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NCT03490760

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

Terminated Phase 2 Results posted Last updated 12 October 2023
What this trial tests

Phase 2 trial testing Durvalumab in Adenocarcinoma of the Pancreas in 9 participants. Terminated before completion.

Timeline
9 November 2018
Primary endpoint
9 July 2020
9 July 2020

Quick facts

Lead sponsorBaptist Health South Florida
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date9 November 2018
Primary completion9 July 2020
Estimated completion9 July 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Baptist Health South Florida — full company profile →

Who can join

18 and older, any sex, with Adenocarcinoma of the Pancreas. 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.

Progression Free Survival Primary · 1 year

Time from initiation of durvalumab to progression per RECIST 1.1 or death, whichever comes first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions. Confirmation of PD for participants who are deemed clinically stable by the Investigator should be acquired preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of PD.

GroupValue95% CI
Durvalumab Plus Radiation Therapy5351 – 53.5
Overall Response Rate (ORR) Secondary · 1 year

ORR is defined as the percentage of the patients who have a complete response (CR) or partial response (PR) as defined by RECIST 1.1. The patient's best overall response rate defined as the best response recorded from the start of the treatment until disease progression. Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR and PR requires a confirmatory scan preferably at the next regularly scheduled imaging visit and no earlier than 4

GroupValue95% CI
Durvalumab Plus Radiation Therapy0
Clinical Benefit Rate (CBR) Secondary · 1 year

The clinical benefit rate is the percentage of patients that have achieved a CR, PR, or stable disease (SD) as defined by RECIST 1.1. Per RECIST 1.1, CR is defined as the disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; PD is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions; SD is defined as not meeting criteria for CR, PR, or SD. CR and PR requires a confirmatory scan preferabl

GroupValue95% CI
Durvalumab Plus Radiation Therapy1
Time to In-field Progression Secondary · 1 year

In-field progression is defined as PD according to RECIST 1.1 criteria (at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions) within the original field or area where the participant had been treated with radiation therapy. Confirmation of PD for participants who are deemed clinically stable by the Investigator should be acquired preferably at the next regularly scheduled imaging visit and no earlier than 4 weeks after the prior assessment of PD. The time to in-field progression is defined as the time from initiati

GroupValue95% CI
Durvalumab Plus Radiation Therapy5351 – 53.5
Overall Survival (OS) Secondary · 1 year

OS is defined as the time from first treatment until death. Patients who are alive will be censored at the last date of patient contact.

GroupValue95% CI
Durvalumab Plus Radiation Therapy8575 – 175

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year, 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Durvalumab Plus Radiation Therapy
Serious: 3/7 (43%)
Deaths: 7/7

Serious adverse events (7 terms)

ReactionSystemDurvalumab Plus Radiation …
HyperglycemiaMetabolism and nutrition disorders
Abdominal painGastrointestinal disorders
SepsisInfections and infestations
Acute cystitisRenal and urinary disorders
Rectal bleedGastrointestinal disorders
GI bleedGastrointestinal disorders
HypoglycemiaMetabolism and nutrition disorders
Other adverse events (23 terms — click to expand)

ReactionSystemDurvalumab Plus Radiation …
DiarrheaGastrointestinal disorders
Abdominal painGastrointestinal disorders
FatigueGeneral disorders
NauseaGastrointestinal disorders
ConstipationGastrointestinal disorders
AnorexiaGastrointestinal disorders
Urinary tract infectionRenal and urinary disorders
Increased alkaline phosphataseHepatobiliary disorders
Back painMusculoskeletal and connective tissue disorders
Testicular painReproductive system and breast disorders
VomitingGastrointestinal disorders
Elevated troponinCardiac disorders
Generalized weaknessGeneral disorders
Protein calorie malnutritionMetabolism and nutrition disorders
AnemiaBlood and lymphatic system disorders
Low Albumin on BloodHepatobiliary disorders
FeverInfections and infestations
HyponatremiaRenal and urinary disorders
SeizureNervous system disorders
Aspiration pneumoniaRespiratory, thoracic and mediastinal disorders
Bilateral pulmonary embolismVascular disorders
Deep vein thrombosisVascular disorders
Shortness of breathRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Hyperglycemia, Abdominal pain, Sepsis, Acute cystitis, Rectal bleed, GI bleed, Hypoglycemia.

Data from ClinicalTrials.gov NCT03490760 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Combination, Modulation and Interplay of Modern Radiotherapy with the Tumor Microenvironment and Targeted Therapies in Pancreatic Cancer: Which Candidates to Boost Radiotherapy?
    Benkhaled S, Peters C, Jullian N, Arsenijevic T, et al · · 2023 · cited 19× · PMID 36765726 · DOI 10.3390/cancers15030768
  2. Nanomaterials-driven in situ vaccination: a novel frontier in tumor immunotherapy.
    Liu N, Wang X, Wang Z, Kan Y, et al · · 2025 · cited 16× · PMID 40247328 · DOI 10.1186/s13045-025-01692-4
  3. Genomics meets immunity in pancreatic cancer: Current research and future directions for pancreatic adenocarcinoma immunotherapy.
    Bowers JS, Bailey SR, Rubinstein MP, Paulos CM, et al · · 2019 · cited 11× · PMID 31456872 · DOI 10.4081/oncol.2019.430
  4. The Achilles' Heel of Pancreatic Cancer: Targeting pancreatic cancer's unique immunologic characteristics and metabolic dependencies in clinical trials.
    Siolas D, Morrissey C, Oberstein PE. · · 2020 · cited 7× · PMID 33133736 · DOI 10.1097/jp9.0000000000000052
  5. Immunotherapy and radiation therapy for gastrointestinal malignancies: hope or hype?
    Badiyan S, Kaiser A, Eastman B, Forsthoefel M, et al · · 2020 · cited 2× · PMID 32258525 · DOI 10.21037/tgh.2019.10.07

Verify or expand the search:

Other trials of Durvalumab

Trials testing the same drug.

Other recruiting trials for Adenocarcinoma of the Pancreas

Currently open trials in the same condition.

Other Baptist Health South Florida trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03490760.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing