3
Indication details
- Control Arm
- Single arm
- Therapeutic Indication
- FDA: Treatment of adult patients with dMMR or MSI-H mCRC after prior fluoropyrimidine-based combination ChT. EMA: Nivolumab in combination with ipilimumab for the treatment adult patients with dMMR or MSI-H colorectal cancer after prior fluoropyrimidine based combination chemotherapy
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Colorectal Cancer
- Tumour Stage
- Metastatic
- Tumour Sub-Group
- dMMR+ or MSI-H+
- Trial Name
- CheckMate142
- NCT Number
- NCT02060188
- Trial Phase
- Phase II
Approval details
- FDA Approval
- FDA approval July 2018
- EMA Approval
- EMA (CHMP) approval May 2021. EC decision July 2021.
Primary Outcome(s)
- Primary Outcome(s)
- ORR, DOR
- Evaluated Outcome
- ORR
- Form(s)
- Form 3
Outcome Data
- PFS Control
- >38 months
- ORR
- 65%
- DoR
- >24 months
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 282
- Scorecard version
- 1
- Issue date
- 25.06.2021
- Last update
- 18.11.2024
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.