| General information |
| Database: | DB00273 |
| Objective: | To determine whether EMD 1201081, a TLR9 agonist, added to cetuximab had antitumor activity in secondline recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). |
| Authors: | Ruzsa A, et al |
| Title: | Phase 2, openlabel, 1:1 randomized controlled trial exploring the efficacy of EMD 1201081 in combination with cetuximab in secondline cetuximabna ve patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). |
| Journal: | Invest New Drugs. |
| Year: | 2014 |
| PMID: | 24894651 |
| Trial Design |
| Clinical Trial Id: | NCT01040832 |
| Agent: | EMD 1201081
|
| Target: | Tolllike receptor 9
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | EMD1201081+ cetuximab |
| Study Type: | a phase II, openlabel, I:I randomized controlled trial |
| Key Patients Feature: | The patient population comprised adults with R/M SCCHN with disease progressing on a firstline cytotoxic chemotherapy regimen, measurable disease, and Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | a trial of EMD 1201081 0.32 mg/kg subcutaneously weekly plus cetuximab (combination) vs cetuximab monotherapy (control) in cetuximabna ve patients with R/M SCCHN who progressed on 1 cytotoxic regimen. |
| Primary End Point: | ORR, DCR, PFS, toxcity |
| Secondary End Point: | NA |
| Patients Number: | 123 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Objective response rate in both arms was 5.7% (95% CI 1.215.7%) by independent assessment. |
| Disease Control Rate: | Disease control was 37.7% for patients on combination (24.852.1%) and 43.4% on control (29.857.7%). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.5 months (1.32.6) for patients on combination, and 1.9 months (1.52.9) on control |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most frequent adverse events in the combination arm were rash (29.6%), acneiform dermatitis (22.2%), and injection site reactions (20.4%). Grade 3/4 dyspnea and hypokalemia were more frequent with cetuximab monotherapy (7.5% and 5.7% vs 1.9% each, respectively), and grade 3/4 respiratory failure and disease progression were more frequent with combination (5.6% each vs 1.9% each). |
| Conclusions: | EMD 1201081 was well tolerated combined with cetuximab, but there was no incremental clinical efficacy. |