GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab
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| ClinicalTrials.gov Identifier: NCT02243371 |
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Recruitment Status :
Completed
First Posted : September 17, 2014
Results First Posted : October 8, 2019
Last Update Posted : April 6, 2021
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Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators:
Bristol-Myers Squibb
Stand Up To Cancer
Aduro Biotech, Inc.
American Association for Cancer Research
Lustgarten Foundation
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Brief Summary:
The primary objective of this study is to compare the overall survival (OS) of subjects with previously treated metastatic pancreatic cancer treated with cyclophosphamide (CY)/nivolumab/GVAX pancreas vaccine followed by nivolumab/CRS-207 (Arm A) to subjects treated with CY/GVAX pancreas vaccine followed by CRS-207 (Arm B).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Previously Treated Metastatic Adenocarcinoma of the Pancreas | Biological: CRS-207 Drug: nivolumab Biological: GVAX Drug: CY | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 93 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 GVAX Pancreas Vaccine (With Cyclophosphamide) and CRS-207 With or Without Nivolumab in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma |
| Actual Study Start Date : | January 2, 2015 |
| Actual Primary Completion Date : | July 21, 2017 |
| Actual Study Completion Date : | July 21, 2017 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Vaccines
Drug Information available for:
Nivolumab
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm A: CY/ GVAX/ CRS-207/ nivolumab |
Biological: CRS-207
1 × 10^9 CFU administered IV on Day 2 of Cycles 3-6 Drug: nivolumab 3 mg/kg administered IV on Day 1 of Cycles 1-6
Other Name: BMS-936558; anti-PD-1 mAb Biological: GVAX 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
Other Name: GVAX pancreas vaccine, Panc 10.05 pcDNA-1/GM-Neo, Panc 6.03 pcDNA-1/GM-Neo Drug: CY 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2
Other Name: Cytoxan, Cyclophosphamide |
| Experimental: Arm B: CY/ GVAX/ CRS-207 |
Biological: CRS-207
1 × 10^9 CFU administered IV on Day 1 of Cycles 3-6 Biological: GVAX 5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
Other Name: GVAX pancreas vaccine, Panc 10.05 pcDNA-1/GM-Neo, Panc 6.03 pcDNA-1/GM-Neo Drug: CY 200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2
Other Name: Cytoxan, Cyclophosphamide |
Primary Outcome Measures :
- Overall Survival (OS) [ Time Frame: 2 years and 7 months ]OS will be measured from date of randomization until death or end of followup (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis).
Secondary Outcome Measures :
- Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity [ Time Frame: 2 years and 7 months ]When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.
- Progression-free Survival (PFS) in Metastatic Pancreatic Cancer Patients [ Time Frame: 2 years and 7 months ]PFS is defined as the number of months from the date of randomization to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
- Immune-related Progression-free Survival (irPFS) by IRRC in Metastatic Pancreatic Cancer Patients [ Time Frame: 2 years and 7 months ]irPFS is defined as the number of months from the date of randomization to disease progression (PD or relapse from CR as assessed using irRC RECIST 1.1 criteria) or death due to any cause. Per irRC criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in tumor burden compared with baseline, Progressive Disease (PD) is >20% increase in tumor burden compared with nadir, Stable Disease (SD) is <30% decrease in tumor burden compared with baseline or <20% increase in tumor burden compared to nadir.
- Time to Progression (TTP) by RECIST 1.1 in Metastatic Pancreatic Cancer Patients [ Time Frame: 2 years and 7 months ]Time to progression (TTP) is defined as the time from randomization to the date of documented disease progression as defined by RECIST 1.1 criteria. Individuals are censored at the date of the last radiological assessment that occurs prior to any of the following: death, switch to another anti-cancer therapy, or end of follow-up. Individuals without follow-up or baseline measurements are censored at 1 day. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
- Number of Participants With Partial Response (PR) or Complete Response (CR) as Defined by RECIST 1.1 in Metastatic Pancreatic Cancer Patients [ Time Frame: 2 years and 7 months ]Per RECIST 1.1 criteria, PR is defined as =>30% decrease in sum of diameters of target lesions and CR is the disappearance of all target lesions.
- Tumor Marker Kinetics (CA 19-9) in Patients With Baseline Abnormal Levels as Measured by Number of Participants With Stable or Responding CA19-9 Concentration [ Time Frame: 120 days ]Number of participants with stable or responding (<50% increase of serum CA19-9 concentration) at 120 days.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥18 years.
- Have histologically- or cytologically-proven adenocarcinoma of the pancreas. Patients with mixed histology will be excluded.
- Have metastatic disease.
- Have failed only 1 prior chemotherapy regimen for metastatic pancreatic cancer.
- Patients with the presence of at least one measurable lesion.
- Patients 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).
- ECOG performance status 0 or 1.
- Life expectancy of greater than 3 months.
- Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
- Must use acceptable form of birth control while on study.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
- known history or evidence of brain metastases.
- Had surgery within the last 28 days
- Have received any non-oncology vaccine therapy used for prevention of infectious diseases including seasonal vaccinations within 28 days of study treatment.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, GVAX or CRS-207
- Systemic steroids within the last 14 days
- Use more than 3 g/day of acetaminophen.
- Patients on immunosuppressive agents.
- Patients receiving growth factors within the last 14 days
- Known allergy to both penicillin and sulfa.
- Severe hypersensitivity reaction to any monoclonal antibody.
- Have artificial joints or implants that cannot be easily removed
- Have any evidence of hepatic cirrhosis or clinical or radiographic ascites.
- Have significant and/or malignant pleural effusion
- Infection with HIV or hepatitis B or C at screening
- Significant heart disease
- 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
- Unable to avoid intimate contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen.
- Are pregnant or breastfeeding.
- Have rapidly progressing disease
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): NCT02243371
Locations
| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Oregon | |
| Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bristol-Myers Squibb
Stand Up To Cancer
Aduro Biotech, Inc.
American Association for Cancer Research
Lustgarten Foundation
Investigators
| Principal Investigator: | Dung Le, MD | Johns Hopkins University |
Study Documents (Full-Text)
Documents provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Documents provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Study Protocol and Statistical Analysis Plan [PDF] November 15, 2016
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| ClinicalTrials.gov Identifier: | NCT02243371 |
| Other Study ID Numbers: |
J14113 ADU-CL-06 IRB00043936 ( Other Identifier: JHMIRB ) |
| First Posted: | September 17, 2014 Key Record Dates |
| Results First Posted: | October 8, 2019 |
| Last Update Posted: | April 6, 2021 |
| Last Verified: | February 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
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Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Cyclophosphamide Nivolumab Immunologic Factors Physiological Effects of Drugs |
Immunosuppressive Agents Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Immunological Immune Checkpoint Inhibitors |