Trial results for a Phase 2 study (NCT03547999) investigating Nivolumab in combination with CV301 vaccination and systemic chemotherapy for metastatic colorectal cancer were posted on ClinicalTrials.gov on 2025-07-22. The experimental arm achieved an Overall Response Rate (ORR) of 100%, compared to 57.14% in the control arm.
Background
The trial investigated treatment strategies for patients with metastatic colorectal cancer.
Trial design
The study (NCT03547999) was a Phase 2 randomized trial that enrolled 17 participants before its termination. It investigated treatment for metastatic colorectal cancer, specifically in patients with biopsy-proven hepatic-limited metastatic colorectal cancer deemed resectable. Participants were randomized to either a control arm or an experimental arm.
- The control arm (Arm A) received mFOLFOX6 concurrently with Nivolumab.
- The experimental arm (Arm B) received CV301 vaccination (mva-bn-cv301, fpv-cv301) in combination with Nivolumab and systemic chemotherapy, which included mFOLFOX6.
Key results
The trial reported several outcome measurements:
- 3-year Overall Survival (OS) Rate From Metastasectomy:
- Arm A - Control: 100 Percentage of participants
- Arm B - Experimental: 100 Percentage of participants
- 3-Year Recurrence Free Survival (RFS) Rate:
- Arm A - Control: 53.6 Percentage of participants
- Arm B - Experimental: 61 Percentage of participants
- Overall Response Rate (ORR):
- Arm A - Control: 57.14 Percentage of participants
- Arm B - Experimental: 100 Percentage of participants
- Patients Amenable to Complete Resection/Ablation:
- Arm A - Control: 40 Percentage of participants
- Arm B - Experimental: 0 Percentage of participants
- Perioperative Surgical Outcomes:
- Arm A - Control: 4 Participants
- Arm B - Experimental: 4 Participants
- Arm A - Control: 1 Participants
- Arm B - Experimental: 2 Participants
What this means
The results from this Phase 2 trial for metastatic colorectal cancer suggest that the addition of CV301 vaccination to Nivolumab and systemic chemotherapy may improve certain efficacy outcomes. Notably, the experimental arm demonstrated a 100% Overall Response Rate, which was substantially higher than the 57.14% observed in the control arm. The 3-year Recurrence Free Survival Rate was also numerically higher in the experimental arm at 61% compared to 53.6% in the control arm. However, it is important to note the trial's termination and the small enrollment of 17 participants, which limits the generalizability of these findings. The observation that 0% of patients in the experimental arm were amenable to complete resection/ablation, compared to 40% in the control arm, warrants further investigation into the implications of this combination therapy on surgical resectability.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03547999, titled "A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC," were posted on 2025-07-22 on clinicaltrials.gov.