NCT05721846: CheckVAC

Phase 1 Study of Nivolumab With Ipilimumab Combined With TGFβ-15 Peptide Vaccine and Stereotactic Body Radiotherapy for Refractory Pancreatic Cancer (CheckVAC)

Active, enrolled Phase 1 Last updated 8 September 2025

What this trial tests

Phase 1 trial testing Nivolumab in Pancreatic Cancer in 20 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

3 May 2023

Primary endpoint
1 May 2026

1 December 2026

Quick facts

Lead sponsor	Inna Chen, MD
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	3 May 2023
Primary completion	1 May 2026
Estimated completion	1 December 2026
Sites	1 location across Denmark

Drugs / interventions tested

• Nivolumab (nivolumab) — full drug profile →
• Ipilimumab — full drug profile →
• SBRT
• TGFβ-B-15 peptide — full drug profile →

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

Inna Chen, MD — full company profile →

Who can join

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

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Adverse events
  Time frame: 6 months

Sponsor's own description

"Non-immunogenicity" of PC with high prevalence of immunosuppressive cells and typically a scarcity of tumor-infiltrating effector lymphocytes is considered as one of the reasons for lacking responsiveness to single-agent immunotherapies. 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. For example, the data from the phase 2 study CheckPAC (NCT02866383) showed durable clinical benefit in a small subgroup of patients after adding SBRT of 15 Gy to a combination of nivolumab and ipilimumab (presented at ASCO GI 2022, San Fransisco) in patients with resistant metastatic PC. Furthermore, we have found that the TGFβ-15 immune response is corelated to clinical benefit, supporting the rationale for combining of TGFβ-15 peptide vaccine with CheckPAC strategy (SBRT of 15 in combination with nivolumab and ipilimumab).

Publications & conference data

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

1. Targeting transforming growth factor beta signaling in metastatic osteosarcoma.
   Ge R, Huang GM. · · 2023 · cited 25× · PMID 38021074 · DOI 10.1016/j.jbo.2023.100513
2. The Role of Tumor Microenvironment in Pancreatic Cancer Immunotherapy: Current Status and Future Perspectives.
   Poyia F, Neophytou CM, Christodoulou MI, Papageorgis P. · · 2024 · cited 13× · PMID 39273502 · DOI 10.3390/ijms25179555
3. The Road Ahead in Pancreatic Cancer: Emerging Trends and Therapeutic Prospects.
   Do CTP, Prochnau JY, Dominguez A, Wang P, et al · · 2024 · cited 7× · PMID 39335494 · DOI 10.3390/biomedicines12091979
4. Clinical Evaluation of the Pancreatic Cancer Microenvironment: Opportunities and Challenges.
   Szczepanski JM, Rudolf MA, Shi J. · · 2024 · cited 7× · PMID 38398185 · DOI 10.3390/cancers16040794
5. Pancreatic Cancer: Pathogenesis and Clinical Studies.
   Zhou K, Liu Y, Tang C, Zhu H. · · 2025 · cited 6× · PMID 40182139 · DOI 10.1002/mco2.70162
6. Domestication and feedback: bidirectional hijacking in pancreatic ductal adenocarcinoma microenvironment.
   Qiao Y, Yin H, Zhang Y, Zhang J, et al · · 2025 · cited 2× · PMID 40861469 · DOI 10.3389/fimmu.2025.1585858
7. Cancer Vaccination and Immune-Based Approaches in Pancreatic Cancer.
   Bloom M, Shaikh AR, Sun Z, Bashir B, et al · · 2025 · cited 2× · PMID 40723238 · DOI 10.3390/cancers17142356
8. Emerging Therapeutic Approaches to Pancreatic Adenocarcinoma: Advances and Future Directions.
   Peng C, Oberstein PE. · · 2025 · cited 1× · PMID 40884689 · DOI 10.1007/s11864-025-01352-2