Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer
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| ClinicalTrials.gov Identifier: NCT03190265 |
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Recruitment Status :
Active, not recruiting
First Posted : June 16, 2017
Last Update Posted : March 9, 2023
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Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators:
Aduro Biotech, Inc.
Bristol-Myers Squibb
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 61 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 |
| Actual Study Start Date : | December 14, 2017 |
| Actual Primary Completion Date : | August 3, 2022 |
| Estimated Study Completion Date : | August 1, 2023 |
Resource links provided by the National Library of Medicine
| 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. |
Primary Outcome Measures :
- Objective response rate (ORR) using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) [ Time Frame: 4 years ]
Secondary Outcome Measures :
- 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 ]
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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.
- Have metastatic disease.
- Have disease progression.
- Patients with the presence of at least one measurable lesion.
- 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).
- 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
- Had chemotherapy, radiation, or biological cancer therapy within the last 14 days
- Have received a prophylactic vaccine within 14 days or received a live vaccine within 30 days of planned start of study therapy.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4
- Systemic steroids within the last 14 days
- Use more than 2 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 clinical or radiographic ascites.
- Have significant and/or malignant pleural effusion
- Have had a new pulmonary embolism, extremity deep venous thromboembolism, or portal vein thrombosis within 2 months of study treatment
- 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
- 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): NCT03190265
Locations
| United States, Maryland | |
| Johns Hopkins SKCCC | |
| Baltimore, Maryland, United States, 21231 | |
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Aduro Biotech, Inc.
Bristol-Myers Squibb
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Dung Le, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| ClinicalTrials.gov Identifier: | NCT03190265 |
| Other Study ID Numbers: |
J1790 IRB00137389 ( Other Identifier: Johns Hopkins University ) 5P01CA247886-02 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 16, 2017 Key Record Dates |
| Last Update Posted: | March 9, 2023 |
| Last Verified: | March 2023 |
| 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 at Johns Hopkins:
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cy Cyclophosphamide Pancreatic Vaccine GVAX Nivolumab Vaccine Ipilimumab |
CRS-207 Immunotherapy PD-1 Adenocarcinoma Carcinoma Neoplasms |
Additional relevant MeSH terms:
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Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Cyclophosphamide Nivolumab Ipilimumab Pancrelipase Vaccines |
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 Gastrointestinal Agents |