Molecularly Tailored Therapy in Advanced Pancreatic Cancer
ConditionPancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHerlev Hospital
About this trial
Pancreatic cancer that has spread or cannot be removed by surgery is difficult to treat. Standard chemotherapy can slow the disease, but the cancer often starts growing again. Some pancreatic cancers have specific genetic changes that may be targeted by medicines already available in Denmark. It is not yet known whether selecting treatment based on these genetic changes is more effective than standard treatment.
TAILOR-PANC is a randomized phase 2 study evaluating treatment guided by the molecular characteristics of the cancer. Adults with advanced pancreatic cancer whose disease has progressed during or after first-line chemotherapy may participate if molecular testing results are available. A national molecular tumor board will review these results and determine whether the cancer has a genetic change that can be matched to an available targeted treatment.
Participants with a suitable genetic change will be randomly assigned in a 1:1 ratio to receive either the matched treatment recommended by the molecular tumor board or standard second-line treatment according to Danish guidelines. Participants without a suitable genetic change will receive standard treatment and will be followed in a separate observational group. Treatment will continue until the cancer progresses, unacceptable side effects occur, the participant withdraws consent, or the treating physician decides that treatment should stop.
The main purpose of the study is to determine whether molecularly matched treatment delays cancer progression compared with standard treatment. The study will also evaluate overall survival, tumor response, side effects, and quality of life. Participants in the randomized groups will undergo scans, blood tests, and quality-of-life assessments at baseline and approximately every 8 weeks. Optional blood and tumor samples may also be collected through the BIOPAC project to explore biomarkers that could help predict treatment response or side effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (aged 18 and over)
PC confirmed by cytology or histology
Written informed consent before any specific study procedures
Available personalized report communicating the molecular testing results and detailed treatment options
Disqualifiers
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
Allergies and Adverse Drug Reaction
History of allergy to study drug components
History of severe hypersensitivity reaction to any monoclonal antibody (applicable for participants to receive a monoclonal antibody in the trial)
Trial design
Design model
Parallel
Treatments tested in this trial
Arm 1: Molecularly Tailored Therapy
DrugAxitinib Crizotinib Dabrafenib Trametinib Erlotinib Larotrectinib Olaparib Pembrolizumab Pemigatinib Pertuzumab and trastuzumab (Phesgo9 Selpercatinib Vismodegib
Arms 2: Standard-of-Care Therapy
DrugGemcitabine Nab-paclitaxel 5-Fluorouracil; 5-FU Calcium folinate Oxaliplatin Irinotecan Capecitabine
Arm 3: Standard-of-Care Observational Cohort
DrugGemcitabine Nab-paclitaxel 5-Fluorouracil; 5-FU Calcium folinate Oxaliplatin Irinotecan Capecitabine
Treatment groups
1,200 Participants
are divided into 3 treatment groupsGroup A: Arm 1: Molecularly Tailored TherapyExperimental treatment 1 intervention
Group B: Arm 2: Standard-of-Care TherapyActive comparator 1 intervention
Group C: Arm 3: Standard-of-Care Observational CohortOther 1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival in Randomized Participants
Progression-free survival is defined as the time from the first dose of study treatment to investigator-assessed objective disease progression according to RECIST version 1.1 or death from any cause in the absence of documented progression, whichever occurs first. Participants without progression or death at the analysis will be censored at their latest evaluable RECIST assessment. The primary comparison is between molecularly tailored therapy (Arm 1) and standard-of-care therapy (Arm 2).
Time frame
1 yearSecondary outcomes
1
Overall Survival in Randomized Participants
Overall survival is defined as the time from the first dose of study treatment until death from any cause. Participants not known to have died at the time of analysis will be censored on the last date they were known to be alive. Overall survival will be compared between Arm 1 and Arm 2.
Time frame
1 year2
Overall Survival Rate at 6 Months
The proportion of randomized participants alive 6 months after the first dose of study treatment, estimated using the Kaplan-Meier method.
Time frame
6 months3
Overall Survival Rate at 12 Months
The proportion of randomized participants alive 12 months after the first dose of study treatment, estimated using the Kaplan-Meier method.
Time frame
12 months4
Confirmed Objective Response Rate
The percentage of randomized participants with a confirmed complete response or partial response according to investigator assessment using RECIST version 1.1. A response must be confirmed by repeat imaging performed at least 4 weeks after the response was first observed, with no evidence of progression between assessments.
Time frame
1 yearOther outcomes
1
Overall Survival Across Molecular and Treatment Cohorts
Overall survival will be explored by comparing molecularly tailored therapy in Arm 1 with standard-of-care therapy in Arm 3 and standard-of-care therapy in Arm 2 with standard-of-care therapy in Arm 3. Because Arm 3 includes participants without an actionable reimbursed molecular alteration and is not randomized, these comparisons are exploratory and may be affected by differences in molecular and clinical characteristics.
Time frame
1 year2
Objective Response Rate Across Molecular and Treatment Cohorts
Objective response rate will be explored by comparing Arm 1 with Arm 3 and Arm 2 with Arm 3. Objective response is defined as complete or partial response based on available investigator-assessed tumor evaluations. Comparisons involving Arm 3 are non-randomized and exploratory.
Time frame
1 year3
Correlations of Tumor and Blood Biomarkers With Clinical Outcomes
Exploratory biomarkers measured in available tumor tissue and peripheral blood before and during treatment will be summarized and evaluated for associations with objective response, best overall response, duration of response, disease control, progression-free survival, safety, and other clinical outcomes. Analyses will include baseline biomarker values and absolute or percentage changes from baseline. Biomarker sampling is optional through the BIOPAC project and requires separate consent.
Time frame
Up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Herlev Hospital
Lead sponsor
Aalborg University Hospital
Collaborator
Aarhus University Hospital
Collaborator
Vejle Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: