OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or M… (NCT03806309) | Clinical Trial Compass
Active — Not RecruitingPhase 2
OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC
France106 participantsStarted 2021-04-10
Plain-language summary
TEDOPAM is a randomized (1.1.1) non-comparative phase II study. This study will assess the efficacy and safety of OSE2101 alone or in combination with nivolumab followed by FOLFIRI reintroduction, versus FOLFIRI as maintenance therapy in patients with advanced PDAC after induction therapy with FOLFIRINOX.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed and dated informed consent document, willing and able to comply with protocol requirements,
. Histologically or cytologically proven pancreatic ductal adenocarcinoma,
. Age ≥ 18 years,
. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1,
. Human Leukocyte Antigen (HLA-A2) genotype,
. Recurrent or advanced disease not amenable to surgery with curative intent (previous resection of primary tumor allowed),
. Measurable or evaluable (radiologically detectable disease which does not fulfill RECIST criteria for measurable disease) lesions according to RECIST v1.1 criteria (CT-scan \< 4 weeks),
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival (OS)
Timeframe: At 12 months
Trial details
NCT IDNCT03806309
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
. Stable disease or tumor response according to RECIST v1.1 after a 4-month (8 cycles) course of first-line FOLFIRINOX or modified FOLFIRINOX induction chemotherapy,
. Active HBV (hepatitis B virus), HCV (hepatitis C virus ), or HIV infection, Note: Patients with past HBV infection or resolved HBV infection (defined as having a negative HBsAg test and a positive HBc (hepatitis B core antigen) antibody test are eligible.
. Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri,
. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of neuropathy, alopecia, and the laboratory values defined in the inclusion criteria,
. Known active central nervous system metastases and/or carcinomatous meningitis; patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of trial treatment and any neurological symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids at a dose \> 10 mg/day of prednisone or equivalent for at least 14 days prior to trial treatment,
. Uncontrolled massive pleural effusion or massive ascites,
. Evidence of interstitial lung disease, any active, non-infectious pneumonitis, or known active tuberculosis,