A Study of Galunisertib (LY2157299) and Durvalumab (MEDI4736) in Participants With Metastatic Pancreatic Cancer
A Study of Galunisertib (LY2157299) and Durvalumab (MEDI4736) in Participants With Metastatic Pancreatic Cancer
The main purpose of this study is to evaluate the safety and efficacy of the study drug known
 as galunisertib administered in combination with the anti-programmed cell death-ligand 1
 (PD-L1) antibody durvalumab in participants with refractory metastatic pancreatic cancer.
Inclusion Criteria:

 -  Must have histologic or cytologic confirmation of recurrent metastatic pancreatic
 adenocarcinoma based on standard diagnostic criteria. Recurrence must be documented by
 diagnostic biopsy.

 -  Have measurable disease as defined by Response Evaluation Criteria in Solid Tumours
 (RECIST) version 1.1.

 -  Have had disease progression, been refractory or intolerant to no more than 2 prior
 systemic regimens for locally advanced or metastatic pancreatic cancer. Participants
 who have received prior neoadjuvant therapy and who now have metastatic disease must
 have received 1 of the following for their metastatic disease: FOLFIRINOX,
 nanoparticle albumin-bound paclitaxel/gemcitabine, TS-1 (tegafur gimeracil oteracil
 potassium), irinotecan liposome injection/5-fluorouracil (5FU)/Leucovorin or
 single-agent gemcitabine prior to enrolment in this study.

 -  Dose Escalation: Able and willing to give valid written consent to undergo a new
 tumour biopsy (prior to study treatment) or to provide an available archival tumour
 sample if taken <3 years prior to enrolment if a new tumour biopsy is not feasible
 with an acceptable clinical risk.

 -  Cohort Expansion: Able and willing to give valid written consent to undergo a new
 tumour biopsy (prior to study treatment). Able and willing to undergo a second tumour
 biopsy on treatment. Where possible, tumour lesions used for new biopsies should not
 be the same lesions used as RECIST target lesions, unless there are no other lesions
 suitable for biopsy. Archival samples may be required if there is inadequate tissue in
 the biopsy specimen.

 -  Have adequate organ function.

 -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
 scale.

 -  Use approved contraceptive methods.

 Exclusion Criteria:

 -  Have moderate or severe cardiovascular disease:

 -  Have the presence of cardiac disease, including a myocardial infarction within 6
 months prior to study entry, unstable angina pectoris, New York Heart Association
 Class III/IV congestive heart failure, or uncontrolled hypertension.

 -  Have documented major electrocardiogram (ECG) abnormalities (not responding to
 medical treatments; for example, atrial fibrillation, bundle branch blocks, or as
 approved by the sponsors).

 -  Have major abnormalities documented by ECHO with Doppler (for example, moderate
 or severe heart valve function defect including moderate or severe valve stenosis
 or regurgitation, left ventricular ejection fraction <50%, evaluation based on
 the institutional lower limit of normal, septal aneurysm or other heart aneurysm,
 any aneurysm of the major vessels or any condition that results in increased risk
 of aneurysm (eg, Marfan syndrome, patent foramen ovale [PFO]).

 -  Have predisposing conditions that are consistent with development of aneurysms of
 the ascending aorta or aortic stress (for example, family history of aneurysms,
 Marfan syndrome, PFO, bicuspid aortic valve, evidence of damage to the large
 vessels of the heart documented by computerized tomography [CT] scan with
 contrast or magnetic resonance imaging [MRI]).

 -  Have evidence of interstitial lung disease that is symptomatic or may interfere with
 the detection or management of suspected drug-related pulmonary toxicity or active,
 noninfectious pneumonitis.