- Arm with active probiotic combined to antispasmodic/antifoam drug

Irritable Bowel Syndrome

I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d)

I31 probiotic

I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d)
Antispasmodic/antifoam drug, consisting of Alverine Citrate 60 mg and Simethicone 300 mg, thrice daily (t.i.d)

I31 probiotic combined to Alverine/Simethicone

Placebo treatment (maltodextrin), once daily (u.i.d)

Placebo

Hospital Juarez de Mexico

Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico

Efficacy of the Combination Therapy With Alverine-simeticone and i3.1 Probiotic Formula in the Quality of Life of Patients With IBS-D or IBS-M in Hospital Juarez Mexico

Irritable bowel syndrome-specific validated IBSQoL questionnaire (Hahn et al. Aliment Pharmacol Ther 1997). Response is defined as an improvement of 15 or more points in the normalized 0-100 score

Abdominal Pain Visual Analog Scale, ranging 0 to 10 (i.e. 11-point scale, as recommended by FDA, May 2012 Guidance on Irritable Bowel Syndrome - Clinical Evaluation of Products for Treatment). Response is defined as an improvement of 30% at the end of the intervention compared to baseline.

Stool consistency as determined with the Bristol scale (Lewis & Heaton, Scand. J. Gastroenterol 1997). Response is defined as a score equal or below 5 at the end of the intervention.

Nuria Pérez López

Digestive Physiology Lab Head

Cohort 1/Dose Level A1 Durvalumab + 8 Gray (Gy) in 1 fraction

Cohort 2/Dose Level A2 Durvalumab +5 Gy in 5 fractions

Cohort 3/Dose Level B1 (was removed with Amendment A) Tremelimumab + 8 Gy in 1 fraction

Cohort 4/Dose Level B2 (was removed with Amendment A) Tremelimumab + 5 Gy in 5 fractions

Cohort C/ Dose Level C1 Durvalumab +Tremelimumab + 8 Gy in 1 fraction

Cohort C/Dose Level C2 Durvalumab +Tremelimumab +5 Gy in 5 fractions

Cohort 1/Dose Level A1 Durvalumab + 8 Gray (Gy) in 1 fraction
Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.
Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5

Durvalumab + 8 Gray (Gy) in 1 Fraction

Cohort 2/Dose Level A2 Durvalumab +5 Gy in 5 fractions
Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.
Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5

Durvalumab +5 Gy in 5 Fractions

Cohort C/ Dose Level C1 Durvalumab +Tremelimumab + 8 Gy in 1 fraction
Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.
Tremelimumab: 75 mg IV, every 4 weeks for 16 weeks
Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5

Durvalumab +Tremelimumab + 8 Gy in 1 Fraction

Cohort C/Dose Level C2 Durvalumab +Tremelimumab +5 Gy in 5 fractions
Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.
Tremelimumab: 75 mg IV, every 4 weeks for 16 weeks
Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5

Durvalumab +Tremelimumab +5 Gy in 5 Fractions

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

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.

Durvalumab + 8 Gray (Gy) in 1 fraction
Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.
Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5

Cohort A Dose Level A1

Durvalumab +5 Gy in 5 fractions
Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.
Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5

Cohort A Dose Level A2

Durvalumab +Tremelimumab + 8 Gy in 1 fraction
Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.
Tremelimumab: 75 mg IV, every 4 weeks for 16 weeks
Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5

Cohort C Dose Level C1

Durvalumab +Tremelimumab +5 Gy in 5 fractions
Durvalumab: 10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.
Tremelimumab: 75 mg IV, every 4 weeks for 16 weeks
Sterostatic body radiation therapy (SBRT): 8 Gray (Gy) x 1; 5Gy x 5

Cohort C Dose Level C2

Number of Adverse Events in Each Cohort With Grade 1 Through 5 Related to Study Drug

Plasma Pharmacokinetic (PK)

Participants who survived at least 6 months after therapy.

Percentage of Participants With 6-month Overall Survival

Amount of time participants survived after therapy.

Overall Survival

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.

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)

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: the appearance of one or more new lesions is also considered progressions). NOTE: While RECIST Progressive Disease (PD) will be noted and recorded the immune-related (IR) RECIST criteria will be applied to determine discontinuation of study treatment. For modified Immune-Related Response Criteria (irRC), only target and measurable lesions are taken into account.

Progression Free Survival (PFS)

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 of the previous outcomes mentioned.

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Overall Study

Dr. Tim Greten

Pancreatic Neoplasms

Pancreatic Cancer

Cancer of Pancreas

Cancer of the Pancreas

Pancreas Cancer

10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.

Durvalumab

Tremelimumab

Sterostatic body radiation therapy (SBRT)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Immune Checkpoint Inhibition (Tremelimumab and/or MEDI4736) in Combination With Radiation Therapy in Patients With Unresectable Pancreatic Cancer

A Pilot Study of Immune Checkpoint Inhibition (Durvalumab With or Without Tremelimumab) in Combination With Radiation Therapy in Patients With Unresectable Pancreatic Cancer

diverticulum/diarrhea

Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico

Immune Checkpoint Inhibition (Tremelimumab and/or MEDI4736) in Combination With Radiation Therapy in Patients With Unresectable Pancreatic Cancer

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