NEOREM: Localized solid malignancies that are eligible to receive neo-adjuvant therapy and have medical unmet needs related to disease-free survival, overall survival or quality of life / NEO-1: Resectable stage III cutaneous or mucosal melanoma amenable to intratumoral neo-adjuvant immunotherapy.
Conditions
Brief summary
NEO-1_The primary efficacy endpoint is defined as a pathological complete response (pCR) rate defined as the percentage of patients with pCR defined as the complete absence of viable tumor cells, or the major pathologic response (MPR) defined as less than 10% of surviving tumor cells in tumor biopsy of the surgical specimen., NEO-1_The primary safety endpoint defined as the percentage of patients whose surgery was delayed by more than 4 weeks beyond the planned timeline, due to treatment-related adverse events.
Detailed description
NEO-1_Objective Response Rate (ORR), defined as the proportion of patients achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST v1.1., NEO-1_Durable Clinical Benefit (DCB), defined as patient alive and without disease progression (complete response [CR] + partial response [PR] + stable disease [SD]) according to RECIST v1.1 at 6 weeks., NEO-1_Overall Survival (OS), defined as the time from inclusion until death from any cause. Patients who are alive at last follow-up news will be censored at this date., NEO-1_Recurrence-free survival (RFS), defined as the length of time from surgery until evidence of cancer recurrence or death of any cause, whichever occurs first., NEO-1_Distant metastasis-free survival (MFS), defined as the length of time from inclusion until evidence of distant metastases or death of any cause, whichever occurs first., NEO-1_Safety will be evaluated according to the incidence of adverse events (AEs) graded by the National Cancer Institute - common terminology criteria for adverse events NCI-CTCAE v5.0., NEO-1_Health-related quality of life will be evaluated through the EORTC QLQ-C30 questionnaire by collecting data at baseline and at each investigational medical product (IMP) administration cycle during the neo-adjuvant treatment period, at surgery and during the first year of the follow-up period (M1, M3, M6, M12).
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGYERVOY 5 mg/ml concentrate for solution for infusion
Sponsors
Unicancer
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NEO-1_The primary efficacy endpoint is defined as a pathological complete response (pCR) rate defined as the percentage of patients with pCR defined as the complete absence of viable tumor cells, or the major pathologic response (MPR) defined as less than 10% of surviving tumor cells in tumor biopsy of the surgical specimen., NEO-1_The primary safety endpoint defined as the percentage of patients whose surgery was delayed by more than 4 weeks beyond the planned timeline, due to treatment-related adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| NEO-1_Objective Response Rate (ORR), defined as the proportion of patients achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST v1.1., NEO-1_Durable Clinical Benefit (DCB), defined as patient alive and without disease progression (complete response [CR] + partial response [PR] + stable disease [SD]) according to RECIST v1.1 at 6 weeks., NEO-1_Overall Survival (OS), defined as the time from inclusion until death from any cause. Patients who are alive at last follow-up news will be censored at this date., NEO-1_Recurrence-free survival (RFS), defined as the length of time from surgery until evidence of cancer recurrence or death of any cause, whichever occurs first., NEO-1_Distant metastasis-free survival (MFS), defined as the length of time from inclusion until evidence of distant metastases or death of any cause, whichever occurs first., NEO-1_Safety will be evaluated according to the incidence of adverse events (AEs) graded by t | — |
Countries
France
Outcome results
None listed