Adults 18 to 99, any sex, with Pancreatic Neoplasms or Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Adverse Events in Each Cohort With Grade 1 Through 5 Related to Study DrugPrimary· Participants were assessed from the start of study treatment at Cycle 1 then after every cycle (1 cycle = 28 days) of protocol treatment until 30 days after they were taken off treatment, approximately 4.0 months.
Adverse Events (AEs) are reported by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1=Mild, Grade 2= Moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Fatal.
Grade 1 Abdominal pain
Group
Value
95% CI
Cohort A Dose Level A1
0
Cohort A Dose Level A2
0
Cohort C Dose Level C1
0
Cohort C Dose Level C2
1
Grade 1 Alanine aminotransferase increased
Group
Value
95% CI
Cohort A Dose Level A1
1
Cohort A Dose Level A2
0
Cohort C Dose Level C1
0
Cohort C Dose Level C2
5
Grade 1 Alkaline Phosphatase increased
Group
Value
95% CI
Cohort A Dose Level A1
0
Cohort A Dose Level A2
2
Cohort C Dose Level C1
0
Cohort C Dose Level C2
2
Grade 1 Anemia
Group
Value
95% CI
Cohort A Dose Level A1
3
Cohort A Dose Level A2
3
Cohort C Dose Level C1
9
Cohort C Dose Level C2
9
Grade 1 Anorexia
Group
Value
95% CI
Cohort A Dose Level A1
1
Cohort A Dose Level A2
0
Cohort C Dose Level C1
0
Cohort C Dose Level C2
3
Grade 1 Atrial fibrillation
Group
Value
95% CI
Cohort A Dose Level A1
0
Cohort A Dose Level A2
0
Cohort C Dose Level C1
0
Cohort C Dose Level C2
1
Grade 1 Aspartate aminotransferase increased
Group
Value
95% CI
Cohort A Dose Level A1
1
Cohort A Dose Level A2
0
Cohort C Dose Level C1
1
Cohort C Dose Level C2
6
Grade 1 Back pain
Group
Value
95% CI
Cohort A Dose Level A1
0
Cohort A Dose Level A2
0
Cohort C Dose Level C1
0
Cohort C Dose Level C2
1
Percentage of Participants With 6-month Overall SurvivalSecondary· 6 month
Participants who survived at least 6 months after therapy.
Group
Value
95% CI
Cohort A Dose Level A1
26
Cohort A Dose Level A2
58
Cohort C Dose Level C1
12
Cohort C Dose Level C2
40
Overall SurvivalSecondary· From study entry to death or date of last contact, whichever occurs first, up to 2 years of follow-up
Amount of time participants survived after therapy.
Group
Value
95% CI
Cohort A Dose Level A1
3.3
1.2 – 6.6
Cohort A Dose Level A2
9.0
0.5 – 18.4
Cohort C Dose Level C1
2.1
1.1 – 4.3
Cohort C Dose Level C2
4.2
2.9 – 9.3
Tumor Response Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Measured by Computed Tomography (CT) and Magnetic Resonance Imaging (MRI)Secondary· At screening then every 8 weeks until disease progression or patient is taken off the trial, whichever comes first, approximately 6 months.
Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Complete Response
Group
Value
95% CI
Cohort A Dose Level A1
0
Cohort A Dose Level A2
0
Cohort C Dose Level C1
0
Cohort C Dose Level C2
0
Partial Response
Group
Value
95% CI
Cohort A Dose Level A1
1
Cohort A Dose Level A2
0
Cohort C Dose Level C1
0
Cohort C Dose Level C2
1
Stable Disease
Group
Value
95% CI
Cohort A Dose Level A1
3
Cohort A Dose Level A2
4
Cohort C Dose Level C1
2
Cohort C Dose Level C2
5
Progressive Disease
Group
Value
95% CI
Cohort A Dose Level A1
4
Cohort A Dose Level A2
4
Cohort C Dose Level C1
6
Cohort C Dose Level C2
10
Progression Free Survival (PFS)Secondary· From study entry to disease progression, death or date of last contact, whichever occurs first, an average of 6 months
PFS is the defined as the median amount of time subject survives without disease progression after treatment. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note:
Group
Value
95% CI
Cohort A Dose Level A1
1.7
0.8 – 2.0
Cohort A Dose Level A2
2.5
0.1 – 3.7
Cohort C Dose Level C1
0.9
0.7 – 2.1
Cohort C Dose Level C2
2.3
1.9 – 3.4
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)Secondary· Date treatment consent signed to date off study, approximately 18 months and 4 days for Cohort 1/Dose Level A1, 23 months and 29 days for Cohort 2/Dose Level A2, 32 months and 19 days for Cohort C/Dose Level C1, and 44 months and 18 days for Cohort C/Dose
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one
Group
Value
95% CI
Durvalumab + 8 Gray (Gy) in 1 Fraction
14
Durvalumab +5 Gy in 5 Fractions
10
Durvalumab +Tremelimumab + 8 Gy in 1 Fraction
19
Durvalumab +Tremelimumab +5 Gy in 5 Fractions
20
Adverse events — posted to ClinicalTrials.gov
Time frame: Date treatment consent signed to date off study, approximately 18 months and 4 days for Cohort 1/Dose Level A1, 23 months and 29 days for Cohort 2/Dose Level A2, 32 months and 19 days for Cohort C/Dose Level C1, and 44 months and 18 days for Cohort C/Dose Level C2..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Durvalumab + 8 Gray (Gy) in 1 Fraction
Serious: 6/14 (43%)
Deaths: 14/14
Durvalumab +5 Gy in 5 Fractions
Serious: 2/11 (18%)
Deaths: 8/11
Durvalumab +Tremelimumab + 8 Gy in 1 Fraction
Serious: 11/19 (58%)
Deaths: 2/19
Durvalumab +Tremelimumab +5 Gy in 5 Fractions
Serious: 12/20 (60%)
Deaths: 3/20
Serious adverse events (46 terms)
Reaction
System
Durvalumab + 8 Gray (Gy) i…
Durvalumab +5 Gy in 5 Frac…
Durvalumab +Tremelimumab +…
Durvalumab +Tremelimumab +…
Dehydration
Metabolism and nutrition disorders
—
—
—
—
Death NOS
General disorders
—
—
—
—
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, death
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Background:
\- Stereotactic body radiation therapy (SBRT) is used to treat cancer. It is a way of giving very focused beams of radiation to tumors. Researchers think that the drugs being used in this study might work better when combined with SBRT in people with pancreatic cancer.
Objective:
\- To study the safety and effectiveness of Durvalumab (MEDI4736) and/or tremelimumab with SBRT.
Eligibility:
\- People 18 and older who have pancreatic cancer that has not responded or to chemotherapy. They must be candidates for radiation but not resection.
Design:
* Participants will be screened with medical history and physical exam. They will have blood tests. Their tumor will be measured using computerized tomography (CT) or magnetic resonance imaging (MRI).
* Participants will have their tumor biopsied with a needle. They will have also have a biopsy after cycle 1.
* Participants will get 1 or 2 drugs in combination with the SBRT.
* For MEDI4736, the duration of each cycle will be 28-days. Participants will get the drug through an intravenous (IV) infusion twice in each cycle (Days 1 and 15).
* For tremelimumab, the duration of the first 6 cycles will each last 28 days. Then the duration of the last 3 cycles will change to 12 weeks. Participants will get the drug through an IV once in each cycle.
* All participants will have SBRT. Some will get 1 dose of radiation and some will get 5. CT scans will map their tumor.
* Participants will have medical history, physical exam, and blood tests in each cycle. They will have a CT scan or MRI every 8 weeks. Cycles will continue for up to 12 months.
* Participants will be contacted yearly for follow-up.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· not yet recruiting
NCT07332351 — Neoadjuvant Intravesical Nadofaragene Firadenovec With Gemcitabine, Cisplatin and Durvalumab for the Treatment of Muscle
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NCT07339059 — Phase II Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Ce
· Phase 2
· recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
· Phase 1
· not yet recruiting
NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
· Phase 2
· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 20 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02311361.