New cocktail aims to outsmart pancreatic cancer
NCT ID NCT05721846
First seen Jun 24, 2026 · Last updated Sep 03, 2026 · Updated 3 times
Summary
This early-phase trial tests a combination of two immunotherapy drugs (nivolumab and ipilimumab), a vaccine targeting TGFβ-15, and targeted radiation for pancreatic cancer that has not responded to standard treatments. The goal is to see if this mix can safely boost the immune system's attack on tumors. Only 20 participants are enrolled, and the main focus is on side effects and signs of tumor shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab, ipilimumab, TGFβ-15 peptide vaccine, and stereotactic body radiotherapy
- What this could lead to
- If successful, this could point toward a new combination treatment that helps control pancreatic cancer when other therapies have failed.
- What could go wrong
- This is a very early Phase 1 trial with only 20 participants, so it is primarily testing safety. The combination may cause significant side effects and may not improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
20 people
The number who actually took part.
- Started
-
May 2023
- Finished
-
Mar 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed informed consent * Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care * Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study * Histological or cytological confirmation of advanced pancreatic carcinoma prior to entering this study * Prior therapy requirements: * There is no upper limit on the number of prior chemotherapy regimens received. Participants must have received and progressed during or after at least 1 line of systemic chemotherapy in the metastatic setting (gemcitabine or 5-FU based regimens). * Notes: * If a participant received adjuvant/neoadjuvant systemic combinational therapy, and progressed within 6 months, the adjuvant/neoadjuvant treatment will be considered as 1 line of systemic treatment. * In general, discontinuation of 1 drug in a multi-drug regimen and continuation of other drug(s), is considered part of the same line of treatment. Restarting the same regimen after a drug holiday or maintenance chemotherapy can also be considered part of the same line of treatment. Switching from IV (5-FU) to an oral formulation (capecitabine) of the same drug is also considered part of the same line of treatment * Minimum time from first systemic therapy for recurrent/metastatic adenocarcinoma of pancreas to progression should be at least 3 months * Age 18 years and older * ECOG Performance Status (PS) 0-1 * All participants will be required to undergo mandatory pre- and on-treatment biopsies at acceptable clinical risk as judged by the investigator. An archival pre-treatment sample is not acceptable. * Participants must have normal organ and marrow function as defined below: * Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L * Platelet count ≥ 75 x 10⁹/L * Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) * AST/ALT ≤ 5 x ULN * Serum creatinine ≤ 1.5 x ULN or CrCl ≥ 40 mL/min (using the Cockcroft-Gault formula) * Women of childbearing potential (WOCBP) must use method(s) of contraception as indicated in Appendix 3. For a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required. The individual methods of contraception and duration should be determined in consultation with the investigator. WOCBP must follow instructions for birth control when the half-life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 30 days plus the time required for the investigational drug to undergo five half-lives. The half-life of nivolumab and ipilimumab is up to 25 days and 18 days, respectively. WOCBP should therefore use an adequate method to avoid pregnancy during the treatment and for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug * Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. The investigator shall review contraception methods and the time period that contraception must be followed. Men that are sexually active with WOCBP must follow instructions for birth control when the half-life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 90 days plus thetime required for the investigational drug to undergo five half-lives. The half-life of nivolumab is up to 25 days. Men who are sexually active with WOCBP must continue contraception during the treatment and for 31 weeks (90 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug. Women who are not of childbearing potential (i.e. who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception * Subjects must have signed and dated a BIOPAC approved written informed consent form in accordance with regulatory and institutional guidelines. Exclusion Criteria: * Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways * Participants with active, known or suspected autoimmune disease. Participants are permitted to enroll with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger. * Current or prior use of immunosuppressive medication within 14 days before the first dose of nivolumab, ipilimumab and radiation in combination with TGFβ-15 peptide vaccine. The following are exceptions to this criterion: * Intranasal, inhaled, or topical steroids; or local steroid injections (e.g. intra-articular injection) * Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent * Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication) * Participants should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Allergies and Adverse Drug Reaction * History of allergy to study drug components * History of severe hypersensitivity reaction to any monoclonal antibody * WOCBP who are pregnant or breastfeeding
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pancreatic cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Herlev & Gentofte University Hospital, Denmark
Herlev, 2730, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a blood test before pancreatic surgery predict a dangerous leak?
- New chemo cocktail targets pancreatic cancer at every stage
- Bacteria-Based immunotherapy targets pancreatic tumors in first human test
- Can a new radiation machine cut breath holds for cancer patients?
- Two oral drugs join chemotherapy in a bid to shrink pancreatic tumors
- Nerve-Block procedure tested against severe pancreatic and stomach cancer pain