Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03817125 | Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention | PHASE1 | COMPLETED | 14 | — | — | Jan 28, 2019 | Mar 4, 2022 | Jun 6, 2024 | 7 | United States |
Investigators recorded AEs during each participant interaction. Symptoms were evaluated by the Investigator using the CTCAE version 5.0. This system grades AEs on a 1 to 5 scale: Grades 1 and 2 indicate mild to moderate events; Grade 3 denotes severe events; Grades 4 and 5 signify life-threatening or fatal outcomes. A treatment-emergent adverse event (TEAE) is defined as any event that either occurs after the initiation of study intervention, having been absent at baseline, or, if present at baseline, appears to have worsened in severity or frequency, regardless of its relation to the intervention. Adverse events deemed 'Possibly', 'Probably', or 'Definitely' related to the intervention were labeled as treatment-related adverse events (TRAE).
| Arm | Type | Description |
|---|---|---|
| SER-401 Matching Placebo/ Nivolumab | PLACEBO_COMPARATOR | Participants will undergo a 4-day lead-in pretreatment with antibiotic placebo, then matching placebo for SER-401 and nivolumab (480 mg) treatment. |
| SER-401/ Nivolumab | EXPERIMENTAL | Participants will undergo a 4-day lead-in pretreatment with antibiotic (vancomycin) to prime the gut microbiome for engraftment of the oral microbiome study intervention, then SER-401 and nivolumab treatment. |
| Name | Type | Description |
|---|---|---|
| Placebo for antibiotic | DRUG | Placebo for antibiotic will be administered orally four times a day for 4 days, followed by a 2-3 day washout. |
| Vancomycin pretreatment | DRUG | Vancomycin (125mg) will be administered orally four times a day, followed by a 2-3 day washout. |
| Nivolumab | DRUG | Nivolumab (480 mg) will be administered intravenously (IV) according to institutional guidelines every 4 weeks for up to 12 cycles. A cycle is defined as 4 calendar weeks. |
| Matching Placebo for SER-401 | DRUG | Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase. |
| SER-401 | DRUG | Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase. |
Inclusion Criteria: 1. Participant must be willing to provide a baseline stool sample. 2. Histologically-confirmed Stage IV cutaneous melanoma or Stage III cutaneous, acral or mucosal melanoma that is judged inoperable. Participants with a history of uveal melanoma are not eligible. 3. Measurable d...