Brain MetastasesPhase 2EViDENCE-BMNCT06620380
Ex Vivo Drug Response Evaluation for Next Generation Care of Brain Metastases
A Phase 2 study testing Pharmacoscopy 1.0 in people with Brain Metastases and Brain Metastases, Adult, run by University of Zurich at 3 sites in Switzerland.
Trial summary
Pharmacoscopy refers to an ex vivo real-time drug sensitivity profiling platform that has been shown to be of value in the treatment of leukemia (Snijder et al. 2017) (Kornauth et al. 2022) and may help to identify novel treatment opportunities for brain tumors as well (Lee et al. 2022). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Brain Metastases, Adult
- What is being tested?
- Pharmacoscopy 1.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 12 Sep 2025to Jun 2027
- Phase
- Phase 2
- 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
- Patients must be 18 years or older on the day of signing the informed consent, female or male.
- Patients must have a Karnofsky performance status of 60 or more
- Patients must have limited systemic therapeutic options as per treating physician judgement. The number of previous lines of therapies is not limited.
- Patients with a tumor with a targetable oncogenic driver mutation should have already been treated with a targeted agent and options must have been exhausted.
- Patients must have a clinical indication for surgery for probable brain metastasis
- Patients will be considered eligible for the study only if the diagnosis of brain metastasis has been histologically confirmed on the sample obtained during the surgery performed after signing the informed consent form for the trial.
Show all 11Show fewer
- Any type of primary cancer is allowed: breast cancer, lung cancer, melanoma, other cancers. Patients may have several primary cancers.
- Patients must have adequate bone marrow, renal and hepatic function documented at screening before surgery
- Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test
- Patients must have the ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
- Written informed consent for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.
Who cannot join
- Patients with rapidly progressive systemic disease
- Patients with inability to undergo brain MRI evaluation.
- Patients with progressive parenchymal brain metastases with an indication for requiring whole brain radiotherapy after surgery. Focal brain radiotherapy after surgery is allowed.
- Judgement by the investigator that the patient is unlikely to comply with study procedures, restrictions and requirements.
- Intention to become pregnant during the course of the study.
- Female who are pregnant.
- Female who are breastfeeding and who do not agree to discontinue nursing prior to the first treatment initiated during the study.
- Sexually active males and females of childbearing potential who are not willing to use an effective contraceptive method during the study. Male participants who do not agree not to donate sperm.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites, 3 recruiting
- Recruiting
University Hospital Basel
Basel
Gregor Hutter, +41 61 265 38 97, Gregor.Hutter@usb.ch
- Not yet recruiting
Cantonal Hospital St Gallen
Sankt Gallen
Marian Neidert, +41 71 494 11 11, marian.neidert@kssg.ch
- Recruiting
University Hospital Zurich
Zurich
Emilie Le Rhun, +41 44 255 38 99, emilie.lerhun@usz.ch
About this study
Pharmacoscopy refers to an ex vivo real-time drug sensitivity profiling platform that has been shown to be of value in the treatment of leukemia (Snijder et al. 2017) (Kornauth et al. 2022) and may help to identify novel treatment opportunities for brain tumors as well (Lee et al. 2022). The rationale for pharmacoscopy-based drug sensitivity testing on real-time patient biopsies or surgery material is multiple: measuring drug response and sensitivity directly in real-time patient material, overcomes the problem of limited molecular biomarkers for established targeted therapeutic options and can identify effective drugs even for non-targeted therapies such as chemotherapy. It can also identify hitherto unknown specific vulnerabilities of cancer cells. Furthermore, testing directly on patient material overcomes the limitations of patient-derived cell cultures, organoids, and patient xenografts, as their prolonged culture times risk cellular adaptations and clonal selection that alter drug sensitivity. Pharmacoscopy maintains the tumor cell composition, including bystander cells or tumor microenvironment, and limits cell culture to max 48 hours. Furthermore, pharmacoscopy measures drug responses on a single-cell and on a high-content level, uniquely allowing to measure the drug sensitivity of tumor cells, and allowing to compare it to the drug cytotoxicity on healthy cells from the same patient. This relative readout has previously been shown to be essential for the correct prediction of a clinical response in haematological malignancies (Snijder et al. 2017) (Kornauth et al. 2022).
The aim of this study is to generate preliminary data regarding superiority of the personalized pharmacoscopy-guided approach compared to a standard non-pharmacoscopy-guided approach, in patients with brain metastases with an indication for surgery, and limited therapeutic systemic options according to the treating physician.
- Conditions
- Brain Metastases, Brain Metastases, Adult
- Being tested
- Pharmacoscopy 1.0, Control
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacoscopy 1.0Device
Pharmacoscopy is currently an academically developed platform. The study is designed to investigate the clinical performance of this academic platform. In the interventional arm, the best candidate agent defined by pharmascopy will be considered to guide the therapeutic decision for each patient.
ControlOther
The next systemic treatment after surgery will be discussed, with the investigator and at the tumor board, considering also standard histopathological and molecular analysis, including next generation sequencing, molecular profiling analysis and previous treatments received
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: experimental arm, Pharmacoscopy-guided treatment | Experimental | Arm 1 (experimental arm): Pharmacoscopy-guided treatment will be prescribed by the investigator according to the results of the analysis (relevant on-target effect) and per drug prescription guidelines. Receives: Device: Pharmacoscopy 1.0 |
| Arm 2: control arm | Active comparator | For patients randomized to the control arm, no pharmacoscopy analysis will be performed. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 8 months
Secondary outcomes (12)
Response assessment
(A) in all patients: type of response; correlation of the type of response between CNS and extra-CNS compartments (B) in patients with measurable disease: type and duration of response; correlation of response rate between CNS and extra-CNS compartments.
Measured: 8 months
Progression free survival
Measured: 8 months
Quality of life and neurological status 1
EORTC-QLQ C30 scale
Measured: 8 months
Quality of life and neurological status 2
EORTC BN20 scale
Measured: 8 months
Quality of life and neurological status 3
NANO scale (Neurological Assessment in Neuro-Oncology)
Measured: 8 months
Quality of life and neurological status 4
Response assessement in Neuro-Oncology (RANO) seizure scale
Measured: 8 months
Quality of life and neurological status 5
Karnofsky performance status scale
Measured: 8 months
Steroid use
Consumption of steroids during the study
Measured: 8 months
Pharmacoscopy assessment 1
rate of interpretable pharmacoscopy results, in the pharmacoscopy arm only
Measured: 1 month
Pharmacoscopy assessment 2
description of potential causes of failure of the pharmacoscopy analysis, in the pharmacoscopy arm only
Measured: 1 month
Pharmacoscopy assessment 3
rate of indication of pharmacoscopy guided-treatment, in the pharmacoscopy arm only
Measured: 1 month
Pharmacoscopy assessment 4
access to the preferred drug selected by the pharmacoscopy, in the pharmacoscopy arm only
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start12 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase II interventional randomized non-comparative clinical study
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- anticancerfund.org
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620380
- Sponsor's protocol ID
- EViDENCE-BM
- Acronym
- EViDENCE-BM
- Status last verified
- Jun 2026
- First submitted
- 27 May 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee S, Weiss T, Buhler M, Mena J, Lottenbach Z, Wegmann R, Sun M, Bihl M, Augustynek B, Baumann SP, Goetze S, van Drogen A, Pedrioli PGA, Penton D, Festl Y, Buck A, Kirschenbaum D, Zeitlberger AM, Neidert MC, Vasella F, Rushing EJ, Wollscheid B, Hediger MA, Weller M, Snijder B. High-throughput identification of repurposable neuroactive drugs with potent anti-glioblastoma activity. Nat Med. 2024 Nov;30(11):3196-3208. doi: 10.1038/s41591-024-03224-y. Epub 2024 Sep 20.
PubMed 39304781Snijder B, Vladimer GI, Krall N, Miura K, Schmolke AS, Kornauth C, Lopez de la Fuente O, Choi HS, van der Kouwe E, Gultekin S, Kazianka L, Bigenzahn JW, Hoermann G, Prutsch N, Merkel O, Ringler A, Sabler M, Jeryczynski G, Mayerhoefer ME, Simonitsch-Klupp I, Ocko K, Felberbauer F, Mullauer L, Prager GW, Korkmaz B, Kenner L, Sperr WR, Kralovics R, Gisslinger H, Valent P, Kubicek S, Jager U, Staber PB, Superti-Furga G. Image-based ex-vivo drug screening for patients with aggressive haematological malignancies: interim results from a single-arm, open-label, pilot study. Lancet Haematol. 2017 Dec;4(12):e595-e606. doi: 10.1016/S2352-3026(17)30208-9. Epub 2017 Nov 15.
PubMed 29153976Kornauth C, Pemovska T, Vladimer GI, Bayer G, Bergmann M, Eder S, Eichner R, Erl M, Esterbauer H, Exner R, Felsleitner-Hauer V, Forte M, Gaiger A, Geissler K, Greinix HT, Gstottner W, Hacker M, Hartmann BL, Hauswirth AW, Heinemann T, Heintel D, Hoda MA, Hopfinger G, Jaeger U, Kazianka L, Kenner L, Kiesewetter B, Krall N, Krajnik G, Kubicek S, Le T, Lubowitzki S, Mayerhoefer ME, Menschel E, Merkel O, Miura K, Mullauer L, Neumeister P, Noesslinger T, Ocko K, Ohler L, Panny M, Pichler A, Porpaczy E, Prager GW, Raderer M, Ristl R, Ruckser R, Salamon J, Schiefer AI, Schmolke AS, Schwarzinger I, Selzer E, Sillaber C, Skrabs C, Sperr WR, Srndic I, Thalhammer R, Valent P, van der Kouwe E, Vanura K, Vogt S, Waldstein C, Wolf D, Zielinski CC, Zojer N, Simonitsch-Klupp I, Superti-Furga G, Snijder B, Staber PB. Functional Precision Medicine Provides Clinical Benefit in Advanced Aggressive Hematologic Cancers and Identifies Exceptional Responders. Cancer Discov. 2022 Feb;12(2):372-387. doi: 10.1158/2159-8290.CD-21-0538. Epub 2021 Oct 11.
PubMed 34635570
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Drug Response Evaluation for Next Generation Care of Brain Metastases
- ClinicalTrials.gov ID
- NCT06620380
- Acronym / sponsor ID
- EViDENCE-BM / EViDENCE-BM
- Conditions
- Brain Metastases, Brain Metastases, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- anticancerfund.org
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pharmacoscopy refers to an ex vivo real-time drug sensitivity profiling platform that has been shown to be of value in the treatment of leukemia (Snijder et al. 2017) (Kornauth et al. 2022) and may help to identify novel treatment opportunities for brain tumors as well (Lee et al. 2022). The rationale for pharmacoscopy-based drug sensitivity testing on real-time patient biopsies or surgery material is multiple: measuring drug response and sensitivity directly in real-time patient material, overcomes the problem of limited molecular biomarkers for established targeted therapeutic options and can identify effective drugs even for non-targeted therapies such as chemotherapy. It can also identify hitherto unknown specific vulnerabilities of cancer cells. Furthermore, testing directly on patient material overcomes the limitations of patient-derived cell cultures, organoids, and patient xenografts, as their prolonged culture times risk cellular adaptations and clonal selection that alter drug sensitivity. Pharmacoscopy maintains the tumor cell composition, including bystander cells or tumor microenvironment, and limits cell culture to max 48 hours. Furthermore, pharmacoscopy measures drug responses on a single-cell and on a high-content level, uniquely allowing to measure the drug sensitivity of tumor cells, and allowing to compare it to the drug cytotoxicity on healthy cells from the same patient. This relative readout has previously been shown to be essential for the correct prediction of a clinical response in haematological malignancies (Snijder et al. 2017) (Kornauth et al. 2022).
The aim of this study is to generate preliminary data regarding superiority of the personalized pharmacoscopy-guided approach compared to a standard non-pharmacoscopy-guided approach, in patients with brain metastases with an indication for surgery, and limited therapeutic systemic options according to the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase II interventional randomized non-comparative clinical study
| Arm | Type | Receives |
|---|---|---|
| Arm 1: experimental arm, Pharmacoscopy-guided treatment | Experimental | Device: Pharmacoscopy 1.0Arm 1 (experimental arm): Pharmacoscopy-guided treatment will be prescribed by the investigator according to the results of the analysis (relevant on-target effect) and per drug prescription guidelines. |
| Arm 2: control arm | Active comparator | Other: ControlFor patients randomized to the control arm, no pharmacoscopy analysis will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must be 18 years or older on the day of signing the informed consent, female or male.
- Patients must have a Karnofsky performance status of 60 or more
- Patients must have limited systemic therapeutic options as per treating physician judgement. The number of previous lines of therapies is not limited.
- Patients with a tumor with a targetable oncogenic driver mutation should have already been treated with a targeted agent and options must have been exhausted.
- Patients must have a clinical indication for surgery for probable brain metastasis
Key exclusion criteria (8 listed)
- Patients with rapidly progressive systemic disease
- Patients with inability to undergo brain MRI evaluation.
- Patients with progressive parenchymal brain metastases with an indication for requiring whole brain radiotherapy after surgery. Focal brain radiotherapy after surgery is allowed.
- Judgement by the investigator that the patient is unlikely to comply with study procedures, restrictions and requirements.
- Intention to become pregnant during the course of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacoscopy 1.0Pharmacoscopy is currently an academically developed platform. The study is designed to investigate the clinical performance of this academic platform. In the interventional arm, the best candidate agent defined by pharmascopy will be considered to guide the therapeutic decision for each patient. | Device | Arm 1: experimental arm, Pharmacoscopy-guided treatment |
| ControlThe next systemic treatment after surgery will be discussed, with the investigator and at the tumor board, considering also standard histopathological and molecular analysis, including next generation sequencing, molecular profiling analysis and previous treatments received | Other | Arm 2: control arm |
Primary outcome
Overall survival
Time frame: 8 months
12 secondary outcomes
Response assessment
Time frame: 8 months
Progression free survival
Time frame: 8 months
Quality of life and neurological status 1
Time frame: 8 months
Quality of life and neurological status 2
Time frame: 8 months
Quality of life and neurological status 3
Time frame: 8 months
Quality of life and neurological status 4
Time frame: 8 months
Quality of life and neurological status 5
Time frame: 8 months
Steroid use
Time frame: 8 months
Pharmacoscopy assessment 1
Time frame: 1 month
Pharmacoscopy assessment 2
Time frame: 1 month
Pharmacoscopy assessment 3
Time frame: 1 month
Pharmacoscopy assessment 4
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Background: PubMed 39304781Lee S, Weiss T, Buhler M, Mena J, Lottenbach Z, Wegmann R, Sun M, Bihl M, Augustynek B, Baumann SP, Goetze S, van Drogen A, Pedrioli PGA, Penton D, Festl Y, Buck A, Kirschenbaum D, Zeitlberger AM, Neidert MC, Vasella F, Rushing EJ, Wollscheid B, Hediger MA, Weller M, Snijder B. High-throughput identification of repurposable neuroactive drugs with potent anti-glioblastoma activity. Nat Med. 2024 Nov;30(11):3196-3208. doi: 10.1038/s41591-024-03224-y. Epub 2024 Sep 20.
- Background: PubMed 29153976Snijder B, Vladimer GI, Krall N, Miura K, Schmolke AS, Kornauth C, Lopez de la Fuente O, Choi HS, van der Kouwe E, Gultekin S, Kazianka L, Bigenzahn JW, Hoermann G, Prutsch N, Merkel O, Ringler A, Sabler M, Jeryczynski G, Mayerhoefer ME, Simonitsch-Klupp I, Ocko K, Felberbauer F, Mullauer L, Prager GW, Korkmaz B, Kenner L, Sperr WR, Kralovics R, Gisslinger H, Valent P, Kubicek S, Jager U, Staber PB, Superti-Furga G. Image-based ex-vivo drug screening for patients with aggressive haematological malignancies: interim results from a single-arm, open-label, pilot study. Lancet Haematol. 2017 Dec;4(12):e595-e606. doi: 10.1016/S2352-3026(17)30208-9. Epub 2017 Nov 15.
- Background: PubMed 34635570Kornauth C, Pemovska T, Vladimer GI, Bayer G, Bergmann M, Eder S, Eichner R, Erl M, Esterbauer H, Exner R, Felsleitner-Hauer V, Forte M, Gaiger A, Geissler K, Greinix HT, Gstottner W, Hacker M, Hartmann BL, Hauswirth AW, Heinemann T, Heintel D, Hoda MA, Hopfinger G, Jaeger U, Kazianka L, Kenner L, Kiesewetter B, Krall N, Krajnik G, Kubicek S, Le T, Lubowitzki S, Mayerhoefer ME, Menschel E, Merkel O, Miura K, Mullauer L, Neumeister P, Noesslinger T, Ocko K, Ohler L, Panny M, Pichler A, Porpaczy E, Prager GW, Raderer M, Ristl R, Ruckser R, Salamon J, Schiefer AI, Schmolke AS, Schwarzinger I, Selzer E, Sillaber C, Skrabs C, Sperr WR, Srndic I, Thalhammer R, Valent P, van der Kouwe E, Vanura K, Vogt S, Waldstein C, Wolf D, Zielinski CC, Zojer N, Simonitsch-Klupp I, Superti-Furga G, Snijder B, Staber PB. Functional Precision Medicine Provides Clinical Benefit in Advanced Aggressive Hematologic Cancers and Identifies Exceptional Responders. Cancer Discov. 2022 Feb;12(2):372-387. doi: 10.1158/2159-8290.CD-21-0538. Epub 2021 Oct 11.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pharmacoscopy 1.0 in people with Brain Metastases and Brain Metastases, Adult, run by University of Zurich at 3 sites in Switzerland.
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 11 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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 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.
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 Emilie Le Rhun (+41 44 255 38 99, emilie.lerhun@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 8 months). 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 NCT06620380, which also lists 3 linked publications.
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 29 Jun 2026.