Clinical trialPhase 2Terminated
Durvalumab and "Booster" Radiation in Metastatic Adenocarcinoma of the Pancreas
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
- Outcome
- Stopped early. Results posted; single-arm, no comparisonSlow/poor enrollment (Enrollment)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 9 November 2018
- Ended
- 9 July 2020
- Enrollment
- 9 participants
- Sites
- 1
- Primary outcomes
- Progression Free Survival
- Sponsor type
- Academic / other
- Results posted
- 12 October 2023
- Last update
- 12 October 2023
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
Results
- Primary endpoint
- Results posted; single-arm, no comparisonAs posted on ClinicalTrials.gov ↗, registry record of 12 October 2023
- PFS
- Progression Free SurvivalDurvalumab Plus Radiation Therapy: 53 (51 to 53.5), n = 7Values: median days, Inter-Quartile RangeTime frame: 1 yearNo analysis posted for this outcome (outcome 1)
- Participants
- Durvalumab Plus Radiation Therapy: 9 started, 7 completed
- Serious adverse events
- Durvalumab Plus Radiation Therapy: 3 of 7Participants with at least one serious adverse event, of those at risk, as posted
4 secondary outcomes
- ORR · Overall Response Rate (ORR)
- Durvalumab Plus Radiation Therapy 0/6 [Participants]
- Clinical Benefit Rate (CBR)
- Durvalumab Plus Radiation Therapy 1/6 [Participants]
- Time to In-field Progression
- Durvalumab Plus Radiation Therapy 53 (51 to 53.5), n=3 [median days, Inter-Quartile Range]
- OS · Overall Survival (OS)
- Durvalumab Plus Radiation Therapy 85 (75 to 175), n=7 [median days, Inter-Quartile Range]
Every value is copied from the trial’s results record at ClinicalTrials.gov. “Statistically significant” describes the posted test only: it does not say which group did better, and nothing here is read from a paper.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Progression Free Survival [1 year]. Median, days (Inter-Quartile Range). Durvalumab Plus Radiation Therapy (n=7): 53 (51 to 53.5).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Response Rate (ORR) [1 year]. Count Of Participants, Participants. Durvalumab Plus Radiation Therapy (n=6): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Clinical Benefit Rate (CBR) [1 year]. Count Of Participants, Participants. Durvalumab Plus Radiation Therapy (n=6): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to In-field Progression [1 year]. Median, days (Inter-Quartile Range). Durvalumab Plus Radiation Therapy (n=3): 53 (51 to 53.5).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [1 year]. Median, days (Inter-Quartile Range). Durvalumab Plus Radiation Therapy (n=7): 85 (75 to 175).