CheckMate 067: Long-term outcomes in patients with mucosal melanoma.
Bibliographic record
Abstract
10019 Background: Mucosal melanoma is a rare but aggressive malignancy with a poor prognosis. Here we report 5-y outcomes in a subgroup of patients with mucosal melanoma treated in CheckMate 067 with nivolumab plus ipilimumab (NIVO+IPI), NIVO alone, or IPI alone. Methods: Patients with previously untreated stage III or IV melanoma were randomized 1:1:1 to receive NIVO 1 mg/kg + IPI 3 mg/kg for 4 doses Q3W followed by NIVO 3 mg/kg Q2W, NIVO 3 mg/kg Q2W + placebo, or IPI 3 mg/kg Q3W for 4 doses + placebo until progression or unacceptable toxicity. Mucosal histology was not a stratification factor, and patients with mucosal melanoma were identified by local investigators in the study. Descriptive subgroup analyses were performed to evaluate efficacy (objective response rate [ORR], progression-free survival [PFS], overall survival [OS]), and safety. Results: A total of 79 patients with mucosal melanoma were treated. With a minimum follow-up of 60 mo, NIVO+IPI treatment was associated with the highest 5-y ORR (43% [vs 30% with NIVO and 7% with IPI]), PFS (29% [vs 14% and 0%, respectively]), and OS (36% [vs 17% and 7%, respectively]; Table), consistent with trends in the intent-to-treat (ITT) population; however, efficacy outcomes were generally less favorable overall relative to the ITT population. Complete response rates were higher with NIVO+IPI (14%) relative to monotherapy (NIVO, 4%; IPI, 0%) in patients with mucosal melanoma. Safety outcomes, including the grade 3/4 treatment-related adverse event rates of 54%, 26%, and 25%, respectively, were similar to the ITT population. Conclusions: This 5-y analysis showed that patients with mucosal melanoma in CheckMate 067 had similar safety outcomes but poorer long-term efficacy vs the ITT population. Patients with mucosal melanoma treated with NIVO+IPI appeared to have more favorable survival outcomes than those treated with NIVO or IPI alone. Novel therapies are needed to further improve long-term benefit in patients with mucosal melanoma. Clinical trial information: NCT01844505. [Table: see text]
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".