Trials / Active Not Recruiting
Active Not RecruitingNCT06540391
A Phase 1b Trial to Evaluate Safety of MB097 in Combination With Pembrolizumab in Melanoma Patients
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Microbiotica Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MB097 | Live bacterial therapeutic for oral administration |
| BIOLOGICAL | Pembrolizumab | IV infusion |
| DRUG | Vancomycin | Antibiotic |
Timeline
- Start date
- 2024-08-28
- Primary completion
- 2025-12-01
- Completion
- 2027-08-01
- First posted
- 2024-08-06
- Last updated
- 2025-09-26
Locations
19 sites across 4 countries: France, Italy, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT06540391. Inclusion in this directory is not an endorsement.