Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Mar 10, 2025
  • participants needed
    247
  • sponsor
    Institut Bergonié
Updated on 10 October 2021
cancer
serum pregnancy test
carcinoma
lung cancer
metastasis
cancer chemotherapy
alopecia
triple negative breast cancer
atezolizumab
bladder tumor
mammogram
lung carcinoma

Summary

Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.

Description

6 independent, multicenter, prospective, single-arm phase II trials, based on 2-stage Simon's optimal design, will be conducted in parallel to assess the efficacy of atezolimab + BDB001+ radiotherapy, separately, in distinct populations of solid tumors:

  • Population 1: pancreatic cancer
  • Population 2: virus-associated tumors
  • Population 3: anti-PD-1/L1 refractory non-small lung cancer
  • Population 4: soft-tissue sarcoma
  • Population 5: anti-PD-1/L1 refractory bladder cancer
  • Population 6: triple negative breast cancer

Details
Condition Pancreatic Disorders, Virus-associated Tumors, Urologic Cancer, melanoma, pancreatic cancers, nsclc, Digestive System Neoplasms, bladder disorder, bladder tumor, cancer of the pancreas, urinary tract neoplasm, Pancreatic disorder, Neoplasm of unspecified nature of digestive system, Melanoma, Solid Tumor, Adult, skin cancer, Pancreatic Cancer, cancer, pancreatic, Bladder Cancer, Malignant Melanoma, Skin Cancer, bladder cancer, Breast Cancer, Bladder Disorders, Triple Negative Breast Cancer, Urothelial Cancer, Metastatic Melanoma, Bladder Carcinoma, Islet Ce417ll Cancer, Non-Small Cell Lung Cancer, carcinoma of the bladder
Treatment Association atezolizumab + BDB001 + RT, Association atezolizumab + BDB001+ RT
Clinical Study IdentifierNCT03915678
SponsorInstitut Bergonié
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Metastatic disease
Age 18 years
ECOG 1
At least two lesions: one 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
Life expectancy > 6 months
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
Availability of archived paraffin-embedded tumor tissue for research purpose
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
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
Adequate hematological, renal, metabolic and hepatic functions
No prior or concurrent malignant disease needing an active treatment
At least three weeks since last chemotherapy, immunotherapy or any other pharmacological treatment and/or radiotherapy
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
Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to inclusion
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
Voluntary signed and dated written informed consents prior to any specific study procedure
Participants with a social security in compliance with the French law

Exclusion Criteria

Previous treatment with a TLR agonist
Evidence of progressive or symptomatic central nervous system (CNS) or leptomeningeal metastases
Women who are pregnant or breast feeding
Participation in a study involving a medical or therapeutic intervention in the last 30 days
Known hypersensitivity to CHO cell products or to any involved study drug or of its formulation components
History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
Treatment with systemic immunosuppressive medications including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents within 2 weeks prior to inclusion
Major surgical procedure, open biopsy or significant traumatic injury within 28 days before inclusion
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%
Individuals deprived of liberty or placed under legal guardianship
Prior organ transplantation, including allogeneic stem cell transplantation
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver and inherited liver disease
History of intra-abdominal inflammatory process within the last 12 months such as, but not limited to, diverticulitis, peptic ulcer disease or colitis
History of autoimmune disease including, but not limited to systemic lupus erythematosus (SLE), Sjgren's syndrome, glomerulonephritis, multiple sclerosis, rheumatoid arthritis, vasculitis, systemic immune activation, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Guillain-Barr syndrome, Bell's palsy
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
Poorly controlled Type II diabetes mellitus defined as a screening fasting plasma glucose 160 mg/dL (or 8.8 mmol/L)
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
Received therapeutic oral or IV antibiotics within 2 weeks prior to inclusion
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
Administration of a live, attenuated vaccine within 4 weeks before the start of study medication
Has known active hepatitis B or hepatitis C,known history of Human Immunodeficiency or known acquired immunodeficiency syndrome, known history of tuberculosis
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
Patients who wear contact lenses unable to replace them with glasses
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