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 range18 Years
SexALL
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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),
✓. 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.
✕
What they're measuring
1
Overall Survival (OS)
Timeframe: At 12 months
Trial details
NCT IDNCT03806309
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
. 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,