Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nivolumab · 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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Nivolumab is an investigational small molecule being studied for use in metastatic melanoma. It is being evaluated in a Phase 1 clinical trial that combines microbiome intervention with checkpoint therapy to alter the gut microbiome in patients with this condition. The drug is still in clinical development and is not approved.
Nivolumab is being developed by Seres Therapeutics, Inc., a company traded on NASDAQ under the ticker MCRB. The company is conducting clinical research on this drug for metastatic melanoma, with the most recent trial being a Phase 1 study.
Nivolumab is in Phase 1 clinical development. A Phase 1 trial has been completed, which enrolled 14 participants with metastatic melanoma. The drug remains investigational and has not yet progressed to later-stage trials or received regulatory approval.
Nivolumab has been studied in one completed Phase 1 clinical trial with the identifier NCT03817125. The trial, titled "Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention," enrolled 14 participants in the United States and was a randomized, double-blind, placebo-controlled study.
Nivolumab is being studied in combination with a microbiome intervention in a clinical trial for metastatic melanoma. The trial investigates how altering the gut microbiome may affect checkpoint therapy. Nivolumab itself is a small molecule drug, and the microbiome intervention is a separate component of the study.