4
Indication details
- Control Arm
- Chemotherapy
- Therapeutic Indication
- Nivolumab in combination with ipilimumab is indicated for the treatment of adults patients with mismatch repair deficient or microsatellite instability-high in first-line treatment of unresectable or metastatic colorectal cancer. (Arm B + Arm C)
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Colorectal cancer
- Tumour Stage
- Unresectable or metastatic
- Tumour Sub-Group
- dMMR or MSI-H
- Trial Name
- CheckMate 8HW
- NCT Number
- NCT04008030
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) November 2024. EC decision January 2025
Primary Outcome(s)
- Primary Outcome(s)
- PFS (by BICR, arm B vs C, 1L, centrally confirmed)
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 24-month, 72%
- PFS Gain
- Estimated median PFS gain >21 months. 24mth PFS gain 58% (with plateau)
- PFS HR
- HR not reported, estimated HR = 0.20 (based on a conservative approach of dividing the upper limit of median control by the lower limit of median experimental : 7.8 / 38.4). P<0.001 with the use of a two-sided stratified log-rank test.
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
3
- OS advantage continues to be observed
- +1
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 485
- Scorecard version
- 1
- Issue date
- 05.02.2025
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.