Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer

Johns Hopkins Medicine

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Nivolumab; Drug: GVAX Pancreas Vaccine; Drug: Cyclophosphamide; Drug: Ipilimumab; Drug: CRS-207

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03190265

IRB00137389 (Other Identifier)

J1790

5P01CA247886-02 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207

Experimental group

Treatment:

Drug: CRS-207

Drug: CRS-207

Drug: Ipilimumab

Drug: GVAX Pancreas Vaccine

Drug: Cyclophosphamide

Drug: Nivolumab

Arm B: Nivolumab, Ipilimumab, CRS-207

Experimental group

Treatment:

Drug: CRS-207

Drug: CRS-207

Drug: Ipilimumab

Drug: Nivolumab