Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SER-401 · 1 trial · 1 indication
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...
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SER-401 is an investigational small molecule being developed by Seres Therapeutics, Inc. for metastatic melanoma. It is designed to target PD-1, a protein involved in immune checkpoint regulation. SER-401 has completed a Phase 1 clinical trial and is not approved for any indication.
SER-401 is being studied for use in metastatic melanoma, a form of skin cancer that has spread to other parts of the body. It is an investigational agent and has not been approved for commercial use. Its only recorded clinical trial enrolled 14 patients with metastatic melanoma.
SER-401 targets PD-1, a protein that functions as an immune checkpoint. By binding to PD-1, the drug is intended to modulate checkpoint activity in the tumor microenvironment. This mechanism is being explored in the context of metastatic melanoma, where checkpoint pathways influence antitumor immune responses.
SER-401 is being developed by Seres Therapeutics, Inc., which trades on the Nasdaq under the ticker MCRB. The company is the sponsor of the clinical program evaluating SER-401 in metastatic melanoma.
SER-401 is in Phase 1 development. Its single recorded clinical trial, NCT03817125, has been completed. The study was a randomized, double-blind, placebo-controlled Phase 1 trial that enrolled 14 participants with metastatic melanoma in the United States.
SER-401 has been evaluated in one clinical trial, NCT03817125, titled Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention. The Phase 1 study was randomized, double-blind, and placebo-controlled, enrolled 14 patients with metastatic melanoma, and has completed. No active trials are currently listed.