Ignite Creation Date:
2024-05-06 @ 2:34 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02076646
Status:
UNKNOWN
Last Update Posted:
2022-04-14
First Post:
2014-02-24
Brief Title:
A Phase III Dose Escalation Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Dacarbazine for Patients With Metastatic Melanoma
Sponsor:
Philogen SpA
Organization:
Philogen SpA
Study Overview
Official Title:
A Phase III Dose Escalation Study of the Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Dacarbazine for Patients With Metastatic Melanoma
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective open-label multi-center Phase III study of L19IL2 in combination with Dacarbazine in patients with metastatic melanoma
Detailed Description:
A prospective open-label multi-center Phase III dose escalation study in which cohorts of 3-6 patients with metastatic melanoma will be assigned to receive escalating doses of L19-IL2 in combination with a fixed dose of Dacarbazine
After definition of MTD and RD during the phase II part of this study 60 patients with Stage IV M1a and M1b melanoma will be randomized in a 11 ratio to receive open label the combination treatment at the RD Arm 1 or DTIC monotherapy Arm 2
After definition of MTD and RD during the phase II part of this study 60 patients with Stage IV M1a and M1b melanoma will be randomized in a 11 ratio to receive open label the combination treatment at the RD Arm 1 or DTIC monotherapy Arm 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None