Cel Sci Corporation (CVM)

[sushifishman]

Here is the list of Secondary Endpoints From CT.Gov

Verifiable Links are important vs made-up posts. I have provided the link to the CT Site for you all to verify at the end of this post

As of 8/18/22, CVM has yet to share the success or failure of any Secondary Endpoint

Q's assertions should have verifiable facts behind them, dont ya think!?


Secondary Outcome Measures :
Local regional control (LRC) in LI + CIZ + SOC vs. SOC [ Time Frame: 2 years ]
LRC is assessed by classifying the first evidence of progression in local and distal sites for the control groups and for the LI treated group. LRC failure includes progression of tumor(s) and nodes or appearance of new disease above the clavicle (but not distant metastases) the reappearance of tumor in the original tumor bed, development of cervical node metastases and new disease above the clavicle other than distant metastases not present at baseline. The total number and corresponding percent of subjects in each of the treated and untreated control groups as well as the time to LRC in days for each group will also be displayed for each group.

Progression Free Survival (PFS) in LI + CIZ + SOC vs.SOC [ Time Frame: 3 year. ]
PFS will be assessed using Kaplan-Meier life-table and compared using a logrank test and confirmed further with stage location and geographic stratified log rank tests. The unstratified logrank test constitutes the primary analysis.A two sided p-value of 0.05 or less will be considered statistically significant in comparing the groups. The Holm closed-sequential procedure will be used to control type 1 error probability to at most 0.05

Quality of Life (QOL) in LI + CIZ + SOC vs. SOC [ Time Frame: 3 yr. ]
QOL will be based on the EORTC QLOQ-C30 and EORTC QLQ-H&N35. QOL data will be assessed for change in QOL from baseline within and between treatment groups.Between group comparisons will be performed using ANOVA or Wilcoxon rank sum test. Within treatment group change from baseline will be performed using a paired t-test or a signed rank test. Two-sided t-test will be used with no adjustment for type I error. An exact binomial test of each treatment group will be used to assess a 10 point improvement between treatments. A Fisher Exact Test will be used for between group comparisons.


https://clinicaltrials.gov/ct2/show/study/NCT01265849