NICHE-2
Neoadjuvant Immunotherapy in Locally Advanced Mismatch Repair-Deficient Colon Cancer (NICHE-2)
Phase 2N = 115NCT03026140
- Population
- 115 patients with nonmetastatic, locally advanced, previously untreated dMMR colon cancer; 111 were included in the efficacy analysis.
- Design
- Single-arm phase 2 study of neoadjuvant nivolumab plus ipilimumab in patients with nonmetastatic, locally advanced, previously untreated dMMR colon cancer. Two primary endpoints: safety, defined as timely surgery (no more than 2 weeks of delay of planned surgery owing to treatment-related toxic events), and 3-year disease-free survival. Secondary endpoints included pathological response and genomic analyses. The NCT03026140 record on ClinicalTrials.gov is the parent NICHE study (estimated enrolment 353).
- Primary endpoint
- Timely surgery, DFS
- Arms
- Neoadjuvant nivolumab plus ipilimumab (experimental, n = 115): Neoadjuvant nivolumab plus ipilimumab before surgery (doses and schedule not read)
- People
- Chalabi M
Show the numbers
| Endpoint | Analysis | Neoadjuvant nivolumab plus ipilimumab | Control | Effect |
|---|---|---|---|---|
| Timely surgeryEnrolled patients (115) | primaryChalabi 2024 | 98% | — | 113 of 115 patients; the interval given in the abstract is a 97.5 percent confidence interval (93 to 100), not a 95 percent interval. |
| Pathological responsePatients in the efficacy analysis (111) | primarymedian follow-up 26 monthsChalabi 2024 | 98% (94–100%) | — | 109 of 111 patients. With a median follow-up of 26 months (range 9 to 65), no patients had recurrence of disease at the time of the report; 3-year disease-free survival, the second primary endpoint, is not reported in the abstract. |
| Major pathological responsePatients in the efficacy analysis (111) | primaryChalabi 2024 | 95% | — | 105 of 111 patients. |
| pCRPatients in the efficacy analysis (111) | primaryChalabi 2024 | 68% | — | 75 of 111 patients. |
| Grade 3 or 4 immune-related adverse eventsEnrolled patients; denominator not stated in the abstract | primaryChalabi 2024 | 4% | — | 5 patients; none discontinued treatment because of adverse events. |
| Endpoint | Analysis | Neoadjuvant nivolumab plus ipilimumab | Control | Effect |
|---|---|---|---|---|
| Timely surgeryEnrolled patients (115) | primaryChalabi 2024 | 98% | — | 113 of 115 patients; the interval given in the abstract is a 97.5 percent confidence interval (93 to 100), not a 95 percent interval. |
| Pathological responsePatients in the efficacy analysis (111) | primarymedian follow-up 26 monthsChalabi 2024 | 98% (94–100%) | — | 109 of 111 patients. With a median follow-up of 26 months (range 9 to 65), no patients had recurrence of disease at the time of the report; 3-year disease-free survival, the second primary endpoint, is not reported in the abstract. |
| Major pathological responsePatients in the efficacy analysis (111) | primaryChalabi 2024 | 95% | — | 105 of 111 patients. |
| pCRPatients in the efficacy analysis (111) | primaryChalabi 2024 | 68% | — | 75 of 111 patients. |
| Grade 3 or 4 immune-related adverse eventsEnrolled patients; denominator not stated in the abstract | primaryChalabi 2024 | 4% | — | 5 patients; none discontinued treatment because of adverse events. |