The National Center for Tumor Diseases (NCT/UCC) Dresden has launched enrollment for a groundbreaking Phase 2 clinical trial testing a personalized mRNA-based cancer vaccine for pancreatic cancer patients, marking the first and only site in Saxony to offer this innovative treatment approach.
The IMCODE003 study (NCT05968326) will evaluate the efficacy and safety of Autogene Cevumeran, developed by BioNTech and Genentech, in combination with the PD-L1 checkpoint inhibitor Atezolizumab and mFOLFIRINOX chemotherapy, compared to chemotherapy alone in patients following surgical resection.
Addressing Critical Unmet Need
Pancreatic cancer represents one of the most challenging malignancies, with devastating survival outcomes despite current treatment approaches. "Despite surgical removal of the tumor, most patients experience a recurrence, and even with additional chemotherapy, only one in three to four patients survives five years after surgery," explained PD Dr. Adrian Seifert, surgeon and local co-investigator of the study. "These alarming figures highlight the urgent need for new treatment approaches for pancreatic cancer."
Promising Early Results Drive Phase 2 Advancement
The personalized mRNA vaccine is based on tumor-specific protein fragments called neoantigens and aims to activate the body's immune system to specifically target any remaining cancer cells after surgery. Encouraging results from the Phase 1 study (NCT04161755) led by Prof. Vinod Balachandran at Memorial Sloan Kettering Cancer Center in New York demonstrated the vaccine's potential.
In the Phase 1 trial, a strong and sustained T-cell immune response was triggered in half of the patients treated with Autogene Cevumeran after surgery. Critically, these patients experienced a significantly reduced risk of relapse compared to those who did not develop the immune response.
Personalized Medicine Approach
"The mRNA vaccine is an important step toward personalized cancer medicine, tailored to the specific characteristics of each individual tumor," said Prof. Gunnar Folprecht, oncologist and local principal investigator. "With this approach, we may be able to significantly reduce the high risk of recurrence after surgery."
Prof. Jürgen Weitz, Managing Director of the NCT/UCC and Director of the Department of Visceral, Thoracic and Vascular Surgery, emphasized the significance of Dresden's participation: "As NCT/UCC Dresden, we are very proud to be the only center in Saxony participating in the international Phase 2 study."
Study Design and Patient Eligibility
The IMCODE003 study targets patients who have undergone surgical resection for pancreatic ductal adenocarcinoma (PDAC) and have not yet received chemotherapy or radiotherapy, with no evidence of metastasis. The trial will compare outcomes between patients receiving the triple combination therapy versus those receiving standard mFOLFIRINOX chemotherapy alone.
The timing of treatment initiation is critical, as Prof. Folprecht noted: "Participation in the study is only possible in close temporal proximity to the surgery. This highlights the need for close collaboration between medical specialties."
Collaborative Research Framework
The NCT/UCC Dresden represents a joint institution involving the German Cancer Research Center (DKFZ), the Faculty of Medicine at TU Dresden, the Carl Gustav Carus University Hospital Dresden, and the Helmholtz-Zentrum Dresden-Rossendorf (HZDR). The center operates on a model where patients serve as research partners on equal footing.
Interested patients and physicians can contact the NCT/UCC study office for further information about participation eligibility and enrollment procedures.
