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. 2022 Oct 21;12:945867. doi: 10.3389/fonc.2022.945867

Table 1.

General features of the included literature.

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.