Cel Sci Corporation (CVM)

[drkazmd65]

Read the study design and what they are using as a set of Primary and Secondary outcome measures steve2150.

https://clinicaltrials.gov/ct2/show/NCT01265849?term=Multikine&rank=2

Primary Outcome Measures: •Overall Survival (OS) in LI + CIZ + SOC vs. SOC [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
OS will be assessed using Kaplan-Meier life-table and compared using a logrank test and confirmed further with tumor 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 for comparing the two groups. Interim analyses will be performed throughout the study to assess safety, sample size and futility.


Secondary Outcome Measures: •Progression Free Survival (PFS) in LI + CIZ + SOC vs.SOC [ Time Frame: 3 year. ] [ Designated as safety issue: Yes ]
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

•Local regional control (LRC) in LI + CIZ + SOC vs. SOC [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
LRC is assessed by classifying the first evidence of progression in local and distal sites for the control group 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 number and percent of subjects in the treated and untreated groups and the timing of LRC will be displayed for each group.

•Quality of Life (QOL) in LI + CIZ + SOC vs. SOC [ Time Frame: 3 yr. ] [ Designated as safety issue: Yes ]
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.

I think that the biggest problem is just that (absent the patients that InVentiv enrolled that have to be discounted) there is just no big enough chunk of data to evaluate yet.