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 : September 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Pancreas||Drug: Durvalumab Radiation: Radiation Therapy||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-arm Phase II|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 17, 2018|
|Estimated Primary Completion Date :||July 2025|
|Estimated Study Completion Date :||July 2026|
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.
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.
- Progression free survival [ Time Frame: assessed up to 3 years ]Time to progression or death, whichever comes first
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490760
|Contact: Michael D. Chuong, MDfirstname.lastname@example.org|
|United States, Florida|
|Miami Cancer Institute at Baptist Health, Inc.||Recruiting|
|Miami, Florida, United States, 33176|
|Contact: Michael Chuong, MD 786-527-8175 email@example.com|
|Principal Investigator:||Michael D. Chuong, MD||Miami Cancer Institute at Baptist Health, Inc.|