Multicenter Phase 1b Trial Testing the Neoadjuvant Combination of Domatinostat, Nivolumab and Ipilimumab in IFN-gamma Signature-low and IFN-gamma Signature-high RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

January 7, 2020

Primary Completion Date

January 11, 2022

Study Completion Date

November 26, 2024

Conditions
Malignant Melanoma Stage III
Interventions
DRUG

Domatinostat

"Patients in arm B and C will receive domatinostat 200 mg BID, days 1-14 q3weeks.~Patients in arm D will start with once daily (OD) dosing scheme of domatinostat 200mg, d1-14 q3wks. Based on safety data of the first 5 patients in this arm, the next patients will be treated with either a higher dosing scheme (200mg BID, d1-14, q3wks), a lower dosing scheme (100mg OD, d1-14, q3wks) or the same dosing scheme (200mg OD, d1-14, q3wks)."

DRUG

Nivolumab

2 courses nivolumab 240 mg q3weeks

DRUG

Ipilimumab

2 courses ipilimumab 80 mg q3weeks

Trial Locations (2)

2065

Melanoma Institute Australia, Sydney

1066CX

Antoni van Leeuwenhoek Hospital, Amsterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

4SC

UNKNOWN

lead

The Netherlands Cancer Institute

OTHER

NCT04133948 - Multicenter Phase 1b Trial Testing the Neoadjuvant Combination of Domatinostat, Nivolumab and Ipilimumab in IFN-gamma Signature-low and IFN-gamma Signature-high RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma | Biotech Hunter | Biotech Hunter