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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01536054 | Sirolimus and Vaccine Therapy in Treating Patients With Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer | PHASE1 | COMPLETED | 7 | — | — | Aug 20, 2012 | Apr 21, 2015 | Mar 27, 2020 | 1 | United States |
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...