Um estudo de fase 1 de pegilodecaquina (LY3500518) em participantes com tumores sólidos avançados (IVY)
Um primeiro estudo de escalonamento de dose aberto de fase 1 em humanos para avaliar a tolerabilidade, segurança, dose máxima tolerada, atividade clínica preliminar e farmacocinética de AM0010 em pacientes com tumores sólidos avançados
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
- Medicamento: Pegilodecaquina
- Medicamento: Paclitaxel or Docetaxel and Carboplatin or Cisplatin
- Medicamento: FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
- Medicamento: gemcitabine/nab-paclitaxel
- Medicamento: Capecitabine
- Medicamento: Paclitaxel
- Medicamento: Pazopanib
- Medicamento: Pembrolizumab
- Medicamento: Gemcitabine/carboplatin
- Medicamento: nivolumab
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90024
- UCLA Medical Hematology & Oncology
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San Francisco, California, Estados Unidos
- UCSF
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Colorado
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Denver, Colorado, Estados Unidos, 80218
- Sarah Cannon Research Institute at HealthONE
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Florida
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Sarasota, Florida, Estados Unidos, 34232
- Florida Cancer Specialists & Research Institute
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Dana Farber Cancer Institute
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New York
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New York, New York, Estados Unidos, 10065
- Memorial Sloan Kettering Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon Research Institute
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Texas
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Houston, Texas, Estados Unidos, 77030
- The University of Texas M.D. Anderson Cancer Center
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San Antonio, Texas, Estados Unidos, 78229
- South Texas Accelerated Research Therapeutics
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Descrição
Critério de inclusão:
Coortes de escalonamento da Parte A:
o Tumor sólido maligno avançado confirmado histologicamente ou citologicamente, limitado a melanoma, câncer de próstata resistente à castração (CRPC), câncer de ovário (OVCA), carcinoma de células renais, carcinoma colorretal (CRC), carcinoma pancreático ou carcinoma pulmonar de células não pequenas (NSCLC) que é refratário, intolerante, para o qual nenhum padrão de terapia está disponível ou onde o participante recusa as terapias existentes
Coortes de Expansão Parte A, Coortes de Escalação e Expansão Parte B e C:
- Tumores com todos os diagnósticos histológicos ou origem tecidual podem ser inscritos
Os participantes devem ter falhado na quimioterapia curativa padrão anterior para sua doença, recusar as terapias existentes OU o regime de quimioterapia proposto ao qual a pegilodecaquina é adicionada representa um tratamento padrão aceitável para sua doença.
- Doença mensurável ou avaliável de acordo com IRRC ou doença metastática óssea avaliável pelos critérios do Prostate Cancer Working Group 2 (PCWG2) para câncer de próstata resistente à castração (CRPC)
- Pelo menos 18 anos de idade
- Status de desempenho de 0 ou 1
- Função adequada do órgão
Critério de exclusão:
- neoplasias hematológicas
- Grávida ou lactante
- Presente ou histórico de distúrbios neurológicos, como esclerose múltipla e síndrome de Guillain-Barre ou distúrbios inflamatórios do sistema nervoso central/sistema nervoso periférico (SNC/SNP)
- Infarto do miocárdio nos últimos 6 meses
- Angina instável ou arritmia cardíaca instável que requer medicação
- Cirurgia nos últimos 28 dias
- Infecção sistêmica fúngica, bacteriana, viral ou outra
- História de diátese hemorrágica nos últimos 6 meses
- Positivo para o vírus da imunodeficiência humana (HIV), hepatite C ou hepatite B
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
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Experimental: 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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Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
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Experimental: 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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Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
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Experimental: 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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Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
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Experimental: 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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Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
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Experimental: 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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Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
Platinum/ Taxane administered IV on Day 1 of every 21 day cycle
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
FOLFOX administered IV on Day 1 and 2 of every 14 day cycle
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
Gemcitabine/nab-paclitaxel administered IV on Day 1, 8 and 15 of each 28 day treatment cycle.
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
Capecitabine administered orally twice daily for 14 days out of every 21 days.
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
Paclitaxel administered IV on Days 1, 8, 15 of each cycle (28 days= 1 cycle)
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
Pazopanib administered orally daily continuously
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
Pembrolizumab administered IV on Day 1 of every 21 day cycle.
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
Nivolumab administered IV on Day 1 of each cycle (14 days = 1 cycle)
Outros nomes:
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Experimental: 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. |
Injeções subcutâneas diárias de pegilodecaquina até 12 meses
Outros nomes:
Gemcitabine and carboplatin administered IV on Days 1, 8 of each cycle (21 days = 1 cycle)
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Participants With TEAEs and SAEs Observed During the Study of Pegilodecakin
Prazo: 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
Prazo: Day 29
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Serum concentration of Pegilodecakin is reported.
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Day 29
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Participants With Anti-Pegilodecakin Antibody Formation
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: 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
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimado)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
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Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Doenças do Sistema Endócrino
- Neoplasias Genitais Masculinas
- Neoplasias urogenitais
- Neoplasias por local
- Doenças Genitais, Masculino
- Doenças prostáticas
- Doenças Urogenitais Masculinas
- Doenças renais
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças Intestinais
- Doenças Respiratórias
- Neoplasias por Tipo Histológico
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Neoplasias Intestinais
- Doenças retais
- Doenças Genitais Femininas
- Doenças pulmonares
- Neoplasias das Glândulas Endócrinas
- Doenças pancreáticas
- Neoplasias Glandulares e Epiteliais
- Adenocarcinoma
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Doenças do cólon
- Neoplasias Pulmonares
- Doenças ovarianas
- Doenças anexiais
- Neoplasias Genitais Femininas
- Distúrbios Gonadais
- Doenças de pele
- Doenças da mama
- Neoplasias Urológicas
- Carcinoma
- Tumores Neuroectodérmicos
- Neoplasias, Células Germinativas e Embrionárias
- Neoplasias, Tecido Nervoso
- Neoplasias Renais
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Tumores Neuroendócrinos
- Nevos e Melanomas
- Neoplasias Cutâneas
- Doenças da Pele e do Tecido Conjuntivo
- Neoplasias
- Neoplasias prostáticas
- Neoplasias Colorretais
- Neoplasias ovarianas
- Neoplasias da Mama
- Neoplasias Pancreáticas
- Carcinoma de Células Renais
- Carcinoma pulmonar de células não pequenas
- Melanoma
- Aminoácidos, peptídeos e proteínas
- Proteínas
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Ácidos nucleicos, nucleotídeos e nucleosídeos
- Hidrocarbonetos
- Cicloparaffinas
- Hidrocarbonetos, aliciclicos
- Hidrocarbonetos, cíclicos
- Terpenos
- Anticorpos, monoclonais, humanizados
- Anticorpos, monoclonais
- Anticorpos
- Imunoglobulinas
- Imunoproteínas
- Proteínas sanguíneas
- Globulinas de soro
- Globulins
- Produtos químicos inorgânicos
- Compostos de cloro
- Compostos de nitrogênio
- Complexos de coordenação
- Taxóides
- Ciclodecanos
- Diterpenos
- Desoxicitidina
- Citidina
- Nucleosídeos de pirimidina
- Pirimidinas
- Nucleosídeos
- Uracil
- Pirimidinonas
- Compostos de platina
- Desoxirribonucleosídeos
- Fluorouracil
- Docetaxel
- Capecitabina
- Oxaliplatina
- Nivolumabe
- Gemcitabina
- Carboplatina
- Paclitaxel
- Cisplatina
- Pembrolizumab
- Protocolo Folfox
- Pazopanib
- pegilodecakin
- AM0010
Outros números de identificação do estudo
- 17159
- J1L-AM-JZGA (Outro identificador: Eli Lilly and Company)
- AM0010-001 (Outro identificador: ARMO BioSciences)
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Informações sobre medicamentos e dispositivos, documentos de estudo
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