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MelanomaPhase 1MELODY-1NCT06540391

A Phase 1b Trial to Evaluate Safety of MB097 in Combination With Pembrolizumab in Melanoma Patients

A Phase 1 study testing MB097, Pembrolizumab and Vancomycin in people with Melanoma, run by Microbiotica Ltd at 19 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A Phase 1b study to evaluate the safety and tolerability of MB097 given in combination with pembrolizumab in patients with melanoma who demonstrate primary resistance to anti-PD1 therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
MB097, Pembrolizumab and Vancomycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
19 sitesin 4 countries
Study dates
28 Aug 2024to Aug 2027
Phase
Phase 1
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

  • The main inclusion criteria include but are not limited to the following:
  • Must have primary resistant cutaneous melanoma and have experienced disease progression as defined by RECIST v1.1 after receiving at least 6 weeks of exposure to PD-1/PD-L1 inhibitor therapy, generally correlating with 2 complete cycles of PD-1/PD-L1 inhibitor therapy.
  • Must have histological or cytological confirmation of Stage III (unresectable) or Stage IV cutaneous melanoma
  • Must have radiographically measurable disease per RECIST v1.1
  • Must be at least 18 years of age at time of informed consent
  • Must provide written informed consent, according to local guidelines, signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analysis
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  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at time of informed consent.
  • Must have acceptable organ function, as evidenced by laboratory data prior to first dose of any study drug
  • Female patients must not be lactating or pregnant
  • Male patients, and female patients of childbearing potential who are at risk of pregnancy must agree to use a highly effective method of contraception
  • Must have life expectancy ≥12 weeks after the start of any study drug per Investigator's judgment
  • Must be willing and able to comply with the Protocol, scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and all other study procedures.

Who cannot join

  • The main exclusion criteria include but are not limited to the following
  • Any treatment for melanoma following the failure of an aPD-1-containing treatment, i.e., no intervening treatments between aPD-1 failure and enrollment into study;
  • Prior therapy with any of the following:
  • Radiation therapy to target lesions within 6 weeks of the first dose of MB097
  • Major invasive surgery, excluding placement of vascular access, within 28 days of the first dose of any study drug
  • Probiotic supplement use within 7 days of the first dose of any study
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  • LBP use, including FMT, within 6 months of start of therapy with MB097.
  • Active, uncontrolled infection requiring systemic antimicrobial, antiviral, or antifungal therapy.
  • Active, uncontrolled, symptomatic brain metastases or leptomeningeal metastases
  • Ocular, uveal, acral, or mucosal melanoma
  • Prior treatment-related toxicities that have not resolved to Grade 2 or less per NCI CTCAE v5.0;
  • Patients with a history of immune-related colitis may be included if symptoms have resolved to Grade 1 or less for at least 14 days prior to screening
  • Any history of CTCAE v5.0 immune-related toxicity Grade 3 or greater from prior CPI that is recurrent or steroid-refractory
  • Known hypersensitivity to any of the ingredients of the study drug(s) or known hypersensitivity to vancomycin (oral or IV)
  • Significant medical conditions which, in the Investigator's opinion, could compromise or interfere with the patient's safety or integrity of the study outcomes
  • Severe colitis of any etiology (except colitis associated with treatment with an aPD-1 inhibitor)
  • History of another malignancy within 3 years before the first dose of any study drug, or any evidence of residual disease from a previously diagnosed malignancy
  • Clinically significant (i.e., active) cardiovascular disease
  • Any clinically significant safety concern related to prior CPI therapy
  • Active autoimmune disease that required systemic treatment in the past 2 years prior to screening
  • History of investigational agent or device use within 4 weeks prior to the first dose of study treatment or current participation in a study of an investigational agent
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation, or, in the opinion of the Investigator, is considered to not be in the best interest of the patient to participate in the study.

Trial locations and contacts

19 sites in 4 countries.

19 sites in 4 countries

United Kingdom7 sites

  • Sussex Cancer Centre

    Brighton

  • Addenbrooke's Hospital

    Cambridge

  • Beatson West of Scotland Cancer Centre

    Glasgow

  • The Royal Marsden NHS Foundation Trust

    London

  • The Christie NHS Foundation Trust

    Manchester

  • Freeman Hospital

    Newcastle

  • Royal Marsden Hospital - Surrey

    Sutton

Other trials in United Kingdom

France5 sites

  • Centre Georges Francois Leclerc

    Dijon

  • CHU de Lille - Hopital Claude Huriez

    Lille

  • Centre Leon Berard

    Lyon

  • AP-HM - Hopital de la Timone

    Marseille

  • HCL Centre Hospitalier Lyon Sud

    Pierre-Bénite

Other trials in France

Spain4 sites

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Ramon y Cajal

    Madrid

  • South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC

    Madrid

  • Consorcio Hospital General Universitario de Valencia

    Valencia

Other trials in Spain

Italy3 sites

  • Istituto Europeo di Oncologia

    Milan

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples

  • Istituto Clinico Humanitas

    Rozzano

Other trials in Italy

About this study

Official title: A Phase 1b, Randomized, Open-Label Trial to Evaluate Safety, Engraftment, and Initial Signs of Clinical Activity of MB097 in Combination With Pembrolizumab in Melanoma Patients With Primary Resistance to an AntiPD1Containing Immunotherapy

A Phase 1b study to evaluate the safety and tolerability of MB097 given in combination with pembrolizumab in patients with melanoma who demonstrate primary resistance to anti-PD1 therapy.

Conditions
Melanoma
Being tested
MB097, Pembrolizumab, Vancomycin
Medical subject headings
Melanoma

What participants receive

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

  • MB097Biological

    Live bacterial therapeutic for oral administration

  • PembrolizumabBiological

    Also called KEYTRUDA®

    IV infusion

  • VancomycinDrug

    Antibiotic

Study groups in NCT06540391
Study groupRoleWhat they receive
MB097 and pembrolizumabExperimentalMB097 PO (2 capsules once a day) for 6 months Pembrolizumab IV 200mg Q3W for 6 months
Receives: Biological: MB097; Biological: Pembrolizumab
MB097 and pembrolizumab with vancomycin preconditioningExperimentalVancomycin 125mg QID for 5 days plus 2 day wash-out prior to receiving MB097 PO (2 capsules once a day) for 6 months Pembrolizumab IV 200mg Q3W for 6 months
Receives: Biological: MB097; Biological: Pembrolizumab; Drug: Vancomycin
Extended treatmentExperimentalPatients experiencing clinical benefit may continue to receive study intervention (pembrolizumab only IV 200mg Q3W) until such time as a criterion for discontinuation is met or 35 doses of pembrolizumab have been administered.
Receives: Biological: Pembrolizumab

What is being measured

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

  1. Safety and tolerability of MB097 in combination with pembrolizumab

    Assessed by the following:

    • The incidence and severity of treatment-emergent AEs (TEAEs) per NCI CTCAE v5.0;
    • Immune-related AEs (irAEs);
    • AESIs; and
    • Any clinically significant abnormalities in laboratory results, physical examination findings, 12-lead ECG findings, and vital signs using the NCI CTCAE v5.0.

    Measured: From Visit 1 to 30 days after the last dose of study treatment

Secondary outcomes (7)

  1. Best objective response rate (b-ORR) by RECIST v1.1 and iRECIST

    b-ORR is the best response recorded from the start of the treatment until disease progression/recurrence (Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD))

    Measured: Up to Week 24 or Week 105(for patients in extended treatment)

  2. Overall response rate (ORR) by RECIST v1.1 and iRECIST

    Overall response of CR, PR, SD or PD.

    Measured: Up to Week 24 or Week 105(for patients in extended treatment)

  3. Disease control rate (DCR) by RECIST v1.1 and iRECIST

    DCR is defined as the proportion of patients with CR, PR, or SD for 8 weeks or more, by RECIST v1.1 and iRECIST

    Measured: Up to Week 24 or Week 105(for patients in extended treatment)

  4. Duration of response

    The time from first objective response until progression of disease or death

    Measured: Up to Week 24 or Week 105(for patients in extended treatment)

  5. Progression-free survival,

    The time from enrollment until disease progression or death

    Measured: Up to Week 24 and Week 36, and Week 105(for patients in extended treatment)

  6. Time to progression

    Time until disease progression and overall survival

    Measured: Up to Week 24 or Week 105(for patients in extended treatment)

  7. Quantification of MB097 strains at baseline and over the intervention period in patients treated with MB097 with and without vancomycin preconditioning and correlation to efficacy measures

    Measured: Up to Week 24 or Week 105(for patients in extended treatment)

Timeline

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

  1. First posted6 Aug 2024
  2. Study start28 Aug 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionAug 2027 (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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06540391
Sponsor's protocol ID
MB097-01
Other IDs
KEYNOTE-E75, MK-3475-E75, 2023-507377-17, 2023
Acronym
MELODY-1
Status last verified
Sep 2025
First submitted
1 Aug 2024
Last updated
26 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MB097, Pembrolizumab and Vancomycin in people with Melanoma, run by Microbiotica Ltd at 19 sites in 4 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 12 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: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United Kingdom, France, Spain, Italy. 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 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.

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?

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 and tolerability of MB097 in combination with pembrolizumab (time frame: From Visit 1 to 30 days after the last dose of study treatment). 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 NCT06540391.

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 26 Sep 2025.

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