Informations générales (source: ClinicalTrials.gov)
Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors (AGADIR)
Interventional
Phase 2
Institut Bergonié (Voir sur ClinicalTrials)
mars 2021
mars 2026
29 juin 2024
Basket trial concept to independently and simultaneously assess the effects of the
association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Marie-Paule SABLIN, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Georges François Leclerc - 21079 - Dijon - France | François GHIRINGHELLI, MD, PhD | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - 59020 - Lille Cedex - France | David PASQUIER, MD | Contact (sur clinicalTrials) | |||
| Institut Bergonié - 33076 - Bordeaux - France | Antoine ITALIANO, MD, PhD | Contact (sur clinicalTrials) | |||
| IUCT Oncopôle - 31052 - Toulouse - France | Carlos Alberto GOMEZ-ROCA, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Eugène Marquis - 35042 - Rennes - France | Florian ESTRADE, MD | Contact (sur clinicalTrials) | |||
| Centre François Baclesse - 14076 - Caen - France | Pierre-Emmanuel BRACHET, MD | Contact (sur clinicalTrials) | |||
| Chu Brest - 29200 - Brest - France | Jean-Philippe METGES, MD,PhD | Contact (sur clinicalTrials) | |||
| CHU Poitiers - 86000 - Poitiers - France | Nicolas ISAMBERT, MD,PhD | Contact (sur clinicalTrials) | |||
| Hôpital La Timone - 13005 - Marseille - France | Arnaud JEANSON, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - 13273 - Marseille - France | Philippe ROCHIGNEUX, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion criteria:
1. histologically confirmed pancreatic cancer, virus-associated tumors [including
papillomaviruses-related cancers (cervical, head and neck, and nasal), Epstein-Barr
virus (nasopharyngeal carcinoma) and Kaposi's sarcoma-associated herpes virus),
non-small cell lung cancer, soft-tissue sarcomas, bladder cancer, triple negative
breast cancer. For population 4, diagnosis must be confirmed by the RRePS Network as
recommended by the French NCI. For population 2, papillomavirus-related cancers must
be eligible whatever the genotype but in case of viral genotype is not available,
IHC p16 positive must be provided, hepatocellular carcinoma must be confirmed by
Hepatite B or C infection, HHV-8 and Epstein-Barr virus related cancers must be
confirmed by molecular analysis,
2. Metastatic disease,
3. Age ≥ 18 years,
4. ECOG ≤ 1,
5. At least two lesions: one extra cerebral lesion that can be treated by radiotherapy
and one site of disease that must be uni-dimensionally ≥ 10 mm considered as
measurable according to RECIST v1.1. This lesion will not be treated by
radiotherapy, however, note that lesion(s) that will be treated by radiotherapy will
also be considered as measurable. Note that the largest size of the metastases to be
irradiated will be 3cm and at that previous irradiation of these lesions is not
allowed,
6. Life expectancy > 6 months,
7. At least one tumor site that can be biopsied for research purpose. Tumor lesion in
close proximity to vascular structures such as large vessels, aneurysm or pulmonary
arteriovenous malformation will not be considered for biopsy,
8. Availability of archived paraffin-embedded tumor tissue for research purpose,
9. Participant must have advanced disease and must not be a candidate for other
approved therapeutic regimen known to provide significant clinical benefit based on
investigator judgement,
10. Participants who received prior anti-PD-1/L1 therapy must fulfill the following
requirements - population 3 and population 5 only
- Have achieved a complete response, partial response or stable disease and
subsequently had disease progression while still on anti-PD-1/L1 therapy
- Have received at least two doses of an approved anti-PD-1/L1 therapy (by any
regulatory authority)
- Have demonstrated disease progression as defined by RECIST v1.1 within 18 weeks
from the last dose of the anti- PD-1/L1 therapy.
11. Adequate hematological, renal, metabolic and hepatic functions
12. No prior or concurrent malignant disease needing an active treatment,
13. At least three weeks since last chemotherapy, immunotherapy or any other
pharmacological treatment and/or radiotherapy,
14. Recovery to grade ≤ 1 from any adverse event (AE) derived from previous treatment,
excluding alopecia of any grade and non-painful peripheral neuropathy grade ≤ 2,
15. Women of childbearing potential must have a negative serum pregnancy test within 7
days prior to inclusion.
16. Both women and men must agree to use an effective method of contraception throughout
the treatment period and for five months after discontinuation of treatment.
17. Voluntary signed and dated written informed consents prior to any specific study
procedure,
18. Participants with a social security in compliance with the French law.
1. histologically confirmed pancreatic cancer, virus-associated tumors [including
papillomaviruses-related cancers (cervical, head and neck, and nasal), Epstein-Barr
virus (nasopharyngeal carcinoma) and Kaposi's sarcoma-associated herpes virus),
non-small cell lung cancer, soft-tissue sarcomas, bladder cancer, triple negative
breast cancer. For population 4, diagnosis must be confirmed by the RRePS Network as
recommended by the French NCI. For population 2, papillomavirus-related cancers must
be eligible whatever the genotype but in case of viral genotype is not available,
IHC p16 positive must be provided, hepatocellular carcinoma must be confirmed by
Hepatite B or C infection, HHV-8 and Epstein-Barr virus related cancers must be
confirmed by molecular analysis,
2. Metastatic disease,
3. Age ≥ 18 years,
4. ECOG ≤ 1,
5. At least two lesions: one extra cerebral lesion that can be treated by radiotherapy
and one site of disease that must be uni-dimensionally ≥ 10 mm considered as
measurable according to RECIST v1.1. This lesion will not be treated by
radiotherapy, however, note that lesion(s) that will be treated by radiotherapy will
also be considered as measurable. Note that the largest size of the metastases to be
irradiated will be 3cm and at that previous irradiation of these lesions is not
allowed,
6. Life expectancy > 6 months,
7. At least one tumor site that can be biopsied for research purpose. Tumor lesion in
close proximity to vascular structures such as large vessels, aneurysm or pulmonary
arteriovenous malformation will not be considered for biopsy,
8. Availability of archived paraffin-embedded tumor tissue for research purpose,
9. Participant must have advanced disease and must not be a candidate for other
approved therapeutic regimen known to provide significant clinical benefit based on
investigator judgement,
10. Participants who received prior anti-PD-1/L1 therapy must fulfill the following
requirements - population 3 and population 5 only
- Have achieved a complete response, partial response or stable disease and
subsequently had disease progression while still on anti-PD-1/L1 therapy
- Have received at least two doses of an approved anti-PD-1/L1 therapy (by any
regulatory authority)
- Have demonstrated disease progression as defined by RECIST v1.1 within 18 weeks
from the last dose of the anti- PD-1/L1 therapy.
11. Adequate hematological, renal, metabolic and hepatic functions
12. No prior or concurrent malignant disease needing an active treatment,
13. At least three weeks since last chemotherapy, immunotherapy or any other
pharmacological treatment and/or radiotherapy,
14. Recovery to grade ≤ 1 from any adverse event (AE) derived from previous treatment,
excluding alopecia of any grade and non-painful peripheral neuropathy grade ≤ 2,
15. Women of childbearing potential must have a negative serum pregnancy test within 7
days prior to inclusion.
16. Both women and men must agree to use an effective method of contraception throughout
the treatment period and for five months after discontinuation of treatment.
17. Voluntary signed and dated written informed consents prior to any specific study
procedure,
18. Participants with a social security in compliance with the French law.
1. Previous treatment with a TLR agonist
2. Evidence of progressive or symptomatic central nervous system (CNS) or
leptomeningeal metastases,
3. Women who are pregnant or breast feeding,
4. Participation in a study involving a medical or therapeutic intervention in the last
30 days,
5. Known hypersensitivity to CHO cell products or to any involved study drug or of its
formulation components,
6. History of severe allergic anaphylactic reactions to chimeric, human or humanized
antibodies, or fusion proteins,
7. Treatment with systemic immunosuppressive medications including, but not limited to,
cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents
within 2 weeks prior to inclusion.
8. Major surgical procedure, open biopsy or significant traumatic injury within 28 days
before inclusion,
9. Any of the following cardiac criteria: congestive heart failure ≥ New York Heart
Association (NYHA) class 2, unstable angina, new-onset angina, myocardial infarction
less than 6 months before inclusion, uncontrolled cardiac arrhythmias, known left
ventricular ejection fraction (LVEF) <50%, previously experience of pericardial
disorder
10. Individuals deprived of liberty or placed under legal guardianship,
11. Prior organ transplantation, including allogeneic stem cell transplantation,
12. Known clinically significant liver disease, including active viral, alcoholic, or
other hepatitis, cirrhosis, fatty liver and inherited liver disease,
13. History of intra-abdominal inflammatory process within the last 12 months such as,
but not limited to, diverticulitis, peptic ulcer disease or colitis.
14. History of autoimmune disease including, but not limited to systemic lupus
erythematosus (SLE), Sjögren's syndrome, glomerulonephritis, multiple sclerosis,
rheumatoid arthritis, vasculitis, systemic immune activation, inflammatory bowel
disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's
granulomatosis, Guillain-Barré syndrome, Bell's palsy.
15. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest CT scan.
16. Poorly controlled Type II diabetes mellitus defined as a screening fasting plasma
glucose ≥160 mg/dL (or 8.8 mmol/L).
17. Severe infections within 2 weeks prior to inclusion, including but not limited to
SARS-Cov-2 infection, hospitalization for complications of infection, bacteremia, or
severe pneumonia.
18. Received therapeutic oral or IV antibiotics within 2 weeks prior to inclusion.
19. Participant has spinal cord compression not definitively treated with surgery and/or
radiation or previously diagnosed and treated spinal cord compression without
evidence that disease is clinically stable at least 14 days prior to inclusion.
20. Administration of a live, attenuated vaccine within 4 weeks before the start of
study medication .
21. Has known active hepatitis B or hepatitis C,known history of Human Immunodeficiency
or known acquired immunodeficiency syndrome, known history of tuberculosis
22. Patients with current retinal disorder confirmed by retinal examination (external
ocular examination, routine slit lamp biomicroscopy of anterior ocular structures
and evaluation of the anterior and posterior chamber,
23. Patients who wear contact lenses unable to replace them with glasses.