Metastatic Pancreatic AdenocarcinomaPhase 2NCT03006302
Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer
A Phase 2 study testing Epacadostat, Pembrolizumab and CRS-207 in people with Metastatic Pancreatic Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This study will enroll patients who have metastatic pancreatic cancer and have progressed on prior chemotherapy. Part 1 (dose escalation) participants will receive epacadostat/pembrolizumab/cyclophosphamide(CY)/GVAX pancreas vaccine followed by epacadostat/pembrolizumab/CRS-207, Part 1X (dose escalation) participants… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- Epacadostat, Pembrolizumab and CRS-207
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 5 Aug 2024
- 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
- Documented adenocarcinoma of the pancreas
- Have disease progression after prior chemotherapy for metastatic pancreas cancer (or adjuvant or neoadjuvant if progression occurred within 6 months of completing this regimen)
- Presence of at least one measurable lesion
- Patient acceptance to have a tumor biopsy of an accessible lesion at 2 time points (baseline and on study)
- ECOG performance status of 0 or 1
- Life expectancy of greater than 3 months
- Adequate organ and marrow function defined by study-specified laboratory tests
Who cannot join
- Brain metastases
- Clinical or radiographic ascites (some trace amount may be allowed)
- Rapidly progressing disease
- Live vaccine within 30 days of study treatment (flu vaccine allowed)
- Surgery within 28 days of study treatment (some exceptions for minor procedures)
- Use of an investigational agent or device within 28 days of study treatment.
Show all 30Show fewer
- Chemotherapy, radiation, or biological cancer therapy within 14 days of study treatment.
- Prior treatment with anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti PD-L2, or with IDO inhibitor.
- Use of growth factors within 14 days of study treatment
- Use of any systemic steroids within 14 days of study treatment or other immunosuppressive agents within 7 days of study treatment.
- Use of more than 2 g/day of acetaminophen
- Use of any UGT1A9 inhibitor
- Use of warfarin
- Use of MAOIs or drugs with significant MAOI activity within the 21 days of screening
- History of Seratonin Syndome
- Known allergy to both penicillin and sulfa
- Known or suspected hypersensitivity to any monoclonal antibody or any study drug component
- Have artificial joints or implants that cannot be easily removed or a history of infection associated with an implant
- Significant or malignant pleural effusion
- New pulmonary embolism, extremity deep venous thromboembolism, or portal vein thrombosis within 2 months of study enrollment
- History of autoimmune disease (exceptions for Graves or Hashimoto's disease, vitiligo, and type I diabetes mellitus)
- Gastrointestinal condition that may affect drug absorption
- Significant heart disease or heart disease requiring antibiotic for prevention of endocarditis
- History of abnormal electrocardiogram (ECG) that is deemed meaningful by the investigator
- History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis
- Pulse oximetry of < 92% on room air or the need for supplemental home oxygen
- Infection with HIV, hepatitis B or hepatitis C
- Other 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
- Pregnant or breastfeeding women
- Unwillingness or inability to follow the study schedule for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
About this study
Official title: Phase 2 Study of Epacadostat, Pembrolizumab, and CRS-207, With or Without Cyclophosphamide and GVAX Pancreas Vaccine in Patients With Metastatic Pancreas Cancer
This study will enroll patients who have metastatic pancreatic cancer and have progressed on prior chemotherapy.
Part 1 (dose escalation) participants will receive epacadostat/pembrolizumab/cyclophosphamide(CY)/GVAX pancreas vaccine followed by epacadostat/pembrolizumab/CRS-207, Part 1X (dose escalation) participants will receive epacadostat/pembrolizumab/CRS-207. Part 2X (dose expansion) participants will receive epacadostat/pembrolizumab/CRS-207.
The primary objectives of this study are to determine the recommended dose of epacadostat in this combination and assess survival of subjects in both treatment groups.
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Being tested
- Epacadostat, Pembrolizumab, CRS-207, Cyclophosphamide, GVAX Pancreas Vaccine
- Keywords
- Pancreatic cancer, Vaccine, Immunotherapy, Pembrolizumab, PD-1, IDO, CRS-207, Epacadostat
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpacadostatDrug
Also called INCB024360
Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100, 300, or 600 mg) is taken by mouth twice a day, every day.
PembrolizumabDrug
Also called MK-3475, KEYTRUDA
Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6.
CRS-207Biological
CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6.
CyclophosphamideDrug
Also called CY, CYTOXAN
Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m^2) will be administered IV on day 1 of Cycles 1 and 2.
GVAX Pancreas VaccineBiological
Also called GVAX, Panc 10.05 pcDNA-1/GM-Neo, Panc 6.03 pcDNA-1/GM-Neo
Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Level 1 | Experimental | Epacadostat/Pembrolizumab/CY/GVAX/CRS-207 Receives: Drug: Epacadostat; Drug: Pembrolizumab; Biological: CRS-207; Drug: Cyclophosphamide; Biological: GVAX Pancreas Vaccine |
| Part 1: Dose Level 2 | Experimental | Epacadostat/Pembrolizumab/CY/GVAX/CRS-207 Receives: Drug: Epacadostat; Drug: Pembrolizumab; Biological: CRS-207; Drug: Cyclophosphamide; Biological: GVAX Pancreas Vaccine |
| Part 1X: Dose Level 2 | Experimental | Epacadostat/Pembrolizumab/CRS-207 Receives: Drug: Epacadostat; Drug: Pembrolizumab; Biological: CRS-207 |
| Part 1X: Dose Level 3 | Experimental | Epacadostat/Pembrolizumab/CRS-207 Receives: Drug: Epacadostat; Drug: Pembrolizumab; Biological: CRS-207 |
| Part 2: Dose Expansion | Experimental | Epacadostat/Pembrolizumab/CRS-207 Receives: Drug: Epacadostat; Drug: Pembrolizumab; Biological: CRS-207 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Epacadostat
Dose escalation (part I of the trial only) to determine the maximum tolerated dose (MTD) in mg BID. Epacadostat (100, 300, or 600 mg) was taken by mouth twice a day, every day.
Measured: 9 weeks
6 Month Survival
Number of subjects who are alive 6 months or longer after the date of first treatment.
Measured: 6 months
Secondary outcomes (1)
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study start31 Jan 2018
- Primary completion22 Aug 2023
- Study completion5 Aug 2024
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 Metastatic Pancreatic AdenocarcinomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dung Le, M.D., Principal investigator, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006302
- Sponsor's protocol ID
- J16173
- Other IDs
- IRB00118520, 5P01CA247886-02
- Status last verified
- Sep 2024
- First submitted
- 28 Dec 2016
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Epacadostat, Pembrolizumab, and CRS-207, With or Without Cyclophosphamide and GVAX Pancreas Vaccine in Patients With Metastatic Pancreas Cancer
- ClinicalTrials.gov ID
- NCT03006302
- Acronym / sponsor ID
- J16173
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Keywords
- Pancreatic cancer, Vaccine, Immunotherapy, Pembrolizumab, PD-1, IDO, CRS-207, Epacadostat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, National Cancer Institute (NCI), Incyte Corporation
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 30 Dec 2016 (estimated)
- Results
- Posted 20 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll patients who have metastatic pancreatic cancer and have progressed on prior chemotherapy.
Part 1 (dose escalation) participants will receive epacadostat/pembrolizumab/cyclophosphamide(CY)/GVAX pancreas vaccine followed by epacadostat/pembrolizumab/CRS-207, Part 1X (dose escalation) participants will receive epacadostat/pembrolizumab/CRS-207. Part 2X (dose expansion) participants will receive epacadostat/pembrolizumab/CRS-207.
The primary objectives of this study are to determine the recommended dose of epacadostat in this combination and assess survival of subjects in both treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Level 1 | Experimental | Drug: Epacadostat, Drug: Pembrolizumab, Biological: CRS-207, Drug: Cyclophosphamide, Biological: GVAX Pancreas VaccineEpacadostat/Pembrolizumab/CY/GVAX/CRS-207 |
| Part 1: Dose Level 2 | Experimental | Drug: Epacadostat, Drug: Pembrolizumab, Biological: CRS-207, Drug: Cyclophosphamide, Biological: GVAX Pancreas VaccineEpacadostat/Pembrolizumab/CY/GVAX/CRS-207 |
| Part 1X: Dose Level 2 | Experimental | Drug: Epacadostat, Drug: Pembrolizumab, Biological: CRS-207Epacadostat/Pembrolizumab/CRS-207 |
| Part 1X: Dose Level 3 | Experimental | Drug: Epacadostat, Drug: Pembrolizumab, Biological: CRS-207Epacadostat/Pembrolizumab/CRS-207 |
| Part 2: Dose Expansion | Experimental | Drug: Epacadostat, Drug: Pembrolizumab, Biological: CRS-207Epacadostat/Pembrolizumab/CRS-207 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Documented adenocarcinoma of the pancreas
- Have disease progression after prior chemotherapy for metastatic pancreas cancer (or adjuvant or neoadjuvant if progression occurred within 6 months of completing this regimen)
- Presence of at least one measurable lesion
- Patient acceptance to have a tumor biopsy of an accessible lesion at 2 time points (baseline and on study)
- ECOG performance status of 0 or 1
Key exclusion criteria (30 listed)
- Brain metastases
- Clinical or radiographic ascites (some trace amount may be allowed)
- Rapidly progressing disease
- Live vaccine within 30 days of study treatment (flu vaccine allowed)
- Surgery within 28 days of study treatment (some exceptions for minor procedures)
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 |
|---|---|---|
| EpacadostatAlso: INCB024360Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Epacadostat (100, 300, or 600 mg) is taken by mouth twice a day, every day. | Drug | Part 1: Dose Level 1, Part 1: Dose Level 2, Part 1X: Dose Level 2, Part 1X: Dose Level 3, Part 2: Dose Expansion |
| PembrolizumabAlso: MK-3475, KEYTRUDAPatients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on day 1 of Cycles 1-6. | Drug | Part 1: Dose Level 1, Part 1: Dose Level 2, Part 1X: Dose Level 2, Part 1X: Dose Level 3, Part 2: Dose Expansion |
| CRS-207CRS-207: Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 10^9 CFU) will be administered IV on Day 2 of Cycles 3-6. | Biological | Part 1: Dose Level 1, Part 1: Dose Level 2, Part 1X: Dose Level 2, Part 1X: Dose Level 3, Part 2: Dose Expansion |
| CyclophosphamideAlso: CY, CYTOXANPatients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m^2) will be administered IV on day 1 of Cycles 1 and 2. | Drug | Part 1: Dose Level 1, Part 1: Dose Level 2 |
| GVAX Pancreas VaccineAlso: GVAX, Panc 10.05 pcDNA-1/GM-Neo, Panc 6.03 pcDNA-1/GM-NeoPatients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). GVAX will be administered on Day 2 of Cycles 1 and 2. | Biological | Part 1: Dose Level 1, Part 1: Dose Level 2 |
Primary outcome
Maximum Tolerated Dose (MTD) of Epacadostat
Time frame: 9 weeks
Dose escalation (part I of the trial only) to determine the maximum tolerated dose (MTD) in mg BID. Epacadostat (100, 300, or 600 mg) was taken by mouth twice a day, every day.
6 Month Survival
Time frame: 6 months
Number of subjects who are alive 6 months or longer after the date of first treatment.
1 secondary outcome
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation
Time frame: 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, M.D. principal investigator
The 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 Epacadostat, Pembrolizumab and CRS-207 in people with Metastatic Pancreatic Adenocarcinoma, 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 7 inclusion and 30 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 8 Oct 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 20 Jun 2024). 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?
Maximum Tolerated Dose (MTD) of Epacadostat (time frame: 9 weeks). The study lists 2 primary outcomes in all. 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 8 Oct 2024.