Description:
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.
Title
- Brief Title: Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
J1790
- SECONDARY ID:
IRB00137389
- NCT ID:
NCT03190265
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Cyclophosphamide | CY | CY, Nivolumab, Ipilimumab, GVAX, CRS-207 |
Nivolumab | anti-PD-1, OPDIVO | CY, Nivolumab, Ipilimumab, GVAX, CRS-207 |
Ipilimumab | YERVOY® | CY, Nivolumab, Ipilimumab, GVAX, CRS-207 |
GVAX Pancreas Vaccine | GVAX, PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine | CY, Nivolumab, Ipilimumab, GVAX, CRS-207 |
CRS-207 | | CY, Nivolumab, Ipilimumab, GVAX, CRS-207 |
CRS-207 | | Nivolumab, Ipilimumab, CRS-207 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
CY, Nivolumab, Ipilimumab, GVAX, CRS-207 | Experimental | | - Cyclophosphamide
- Nivolumab
- Ipilimumab
- GVAX Pancreas Vaccine
- CRS-207
|
Nivolumab, Ipilimumab, CRS-207 | Experimental | | - Nivolumab
- Ipilimumab
- CRS-207
|
Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 years.
2. Have histologically or cytologically proven adenocarcinoma of the pancreas.
3. Have metastatic disease.
4. Have disease progression.
5. Patients with the presence of at least one measurable lesion.
6. 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).
7. ECOG performance status 0 or 1
8. Life expectancy of greater than 3 months.
9. Patients must have adequate organ and marrow function defined by study-specified
laboratory tests.
10. Must use acceptable form of birth control while on study.
11. Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
1. Known history or evidence of brain metastases.
2. Had surgery within the last 28 days
3. Had chemotherapy, radiation, or biological cancer therapy within the last 14 days
4. Have received a prophylactic vaccine within 14 days or received a live vaccine within
30 days of planned start of study therapy.
5. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4
6. Systemic steroids within the last 14 days
7. Use more than 2 g/day of acetaminophen.
8. Patients on immunosuppressive agents.
9. Patients receiving growth factors within the last 14 days
10. Known allergy to both penicillin and sulfa.
11. Severe hypersensitivity reaction to any monoclonal antibody.
12. Have artificial joints or implants that cannot be easily removed
13. Have any evidence of clinical or radiographic ascites.
14. Have significant and/or malignant pleural effusion
15. Have had a new pulmonary embolism, extremity deep venous thromboembolism, or portal
vein thrombosis within 2 months of study treatment
16. Infection with HIV or hepatitis B or C at screening
17. Significant heart disease
18. Conditions, including alcohol or drug dependence, intercurrent illness, or lack of
sufficient peripheral venous access, that would affect the patient's ability to comply
with study visits and procedures
19. Are pregnant or breastfeeding.
20. Have rapidly progressing disease
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate (ORR) using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) |
Time Frame: | 4 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Number of participants experiencing study drug-related toxicities |
Time Frame: | 4 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | 4 years |
Safety Issue: | |
Description: | |
Measure: | Progression free survival (PFS) |
Time Frame: | 4 years |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DOR) |
Time Frame: | 4 years |
Safety Issue: | |
Description: | |
Measure: | Time to progression (TTP) |
Time Frame: | 4 years |
Safety Issue: | |
Description: | |
Measure: | Tumor marker kinetics (CA19-9) |
Time Frame: | 4 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Trial Keywords
- cy
- Cyclophosphamide
- Pancreatic Vaccine
- GVAX
- Nivolumab
- Vaccine
- Ipilimumab
- CRS-207
- Immunotherapy
- PD-1
- Adenocarcinoma
- Carcinoma
- Neoplasms
Last Updated
August 20, 2021