NeoLIPA: A single center phase II open label study of neoadjuvant LTX-315 in combination with pembrolizumab in patients with clinically detectable and resectable stage III-IV melanoma

Conditions

Patients with clinically detectable and resectable stage III-IV melanoma

Brief summary

Rate of pathologic complete response (cPR)

Detailed description

Frequency, nature and severity of AE according to NCI CTCAE v 5.0: • All AEs • LTX-315 treatment-related AEs • Pembrolizumab treatment-related AEs The proportion of patients who received surgery as planned Number of doses of LTX-315 and pembrolizumab recieved, Objective response rate (ORR), i.e. rate of CR or PR as per RECIST version 1.1 prior to surgery Pathologic response rate (pCR + pPR) Rate of major pathologic response (MPR) defined as pCR and pnCR, Event free survival (EFS), defined as time from start of treatment to progression of disease per RECIST version 1.1 that precludes surgery, recurrence (local or distant) or death. Recurrence free survival (RFS), defined as the time from surgery to recurrence or death. Overall Survival (OS), Patient reported outcomes (PRO)

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Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rate of pathologic complete response (cPR)	—

Secondary

Measure	Time frame
Frequency, nature and severity of AE according to NCI CTCAE v 5.0: • All AEs • LTX-315 treatment-related AEs • Pembrolizumab treatment-related AEs The proportion of patients who received surgery as planned Number of doses of LTX-315 and pembrolizumab recieved, Objective response rate (ORR), i.e. rate of CR or PR as per RECIST version 1.1 prior to surgery Pathologic response rate (pCR + pPR) Rate of major pathologic response (MPR) defined as pCR and pnCR, Event free survival (EFS), defined as time from start of treatment to progression of disease per RECIST version 1.1 that precludes surgery, recurrence (local or distant) or death. Recurrence free survival (RFS), defined as the time from surgery to recurrence or death. Overall Survival (OS), Patient reported outcomes (PRO)	—

Measure

Time frame

Frequency, nature and severity of AE according to NCI CTCAE v 5.0: • All AEs • LTX-315 treatment-related AEs • Pembrolizumab treatment-related AEs The proportion of patients who received surgery as planned Number of doses of LTX-315 and pembrolizumab recieved, Objective response rate (ORR), i.e. rate of CR or PR as per RECIST version 1.1 prior to surgery Pathologic response rate (pCR + pPR) Rate of major pathologic response (MPR) defined as pCR and pnCR, Event free survival (EFS), defined as time from start of treatment to progression of disease per RECIST version 1.1 that precludes surgery, recurrence (local or distant) or death. Recurrence free survival (RFS), defined as the time from surgery to recurrence or death. Overall Survival (OS), Patient reported outcomes (PRO)

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Countries

Norway

Outcome results

None listed