PANCEP-1

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vaestra Goetalandsregionen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

2 Sep 2025 → ongoing

Decision date (initial)

2024-05-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To assess the frequency and extent of adverse events associated with the therapy.

Secondary objectives 2

1. To determine the clinical efficacy of peri- and postoperative treatment with HDC/IL-2 in patients with primary resectable pancreatic cancer using matched, contemporary control patients as the comparator.
2. To investigate the efficacy of peri- and postoperative therapy with HDC/IL-2 vs. control patients in the IPEP study on certain biomarkers relating to inflammation and/or immune responses.

Conditions and MedDRA coding

Pancreatic cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 1. Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution.
2. 2. Patient is a male or female age >18
3. 3. By the surgeons evaluation fit for pancreatic surgery
4. 4. Subjects must have radiologic, and/or cytologic confirmation of primary resectable pancreatic or periampullary cancer. Pancreatic ductal adenocarcinoma, ampullary carcinoma and cholangiocarcinoma are the most common forms, but also other rare forms of pancreatic and periampullary cancer may be included.

Exclusion criteria 7

1. 1. Class III or IV cardiac disease, hypotension or severe hypertension, vasomotor instability, serious or uncontrolled cardiac dysrhythmias (including ventricular arrhythmias) at any time, acute myocardial infarction within the past 6 months, active uncontrolled angina pectoris or symptomatic arteriosclerotic blood vessel disease.
2. 2. History of uncontrolled seizures, severe central nervous system disorders, or psychiatric disability thought to be clinically significant in the opinion of the Investigator and adversely affecting compliance to protocol.
3. 3. Ongoing treatment with immunomodulating medication, i.e. corticosteroids.
4. 4. Ongoing active peptic ulcer.
5. 5. Ongoing asthma.
6. 6. Any other condition or symptoms preventing the patient from entering the study, according to the PI's judgement.
7. 7. A woman of childbearing potential (WOCBP) must agree to comply with using an effective contraceptive method for the duration of the treatment (a WOCBP is a sexually mature woman who is not surgically sterile or has not been naturally postmenopausal for at least 12 consecutive months). Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of < 1% when used consistently and correctly. Local laws and regulations may require use of alternative and/or additional contraception methods. One of the highly effective methods of contraception listed below is required during study duration and until the end of relevant systemic exposure, defined as 5 months after the end of study treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The safety and tolerability of the treatment will be evaluated by the assessment of all adverse events (AEs) occurring during treatment—both those considered treatment-related and unrelated. Adverse events will be collected from Cycle 1 Day 1 through the final study visit and will be graded for severity according to the NCI-CTCAE, version 5.0. Safety will also be evaluated by clinical laboratory tests, physica

Secondary endpoints 3

1. Secondary Efficacy Variables: Progression-free survival and overall survival
2. Secondary Outcome Biomarker Variables: • NK cell subsets in blood, including immature (CD16-) and cytotoxic (CD16+) subsets, activation markers, natural cytotoxicity receptors including NKp30, NKp46 and NKG2D, killer-immunoglobulin receptors. • T cell subsets including CD4+/25 regulatory T cells and naive, central memory, effector memory and effector CD8+ T cells
3. continuation Secondary Outcome: Biomarker Variables: • Myeloid cell populations including granulocytes and monocytes, MDSC, dendritic cells, activation markers, PD-L1, PD-L2 and related immune biomarkers. • Serum CA 19-9 • Serum levels of cytokines, chemokines and other soluble mediators of inflammation • Amount of tumor-infiltrating lymphocytes (TILs) and tumor-infiltrating myeloid cells

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vaestra Goetalandsregionen

Sponsor organisation

Vaestra Goetalandsregionen

Address

Regionens Hus

City

Vänersborg

Postcode

462 80

Country

Sweden

Scientific contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Svein Olav Bratlie

Public contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Svein Olav Bratlie

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications