Pancreatic CancerPhase 1/2UVA-PC-PD101NCT02305186
Safety and Immunological Effect of Pembrolizumab in Resectable or Borderline Resectable Pancreatic Cancer
A Phase 1/2 study testing Pembrolizumab and Neoadjuvant Chemoradiation in people with Pancreatic Cancer, run by Craig L Slingluff, Jr at 6 sites in United States.
Trial summary
The purpose of this clinical trial is to study an experimental drug called pembrolizumab or MK-3475 for use in combination with chemotherapy and radiation therapy for patients with resectable (surgical removal) or borderline resectable 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?
- Pembrolizumab and Neoadjuvant Chemoradiation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2015to Dec 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Adequate organ function
- In subjects requiring biliary decompression, metal stent or drainage using percutaneous transhepatic cholangiogram (PTC) are allowed
Who cannot join
- Immunodeficiency or taking steroid or any other form of immunosuppressive therapy
- Has a plastic biliary stent for decompression
- Metastatic disease
- Prior treatment for pancreatic cancer (other than 4-8 cycles of Folfirinox) or prior treatment with radiation for other diagnoses to the expected pancreatic cancer treatment area
- Active autoimmune disease
- Pregnancy or Nursing
Show all 12Show fewer
- Known history of Human Immunodeficiency Virus (HIV) or Hepatitis B or C
- Prior monoclonal antibody within 4 weeks prior to study Day 1
- Known additional malignancy that is progressing or requires active treatment
- Evidence of interstitial lung disease or active, non-infectious pneumonitis
- Active infection requiring systemic therapy
- Prior therapy with an anti-Program Death (PD-1) antibody, anti-PD-L1, anti-PD-L2, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites, 5 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Katherine Metayer, 617-632-6316, KatherineA_Metayer@DFCI.HARVARD.EDU
Osama Rahma, MD, OsamaE_Rahma@DFCI.HARVARD.EDU
- Recruiting
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Adela Mahmutovic, am6bd@hscmail.mcc.virginia.edu
Todd Bauer, MD
- Recruiting
Hartford HealthCare
Hartford, Connecticut, 06102
Leah Persky, leah.persky@hhchealth.org
Rawad Elias, MD
- Recruiting
MD Anderson
Houston, Texas, 77030
Edsel Esquivel, EFEsquivel@mdanderson.org
Matthew Katz, MD
- Completed
University of Miami
Miami, Florida, 33136
- Recruiting
Mayo Clinic Cancer Center
Phoenix, Arizona, 85054
Justin Weber, 855-776-0015
weber.justin@mayo.edu
About this study
Official title: A Randomized Multicenter Ib/II Study to Assess the Safety & Immunological Effect of Chemoradiation Therapy in Combination With Pembrolizumab Compared to CRT Alone Resectable/Borderline Resectable Pancreatic Cancer
The purpose of this clinical trial is to study an experimental drug called pembrolizumab or MK-3475 for use in combination with chemotherapy and radiation therapy for patients with resectable (surgical removal) or borderline resectable pancreatic cancer. In general, pancreatic cancer that cannot be removed by surgery is sometimes treated with chemotherapy and radiation therapy, called neoadjuvant treatment, to shrink the tumor so that surgery might be possible. However, this is not always effective at shrinking the tumor enough to allow it to be removed with surgery. Recent discoveries suggest that the investigators own immune system might have a role in controlling the growth of tumors. Drugs such as pembrolizumab can stimulate the immune system against cancer. The purpose of this study is to investigate whether pembrolizumab can be used safely during neoadjuvant treatment and can improve the body's immune response against pancreatic cancer.
Pembrolizumab has been approved for treatment of patients with melanoma but has not been proven to be safe or helpful in patients with pancreatic cancer and is not approved by the U.S. Food and Drug Administration (FDA) for this purpose.
- Conditions
- Pancreatic Cancer
- Being tested
- Pembrolizumab, Neoadjuvant Chemoradiation
- Keywords
- Immunotherapy, Neoadjuvant, Resectable, Borderline resectable
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called MK-3475, Keytruda
Pembrolizumab administered at a dose of 200 mg IV every 3 weeks on days 1, 22, and 43 during concurrent neoadjuvant chemoradiation treatment
Neoadjuvant ChemoradiationRadiation
Chemoradiation with capecitabine (825 mg/m2 orally twice daily, Monday through Friday, on days of radiation only) and radiation (50.4 Gy in 28 fractions over 28 days)
| Study group | Role | What they receive |
|---|---|---|
| Neodjuvant CRT + Pembrolizumab | Experimental | Standard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab Receives: Drug: Pembrolizumab; Radiation: Neoadjuvant Chemoradiation |
| Neoadjuvant CRT | Active comparator | Standard neoadjuvant chemoradiation treatment (CRT) alone Receives: Radiation: Neoadjuvant Chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Tumor Infiltrating Lymphocytes (TILs) per high powered field (hpf) in pancreatic tissue (resected tissue).
Measured: 2-3 years
Safety: Incidence of Dose-Limiting Toxicities (DLTs)
Measured: 2-3 years
Secondary outcomes (3)
Disease-free survival (DFS)
Measured: 2-4 years
Overall survival (OS)
Measured: 2-4 years
Response Rate (RR)
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Craig L Slingluff, Jr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Craig L Slingluff, Jr, University of Virginia
- Investigators
- Osama Rahma, MD, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305186
- Sponsor's protocol ID
- 17801
- Acronym
- UVA-PC-PD101
- Status last verified
- Aug 2021
- First submitted
- 21 Nov 2014
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Ib/II Study to Assess the Safety & Immunological Effect of Chemoradiation Therapy in Combination With Pembrolizumab Compared to CRT Alone Resectable/Borderline Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02305186
- Acronym / sponsor ID
- UVA-PC-PD101 / 17801
- Conditions
- Pancreatic Cancer
- Keywords
- Immunotherapy, Neoadjuvant, Resectable, Borderline resectable
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Craig L Slingluff, JrUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Dec 2014 (estimated)
- Results
- Not posted in the source record
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 clinical trial is to study an experimental drug called pembrolizumab or MK-3475 for use in combination with chemotherapy and radiation therapy for patients with resectable (surgical removal) or borderline resectable pancreatic cancer. In general, pancreatic cancer that cannot be removed by surgery is sometimes treated with chemotherapy and radiation therapy, called neoadjuvant treatment, to shrink the tumor so that surgery might be possible. However, this is not always effective at shrinking the tumor enough to allow it to be removed with surgery. Recent discoveries suggest that the investigators own immune system might have a role in controlling the growth of tumors. Drugs such as pembrolizumab can stimulate the immune system against cancer. The purpose of this study is to investigate whether pembrolizumab can be used safely during neoadjuvant treatment and can improve the body's immune response against pancreatic cancer.
Pembrolizumab has been approved for treatment of patients with melanoma but has not been proven to be safe or helpful in patients with pancreatic cancer and is not approved by the U.S. Food and Drug Administration (FDA) for this purpose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neodjuvant CRT + Pembrolizumab | Experimental | Drug: Pembrolizumab, Radiation: Neoadjuvant ChemoradiationStandard neoadjuvant chemoradiation treatment (CRT) with pembrolizumab |
| Neoadjuvant CRT | Active comparator | Radiation: Neoadjuvant ChemoradiationStandard neoadjuvant chemoradiation treatment (CRT) alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Adequate organ function
- In subjects requiring biliary decompression, metal stent or drainage using percutaneous transhepatic cholangiogram (PTC) are allowed
Key exclusion criteria (12 listed)
- Immunodeficiency or taking steroid or any other form of immunosuppressive therapy
- Has a plastic biliary stent for decompression
- Metastatic disease
- Prior treatment for pancreatic cancer (other than 4-8 cycles of Folfirinox) or prior treatment with radiation for other diagnoses to the expected pancreatic cancer treatment area
- Active autoimmune disease
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 |
|---|---|---|
| PembrolizumabAlso: MK-3475, KeytrudaPembrolizumab administered at a dose of 200 mg IV every 3 weeks on days 1, 22, and 43 during concurrent neoadjuvant chemoradiation treatment | Drug | Neodjuvant CRT + Pembrolizumab |
| Neoadjuvant ChemoradiationChemoradiation with capecitabine (825 mg/m2 orally twice daily, Monday through Friday, on days of radiation only) and radiation (50.4 Gy in 28 fractions over 28 days) | Radiation | Neoadjuvant CRT, Neodjuvant CRT + Pembrolizumab |
Primary outcome
Number of Tumor Infiltrating Lymphocytes (TILs) per high powered field (hpf) in pancreatic tissue (resected tissue).
Time frame: 2-3 years
Safety: Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: 2-3 years
3 secondary outcomes
Disease-free survival (DFS)
Time frame: 2-4 years
Overall survival (OS)
Time frame: 2-4 years
Response Rate (RR)
Time frame: 2-3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
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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.
Osama Rahma, MD study chair
Dana-Farber Cancer Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pembrolizumab and Neoadjuvant Chemoradiation in people with Pancreatic Cancer, run by Craig L Slingluff, Jr at 6 sites 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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin Alicea (434-243-5350, xzy7tw@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Tumor Infiltrating Lymphocytes (TILs) per high powered field (hpf) in pancreatic tissue (resected tissue). (time frame: 2-3 years). 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 13 Aug 2021.