Pancreatic CancerPhase 2NCT03190265
Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer
A Phase 2 study testing Cyclophosphamide, Nivolumab and Ipilimumab in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Cyclophosphamide, Nivolumab and Ipilimumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2017to 23 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Cyclophosphamide, Nivolumab, Ipilimumab, GVAX Pancreas Vaccine, CRS-207
- Keywords
- CY, Cyclophosphamide, Pancreatic Vaccine, GVAX, Nivolumab, Vaccine, Ipilimumab, CRS-207, Immunotherapy, PD-1, Adenocarcinoma, Carcinoma, Neoplasms
- Medical subject headings
- Pancreatic Neoplasms, Adenocarcinoma, Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called CY
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.
NivolumabDrug
Also called anti-PD-1, OPDIVO
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.
IpilimumabDrug
Also called YERVOY®
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.
GVAX Pancreas VaccineDrug
Also called GVAX, PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo 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.
CRS-207Drug
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.
CRS-207Drug
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 group | Role | What they receive |
|---|---|---|
| Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207 | Experimental | Not described Receives: Drug: Cyclophosphamide; Drug: Nivolumab; Drug: Ipilimumab; Drug: GVAX Pancreas Vaccine; Drug: CRS-207 |
| Arm B: Nivolumab, Ipilimumab, CRS-207 | Experimental | Not described Receives: Drug: Nivolumab; Drug: Ipilimumab; Drug: CRS-207 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis.
Measured: 18 months
Secondary outcomes (1)
Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs)
When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject. Laboratory abnormalities that were asymptomatic and not clinically significant were excluded.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start14 Dec 2017
- Primary completion3 Aug 2022
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Aduro Biotech, Inc., Bristol-Myers Squibb, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dung Le, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190265
- Sponsor's protocol ID
- J1790
- Other IDs
- IRB00137389, 5P01CA247886-02
- Status last verified
- Aug 2024
- First submitted
- 15 Jun 2017
- Last updated
- 7 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03190265
- Acronym / sponsor ID
- J1790
- Conditions
- Pancreatic Cancer
- Keywords
- CY, Cyclophosphamide, Pancreatic Vaccine, GVAX, Nivolumab, Vaccine, Ipilimumab, CRS-207
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Aduro Biotech, Inc., Bristol-Myers Squibb, National Cancer Institute (NCI)
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Posted 10 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207 | Experimental | Drug: Cyclophosphamide, Drug: Nivolumab, Drug: Ipilimumab, Drug: GVAX Pancreas Vaccine, Drug: CRS-207 |
| Arm B: Nivolumab, Ipilimumab, CRS-207 | Experimental | Drug: Nivolumab, Drug: Ipilimumab, Drug: CRS-207 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideAlso: CYPatients 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. | Drug | Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207 |
| NivolumabAlso: anti-PD-1, OPDIVOPatients 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. | Drug | Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207, Arm B: Nivolumab, Ipilimumab, CRS-207 |
| IpilimumabAlso: YERVOY®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. | Drug | Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207, Arm B: Nivolumab, Ipilimumab, CRS-207 |
| GVAX Pancreas VaccineAlso: GVAX, PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccinePatients 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. | Drug | Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207 |
| CRS-207Patients 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 | Arm A: CY, Nivolumab, Ipilimumab, GVAX, CRS-207 |
| CRS-207Patients 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. | Drug | Arm B: Nivolumab, Ipilimumab, CRS-207 |
Primary outcome
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1)
Time frame: 18 months
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will not included in the analysis.
1 secondary outcome
Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs)
Time frame: 21 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dung Le, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, Nivolumab and Ipilimumab in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) Using Response Evaluation Criteria for Solid Tumors (RECIST 1.1) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.