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Durvalumab and "Booster" Radiation in Metastatic Adenocarcinoma of the Pancreas

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ClinicalTrials.gov Identifier: NCT03490760
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Baptist Health South Florida

Tracking Information
First Submitted Date  ICMJE March 14, 2018
First Posted Date  ICMJE April 6, 2018
Last Update Posted Date November 18, 2019
Actual Study Start Date  ICMJE August 17, 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2018)
Progression free survival [ Time Frame: assessed up to 3 years ]
Time to progression or death, whichever comes first
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Durvalumab and "Booster" Radiation in Metastatic Adenocarcinoma of the Pancreas
Official Title  ICMJE 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
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single-arm Phase II
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adenocarcinoma of the Pancreas
Intervention  ICMJE
  • Drug: Durvalumab
    Durvalumab 1500 mg (or 20 mg/m2 if <30 kg) IV every 4 weeks
  • Radiation: Radiation Therapy
    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 Arms  ICMJE Experimental: Durvalumab plus Radiation Therapy
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.
Interventions:
  • Drug: Durvalumab
  • Radiation: Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 5, 2018)
39
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
  • Adequate blood cell count.
  • Female subjects must either be of non-reproductive potential or must have a negative serum pregnancy test upon study entry.

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael D. Chuong, MD 786-527-8175 michaelchu@baptisthealth.net
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03490760
Other Study ID Numbers  ICMJE ESR 15 11078
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Baptist Health South Florida
Study Sponsor  ICMJE Baptist Health South Florida
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Michael D. Chuong, MD Miami Cancer Institute at Baptist Health, Inc.
PRS Account Baptist Health South Florida
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP