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Pancreatic Ductal Adenocarcinoma (mPDAC)Phase 2/3MATTERS-2NCT07711067

A Study Comparing Whole-Body Heat Treatment Plus Systemic Therapy to Systemic Therapy Alone, for Advanced Pancreatic Cancer

A Phase 2/3 study testing Whole-body hyperthermia and Standard-of-Care Systemic therapy in people with Pancreatic Ductal Adenocarcinoma (mPDAC) and Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), run by ElmediX at 4 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Pancreatic ductal adenocarcinoma (PDAC) is associated with poor prognosis and limited treatment options following failure of first-line therapy. Whole-body hyperthermia (WBHT) is a non-invasive treatment approach that raises the body's core temperature under controlled conditions and may enhance the effects of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Whole-body hyperthermia and Standard-of-Care Systemic therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
4 sitesin 2 countries
Study dates
1 Oct 2026to 31 Dec 2030
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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

  • Subjects at least 18 years of age at time of signing the informed consent
  • Subjects with metastatic pancreatic adenocarcinoma (PDAC) confirmed by histology
  • Measurable disease per RECIST 1.1
  • Subjects previously treated with chemotherapy in first line for metastatic disease
  • ECOG performance status ≤ 1
  • Height ≤ 2,00 m, BMI maximal 40 or positive fitting session
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  • Adequate liver structure (accessible metastasis-free and functional liver parenchyma) allowing stable liver sensor positioning without unacceptable risks of bleeding and perforation, based on echographic assessment (or any imaging modality)
  • Adequate bone marrow function defined as
  • white blood cell count ≥ 2000/µl
  • neutrophils ≥ 1500 cells/μL
  • platelets ≥ 100 x 109/L
  • hemoglobin ≥ 9 g/dl (female) and ≥10 g/dl (male) documented
  • Adequate coagulation defined as
  • PT (%) ≥ 70%
  • aPTT ≤ ULN
  • Adequate liver function defined as
  • Transaminases (AST, ALT) ≤ 2.5 x ULN or ≤ 5.0 in presence of liver metastasis
  • bilirubin ≤ 2 x ULN
  • Adequate renal function defined as calculated eGFR ≥ 60 mL/min (CKD-EPI equation)
  • Normal ionogram
  • Effective contraception for both male and female subjects if applicable. Women of childbearing potential must have a negative pregnancy test at screening visit.
  • Written informed consent must be given according to good clinical practice and national/local regulations.

Who cannot join

  • Pregnant or breastfeeding women
  • Presence of brain metastasis (known or suspected)
  • Other malignant diseases in the medical history during the last 5 years (exceptions: carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin)
  • Serious medical risk factors involving any of the major organ systems, including high cardiovascular risk defined as recent major cardiovascular events (such as myocardial infarction or stroke), clinically relevant heart failure due to structural or mechanical cardiac abnormalities (e.g., valvular disease or myocardial dysfunction), and clinically significant arrhythmias.
  • Pathology that would interfere with the placement of the bladder catheter
  • Clinically significant pulmonary disease which might interfere with mechanical ventilation
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  • History of autonomic dysfunction (due to the influence on skin blood flow)
  • History of malignant hyperthermia
  • History of untreated endocrine pathology (e.g. diabetes type II, hyper- or hypothyroidism).
  • Primary untreated diabetes type I not related to the oncological condition (due to vascular complications).
  • Known allergies to drugs that will be used during the trial (e.g. anesthetic, analgesic, chemotherapy)
  • Active infections not controlled by medication
  • Presence of clinically significant ascites and/or decompensated cirrhosis/portal hypertension
  • Severe, non-healing wounds, ulcers or bone fractures
  • Organ allografts requiring immunosuppressive therapy
  • Implants that are not compatible with temperature changes
  • (History of) clinically significant (investigator decision) psychiatric disorder and/or psychosocial disorder that may interfere with adequate compliance to the protocol or signature of the informed consent
  • Other clinically significant disease which could impair the subject's ability to participate in the study according to the investigator's opinion
  • Participation in another clinical trial 2 weeks prior to the randomization
  • Biological therapy during the 2 weeks prior to the randomization
  • Radiotherapy up to 2 weeks prior to the randomization
  • Major surgery up to 6 weeks prior to the randomization (port-a-cath placement is minor)

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

John-Paul Bogers, Prof. Dr. contact

+32 474296669

john-paul.bogers@elmedix.com

4 sites in 2 countries

Belgium2 sites

  • Universitair Ziekenhuis Antwerpen (UZA)

    Antwerp, Antwerpen, 2650

    Timon Vandamme, Prof. Dr.

  • Algemeen Ziekenhuis Maria Middelares (AZ MM)

    Ghent, Oost-Vlaanderen, 9000

    Vincent Bouderez, Dr.

Other trials in Belgium

Spain2 sites

  • Hospital Universitario HM Sanchinarro (HM CIOCC)

    Madrid, Madrid, 28050

    Antonio Cubillo, Dr.

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

    Mariano Ponz, Dr.

Other trials in Spain

About this study

Official title: A Multi-Centric, Randomized, Pivotal Study, Evaluating Efficacy and Safety of Whole-Body Hyperthermia Alongside Standard Systemic Anticancer Therapy in Patients With Metastatic Pancreatic Cancer After Failure of First Line Treatment.

Pancreatic ductal adenocarcinoma (PDAC) is associated with poor prognosis and limited treatment options following failure of first-line therapy. Whole-body hyperthermia (WBHT) is a non-invasive treatment approach that raises the body's core temperature under controlled conditions and may enhance the effects of anticancer therapies through multiple biological mechanisms, including improved drug delivery, modulation of the immune response, and increased sensitivity to treatment.

The MATTERS-2 study is a multicentre, randomized clinical trial designed to evaluate the efficacy and safety of WBHT in combination with standard systemic anticancer therapy in patients with metastatic PDAC after failure of first-line treatment. Participants will receive either standard systemic therapy alone or standard systemic therapy combined with WBHT.

The primary objective of the study is to determine whether the addition of WBHT improves clinical outcomes compared with standard therapy alone in terms of overall survival (OS) while maintaining safety. Secondary objectives include other clinical outcomes such as progression-free survival (PFS), disease control rate (DCR) and objective response rate (ORR). Further, quality of life assessments (QoL) and exploratory biomarker analyses will also be performed.

Being tested
Whole-body hyperthermia, Standard-of-Care Systemic therapy
Keywords
Hyperthermia, Medical device
Medical subject headings
Hyperthermia

What participants receive

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

  • Whole-body hyperthermiaDevice

    Also called WBHT, WBH, Systemic hyperthermia, Whole-body thermal treatment

    Initially every 2 weeks, until a total of 3 treatments is reached. Thereafter every 4 weeks. The treatment will raise the body temperature to 41,50 °C for a total of 4 hours.

  • Standard-of-Care Systemic therapyDrug

    Standard-of-care systemic therapy for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC, stage IV) after failure of first-line treatment.

Study groups in NCT07711067
Study groupRoleWhat they receive
Control groupActive comparatorParticipants receive standard-of-care systemic treatment as indicated for metastatic pancreatic ductal adenocarcinoma (mPDAC, stage IV) after failure of the first-line treatment.
Receives: Drug: Standard-of-Care Systemic therapy
Whole-body hyperthermia treatment (WBHT) groupExperimentalParticipants will receive whole-body hyperthermia (WBHT) alongside their indicated standard-of-care systemic treatment.
Receives: Device: Whole-body hyperthermia; Drug: Standard-of-Care Systemic therapy

What is being measured

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

  1. Overall survival (OS)

    To compare Overall Survival (OS) between WBHT + standard-of-care (SoC) and SoC treatment group

    Measured: From randomization until death from any cause, assessed up to study completion (primary analysis triggered upon occurrence of 66 death events), an (expected) average of 12 months

  2. Safety and tolerability of WBHT + SoC and SoC alone

    Incidence of Adverse Events (AE), Serious Adverse Events (SAE), treatment-related AE/SAE and Adverse Device Effects (ADE). They will be reported from moment of enrollment (ICF signature) up to End of Treatment visit and will be assessed for seriousness, severity and relationship to the device and to WBHT treatment.

    Measured: From moment of enrollment (ICF signature) up to End of Treatment visit, an (expected) average of 10 months

Secondary outcomes (6)

  1. Progression-free survival (PFS)

    To compare Progression-Free Survival (PFS) between WBHT +SoC and SoC treatment group based on RECIST 1.1. criteria.

    Measured: Up to time of progression, death or study discontinuation; an (expected) average of 8 months

  2. Disease control rate (DCR)

    To compare Disease Control Rate (DCR) between WBHT +SoC and SoC treatment group based on RECIST 1.1 criteria.

    Measured: Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months

  3. Objective response rate (ORR)

    To compare Objective Response Rate (ORR) between WBHT +SoC and SoC treatment group based on RECIST 1.1 criteria and further described with duration of response (DOR) and time to response (TTR).

    Measured: Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months

  4. Quality of Life assessments (EORTC-QLQ-C30 version 3)

    Quality of Life (QoL) according to EORTC-QLQ-C30 version 3 scoring changes from baseline (at 4-weeks, 8-weeks and End of Treatment)

    Measured: Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months

  5. Quality of Life assessments (QLQ Pan 26)

    Quality of Life (QoL) according to QLQ Pan 26 scoring changes from baseline (at 4-weeks, 8-weeks and End of Treatment)

    Measured: Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months

  6. Evolution of CA19-9

    To evaluate CA19-9 changes from baseline in WBHT +SoC and SoC treatment groups (at 4-weeks, 8-weeks and End of Treatment)

    Measured: Until death, end of treatment visit or study discontinuation; an (expected) average of 10 months

Timeline

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

  1. First posted17 Jul 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion31 Mar 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomised to one of two groups: A control group with standard-of-care systemic therapy or a treatment group where WBHT is added to this standard-of-care.
Masking
None (open label)
Enrolment
95 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07711067
Sponsor's protocol ID
CIV-26-06-058215
Acronym
MATTERS-2
Status last verified
Jul 2026
First submitted
29 Jun 2026
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Whole-body hyperthermia and Standard-of-Care Systemic therapy in people with Pancreatic Ductal Adenocarcinoma (mPDAC) and Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), run by ElmediX at 4 sites in 2 countries.

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 22 inclusion and 22 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: opening soon, as of the sponsor's last update on 17 Jul 2026. 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 Belgium, Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact John-Paul Bogers, Prof. Dr. (+32 474296669, john-paul.bogers@elmedix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: From randomization until death from any cause, assessed up to study completion (primary analysis triggered upon occurrence of 66 death events), an (expected) average of 12 months). 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 NCT07711067.

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 17 Jul 2026.

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