Clinical Trials /

Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma

NCT04098432

Description:

Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma
  • Official Title: Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma

Clinical Trial IDs

  • ORG STUDY ID: CA209- 9KH
  • NCT ID: NCT04098432

Conditions

  • Locally Advanced Unresectable Pancreatic Adenocarcinoma

Interventions

DrugSynonymsArms
NivolumabOpdivoArm 1

Purpose

Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma

Detailed Description

      Phase I/II, multicentre, open label, with no control arm clinical trial of 4-weeks
      stereotactic radiotherapy followed by nivolumab 3 mg/kg every two weeks in adults with
      locally advanced pancreatic cancer who does not progress during 4 cycles of standard
      chemotherapy FOLFIRINOX
    

Trial Arms

NameTypeDescriptionInterventions
Arm 1Experimental4-weeks stereotactic radiotherapy followed by nivolumab 3 mg/kg every two weeks
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria:

          1. Male and female patients aged ≥18 years

          2. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1

          3. Locally advanced, unresectable, histologically confirmed primary adenocarcinoma of
             pancreas with no progression during induction chemotherapy (4 cycles of FOLFIRINOX -
             not a part of trial). Within screening period tumor tissue must be available and sent
             to the central pathological reviewer in order to confirm the diagnosis.

          4. Measurable (one target lesion is sufficient) disease as per RECIST 1.1 criteria

          5. Laboratory values:

               1. Aspartate aminotransferase (AST) ≤ 3x ULN (upper limit of normal)

               2. Alanine transaminase (ALT) ≤ 3x ULN

               3. Total bilirubin ≤ 1.5 x ULN (except subjects with Gilbert syndrome who must have
                  a total bilirubin ≤ 3x ULN)

               4. Creatinine: Serum creatinine ≤ 1.5 ULN or creatinine clearance > 50ml/min (using
                  Cockcroft/Gault formula)

               5. White blood cells ≥ 2000 /ul

               6. Neutrophils ≥ 1500 /ul

               7. Platelets ≥ 100x 103 /ul

               8. Hemoglobin ≥ 9.0 g/l

          6. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
             (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the
             start of study treatment. WOCBP is defined as any female who has experienced menarche
             and who has not undergone surgical sterilization (hysterectomy or bilateral
             oophorectomy) and who is not postmenopausal. Menopause is defined as 12 months of
             amenorrhea in a woman over age 45 years in the absence of other biological or
             physiological causes. In addition, females under age of 55 years must have serum
             follicle stimulating hormone (FSH) level > 40mIU/ml to confirm menopause.

        Exclusion Criteria:

          1. Other histology then primary pancreatic adenocarcinoma

          2. Resectable disease

          3. Distant metastases

          4. Progressive disease during induction chemotherapy (4 cycles of FOLFIRINOX)

          5. Other previous treatment of the disease except induction chemotherapy (4 cycles of
             FOLFIRINOX)

          6. ECOG performance score of 2 or more

          7. Previous therapy of malignant disease in 5 years and less before inclusion to the
             trial (except skin epithelial tumors)

          8. Previous radiotherapy in abdominal region

          9. Previous immunological treatment (anti-CTLA-4, anti-PD1 or anti-PD-L1)

         10. Active, known or suspected serious autoimmune disease

         11. Major surgery less than 28 days prior to the first dose of study treatment

         12. Treatment of any investigational medicinal product within 4 weeks before this trial
             enrolment

         13. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or
             chronic infection

         14. Known history of testing positive for human immunodeficiency virus (HIV) or known
             acquired immunodeficiency synrome (AIDS)

         15. Prisoners or subjects who are involuntarily incarcerated

         16. Subjects who are compulsorily detained for treatment of either a psychiatric or
             physical (e.g. infectious disease) illness
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety - incidence of treatment-related adverse events
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:Measured by the incidence of adverse events (AEs), serious adverse events (SAEs), deaths

Secondary Outcome Measures

Measure:Progression free survival
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:To evaluate progression free survival (median of progression free survival and 1-, 2-year progression free survival)
Measure:Overall survival
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:To evaluate overall survival (median of overall survival and 1-, 2-year overall survival)
Measure:Relationship of laboratory markers and progression
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:To evaluate the relationship of laboratory markers (PD-L1 expression, tumor infiltrating lymphocytes presence, neopterin level) to progression status and time related progress of biomarkers (CEA, CA19-9)
Measure:patient's capacity to fulfill the activities of daily living and quality of life
Time Frame:Through study completion, an average of 4 years
Safety Issue:
Description:Assess by questionnaire European Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30) questionnaire. The EORTC QLQ-C30 comprises 30 items (i.e. single questions), 24 of which are aggregated into 9 multi-item scales, that is, 5 functioning scales (physical, role, cognitive, emotional and social), 3 symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining 6 single-item (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea and the financial impact) scales assess symptoms.All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University Hospital Hradec Kralove

Trial Keywords

  • Stereotactic radiotherapy
  • Nivolumab
  • Anti PD-1
  • Pancreatic cancer
  • Pancreatic Adenocarcinoma

Last Updated

June 16, 2020