Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vedolizumab · 1 trial · 4 indications
Feasibility defined by achievement of all pre-specified progression criteria: * Recruitment \>75% target (\>0.53 participants per site per month achieving randomization) * Recruitment: fecal calprotectin after first dose of ICI therapy \>100 μg/g in at least 15% of screened participants * Protocol adherence: \>95% of randomized participants receiving allocated treatment, protocol adherence in \>90% * Outcome data quality: endoscopy and biopsies taken in \>90% of eligible participants, \<10% loss to follow-up * Feedback: no major concerns identified by patients or providers on acceptability survey * \>15% of placebo-treated participants developing the primary outcome (sufficient event rate for feasible prevention) * Rate of PFS and OS is not lower than historical estimates from a similar population
| Arm | Type | Description |
|---|---|---|
| Vedolizumab | EXPERIMENTAL | Participants receive 300 mg vedolizumab IV at Baseline (Week 0) Weeks 2, 6, 14, and 22. |
| Placebo | PLACEBO_COMPARATOR | Participants receive 300 mg placebo IV at Baseline (Week 0) Weeks 2, 6, 14, and 22. |
| Name | Type | Description |
|---|---|---|
| Vedolizumab | BIOLOGICAL | 300 mg IV at weeks Baseline (Week 0) Weeks 2, 6, 14, and 22. |
| Placebo | BIOLOGICAL | 300 mg IV at Baseline (Week 0) Weeks 2, 6, 14, and 22. |
Inclusion Criteria: 1. Signed informed consent prior to initiation of any study specific activities or procedures 2. Adult patient ≥18 years old 3. Diagnosed with unresectable advanced stage III or metastatic stage IV malignant melanoma, lung, or renal cancer 4. Planned for initiation of SOC treatm...
Vedolizumab is a monoclonal antibody being studied for the prevention of immune-related adverse events (IrAE), specifically diarrhea and colitis, in patients with cancer who are receiving immune checkpoint inhibitors. It is currently in Phase 2 clinical development for this indication.
Vedolizumab is a monoclonal antibody that targets the alpha4beta7 integrin, a protein involved in gut-specific inflammation. By blocking this target, it is intended to reduce gastrointestinal inflammation associated with immune-related adverse events.
Vedolizumab is being developed by Avalon GloboCare Corp., a biopharmaceutical company traded under the ticker ALBT. The company is conducting a Phase 2 clinical trial to evaluate the drug for the prevention of immune-related diarrhea or colitis in cancer patients.
Vedolizumab is in Phase 2 clinical development for the prevention of immune-related adverse events, specifically diarrhea and colitis, in patients with cancer. The drug is investigational and has not been approved for this use.
Vedolizumab is being studied in a Phase 2 clinical trial with the identifier NCT06337695. The trial is titled 'Vedolizumab for the Prevention of ICI Related Diarrhea or Colitis in Patients With Cancer' and is currently recruiting participants in Canada.
Vedolizumab is the active ingredient in the approved drug Entyvio, which is used for inflammatory bowel disease. In the context of this Phase 2 trial, Vedolizumab is being investigated as a preventive treatment for immune-related diarrhea or colitis in cancer patients.