FOLFIRINOX Followed by Ipilimumab With Pancreatic Tumor Vaccine in Treatment of Metastatic Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

This study will enroll patients who have metastatic pancreatic cancer with stable disease on FOLFIRINOX chemotherapy. The main purpose of this study is to compare survival between patients that receive ipilimumab and a pancreatic tumor vaccine and patients who continue to receive FOLFIRINOX. Funding Source - FDA Office of Orphan Product Development (OOPD)

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) [4 years]. Median, Months (95% Confidence Interval). Ipilimumab + Vaccine (n=40): 9.38 (5.0 to 12.2); FOLFIRINOX (n=42): 14.7 (11.6 to 20.0).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Toxicity of Ipilimumab in Combination With Pancreatic Tumor Vaccine [From the first dose of study drug through 70 days after last dose, up to 13 months]. Count Of Participants, Participants. Any study drug-related AE: 3 mg/kg (n=14): 13; 10 mg/kg (n=25): 25. adrenal insufficiency: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. alopecia: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. ALT increased: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 2. arthralgia: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 2. AST increased: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. chills: 3 mg/kg (n=14): 2; 10 mg/kg (n=25): 5. colitis: 3 mg/kg (n=14): 1; 10 mg/kg (n=25): 4. cough: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. diarrhea: 3 mg/kg (n=14): 1; 10 mg/kg (n=25): 2. dry mouth: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. dry skin: 3 mg/kg (n=14): 1; 10 mg/kg (n=25): 0. edema face: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. fatigue: 3 mg/kg (n=14): 1; 10 mg/kg (n=25): 7. fever: 3 mg/kg (n=14): 3; 10 mg/kg (n=25): 11. flu-like symptoms: 3 mg/kg (n=14): 1; 10 mg/kg (n=25): 2. flushing: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. hepatitis: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. hyperhidrosis: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 2. hypophysitis: 3 mg/kg (n=14): 1; 10 mg/kg (n=25): 2. hypotension: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. hypothyroidism: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. lymph node pain: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 2. lymph node swelling: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. malaise: 3 mg/kg (n=14): 1; 10 mg/kg (n=25): 0. myalgia: 3 mg/kg (n=14): 2; 10 mg/kg (n=25): 0. nausea: 3 mg/kg (n=14): 1; 10 mg/kg (n=25): 2. pneumonitis: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. pruritus: 3 mg/kg (n=14): 2; 10 mg/kg (n=25): 7. rash: 3 mg/kg (n=14): 8; 10 mg/kg (n=25): 18. swelling, chest wall mass: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. thyroiditis: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. urticaria: 3 mg/kg (n=14): 2; 10 mg/kg (n=25): 1. vomiting: 3 mg/kg (n=14): 1; 10 mg/kg (n=25): 2. weight loss: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. vaccine site blisters: 3 mg/kg (n=14): 1; 10 mg/kg (n=25): 4. vaccine site bruising: 3 mg/kg (n=14): 1; 10 mg/kg (n=25): 2. vaccine site erythema: 3 mg/kg (n=14): 11; 10 mg/kg (n=25): 20. vaccine site flares: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 2. vaccine site induration: 3 mg/kg (n=14): 12; 10 mg/kg (n=25): 25. vaccine site oozing: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. vaccine site pruritus: 3 mg/kg (n=14): 11; 10 mg/kg (n=25): 22. vaccine site scabbing: 3 mg/kg (n=14): 0; 10 mg/kg (n=25): 1. vaccine site tenderness: 3 mg/kg (n=14): 3; 10 mg/kg (n=25): 13.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression Free Survival (PFS) [Up to 4 years]. Median, Months (95% Confidence Interval). Ipilimumab + Vaccine (n=40): 2.40 (1.87 to 2.53); FOLFIRINOX (n=42): 5.55 (3.32 to 8.51).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Immune-related Progression Free Survival (irPFS) [Up to 4 years]. Median, Months (95% Confidence Interval). Ipilimumab + Vaccine (n=40): 2.50 (2.14 to 2.92); FOLFIRINOX (n=42): 5.55 (3.38 to 8.51).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Objective Response Rate [Assessed until disease progression, up to 2 years]. Count Of Participants, Participants. Ipilimumab + Vaccine (n=35): 1; FOLFIRINOX (n=29): 3.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Immune-related Objective Response Rate [Assessed until disease progression, up to 2 years]. Count Of Participants, Participants. Ipilimumab + Vaccine (n=35): 2; FOLFIRINOX (n=29): 4.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Duration of Response [Up to 22 months]. Mean, months (Full Range). Ipilimumab + Vaccine (n=1): 2.5 (2.5 to 2.5); FOLFIRINOX (n=3): 8.49 (2.73 to 17.45).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Tumor Marker Kinetics as Assessed by Median Carbohydrate Antigen 19-9 (CA19-9) Levels [Baseline, Week 7, and Week 10 visits]. Median, IU/mL (Inter-Quartile Range). Baseline: Ipilimumab + Vaccine (n=32): 185.0 (46.0 to 1091.5); FOLFIRINOX (n=31): 85.0 (41.6 to 178.7). Week 7: Ipilimumab + Vaccine (n=32): 189.2 (61.2 to 7123.7); FOLFIRINOX (n=31): 77.9 (23.4 to 430.0). Week 10: Ipilimumab + Vaccine (n=32): 237.1 (64.4 to 4690.1); FOLFIRINOX (n=31): 66.8 (24.0 to 443.5).