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Locally Advanced Unresectable Pancreatic AdenocarcinomaPhase 1/2CA209-9KHNCT04098432

STR + Anti PD-1 Therapy in Patients with Locally Advanced Unresectable Pancreatic Adenocarcinoma

A Phase 1/2 study testing Nivolumab and Stereotactic radiotherapy in people with Locally Advanced Unresectable Pancreatic Adenocarcinoma, run by University Hospital Hradec Kralove at 4 sites in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab and Stereotactic radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
4 sitesCzechia
Study dates
3 Dec 2018to 30 Sep 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients aged ≥18 years
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
  • 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.
  • Measurable (one target lesion is sufficient) disease as per RECIST 1.1 criteria
  • Laboratory values:
  • Aspartate aminotransferase (AST) ≤ 3x ULN (upper limit of normal)
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  • Alanine transaminase (ALT) ≤ 3x ULN
  • Total bilirubin ≤ 1.5 x ULN (except subjects with Gilbert syndrome who must have a total bilirubin ≤ 3x ULN)
  • Creatinine: Serum creatinine ≤ 1.5 ULN or creatinine clearance > 50ml/min (using Cockcroft/Gault formula)
  • White blood cells ≥ 2000 /ul
  • Neutrophils ≥ 1500 /ul
  • Platelets ≥ 100x 103 /ul
  • Hemoglobin ≥ 9.0 g/l
  • 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.

Who cannot join

  • Other histology then primary pancreatic adenocarcinoma
  • Resectable disease
  • Distant metastases
  • Progressive disease during induction chemotherapy (4 cycles of FOLFIRINOX)
  • Other previous treatment of the disease except induction chemotherapy (4 cycles of FOLFIRINOX)
  • ECOG performance score of 2 or more
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  • Previous therapy of malignant disease in 5 years and less before inclusion to the trial (except skin epithelial tumors)
  • Previous radiotherapy in abdominal region
  • Previous immunological treatment (anti-CTLA-4, anti-PD1 or anti-PD-L1)
  • Active, known or suspected serious autoimmune disease
  • Major surgery less than 28 days prior to the first dose of study treatment
  • Treatment of any investigational medicinal product within 4 weeks before this trial enrolment
  • Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency synrome (AIDS)
  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness

Trial locations and contacts

4 sites in 1 country.

Czechia4 sites

  • Klinika Onkologie a radioterapie, Fakultní nemocnice Hradec Králové

    Hradec Králové, 50005

  • Onkologická klinika, Fakultní nemocnice Olomouc

    Olomouc, 77900

  • Onkologická klinika, Thomayerova nemocnice

    Prague, 14059

  • Ústav radiační onkologie, Nemocnice Na Bulovce

    Prague, 18081

Other trials in Czechia

About this study

Official title: Stereotactic Radiotherapy + Anti PD-1 Therapy in Patients with Locally Advanced Unresectable Pancreatic Adenocarcinoma

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

Read the 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

Being tested
Nivolumab, Stereotactic radiotherapy
Keywords
Stereotactic radiotherapy, Nivolumab, Anti PD-1, Pancreatic cancer, Pancreatic Adenocarcinoma
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called Opdivo

    Nivolumab 3 mg/kg intravenously every two weeks untill disease progression or unacceptable toxicity

  • Stereotactic radiotherapyRadiation

    Also called Radiation

    The prescribed dose will be 32 Gy in four fractions in four weeks (8 Gy per one fraction).

Study groups in NCT04098432
Study groupRoleWhat they receive
Arm 1Experimental4-weeks stereotactic radiotherapy followed by nivolumab 3 mg/kg every two weeks
Receives: Drug: Nivolumab; Radiation: Stereotactic radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety - incidence of treatment-related adverse events

    Measured by the incidence of adverse events (AEs), serious adverse events (SAEs), deaths

    Measured: Through study completion, an average of 4 years

  2. Safety - incidence of laboratory abnormalities

    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)

    Measured: Through study completion, an average of 4 years

Secondary outcomes (4)

  1. Progression free survival

    To evaluate progression free survival (median of progression free survival and 1-, 2-year progression free survival)

    Measured: Through study completion, an average of 4 years

  2. Overall survival

    To evaluate overall survival (median of overall survival and 1-, 2-year overall survival)

    Measured: Through study completion, an average of 4 years

  3. Relationship of laboratory markers and progression

    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)

    Measured: Through study completion, an average of 4 years

  4. patient's capacity to fulfill the activities of daily living and quality of life

    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).

    Measured: Through study completion, an average of 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2019
  2. Study start3 Dec 2018
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04098432
Sponsor's protocol ID
CA209- 9KH
Acronym
CA209-9KH
Status last verified
Sep 2024
First submitted
6 Mar 2019
Last updated
23 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vosmik M, John S, Dvorak J, Mohelnikova-Duchonova B, Melichar B, Lohynska R, Ryska A, Banni AM, Krempova J, Sirak I. Stereotactic Radiotherapy Plus Nivolumab in Patients with Locally Advanced Pancreatic Cancer: Results from Phase 1/2 Clinical CA209-9KH Trial. Oncol Ther. 2024 Dec;12(4):817-831. doi: 10.1007/s40487-024-00309-z. Epub 2024 Oct 23.

    PubMed 39441483

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nivolumab and Stereotactic radiotherapy in people with Locally Advanced Unresectable Pancreatic Adenocarcinoma, run by University Hospital Hradec Kralove at 4 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety - incidence of treatment-related adverse events (time frame: Through study completion, an average of 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04098432, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.

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