Adenocarcinoma of the PancreasPhase 2NCT03490760
Durvalumab and "Booster" Radiation in Metastatic Adenocarcinoma of the Pancreas
A Phase 2 study testing Durvalumab and Radiation Therapy in people with Adenocarcinoma of the Pancreas, run by Baptist Health South Florida at 1 site in United States.
Trial summary
This is a single-institution, single-arm phase II trial of Durvalumab combined with Radiation Therapy (RT) for metastatic pancreatic cancer patients who have progressed through first-line chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Pancreas
- What is being tested?
- Durvalumab and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2018to 9 Jul 2020
- 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
- Biopsy-proven metastatic pancreatic adenocarcinoma with progression through standard first-line chemotherapy. Chemotherapy given as part of prior chemoradiation does not count as a line of therapy. Chemotherapy given as part of prior chemoradiation in the setting of non-metastatic pancreatic cancer does not count as a line of therapy.
- At least 3 radiographically distinct pancreatic cancer lesions that are measurable by RECIST 1.1 criteria, including 2 that are eligible for RT.
- Lesions that will receive RT are separated by ≥3 cm and none >7 cm in greatest dimension.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥12 weeks.
- Adequate liver and kidney function.
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- Adequate blood cell count.
- Female subjects must either be of non-reproductive potential or must have a negative serum pregnancy test upon study entry.
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Who cannot join
- Involvement in the planning and/or conduct of the study
- Previous enrollment in the present study.
- Any previous treatment with a programmed cell death 1 or programmed cell death ligand 1 inhibitor including Durvalumab.
- Prior RT to any lesion that would receive RT on this protocol.
- Prior RT that could lead to an unacceptably high risk of clinically significant normal tissue injury due to high cumulative normal tissue dose as determined by the investigator.
- Subjects who have received more than 1 line of chemotherapy in the metastatic setting.
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- History of another primary malignancy except for: 1) malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study drug and of low potential risk for recurrence; 2) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; 3) adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ).
- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) ≤14 days prior to the first dose of study drug.
- Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction.
- Current or prior use of immunosuppressive medication within 28 days before the first dose of Durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
- Any unresolved toxicity (> grade 2, Common Terminology Criteria for Adverse Events version 4.03) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy).
- Any prior Grade ≥ 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved immune-related adverse event (irAE) >Grade 1.
- Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
- History of primary immunodeficiency.
- History of allogeneic organ transplant.
- History of liver cirrhosis and Child-Pugh class B or C.
- History of hypersensitivity to Durvalumab or any excipient.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
- Known history of previous clinical diagnosis of tuberculosis
- History of leptomeningeal carcinomatosis
- Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab
- Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
- Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids.
- Subjects with uncontrolled seizures.
- Subjects with known radiation hypersensitivity syndromes such as Ataxia-Telangiectasia or Nijmegen Breakage Syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
About this study
Official title: Phase II Trial of In Situ Tumor Vaccination Using Durvalumab and "Booster" Radiation Therapy in Patients With Metastatic Adenocarcinoma of the Pancreas Who Have Progressed Through First-line Chemotherapy
This is a single-institution, single-arm phase II trial of Durvalumab combined with Radiation Therapy (RT) for metastatic pancreatic cancer patients who have progressed through first-line chemotherapy.
Read the detailed description
This is a single-institution phase II trial of Durvalumab combined with Radiation Therapy (RT) for metastatic pancreatic cancer patients who have progressed through first-line chemotherapy. Pancreatic cancer patients who have received second-line or greater chemotherapy in the metastatic setting are not eligible. Target accrual is 39 patients. Durvalumab 1500 mg (or 20 mg/m2 if <30 kg) IV every 4 weeks will be started and continued during RT and afterwards until the patient experiences either unacceptable toxicity or disease progression, whichever comes first. Patients must have at least three radiographically measurable pancreatic cancer lesions in different organs that have not previously received RT, two of which will receive RT. Eligible lesions include either the primary pancreatic tumor in unresected patients or distant metastatic lesions. Three fractions of 8 Gy each will be prescribed to one lesion during Week 3. Three fractions of 8 Gy each will be prescribed to the second lesion during Week 5.
This is a single-arm trial with continuous monitoring of acute non-hematologic toxicity with the primary endpoint of progression free survival. Efficacy will be evaluated by time to progression or death, whichever comes first, and compared to historical control of chemotherapy alone as reported in the literature.
- Conditions
- Adenocarcinoma of the Pancreas
- Being tested
- Durvalumab, Radiation Therapy
- Keywords
- Metastatic Adenocarcinoma of the Pancreas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Durvalumab 1500 mg (or 20 mg/m2 if <30 kg) IV every 4 weeks
Radiation TherapyRadiation
24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab plus Radiation Therapy | Experimental | Durvalumab 1500 mg (or 20 mg/m2 if <30 kg) IV every 4 weeks plus 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5. Receives: Drug: Durvalumab; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Time from initiation of durvalumab to progression per RECIST 1.1 or death, whichever comes first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions. Confirmation of PD for participants who are deemed clinically stable by the Investigator should be acquired preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of PD.
Measured: 1 year
Secondary outcomes (4)
Overall Response Rate (ORR)
ORR is defined as the percentage of the patients who have a complete response (CR) or partial response (PR) as defined by RECIST 1.1. The patient's best overall response rate defined as the best response recorded from the start of the treatment until disease progression. Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR and PR requires a confirmatory scan preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of CR, PR, or stable disease (SD).
Measured: 1 year
Clinical Benefit Rate (CBR)
The clinical benefit rate is the percentage of patients that have achieved a CR, PR, or stable disease (SD) as defined by RECIST 1.1. Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; PD is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions; SD is defined as not meeting criteria for CR, PR, or SD. CR and PR requires a confirmatory scan preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of CR, PR, or stable disease (SD). Confirmation of PD for participants who are deemed clinically stable by the Investigator should be acquired preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of PD.
Measured: 1 year
Time to In-field Progression
In-field progression is defined as PD according to RECIST 1.1 criteria (at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions) within the original field or area where the participant had been treated with radiation therapy. Confirmation of PD for participants who are deemed clinically stable by the Investigator should be acquired preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of PD.
The time to in-field progression is defined as the time from initiation of treatment to progression within the radiation.
Measured: 1 year
Overall Survival (OS)
OS is defined as the time from first treatment until death. Patients who are alive will be censored at the last date of patient contact.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start9 Nov 2018
- Primary completion9 Jul 2020
- Study completion9 Jul 2020
Why it stopped: Slow/poor enrollment
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 Adenocarcinoma of the PancreasStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm Phase II
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Michael D. Chuong, MD, Principal investigator, Miami Cancer Institute at Baptist Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490760
- Sponsor's protocol ID
- ESR 15 11078
- Status last verified
- Sep 2023
- First submitted
- 14 Mar 2018
- Last updated
- 12 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of In Situ Tumor Vaccination Using Durvalumab and "Booster" Radiation Therapy in Patients With Metastatic Adenocarcinoma of the Pancreas Who Have Progressed Through First-line Chemotherapy
- ClinicalTrials.gov ID
- NCT03490760
- Acronym / sponsor ID
- ESR 15 11078
- Conditions
- Adenocarcinoma of the Pancreas
- Keywords
- Metastatic Adenocarcinoma of the Pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow/poor enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Posted 12 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-institution, single-arm phase II trial of Durvalumab combined with Radiation Therapy (RT) for metastatic pancreatic cancer patients who have progressed through first-line chemotherapy.
Detailed description
This is a single-institution phase II trial of Durvalumab combined with Radiation Therapy (RT) for metastatic pancreatic cancer patients who have progressed through first-line chemotherapy. Pancreatic cancer patients who have received second-line or greater chemotherapy in the metastatic setting are not eligible. Target accrual is 39 patients. Durvalumab 1500 mg (or 20 mg/m2 if <30 kg) IV every 4 weeks will be started and continued during RT and afterwards until the patient experiences either unacceptable toxicity or disease progression, whichever comes first. Patients must have at least three radiographically measurable pancreatic cancer lesions in different organs that have not previously received RT, two of which will receive RT. Eligible lesions include either the primary pancreatic tumor in unresected patients or distant metastatic lesions. Three fractions of 8 Gy each will be prescribed to one lesion during Week 3. Three fractions of 8 Gy each will be prescribed to the second lesion during Week 5.
This is a single-arm trial with continuous monitoring of acute non-hematologic toxicity with the primary endpoint of progression free survival. Efficacy will be evaluated by time to progression or death, whichever comes first, and compared to historical control of chemotherapy alone as reported in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm Phase II
| Arm | Type | Receives |
|---|---|---|
| Durvalumab plus Radiation Therapy | Experimental | Drug: Durvalumab, Radiation: Radiation TherapyDurvalumab 1500 mg (or 20 mg/m2 if <30 kg) IV every 4 weeks plus 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Biopsy-proven metastatic pancreatic adenocarcinoma with progression through standard first-line chemotherapy. Chemotherapy given as part of prior chemoradiation does not count as a line of therapy. Chemotherapy given as part of prior chemoradiation in the setting of non-metastatic pancreatic cancer does not count as a line of therapy.
- At least 3 radiographically distinct pancreatic cancer lesions that are measurable by RECIST 1.1 criteria, including 2 that are eligible for RT.
- Lesions that will receive RT are separated by ≥3 cm and none >7 cm in greatest dimension.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥12 weeks.
Key exclusion criteria (27 listed)
- Involvement in the planning and/or conduct of the study
- Previous enrollment in the present study.
- Any previous treatment with a programmed cell death 1 or programmed cell death ligand 1 inhibitor including Durvalumab.
- Prior RT to any lesion that would receive RT on this protocol.
- Prior RT that could lead to an unacceptably high risk of clinically significant normal tissue injury due to high cumulative normal tissue dose as determined by the investigator.
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 |
|---|---|---|
| DurvalumabDurvalumab 1500 mg (or 20 mg/m2 if <30 kg) IV every 4 weeks | Drug | Durvalumab plus Radiation Therapy |
| Radiation Therapy24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5. | Radiation | Durvalumab plus Radiation Therapy |
Primary outcome
Progression Free Survival
Time frame: 1 year
Time from initiation of durvalumab to progression per RECIST 1.1 or death, whichever comes first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions. Confirmation of PD for participants who are deemed clinically stable by the Investigator should be acquired preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of PD.
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: 1 year
Clinical Benefit Rate (CBR)
Time frame: 1 year
Time to In-field Progression
Time frame: 1 year
Overall Survival (OS)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Miami Cancer Institute websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Michael D. Chuong, MD principal investigator
Miami Cancer Institute at Baptist Health, Inc.
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 Durvalumab and Radiation Therapy in people with Adenocarcinoma of the Pancreas, run by Baptist Health South Florida 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 9 inclusion and 27 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: stopped early, as of the sponsor's last update on 12 Oct 2023. 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 12 Oct 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?
Progression Free Survival (time frame: 1 year). 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 12 Oct 2023.