Maintenance With OSE2101 Plus FOLFIRI, or FOLFIRI After FOLFIRINOX-based Induction Therapy in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (TEDOPAM)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    106
  • sponsor
    GERCOR - Multidisciplinary Oncology Cooperative Group
Updated on 26 February 2022
diabetes
measurable disease
maintenance therapy
induction chemotherapy
serum bilirubin level
neoadjuvant therapy
neutrophil count
irinotecan
primary tumor
brain metastases
pd-l1
adjuvant therapy
nivolumab
adenocarcinoma
folfiri regimen
serum total bilirubin
pdac
folfirinox
metastatic pancreatic ductal adenocarcinoma
modified folfirinox regimen

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.

Description

Current standard of care for patients with advanced pancreatic ductal adenocarcinoma (PDAC) is chemotherapy, preferential regimen being FOLFIRINOX (5FU, leucovorin, irinotecan, and oxaliplatin) in fit patients (PS 0-1, bilirubin < 1.5 ULN). The question of how and when the FOLFIRINOX regimen and doses can be deescalated after a period of disease control (i.e. maintenance therapy) remains unanswered. In routine practice, oxaliplatin is usually stopped after 6-8 cycles due to limiting neuropathy, and the fluoropyrimidine is continued, either alone or, more frequently, in combination with irinotecan (FOLFIRI regimen), until disease progression.

Immune therapies have opened new opportunities in cancer therapy. However, results of immunotherapy in PDAC have been disappointing so far, with failure of checkpoint inhibitor monotherapies (anti-CTLA4 and anti-PD-L1 monoclonal antibodies [mAb]) in progressive advanced PDAC, while monovalent vaccines were demonstrated to be safe but with limited activity.

Details
Condition Pancreatic Ductal Adenocarcinoma, Locally Advanced Cancer, Metastatic Cancer
Treatment Nivolumab, FOLFIRI, OSE2101
Clinical Study IdentifierNCT03806309
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last Modified on26 February 2022

Eligibility

Yes No Not Sure

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
Have archival tissue sample that has been identified and confirmed as available for study, or newly obtained core or excisional biopsy of a tumor lesion
Adequate organ function, as defined by the following
Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN)
Total serum bilirubin < 1.5 ULN
Prothrombin ratio > 70%
Serum albumin 2.8 g/dL
Hemoglobin 10,0 g/dl
White blood cell count (WBC) 3,000/L
Absolute neutrophil count (ANC) 1,500/L
Platelets 100,000/L
Serum creatinine 1.5 ULN or creatinine clearance > 50 mL/min (Modification of diet in renal disease [MDRD])
Life expectancy 3 months
Women participants of childbearing potential must have a negative serum pregnancy test within the 3 days prior to the first treatment administration. Both women participants of childbearing potential and men participants who are sexually active with women of childbearing potential must agree to use a reliable method of birth control (i.e. pregnancy rate < 1% per year) until 6 months after the last dose of FOLFIRI, and 90 days after the last dose of OSE2101
Registration in a national health care system (PUMA included)

Exclusion Criteria

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
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
\. Active uncontrolled infection, or current unstable or uncompensated
respiratory or cardiac conditions, or bleeding
\. Known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the study
\. History or current evidence of any condition, therapy, or laboratory
Obstructive jaundice (bilirubin > 1.5 ULN) without adequate biliary drainage
abnormality that might confound the results of the trial, interfere with
participation for the full duration of the trial, or is not in the best
Allograft recipient
interest of the participant, in the opinion of the treating investigator
\. Known or suspected drug hypersensitivity to OSE2101 vaccine
Note: Patients positive for HCV antibody are eligible only if polymerase chain
\. Radiotherapy treatment to more than 30% of the bone marrow or with a wide
reaction testing is negative for HCV ribonucleic acid (RNA)
field of radiation within 4 weeks of the first dose of study drug
\. Diagnosis of any second malignancy within the last 5 years, except for
\. Major surgical procedure (as defined by the Investigator) within 28 days
adequately treated basal cell or squamous cell skin cancer, or in situ
prior to the first dose of investigational product, Note: Local surgery of
carcinoma of the cervix uteri
isolated lesions for palliative intent is acceptable
\. Any unresolved toxicity NCI CTCAE Grade 2 from previous anticancer therapy
\. Treatment with any investigational medicinal product within 28 days prior
with the exception of neuropathy, alopecia, and the laboratory values defined
to study entry
\. Prior intolerance/severe toxicity with 5-fluorouracil (5-FU) or
irinotecan (including dihydropyrimidinedehydrogenase [DPD] and UGT1A1
deficiency)
\. Pregnancy/lactation
\. Tutelage or guardianship
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