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
Overview
- Phase
- Phase 2
- Intervention
- Ipilimumab
- Conditions
- Pancreatic Cancer
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years.
- •Have histologically or cytologically proven adenocarcinoma of the pancreas.
- •Have metastatic disease.
- •Have disease progression.
- •Patients with the presence of at least one measurable lesion.
- •Patient's acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
- •ECOG performance status 0 or 1
- •Life expectancy of greater than 3 months.
- •Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
- •Must use acceptable form of birth control while on study.
Exclusion Criteria
- •Known history or evidence of brain metastases.
- •Had surgery within the last 28 days
- •Had chemotherapy, radiation, or biological cancer therapy within the last 14 days
- •Have received a prophylactic vaccine within 14 days or received a live vaccine within 30 days of planned start of study therapy.
- •Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4
- •Systemic steroids within the last 14 days
- •Use more than 2 g/day of acetaminophen.
- •Patients on immunosuppressive agents.
- •Patients receiving growth factors within the last 14 days
- •Known allergy to both penicillin and sulfa.
Arms & Interventions
Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207
Intervention: Ipilimumab
Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207
Intervention: Cyclophosphamide
Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207
Intervention: Nivolumab
Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207
Intervention: GVAX Pancreas Vaccine
Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207
Intervention: CRS-207
Arm B: Nivolumab, Ipilimumab, CRS-207
Intervention: Nivolumab
Arm B: Nivolumab, Ipilimumab, CRS-207
Intervention: Ipilimumab
Arm B: Nivolumab, Ipilimumab, CRS-207
Intervention: CRS-207
Outcomes
Primary Outcomes
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)
Time Frame: 18 months
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis.
Secondary Outcomes
- Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs)(21 months)