Clinical trialPhase 2Completed
Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer
A Randomized Phase 2 Study of the Safety, Efficacy, and Immune Response of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cyclophosphamide) in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 14 December 2017
- Expected end
- 23 August 2023
- Enrollment
- 61 participants
- Sites
- 1
- Primary outcomes
- Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)
- Sponsor
- Other
- Results posted
- 2023-07-10
- Last update
- 7 August 2024
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Brief summary public domain (ClinicalTrials.gov)
The purpose of this study is to study the safety and clinical activity of nivolumab and ipilimumab in combination with either sequential administration of CY/GVAX pancreas vaccine followed by CRS-207 (Arm A) or with administration of CRS-207 alone (Arm B) in patients with pancreatic cancer.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) [18 months]. Count Of Participants, Participants. Arm A: CY, Nivolumab, Ipilimumab, Pancreas GVAX, CRS-207 (n=29): 0; Arm B: Nivolumab, Ipilimumab, CRS-207 (n=27): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs) [21 months]. Count Of Participants, Participants. Arm A: CY, Nivolumab, Ipilimumab, Pancreas GVAX, CRS-207 (n=30): 10; Arm B: Nivolumab, Ipilimumab, CRS-207 (n=27): 10.