Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03190265
Recruitment Status : Active, not recruiting
First Posted : June 16, 2017
Last Update Posted : March 25, 2022
Sponsor:
Collaborators:
Aduro Biotech, Inc.
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE June 15, 2017
First Posted Date  ICMJE June 16, 2017
Last Update Posted Date March 25, 2022
Actual Study Start Date  ICMJE December 14, 2017
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2017)
Objective response rate (ORR) using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2017)
  • Number of participants experiencing study drug-related toxicities [ Time Frame: 4 years ]
  • Overall survival (OS) [ Time Frame: 4 years ]
  • Progression free survival (PFS) [ Time Frame: 4 years ]
  • Duration of response (DOR) [ Time Frame: 4 years ]
  • Time to progression (TTP) [ Time Frame: 4 years ]
  • Tumor marker kinetics (CA19-9) [ Time Frame: 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Drug: Cyclophosphamide
    Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m2) will be administered IV on day 1 of Cycles 1 and 2.
    Other Name: CY
  • Drug: Nivolumab
    Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.
    Other Name: anti-PD-1, OPDIVO
  • Drug: Ipilimumab
    Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
    Other Name: YERVOY®
  • Drug: GVAX Pancreas Vaccine
    Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Vaccine will be administered on Day 2 of Cycles 1 and 2.
    Other Name: GVAX, PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine
  • Drug: CRS-207
    Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 3-6.
  • Drug: CRS-207
    Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 1-6.
Study Arms  ICMJE
  • Experimental: CY, Nivolumab, Ipilimumab, GVAX, CRS-207
    Interventions:
    • Drug: Cyclophosphamide
    • Drug: Nivolumab
    • Drug: Ipilimumab
    • Drug: GVAX Pancreas Vaccine
    • Drug: CRS-207
  • Experimental: Nivolumab, Ipilimumab, CRS-207
    Interventions:
    • Drug: Nivolumab
    • Drug: Ipilimumab
    • Drug: CRS-207
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2017)
63
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2022
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03190265
Other Study ID Numbers  ICMJE J1790
IRB00137389 ( Other Identifier: Johns Hopkins University )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Aduro Biotech, Inc.
  • Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Dung Le, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP