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ALVAC-NY-ESO-1/TRICOM vaccine · 1 trial · 24 indications
The toxicity rate will be estimated using a one-sided, 95%, exact binomial confidence interval (Clopper-Pearson). The lower one sided limit will be used.
| Arm | Type | Description |
|---|---|---|
| Treatment (vaccine, sirolimus, GM-CSF) | EXPERIMENTAL | Patients receive ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4. Patients also receive sirolimus PO QD on days 1-14 OR 15-28 OR 1-28. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive an additional course of ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine only followed by ALVAC(2)-NY-ESO-I (M)/TRICOM vaccine SC 8 weeks after completion of course 4. |
| Name | Type | Description |
|---|---|---|
| ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine | BIOLOGICAL | Given SC |
| sirolimus | DRUG | Given PO |
| laboratory biomarker analysis | OTHER | Correlative studies |
| sargramostim | BIOLOGICAL | Given SC |
Inclusion Criteria: * Eligible patients will be women with stages II-IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who have completed standard therapy for primary or recurrent disease (i.e., patients who would normally be observed); eligible patients may have asymptomatic r...
ALVAC-NY-ESO-1/TRICOM vaccine is an investigational cancer vaccine being studied for the treatment of recurrent fallopian tube cancer. It is also being evaluated in patients with recurrent ovarian epithelial cancer and recurrent primary peritoneal cavity cancer, as well as various stages of these gynecologic cancers.
ALVAC-NY-ESO-1/TRICOM vaccine is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker symbol SNY.
ALVAC-NY-ESO-1/TRICOM vaccine is in Phase 1 clinical development. It is an investigational agent and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the vaccine is no longer in active clinical trials.
ALVAC-NY-ESO-1/TRICOM vaccine was studied in clinical trial NCT01536054, titled "Sirolimus and Vaccine Therapy in Treating Patients With Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer." This Phase 1 trial was completed in the United States and enrolled 7 female patients aged 18 years and older.
ALVAC-NY-ESO-1/TRICOM vaccine is not FDA approved. It is an investigational vaccine that has only been studied in a Phase 1 clinical trial, which has been completed. The vaccine remains in clinical development and has not received regulatory approval for any indication.