Table 1.
First Author | Year of publication | NCT number | Disease setting | Study type | ECGO performance status | Total N. of pts | N. of experiment pts | N. of control pts | N. of BRCAm pts | N. of BRCAwt pts | N. of BRCA unknown status | Experimental arm (n. of pts assigned) | Control arm (n. of pts assigned) | Course of treatment | Outcome indicators |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Rodney P. Rocconi(21) | 2021 | NCT02346747 | Stage III/IV high grade serious, endometroid or clear cell ovarian cancer | Phase 2b, double blind, RCT | 0、1 | 45 | 25 | 20 | 0 | 45 | NA | 1×107cells/injection of Vigil/month (25) | Placebo/month (20) | a minimum of 4 and maximum of 12 doses | RFS, OS |
Rodney P. Rocconi(2) | 2021 (1) |
NCT01061840 NCT01309230 |
Recurrent ovarian cancer patients | RCT | 0、1 | 33 | 21 | 12 | NA | NA | NA | Vigil at 1×107 or 2.5×107 cells/injection (21) | NanoString® (12) | NA | OS |
Adam Walter(28) | 2021 | NCT02346747 | High-grade papillary serous, clear cell, endometrioid ovarian, fallopian tube or primary peritoneal cancer | Phase 2b, double blind, RCT | 0、1 | 45 | 25 | 20 | 0 | 45 | NA | 1x10e7cells/injection of Vigil/month (25) | Placebo/month (20) | a minimum of 4 and maximum of 12 doses | RFS, OS |
JonathanOh(15) | 2016 | NCT01551745 | Stages III/IV serous/endometrioid ovarian/fallopian cancer or primary peritoneal cancer | Phase II open-label trial, RCT | NA | 42 | 31 | 11 | NA | NA | NA | 1.0×107cells/intradermal injection of Vigil/month (31) | SOC (standard of care maintenance therapy) (11) | a minimum of 4 and maximum of 12 doses | RFS |
NeilSenzer(17) | 2012 | NCT01505153 | A histologically confirmed advanced or metastatic nondurable solid tumor following completion of ≥1 disease appropriate standard of care therapy and recovery from all treatment-related toxicities to ≤ grade 1 (except alopecia) | Phase I, nonrandomized, open-label trial | 0、1 | 45 | 27 | 18 | NA | NA | NA | 1 × 107 cells/injection (cohort 1) or 2.5 × 107 cells/injection (Cohort 2) of FANG (27) | no FANG (18) | a minimum of 5 monthly injections, maximum of 12 intradermal injections | OS |
Rodney P. Rocconi(20) | 2020 | NCT02346747 | Stage III or IV high-grade serous, endometrioid, or clear cell ovarian cancer in clinical completeresponse after a combination of surgery and five to eight cycles of chemotherapy involving carboplatin and paclitaxel | Phase 2b, double blind, RCT | 0、1 | 91 | 47 | 44 | 24 | 67 | NA | 1×107 cells per intradermal injection of Gemogenovatucel-T/month (47) | Placebo/month (44) | a minimum of four and up to 12 doses (within 8 weeks after last chemotherapy) | RFS, OS |
Rodney P. Rocconi(25) | 2021 (2) | NCT03073525 | Stages III/IV HGSC (high-grade serous carcinoma) | phase 1,2-part, open-label trial, RCT | 0、1 | 21 | 11 | 10 | 7 | 13 | 1 | received Vigil (1 × 10e6–10e7 cells/dose intradermally)/three weeks (11) | atezolizumab (1200 mg/dose intravenous infusion)/three weeks (10) | up to 12 doses | PFS, OS |
NA, not available.