CheckMate 141
The first immunotherapy to extend survival in head and neck cancer, in patients who had progressed on platinum within six months.
OS 7.5 vs 5.1 months (HR 0.70); 2-year OS 16.9% vs 6.0%. FDA approval November 2016. Quality of life was preserved with nivolumab and deteriorated with chemotherapy.
Setting
Platinum-refractory recurrent or metastatic HNSCC: nivolumab vs investigator's choice (methotrexate, docetaxel, or cetuximab)
Phase
Phase 3
Sponsor
BMS
Registry
Headline result
OS 7.5 vs 5.1 months; HR 0.70.
Reported
2016
Enrolled
361
Replication
KEYNOTE-040 (pembrolizumab) showed a concordant, borderline OS benefit.
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- Median 7.5 vs 5.1 months with Nivolumab compared with Investigator's choice; about 2.4 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 30 percent lower chance of the event at any given time (hazard ratio 0.7).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Platinum-refractory recurrent or metastatic HNSCC: nivolumab vs investigator's choice (methotrexate, docetaxel, or cetuximab). People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
361 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Nivolumab | — | 7.5 months | 0.7 | — | link |
| Investigator's choice | — | 5.1 months |
Replication
KEYNOTE-040 (pembrolizumab) showed a concordant, borderline OS benefit.Pages like this
not linked directly; found by shared links- TrialCheckMate 9DW
- TrialCheckMate 648
- IdeaAn advance market commitment for PD-1 biosimilars for lower-income countries
- PersonVijay Patil
- TrialJUPITER-02
- InstitutionLaura and Isaac Perlmutter Cancer Center at NYU Langone Health
- IdeaConfirm ultra-low-dose immunotherapy so it can be afforded where most patients live
Shares Nivolumab, PD-1, Head and neck squamous cell carcinoma.
- PersonPatrick M. Forde