Melanoma
Conditions
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.
Interventions
BIOLOGICALMB097
Live bacterial therapeutic for oral administration
BIOLOGICALPembrolizumab
IV infusion
DRUGVancomycin
Antibiotic
Sponsors
Merck Sharp & Dohme LLC
Microbiotica Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 * 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
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of MB097 in combination with pembrolizumab | From Visit 1 to 30 days after the last dose of study treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) by RECIST v1.1 and iRECIST | Up to Week 24 or Week 105(for patients in extended treatment) | Overall response of CR, PR, SD or PD. |
| Disease control rate (DCR) by RECIST v1.1 and iRECIST | Up to Week 24 or Week 105(for patients in extended treatment) | DCR is defined as the proportion of patients with CR, PR, or SD for 8 weeks or more, by RECIST v1.1 and iRECIST |
| Duration of response | Up to Week 24 or Week 105(for patients in extended treatment) | The time from first objective response until progression of disease or death |
| Best objective response rate (b-ORR) by RECIST v1.1 and iRECIST | Up to Week 24 or Week 105(for patients in extended treatment) | 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)) |
| Time to progression | Up to Week 24 or Week 105(for patients in extended treatment) | Time until disease progression and overall survival |
| 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 | 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) | The time from enrollment until disease progression or death |
Countries
France, Italy, Spain, United Kingdom
Outcome results
None listed