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New treatment option for Solid Tumor, Adult
Official title Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT03915678
What this study is testing
What is Association atezolizumab + BDB001 + RT?
Association atezolizumab + BDB001 + RT is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- histologically confirmed pancreatic cancer, virus-associated tumors [including papillomaviruses-related cancers (cervical, head and neck, and nasal)...
- Metastatic disease,
- Age ≥ 18 years,
- ECOG ≤ 1,
- 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...
You likely can't join if
- 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,
See the full eligibility criteria
Who can join
- 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...
- Metastatic disease,
- Age ≥ 18 years,
- ECOG ≤ 1,
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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), Sjögren's syndrome, glomerulonephritis, multiple sclerosis, rheumatoid arthritis, vasculitis, systemic immune activation...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Brest, France
- Caen, France
- Dijon, France
- Lille, France
- Marseille, France
- Paris, France
- Poitiers, France
- Rennes, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Brest, France; Caen, France; Dijon, France; Lille, France; Marseille, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.