Description:
Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients With Locally Advanced Unresectable
Pancreatic Adenocarcinoma
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
Drug | Synonyms | Arms |
---|
Nivolumab | Opdivo | Arm 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
Name | Type | Description | Interventions |
---|
Arm 1 | Experimental | 4-weeks stereotactic radiotherapy followed by nivolumab 3 mg/kg every two weeks | |
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