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

NCT ID: NCT06540391

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-28
• Study Completion Date: 2027-08-31

Brief 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.

Conditions

Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MB097 and pembrolizumab

MB097 PO (2 capsules once a day) for 6 months Pembrolizumab IV 200mg Q3W for 6 months

Group Type: EXPERIMENTAL

MB097

Intervention Type: BIOLOGICAL

Live bacterial therapeutic for oral administration

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion

MB097 and pembrolizumab with vancomycin preconditioning

Vancomycin 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

Group Type: EXPERIMENTAL

MB097

Intervention Type: BIOLOGICAL

Live bacterial therapeutic for oral administration

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion

Vancomycin

Intervention Type: DRUG

Antibiotic

Extended treatment

Patients 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.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: BIOLOGICAL

IV infusion

Interventions

MB097

Live bacterial therapeutic for oral administration

Intervention Type: BIOLOGICAL

Pembrolizumab

IV infusion

Intervention Type: BIOLOGICAL

Vancomycin

Antibiotic

Intervention Type: DRUG

Other Intervention Names

KEYTRUDA®

Eligibility Criteria

Inclusion Criteria

• 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
• 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.

Exclusion Criteria

• 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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Microbiotica Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Georges Francois Leclerc

Dijon, , France

CHU de Lille - Hopital Claude Huriez

Lille, , France

Centre Leon Berard

Lyon, , France

AP-HM - Hopital de la Timone

Marseille, , France

HCL Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Istituto Europeo di Oncologia

Milan, , Italy

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Napoli, , Italy

Istituto Clinico Humanitas

Rozzano, , Italy

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC

Madrid, , Spain

Consorcio Hospital General Universitario de Valencia

Valencia, , Spain

Sussex Cancer Centre

Brighton, , United Kingdom

Addenbrooke's Hospital

Cambridge, , United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

The Royal Marsden NHS Foundation Trust

London, , United Kingdom

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Freeman Hospital

Newcastle, , United Kingdom

Royal Marsden Hospital - Surrey

Sutton, , United Kingdom

Countries

France; Italy; Spain; United Kingdom

Other Identifiers

KEYNOTE-E75

Identifier Type: OTHER

Identifier Source: secondary_id

MK-3475-E75

Identifier Type: OTHER

Identifier Source: secondary_id

2023-507377-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MB097-01

Identifier Type: -

Identifier Source: org_study_id