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

NCT06540391 | Active Not Recruiting Phase 1

• 4 other identifiers: MB097-01KEYNOTE-E75MK-3475-E752023-507377-17
• Study Type: interventional
• Target: 41
• Locations: 4 countries
• Sites: 19

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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (7)

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

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

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

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

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

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

• Duration of response

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

• Progression-free survival,

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

Study Arms (3)

MB097 and pembrolizumab

EXPERIMENTAL

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

Biological: MB097; Biological: Pembrolizumab

MB097 and pembrolizumab with vancomycin preconditioning

EXPERIMENTAL

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

Biological: MB097; Biological: Pembrolizumab; Drug: Vancomycin

Extended treatment

EXPERIMENTAL

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.

Biological: Pembrolizumab

Interventions

MB097 BIOLOGICAL

Live bacterial therapeutic for oral administration

MB097 and pembrolizumab; MB097 and pembrolizumab with vancomycin preconditioning

Pembrolizumab BIOLOGICAL

IV infusion

Also known as: KEYTRUDA®

Extended treatment; MB097 and pembrolizumab; MB097 and pembrolizumab with vancomycin preconditioning

Vancomycin DRUG

Antibiotic

MB097 and pembrolizumab with vancomycin preconditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Microbiotica Ltd: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (19)

Centre Georges Francois Leclerc

Dijon, France

Location

CHU de Lille - Hopital Claude Huriez

Lille, France

Location

Centre Leon Berard

Lyon, France

Location

AP-HM - Hopital de la Timone

Marseille, France

Location

HCL Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

Istituto Europeo di Oncologia

Milan, Italy

Location

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Napoli, Italy

Location

Istituto Clinico Humanitas

Rozzano, Italy

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, Spain

Location

South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC

Madrid, Spain

Location

Consorcio Hospital General Universitario de Valencia

Valencia, Spain

Location

Sussex Cancer Centre

Brighton, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

Freeman Hospital

Newcastle, United Kingdom

Location

Royal Marsden Hospital - Surrey

Sutton, United Kingdom

Location

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumab; Vancomycin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: August 28, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

GB (7); FR (5); ES (4); IT (3)