Trial results for the study NCT02681302, investigating nivolumab in combination with ipilimumab after autologous stem cell transplantation, were posted on ClinicalTrials.gov on 2025-07-25. The study assessed the safety of this combined checkpoint inhibition therapy, reporting between 0 and 2 treatment-related limiting toxicities across six distinct patient groups.
Background
The study NCT02681302, titled "Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence," investigated the use of combined checkpoint inhibition therapy. The trial focused on patients with Multiple Myeloma and Lymphoma who were at high risk of post-transplant recurrence.
Trial design
The study NCT02681302 was a Phase 1/Phase 2 trial that enrolled 46 participants. The trial investigated nivolumab and ipilimumab as combined checkpoint inhibition therapy administered after autologous hematopoietic stem cell transplantation. The study included patients with Multiple Myeloma and Lymphoma. The primary outcome measures were not explicitly detailed in the posted results, but the study aimed to determine the safety and clinical effect of the combined therapy.
Key results
The trial assessed the safety of combined checkpoint inhibition therapy by evaluating adverse events and laboratory findings. The outcome, "Safety of Combined Check Point Inhibition Therapy Via Assessment of Adverse Events and Lab Findings," reported the number of treatment-related limiting toxicities across six groups:
- In Group A, 2 treatment-related limiting toxicities were observed.
- In Group B, 0 treatment-related limiting toxicities were observed.
- In Group C, 0 treatment-related limiting toxicities were observed.
- In Group D, 2 treatment-related limiting toxicities were observed.
- In Group E, 1 treatment-related limiting toxicity was observed.
- In Group F, 2 treatment-related limiting toxicities were observed.
What this means
The posted safety results provide initial data on the tolerability of combined nivolumab and ipilimumab after autologous stem cell transplantation in patients with Multiple Myeloma and Lymphoma. The observed number of treatment-related limiting toxicities, ranging from 0 to 2 across the six patient groups, suggests a variable but generally low incidence of these specific toxicities. It is important to note that the overall status of this study is TERMINATED.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02681302, titled "Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence," were posted on 2025-07-25 on clinicaltrials.gov.