We updated the design of this site on December 18, 2017. Learn more.
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03190265
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Cyclophosphamide Drug: Nivolumab Drug: Ipilimumab Drug: GVAX Pancreas Vaccine Drug: CRS-207 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Anticipated Study Start Date : December 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: CY, Nivolumab, Ipilimumab, GVAX, CRS-207 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.
Experimental: Nivolumab, Ipilimumab, CRS-207 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: 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.


Outcome Measures

Primary Outcome Measures :
  1. Objective response rate (ORR) using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Number of participants experiencing study drug-related toxicities [ Time Frame: 4 years ]
  2. Overall survival (OS) [ Time Frame: 4 years ]
  3. Progression free survival (PFS) [ Time Frame: 4 years ]
  4. Duration of response (DOR) [ Time Frame: 4 years ]
  5. Time to progression (TTP) [ Time Frame: 4 years ]
  6. Tumor marker kinetics (CA19-9) [ Time Frame: 4 years ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190265


Contacts
Contact: Susan Sartorious- Mergenthaler 410-614-3644 sartosu@jhmi.edu
Contact: Jane Zorzi 410-614-5818 jzorzi1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins SKCCC Recruiting
Baltimore, Maryland, United States, 21231
Contact: Dung Le, MD    443-287-0002    dle@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Aduro Biotech, Inc.
Bristol-Myers Squibb
Investigators
Principal Investigator: Dung Le, MD Sidney Kimmel Comprehensive Cancer Center
More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03190265     History of Changes
Other Study ID Numbers: J1790
IRB00137389 ( Other Identifier: Johns Hopkins University )
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
CRS-207
cy
Cyclophosphamide
Pancreatic Vaccine
GVAX
Nivolumab
Vaccine
Ipilimumab
Immunotherapy
PD-1
Adenocarcinoma
Carcinoma
Neoplasms

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Vaccines
Cyclophosphamide
Antibodies, Monoclonal
Nivolumab
Pancrelipase
Pancreatin
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Gastrointestinal Agents