Participants With Overall Response Rate (ORR)
Lasso di tempo: From Date of First Dose of Study Drug until Disease Progression or Death (Up to 11 months)
|
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)
|
|
Part H: Number of Participants With Overall Response Rate (ORR)
Lasso di tempo: From Date of First Dose of Study Drug until Disease Progression or Death (Up to 48 months)
|
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)
|
|
Part I: Number of Participants With Overall Response Rate (ORR)
Lasso di tempo: From Date of First Dose of Study Drug until Disease Progression or Death (Up to 50 months)
|
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)
|
|
Part J: Number of Participants With Overall Response Rate (ORR)
Lasso di tempo: From Date of First Dose of Study Drug until Disease Progression or Death (Up to 8 months)
|
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)
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Direttore dello studio: 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
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stimato)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Malattie del sistema endocrino
- Neoplasie genitali, maschio
- Neoplasie urogenitali
- Neoplasie per sede
- Malattie genitali, maschio
- Malattie della prostata
- Malattie urogenitali maschili
- Malattie renali
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie intestinali
- Malattie delle vie respiratorie
- Neoplasie per tipo istologico
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Neoplasie intestinali
- Malattie del retto
- Malattie genitali, femmina
- Malattie polmonari
- Neoplasie delle ghiandole endocrine
- Malattie pancreatiche
- Neoplasie, ghiandolari ed epiteliali
- Adenocarcinoma
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Malattie del colon
- Neoplasie polmonari
- Malattie ovariche
- Malattie annessiali
- Neoplasie genitali, femmina
- Disturbi gonadici
- Malattie della pelle
- Malattie del seno
- Neoplasie urologiche
- Carcinoma
- Tumori neuroectodermici
- Neoplasie, cellule germinali ed embrionali
- Neoplasie, tessuto nervoso
- Neoplasie renali
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Tumori neuroendocrini
- Nevi e melanomi
- Neoplasie cutanee
- Malattie della pelle e del tessuto connettivo
- Neoplasie
- Neoplasie prostatiche
- Neoplasie colorettali
- Neoplasie ovariche
- Neoplasie mammarie
- Neoplasie pancreatiche
- Carcinoma, cellule renali
- Carcinoma, polmone non a piccole cellule
- Melanoma
- Aminoacidi, peptidi e proteine
- Proteine
- Prodotti chimici organici
- Composti eterociclici, 1-anello
- Composti eterociclici
- Acidi nucleici, nucleotidi e nucleosidi
- Idrocarburi
- Cicloparaffins
- Idrocarburi, aliciclici
- Idrocarburi, ciclici
- Terpeni
- Anticorpi, monoclonali, umanizzati
- Anticorpi, monoclonali
- Anticorpi
- Immunoglobuline
- Immunoproteine
- Proteine del sangue
- Globuline sieriche
- Globuline
- Prodotti chimici inorganici
- Composti di cloro
- Composti di azoto
- Complessi di coordinamento
- Taxoidi
- Ciclodecani
- Diterpenes
- Deossictidina
- Citidina
- Nucleosidi di pirimidina
- Pirimidine
- Nucleosidi
- Uracile
- Pirimidinoni
- Composti di platino
- Deossiribonucleosidi
- Fluorouracile
- Docetaxel
- Capecitabina
- Oxaliplatino
- Nivolumab
- Gemcitabina
- Carboplatino
- Paclitaxel
- Cisplatino
- pembrolizumab
- Protocollo Folfox
- pazopanib
- pegilodecakin
- AM0010
Altri numeri di identificazione dello studio
- 17159
- J1L-AM-JZGA (Altro identificatore: Eli Lilly and Company)
- AM0010-001 (Altro identificatore: ARMO BioSciences)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .