Metastatic Pancreas CancerPhase 2Panc-Durval+RTNCT02885727
Durvalumab Plus "Booster" RT for Metastatic Adenocarcinoma Pancreas Cancer Post Chemotherapy (GCC 1598)
A Phase 2 study testing Durvalumab and Radiation Therapy in people with Metastatic Pancreas Cancer, run by University of Maryland, Baltimore.
Trial summary
Research Hypothesis: The combination of ionizing radiation and immunotherapy (durvalumab) is well tolerated and stimulates a clinically significant pancreas-cancer specific immune response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreas Cancer
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Dec 2022
- Phase
- Phase 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
- Written informed consent and any locally-required authorization (e.g., HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Age > 18 years at time of study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥12 weeks as estimated by the investigator.
- Biopsy-proven metastatic pancreatic adenocarcinoma with progression through standard first-line chemotherapy. Chemotherapy given as part of prior chemoradiation in the setting of non-metastatic pancreatic cancer does not count as a line of therapy.
- ≥2 radiographically distinct and measurable pancreatic cancer lesions (primary and/or metastatic lesions) by RECIST 1.1 criteria separated by ≥5 cm
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- No lesion that would receive RT >7 cm in greatest dimension.
- Subjects must consent to all study procedures described in the protocol including radiographic evaluation and repeated blood draws.
- Adequate normal organ and marrow function as defined below:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (> 1500 per mm3)
- Platelet count ≥ 100 x 109/L (>100,000 per mm3)
- Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤ 5x ULN
- Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
- Males:
- Creatinine CL (mL/min) = Weight (kg) x (140 - Age) / . 72 x serum creatinine (mg/dL)
- Females:
- Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 / 72 x serum creatinine (mg/dL)
- Female subjects must either be of non-reproductive potential, not breast-feeding or must have a negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. Male or female patients of reproductive potential need to employ two highly effective and acceptable forms of contraception throughout their participation in the study and for 90 days after last dose of study drug.
- 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 (applies to both AstraZeneca staff and/or staff at the study site)
- Previous enrollment in the present study
- Any previous treatment with a PD1 or PD-L1 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 second-line or later chemotherapy for metastatic pancreatic cancer (prior chemotherapy received in the non-metastatic setting does not count).
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- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drug and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- 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, CTCAE 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 irAE >Grade 1
- Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's 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.
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
Research Hypothesis: The combination of ionizing radiation and immunotherapy (durvalumab) is well tolerated and stimulates a clinically significant pancreas-cancer specific immune response.
The primary objective will be to evaluate whether the combination of RT and durvalumab can improve median PFS compared to chemotherapy historical control data in metastatic pancreas cancer patients who have progressed through first-line chemotherapy.
The primary intent of RT in this study is to augment a pancreatic cancer-specific immune response when given with durvalumab.
Read the detailed description
This clinical trial will use the combination of ionizing radiation and immunotherapy durvalumab (MEDI4736). It is the investigators hypothesis that this combination of ionizing radiation and immunotherapy is well tolerated and stimulates a clinically significant pancreas-cancer specific immune response. This trial's primary objective will be to evaluate whether the combination of RT and durvalumab can improve median PFS compared to chemotherapy historical control data in metastatic pancreas cancer patients who have progressed through first-line chemotherapy. The study population includes the metastatic pancreatic adenocarcinoma patients who have progressed through first-line chemotherapy. The number of subjects proposed to complete this study is 55.
- Conditions
- Metastatic Pancreas Cancer
- Being tested
- Durvalumab, Radiation Therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called (MEDI4736)
Evaluate if the combination of RT and durvalumab can improve median PFS compared to chemotherapy historical control data in metastatic pancreas cancer patients who have progressed through first-line chemotherapy
Radiation TherapyRadiation
The primary intent of RT in this study is to augment a pancreatic cancer-specific immune response when given with durvalumab.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab + Radiation therapy | Experimental | Durvalumab (MEDI4736) 750 mg (or 10mg/kg if the patient weighs <30 kg) IV Q2W over 1 hour for all patients + Radiation therapy
* First lesion to receive 25 Gy / 5 daily consecutive fractions of 5 Gy
* Second lesion to receive15 Gy / 5 daily consecutive fractions Receives: Drug: Durvalumab; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in median Progression Free Survival using the combination of RT and durvalumab.
The primary objective will be to evaluate whether the combination of RT and durvalumab improves median PFS compared to historical control in metastatic pancreas cancer patients who have progressed through first-line chemotherapy. PFS is defined as the time from the date of durvalumab initiation to the date of pancreatic cancer progression or death, whichever occurs first. This is a clinically relevant and appropriate endpoint for a phase II trial and since there are no prior studies using immune checkpoint blockade with concurrent RT for metastatic pancreatic cancer will allow for historical comparison to PFS using second-line chemotherapy.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startJul 2017 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Funding issues caused the study to not be opened the at local IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreas CancerStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
- Investigators
- Shahed N Badiyan, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885727
- Sponsor's protocol ID
- HP-00070528
- Acronym
- Panc-Durval+RT
- Status last verified
- Sep 2019
- First submitted
- 19 Aug 2016
- Last updated
- 12 Sep 2019
- Results posted
- No
- 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 Sep 2019. 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
- NCT02885727
- Acronym / sponsor ID
- Panc-Durval+RT / HP-00070528
- Conditions
- Metastatic Pancreas Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issues caused the study to not be opened the at local IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 31 Aug 2016 (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.
Research Hypothesis: The combination of ionizing radiation and immunotherapy (durvalumab) is well tolerated and stimulates a clinically significant pancreas-cancer specific immune response.
The primary objective will be to evaluate whether the combination of RT and durvalumab can improve median PFS compared to chemotherapy historical control data in metastatic pancreas cancer patients who have progressed through first-line chemotherapy.
The primary intent of RT in this study is to augment a pancreatic cancer-specific immune response when given with durvalumab.
Detailed description
This clinical trial will use the combination of ionizing radiation and immunotherapy durvalumab (MEDI4736). It is the investigators hypothesis that this combination of ionizing radiation and immunotherapy is well tolerated and stimulates a clinically significant pancreas-cancer specific immune response. This trial's primary objective will be to evaluate whether the combination of RT and durvalumab can improve median PFS compared to chemotherapy historical control data in metastatic pancreas cancer patients who have progressed through first-line chemotherapy. The study population includes the metastatic pancreatic adenocarcinoma patients who have progressed through first-line chemotherapy. The number of subjects proposed to complete this study is 55.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab + Radiation therapy | Experimental | Drug: Durvalumab, Radiation: Radiation TherapyDurvalumab (MEDI4736) 750 mg (or 10mg/kg if the patient weighs <30 kg) IV Q2W over 1 hour for all patients + Radiation therapy * First lesion to receive 25 Gy / 5 daily consecutive fractions of 5 Gy * Second lesion to receive15 Gy / 5 daily consecutive fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Written informed consent and any locally-required authorization (e.g., HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Age > 18 years at time of study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥12 weeks as estimated by the investigator.
- Biopsy-proven metastatic pancreatic adenocarcinoma with progression through standard first-line chemotherapy. Chemotherapy given as part of prior chemoradiation in the setting of non-metastatic pancreatic cancer does not count as a line of therapy.
Key exclusion criteria (29 listed)
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous enrollment in the present study
- Any previous treatment with a PD1 or PD-L1 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 |
|---|---|---|
| DurvalumabAlso: (MEDI4736)Evaluate if the combination of RT and durvalumab can improve median PFS compared to chemotherapy historical control data in metastatic pancreas cancer patients who have progressed through first-line chemotherapy | Drug | Durvalumab + Radiation therapy |
| Radiation TherapyThe primary intent of RT in this study is to augment a pancreatic cancer-specific immune response when given with durvalumab. | Radiation | Durvalumab + Radiation therapy |
Primary outcome
Improvement in median Progression Free Survival using the combination of RT and durvalumab.
Time frame: 6 years
The primary objective will be to evaluate whether the combination of RT and durvalumab improves median PFS compared to historical control in metastatic pancreas cancer patients who have progressed through first-line chemotherapy. PFS is defined as the time from the date of durvalumab initiation to the date of pancreatic cancer progression or death, whichever occurs first. This is a clinically relevant and appropriate endpoint for a phase II trial and since there are no prior studies using immune checkpoint blockade with concurrent RT for metastatic pancreatic cancer will allow for historical comparison to PFS using second-line chemotherapy.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- 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.
Shahed N Badiyan, MD principal investigator
University of Maryland, Baltimore
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab and Radiation Therapy in people with Metastatic Pancreas Cancer, run by University of Maryland, Baltimore.
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 21 inclusion and 29 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: withdrawn, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Improvement in median Progression Free Survival using the combination of RT and durvalumab. (time frame: 6 years). 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 Sep 2019.