Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tu… (NCT03915678) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors
France247 participantsStarted 2021-03-31
Plain-language summary
Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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. 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,
. 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 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,
. 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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines three treatments — atezolizumab, BDB001, and radiotherapy — which is a more complex regimen than single-agent immunotherapy; can you walk me through how each piece works together and what the combined side effect profile looks like based on what's been seen so far in this Phase 2 study?
2The trial is no longer enrolling new patients, so it's in an active but closed phase — does that mean results or safety data might be available soon, and how should that affect my decision about pursuing this approach versus a currently open trial or standard treatment?
3This trial covers several different cancer types, including my specific diagnosis — given that antitumor activity is being measured separately for each cancer type, what do the early signals look like for my particular cancer, and is the combination showing meaningful responses?
4Radiotherapy is part of this combination, which adds logistical and physical demands on top of immunotherapy — how would the radiation schedule fit into my overall treatment plan, and are there specific risks I should weigh given my current health status?
5Since BDB001 is an investigational TLR agonist that most people haven't heard of, can you explain what's known about its safety profile so far, and whether there are patients whose medical history or prior treatments might make this combination riskier?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with pancreatic cancer.
Timeframe: Within 6 months of treatment onset
2
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with virus associated tumors.
Timeframe: Within 6 months of treatment onset
3
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with non-small cell lung cancer.
Timeframe: Within 6 months of treatment onset
4
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with soft-tissue sarcoma.
Timeframe: 6 months of treatment onset
5
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with bladder cancer.
Timeframe: Within 6 months of treatment onset
6
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with triple negative breast cancer.
. Availability of archived paraffin-embedded tumor tissue for research purpose,
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,