Trial results for a Phase 2 study (NCT02060188) investigating Nivolumab alone or in combination therapies for metastatic colon cancer were posted on ClinicalTrials.gov on 2025-11-06. The study showed that a combination of Nivolumab and Ipilimumab achieved an objective response rate of up to 71.1% in one cohort.
Background
The study aimed to examine the efficacy of Nivolumab by itself or in combination with other anti-cancer drugs for participants with colon cancer that has come back or has spread, particularly those with specific tumor biomarkers.
Trial design
The study (NCT02060188) was a Phase 2 trial that enrolled 385 participants. It investigated Nivolumab alone or in combination with other agents such as ipilimumab, cobimetinib, daratumumab, and bms-986016. The trial included participants with various forms of colorectal cancer, including Microsatellite Unstable Colorectal Cancer, Microsatellite Stable Colorectal Cancer, Mismatch Repair Proficient Colorectal Cancer, and Mismatch Repair Deficient Colorectal Cancer.
Key results
The trial evaluated Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Key results for ORR per investigator assessment included:
- Cohort 1: Nivolumab Monotherapy demonstrated an ORR of 40.5%.
- Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg achieved an ORR of 66.4%.
- Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W showed an ORR of 71.1%.
- Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg had an ORR of 3.3%.
- Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg achieved an ORR of 50.0%.
- Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg showed an ORR of 0%.
- For MSS: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W, the ORR was 0%.
- For Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg, the ORR was 0%.
- For Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg, the ORR was 10.0%.
Objective Response Rate (ORR) by Independent Review Committee (IRC) assessment included:
- Cohort 1: Nivolumab Monotherapy demonstrated an ORR of 37.8%.
- Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg achieved an ORR of 61.3%.
- Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W showed an ORR of 62.2%.
What this means
The results indicate that combinations of Nivolumab with Ipilimumab demonstrated notable objective response rates in participants with recurrent or metastatic colon cancer, with the highest response seen in Cohort 3. However, other combinations, such as those involving cobimetinib, daratumumab, or certain subgroups like MSS and Non-MSI-H, showed limited to no objective response. These findings highlight the importance of specific combination therapies and patient biomarkers in achieving clinical benefit in this challenging cancer type.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02060188, titled "A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread," were posted on 2025-11-06 on clinicaltrials.gov.