진행성 고형 종양 환자를 대상으로 한 Pegilodecakin(LY3500518)의 1상 연구 (IVY)

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• 탁솔 또는 탁소테레 및 파라플라틴 또는 플라티놀

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• 탁솔 또는 탁소테레 및 파라플라틴 또는 플라티놀

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• 탁솔 또는 탁소테레 및 파라플라틴 또는 플라티놀

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• 엘록사틴®/류코보린/5-FU

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• 엘록사틴®/류코보린/5-FU

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• 엘록사틴®/류코보린/5-FU

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• 젬자/아브락산 ABI-007

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• 젤로다

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• GW786034

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• 키트루다, MK-3475

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• 키트루다, MK-3475

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• 키트루다, MK-3475

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• 젬자/파라플라틴

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• 옵디보

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• 옵디보

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.

• LY3500518
• AM0010
• 페길화된 재조합 인간 인터루킨-10
• PEG-rHuIL-10

• 젬자/파라플라틴

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.