4
Indication details
- Control Arm
- Investigator Choice (either dacarbazine, ipilimumab or pembrolizumab)
- Therapeutic Indication
- Treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Uveal melanoma
- Tumour Stage
- Unresectable or metastatic
- Tumour Sub-Group
- HLA-A*0201positive
- Trial Name
- IMCgp100-202
- NCT Number
- NCT03070392
- Trial Phase
- Phase II
Approval details
- FDA Approval
- FDA approval January 2022
- EMA Approval
- EMA (CHMP) February 2022 EC decision April 2022
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 2.9 months
- PFS Gain
- 0.4 months
- PFS HR
- 0.73 (0.58-0.94)
- OS Control
- 16.0 months
- OS Gain
- 5.7 months
- OS HR
- 0.51 (0.37-0.71)
Adjustments
- QoL Comment
-
QoL data pending
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 316
- Scorecard version
- 1
- Issue date
- 02.03.2022
- Last update
- 26.09.2023