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

Send

Updated on 26 February 2022

See if I qualify

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 Identifier	NCT03806309
Sponsor	GERCOR - Multidisciplinary Oncology Cooperative Group
Last Modified on	26 February 2022

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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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diabetes

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metastatic pancreatic ductal adenocarcinoma

modified folfirinox regimen

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