NCT05116917: INFLUENCE

Immunotherapy Combined With Radiation and Influenza Vaccine for Pancreatic Cancer.

Terminated Phase 2 Last updated 28 May 2024

What this trial tests

Phase 2 trial testing Nivolumab in Pancreatic Cancer in 19 participants. Terminated before completion.

Timeline

5 November 2021

Primary endpoint
19 October 2023

19 October 2023

Quick facts

Lead sponsor	Herlev Hospital
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	5 November 2021
Primary completion	19 October 2023
Estimated completion	19 October 2023
Sites	1 location across Denmark

Drugs / interventions tested

• Nivolumab (nivolumab) — full drug profile →
• Ipilimumab — full drug profile →
• Influenza vaccine — full drug profile →
• SBRT

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

Herlev Hospital

Who can join

18 and older, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pancreatic cancer (PC) remains a dreadful disease due to its often advanced stage at diagnosis and poor sensitivity to chemotherapy. Progression after 1. line chemotherapy is inevitable in patients with advanced PC, and treatment options for patients who progress after 1. line chemotherapy are limited. Considering the emerging role of the tumor microenvironment, the combination of checkpoint blocking antibodies with immunomodulation of the tumor microenvironment could lead to better responses in tumor historically resistant to radiation and checkpoint blocking antibody approaches as single modalities. Influenza vaccination in cancer patients receiving immune checkpoint inhibitors resulted in a better survival, irrespective of the anticancer treatment outcome. Influenza vaccine facilitates both T- and B cell activation and drives interferon-gamma response, supporting the rationale for combining of influenza vaccine with immune checkpoint inhibition and radiation (NCT02866383).

Based on these considerations, the proposed treatment with SBRT of 15 Gy in combination with nivolumab, ipilimumab and influenza vaccine may have the potential to provide meaningful clinical benefit by generating durable clinical responses, thereby improving quality of life (QoL) and potentially extending survival.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunotherapy in Pancreatic Cancer: Why Do We Keep Failing? A Focus on Tumor Immune Microenvironment, Predictive Biomarkers and Treatment Outcomes.
   Di Federico A, Mosca M, Pagani R, Carloni R, et al · · 2022 · cited 82× · PMID 35626033 · DOI 10.3390/cancers14102429
2. Immunosuppression, immune escape, and immunotherapy in pancreatic cancer: focused on the tumor microenvironment.
   Zhu YH, Zheng JH, Jia QY, Duan ZH, et al · · 2023 · cited 69× · PMID 36367669 · DOI 10.1007/s13402-022-00741-1
3. Personalized pancreatic cancer therapy: from the perspective of mRNA vaccine.
   Huang X, Zhang G, Tang TY, Gao X, et al · · 2022 · cited 61× · PMID 36224645 · DOI 10.1186/s40779-022-00416-w
4. The paradigm shift in treatment from Covid-19 to oncology with mRNA vaccines.
   Wei J, Hui AM. · · 2022 · cited 44× · PMID 35576777 · DOI 10.1016/j.ctrv.2022.102405
5. Stereotactic Body Radiotherapy (SBRT) of Pancreatic Cancer-A Critical Review and Practical Consideration.
   Burkoň P, Trna J, Slávik M, Němeček R, et al · · 2022 · cited 24× · PMID 36289742 · DOI 10.3390/biomedicines10102480
6. Safety and Efficacy of Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitors. Systematic Review with Meta-Analysis.
   Lopez-Olivo MA, Valerio V, Karpes Matusevich AR, Brizio M, et al · · 2022 · cited 20× · PMID 36016085 · DOI 10.3390/vaccines10081195
7. Combination, Modulation and Interplay of Modern Radiotherapy with the Tumor Microenvironment and Targeted Therapies in Pancreatic Cancer: Which Candidates to Boost Radiotherapy?
   Benkhaled S, Peters C, Jullian N, Arsenijevic T, et al · · 2023 · cited 19× · PMID 36765726 · DOI 10.3390/cancers15030768
8. Immunotherapy and Pancreatic Cancer: A Lost Challenge?
   Laface C, Memeo R, Maselli FM, Santoro AN, et al · · 2023 · cited 18× · PMID 37511856 · DOI 10.3390/life13071482