Trial results for a Phase 1/2 study investigating pembrolizumab in combination with CMP-001 for relapsed and refractory lymphomas were posted on ClinicalTrials.gov on 2026-03-30. The study reported 0 dose-limiting toxicities across all evaluated dose cohorts of the combination therapy.
Background
Pembrolizumab (Keytruda) is an established immunotherapy. This study, titled "CMP-001 for Relapsed and Refractory Lymphoma," was designed to evaluate the combination of CMP-001 with pembrolizumab for patients with relapsed and refractory lymphomas.
Trial design
The study (NCT03983668) was a Phase 1/2, single-arm, open-label trial that enrolled 14 participants with lymphoma. The trial's objective was to identify a dose of CMP-001 that, in combination with pembrolizumab, demonstrated optimal clinical efficacy and acceptable toxicity in patients with relapsed and refractory lymphomas.
Key results
The trial results focused on safety and preliminary efficacy in the dose-finding phase. For the outcome of "Number of Participants With Dose Limiting Toxicities Using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0":
- In the CMP-001 Plus Pembrolizumab: Phase I, 5mg Dose Cohort, there were 0 participants with dose-limiting toxicities.
- In the CMP-001 Plus Pembrolizumab: Phase I, 7.5mg Dose Cohort, there were 0 participants with dose-limiting toxicities.
- In the CMP-001 Plus Pembrolizumab: Phase I, 10mg Dose Cohort, there were 0 participants with dose-limiting toxicities.
Regarding Objective Response Rate (ORR), reported as the number of participants achieving a response:
- In the CMP-001 Plus Pembrolizumab: Phase I, 5mg Dose Cohort, responses were observed in 2, 1, and 0 participants across different measurements.
- In the CMP-001 Plus Pembrolizumab: Phase I, 7.5mg Dose Cohort, responses were observed in 1, 3, and 2 participants across different measurements.
- In the CMP-001 Plus Pembrolizumab: Phase I, 10mg Dose Cohort, responses were observed in 2, 0, and 0 participants across different measurements.
What this means
The findings from this Phase 1/2 trial indicate that the combination of CMP-001 with pembrolizumab demonstrated an acceptable safety profile in patients with relapsed and refractory lymphomas, with no dose-limiting toxicities reported across the tested dose cohorts. The observation of objective responses in some participants suggests preliminary clinical activity for this combination therapy, warranting further investigation.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03983668, titled "CMP-001 for Relapsed and Refractory Lymphoma," were posted on 2026-03-30 on clinicaltrials.gov.