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Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma (CA209-9KH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04098432
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : June 16, 2020
Bristol-Myers Squibb
GCP-Service International s.r.o.
Information provided by (Responsible Party):
University Hospital Hradec Kralove

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

Condition or disease Intervention/treatment Phase
Locally Advanced Unresectable Pancreatic Adenocarcinoma Drug: Nivolumab Radiation: Stereotactic radiotherapy Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : December 3, 2022
Estimated Study Completion Date : December 3, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Arm 1
4-weeks stereotactic radiotherapy followed by nivolumab 3 mg/kg every two weeks
Drug: Nivolumab
Nivolumab 3 mg/kg intravenously every two weeks untill disease progression or unacceptable toxicity
Other Name: Opdivo

Radiation: Stereotactic radiotherapy
The prescribed dose will be 32 Gy in four fractions in four weeks (8 Gy per one fraction).
Other Name: Radiation

Primary Outcome Measures :
  1. Safety - incidence of treatment-related adverse events [ Time Frame: Through study completion, an average of 4 years ]
    Measured by the incidence of adverse events (AEs), serious adverse events (SAEs), deaths

  2. Safety - incidence of laboratory abnormalities [ Time Frame: Through study completion, an average of 4 years ]
    Biochemistry - Na (mmol/l), K (mmol/l), Cl (mmol/l), Ca (mmol/l), Ca ionized (mmol/l), Mg (mmol/l), P (mmol/l), urea (mmol/l), creatinine (µmol/l), LDH (µkat/l), AST(µkat/l), ALT(µkat/l), ALP(µkat/l), GMT(µkat/l), total bilirubin (µmol/l), conjuged bilirubin (µmol/l), total protein (g/l), albumin (g/l), fasting glucose (mmol/l), amylase (µkat/l), C-reactive protein (mg/l), endocrine panel - TSH (mU/l), Free T3 (pmol/l), Free T4 (pmol/l), hematology - complete blood count (CBC): hemoglobin (g/l), hematocrit (ratio), white blood cells (WBC) (10E9/l), red blood cells (10E12/l), platelets (10E9/l) including differential (all 10E9/l), coagulation - APTT (ratio), PT (ratio)

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: Through study completion, an average of 4 years ]
    To evaluate progression free survival (median of progression free survival and 1-, 2-year progression free survival)

  2. Overall survival [ Time Frame: Through study completion, an average of 4 years ]
    To evaluate overall survival (median of overall survival and 1-, 2-year overall survival)

  3. Relationship of laboratory markers and progression [ Time Frame: Through study completion, an average of 4 years ]
    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)

  4. patient's capacity to fulfill the activities of daily living and quality of life [ Time Frame: Through study completion, an average of 4 years ]
    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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04098432

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Contact: Milan Vosmik, MD. +420 495 832 176
Contact: Johana Krempova, MSc. + 420 601 087 319

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Klinika Onkologie a radioterapie, Fakultní nemocnice Hradec Králové Recruiting
Hradec Králové, Czechia, 50005
Contact: Milan Vošmik, MD    +420 495 832 176   
Principal Investigator: Milan Vošmik, MD         
Onkologická klinika, Fakultní nemocnice Olomouc Recruiting
Olomouc, Czechia, 77900
Contact: Bohuslav Melichar, MD    +420 588 444 292   
Principal Investigator: Bohuslav Melichar, MD         
Onkologická klinika, Thomayerova nemocnice Recruiting
Praha, Czechia, 14059
Contact: Josef Dvořák, MD    +420 261 083 392   
Principal Investigator: Josef Dvořák, MD         
Ústav radiační onkologie, Nemocnice Na Bulovce Recruiting
Praha, Czechia, 18081
Contact: Miroslav Pála, MD    +420 266 084 258   
Principal Investigator: Miroslav Pála, MD         
Sponsors and Collaborators
University Hospital Hradec Kralove
Bristol-Myers Squibb
GCP-Service International s.r.o.
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Responsible Party: University Hospital Hradec Kralove Identifier: NCT04098432    
Other Study ID Numbers: CA209- 9KH
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University Hospital Hradec Kralove:
Stereotactic radiotherapy
Anti PD-1
Pancreatic cancer
Pancreatic Adenocarcinoma
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents