Clinical Trials /

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

NCT03190265

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.

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

  • Pancreatic Cancer

Interventions

DrugSynonymsArms
CyclophosphamideCYCY, Nivolumab, Ipilimumab, GVAX, CRS-207
Nivolumabanti-PD-1, OPDIVOCY, Nivolumab, Ipilimumab, GVAX, CRS-207
IpilimumabYERVOY®CY, Nivolumab, Ipilimumab, GVAX, CRS-207
GVAX Pancreas VaccineGVAX, PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccineCY, Nivolumab, Ipilimumab, GVAX, CRS-207
CRS-207CY, Nivolumab, Ipilimumab, GVAX, CRS-207
CRS-207Nivolumab, 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

NameTypeDescriptionInterventions
CY, Nivolumab, Ipilimumab, GVAX, CRS-207Experimental
  • Cyclophosphamide
  • Nivolumab
  • Ipilimumab
  • GVAX Pancreas Vaccine
  • CRS-207
Nivolumab, Ipilimumab, CRS-207Experimental
  • 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:100 Years
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

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