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Not yet recruitingNCT07602946SELECTmesoUpdated May 22, 2026

SELECTmeso A Trial for Patients With Relapsed Malignant Mesothelioma SELECTmeso1 A Trial of BMS-986504 in Patients With MTAP-deficient Relapsed Mesothelioma

A Phase 2 interventional study of BMS-986504 in Mesothelioma, sponsored by University of Southampton. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by University of Southampton · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

By incorporating a platform trial protocol design, SELECTmeso will spearhead a next-generation precision medicine trial platform in relapsed mesothelioma for the UK enabling early evaluation of hypothesis-driven targeted therapies. The SELECTmeso Platform trial protocol allows incorporation of a range of identified and yet-to-be-identified candidates as potential treatments for patients with relapsed mesothelioma into the platform. Candidate Specific Trials (CSTs) will be added into the trial via treatment-specific CSTs of this platform trial protocol as appendices. Having one platform trial protocol ensures different candidates are evaluated in the same consistent manner and that opening up new trials for new candidates is more efficient.

SELECTmeso1 is our first Candidate Specific Trial (CST) on the platform. SELECTmeso1 is investigating if a drug called BMS-986504 is effective in shrinking mesothelioma tumours as a targeted treatment for patients with tumours that have specific genetic biomarkers. Biomarkers are molecules that can indicate normal or abnormal processes taking place in the body or tumour, they can indicate how effective certain treatments will be. BMS-986504 has shown to be tolerated and promising signs of activity on patients with MTAP-deficient solid tumours, in a previous mesothelioma trial.

Read the detailed description

SELECTmeso Platform: Participants will consent to the platform and some of the tissue collected from a previous biopsy will be analysed in a laboratory to find out which biomarkers are present in the tumour. Participants will not need to provide any more tissue or attend hospital for this step. Depending on the biomarker(s) present, the participant will then be offered the opportunity to take part in a study looking at a drug that is thought to be best for that biomarker, or possibly a drug for patients without any biomarkers.

If following this screening step, the participant is not eligible for any treatments, they will return to standard care with their doctor. They may be contacted regarding future treatments within the SELECTmeso trial if new treatments are added that they would be eligible for.

SELECTmeso1: This is the first Candidate Specific Trial on the SELECTmeso platform and is investigating if a drug called BMS-986504 is effective in shrinking mesothelioma tumours in participants with MTAP-deficient solid tumours. Once participants are screened and confirmed eligible, they will start treatment with BMS-986504 which will be administered orally in the form of a 3 tablets once a day. Participants will take a 600mg dose. Participants will have a clinic visit every 21 days where they will have routine blood tests and assessment to monitor their health. Some clinic visits will include additional trial bloods. During treatment, participants will have CT scans (computerised tomography scan) every 6 weeks to monitor the effect of the treatment. These are the same type of scans and frequency they would have normally to monitor their health. Treatment will stop after a maximum of 24 weeks (8 cycles) and participants will have an end of treatment visit, followed by a safety visit 30 days later.

02

Conditions studied

  • Mesothelioma

Browse trials for

Keywords

  • MTAP
  • SELECTmeso
  • Meso
03

In context

Mesothelioma

305 studies on the registry are indexed under Mesothelioma; 61 are open to participants now.

This study's planned enrollment of 30 is below the median of 48 across 250 interventional studies indexed under Mesothelioma.

Browse Mesothelioma studies →

Lead sponsor

University of Southampton is the lead sponsor of 122 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

SELECTmeso Platform Inclusion Criteria:

  1. Histological confirmation of malignant mesothelioma (pleural, or non-pleural)
  2. Evidence of disease progression on CT scan
  3. Available block for molecular screening or existing molecular screening result via validated NHS diagnostic grade immunohistochemistry-based assays
  4. Previous treatment with at least licensed systemic anti-cancer therapy. Patients can have received more than one prior line of systemic therapy
  5. No progressing central nervous system disease and not receiving any concurrent systemic therapy at the time of screening
  6. performance status 0-1*
  7. 16 years of age and older
  8. Expected survival of ≥12 weeks
  9. Consent to provide baseline tumour tissue sample for trial
  10. Patients must have signed and dated a REC-approved written form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal patient care

SELECTmeso1 Inclusion Criteria:

A. Evidence of MTAP deficient. MTAP deficiency detected by a validated immunohistochemistry test conducted under the SELECTmeso master protocol, in the Leicester NHS pathology department B. Willing to consent and able to undergo required procedures to provide blood C. 18 years of age and older

D. Adequate organ function, including the following:

  1. Adequate bone marrow reserve:

    i. (ANC) ≥ 1.5 x 109/L, ii. WBC ≥ 3 x 109/L, iii. ≥ 85g/L, iv. count ≥100 × 109/L

  2. Adequate liver function and renal:

    i. \< 1.5 x ii. \& ALT \<3 x ULN iii. > 45ml/min.

  3. ≤ 1.5 × institutional ULN unless on a stable dose of an anticoagulant with no unexplained elevation of INR E. Participants must provide informed consent to SELECTmeso1 before any study specific procedures. The PI must confirm the eligibility of a participant in the participant's medical notes before enrolment F. Women of (WOCBP) participants agree to use (see Section 5.3) while participating in this study, and for a period of 6 months after the last dose of study treatment G. Men whose partner is a WOCBP agree to use contraception (see Section 5.3) while participating in this study, and for a period of 6 months after the last dose of study treatment

SELECTmeso Platform Exclusion Criteria:

  1. Patients with a diagnosis of a second (except prostate or cervical cancer in remission, patients with a diagnosis of basal cell carcinoma or non-muscle invasive bladder cancer, who can all be included)
  2. Class II or greater congestive heart failure
  3. Patients requiring long term oxygen therapy
  4. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
  5. Patients on active treatment in another clinical trial

SELECTmeso1 Exclusion Criteria:

H. Diagnosis, detection, or treatment of another type of cancer 5 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin, non-muscle invasive bladder cancer that has been definitively treated), or prostate or cervical cancer in remission I. Have received treatment with an agent that has no marketing authorisation, within 14 days of study entry. If the Participants has participated in a different SELECTmeso CST, they must comply with the for that CST J. Participants who are pregnant or breast feeding K. Uncontrolled CNS disease. Asymptomatic are allowed if previously treated with radiotherapy > 28 days prior to starting BMS-986504 L. Palliative radiotherapy within the 1.1 area in the 4 weeks prior to baseline CT scan M. Participants with severe hepatic insufficiency or severe renal impairment N. Uncontrolled/symptomatic or significant cardiovascular conditions within 6 months prior to enrolment, including, but not limited to, any of the following: i) Cardiac angioplasty or stenting, unstable angina pectoris, myocardial infarction, stroke/, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, New York Heart Association (NYHA) class III-IV congestive heart failure, pericarditis, atrial fibrillation or other arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).Ongoing need for a medication with a known risk of Torsades de Pointes that cannot be switched to alternative treatment prior to study entry

O. Participant has any of the following cardiac criteria:

i. Mean resting interval (QTcF) >470 msec ii. Any abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting ECGs, e.g., complete left bundle branch block, third degree heart block iii. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval (including IV ondansetron) iv. (EF) \<50% or the lower limit of normal of the institutional standard. A historic measurement of EF no older than 6 months prior to first administration of trial drug can be accepted provided that there is clinical evidence that the Participant's cardiac disease has not significantly worsened since this measurement in the opinion of the Investigator or of the treating physician or both P. Active bleeding, significant risk of haemorrhage (e.g. previous severe gastrointestinal bleeding, previous haemorrhagic stroke at any time), or current bleeding disorder (e.g. haemophilia, von Willebrand disease) Q. Recovery from the adverse effects of prior therapy at the time of enrolment to baseline or ≤ Grade 1 (excluding alopecia, peripheral neuropathy, and parameters superseded by other eligibility criteria [eg, haematology parameters]). Note: Participants with prior endocrine adverse effects are permitted to enrol if they are stably maintained on appropriate replacement therapy and are asymptomatic. Major surgery, open biopsy or significant traumatic injury within 28 days before the start of study treatment or planned within 6 months after screening R. Participants who have received live/attenuated vaccine within 30 days of first treatment. The use of inactivated seasonal influenza vaccines will be permitted on study without restriction S. Pre-existing duodenal stent and/or history of gastrointestinal disease or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications T. Previous significant surgical resection of stomach or small bowel U. Participants who have difficulty swallowing V. Participants who have received prior treatment with a PRMT5 inhibitor including BMS-986504, or MAT2A inhibitor W. Participants with active bacterial infection (requiring intravenous [IV] antibiotics at time of initiating study treatment) fungal infection or detectable viral infection or viral load (such as known positivity) X. Active viral hepatitis, including the following: i) Any positive test result for virus (HBV) indicating presence of virus, eg, HBV DNA positive would be excluded. Participants with anti-HBsAg positive in line with prior vaccination are eligible to enrol. ii) Any positive test result for virus (HCV) indicating presence of active viral replication (detectable HCV-RNA). iii) Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enrol. Screening is not required for enrolment Y. Known HIV positive with an AIDS-defining opportunistic infection within the last year, or a current \< 350 cells/μL. Participants with HIV are eligible if they have received established ART for at least 4 weeks prior to randomization and continue on ART as clinically indicated while enrolled on study. Viral serology only to be conducted if locally mandated and, if done, must be performed within 28 days prior to randomization. Screening is not required for enrolment Z. Known severe to study treatment and/or any of its AA. Ongoing need for a medication known as a strong inhibitor or strong inducer of and/or P-glycoprotein or a proton-pump inhibitor that cannot be switched to an alternative treatment prior to enrolment. The following drug interaction databases and other literature can be utilized to determine the CYP3A4/P-gp inhibitors and inducers. Examples of CYP3A4/P-gp inhibitors and inducers are also provided in See Section 7.8 for further information BB. Prior organ allograft CC. Any botanical preparation (eg, herbal supplements or traditional Chinese medicines) intended to treat the disease under study within 4 weeks prior to treatment. The concurrent use of any botanical preparation is not permitted while on study

Terms in these criteria, in plain language(30)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

iRECIST and mRECIST

Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    A phase II trial of BMS-986504 in patients with MTAP-deficient relapsed mesothelioma

    Drug: BMS-986504

Interventions

  • BMS-986504 - next-generation MTA-cooperative PRMT5 inhibitor

06

What researchers measure

Primary outcomes

  1. SELECTmeso Platform : Molecular profiling of participant's tumour block SELECTmeso1: Disease Control Rate (DCR) using RECIST 1.1 at 12 weeks.

    Time frame: SELECTmeso Platform: Baseline SELECTmeso1: at 12 weeks of treatment

Secondary outcomes

  1. SELECTmeso Platform: Further translational research on participant's tumour block SELECTmeso1: Disease control rate using RECIST 1.1 at 24 weeks.

    Time frame: SELECTmeso Platform: through study completion, an average of 1 year SELECTmeso1: 24 weeks of treatment

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2026; primary completion for Jul 2027, 14 months later.

Of 36 phase 2 interventional studies under Mesothelioma, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 67. This study's planned 14 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 5, 2026
First posted
May 22, 2026
StartEst.
May 11, 2026
Primary completionEst.
Jul 2027
CompletionEst.
Aug 2027
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07602946
Responsible party
Sponsor
First posted
May 22, 2026
Start date
May 11, 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
May 22, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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