Solid Tumor, AdultPhase 2AGADIRNCT03915678
Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors
A Phase 2 study testing Association atezolizumab + BDB001 + RT and Association atezolizumab + BDB001+ RT in people with Solid Tumor, Adult and Pancreatic Cancer, run by Institut Bergonié at 11 sites in France.
Trial summary
Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Pancreatic Cancer, Virus-associated Tumors
- What is being tested?
- Association atezolizumab + BDB001 + RT and Association atezolizumab + BDB001+ RT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 11 sitesFrance
- Study dates
- 31 Mar 2021to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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,
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- 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.
Who cannot join
- 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,
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- 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%, previously experience of pericardial disorder
- 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, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Guillain-Barré 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Institut Bergonié
Bordeaux, 33076
Chu Brest
Brest, 29200
Centre François Baclesse
Caen, 14076
Centre Georges François Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Hôpital La Timone
Marseille, 13005
Institut Paoli Calmettes
Marseille, 13273
Institut Curie
Paris, 75005
CHU Poitiers
Poitiers, 86000
Centre Eugène Marquis
Rennes, 35042
IUCT Oncopôle
Toulouse, 31052
About this study
Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.
Read the detailed 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
- Conditions
- Solid Tumor, Adult, Pancreatic Cancer, Virus-associated Tumors, Non Small Cell Lung Cancer, Melanoma, Bladder Cancer
- Being tested
- Association atezolizumab + BDB001 + RT, Association atezolizumab + BDB001+ RT
- Keywords
- Immunotherapy, Radiotherapy, Oncology, Metastatic
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma, Urinary Bladder Neoplasms, Triple Negative Breast Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Association atezolizumab + BDB001 + RTDrug
A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).
BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.
Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy.
Association atezolizumab + BDB001+ RTDrug
A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).
BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.
Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy.
Association atezolizumab + BDB001+ RTDrug
A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).
BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.
Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy.
Association atezolizumab + BDB001 + RTDrug
A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).
BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.
Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy.
Association atezolizumab + BDB001 + RTDrug
A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).
BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.
Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy.
Association atezolizumab + BDB001 + RTDrug
A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).
BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.
Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy.
| Study group | Role | What they receive |
|---|---|---|
| Population 1: Pancreatic cancer | Experimental | Participants with pancreatic cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy. Receives: Drug: Association atezolizumab + BDB001 + RT |
| Population 2: Virus-associated tumors | Experimental | Participants with virus-associated tumors will be treated with Atezolizumab combined with BDB001 and radiotherapy. Receives: Drug: Association atezolizumab + BDB001+ RT |
| Population 3: anti-PD-1/L1 refractory non-small lung cancer | Experimental | Participants with anti-PD-1/L1 refractory non-small lung cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy. Receives: Drug: Association atezolizumab + BDB001+ RT |
| Population 4: Soft-tissue sarcoma | Experimental | Participants with soft-tissue sarcoma will be treated with Atezolizumab combined with BDB001 and radiotherapy. Receives: Drug: Association atezolizumab + BDB001 + RT |
| Population 5: anti-PD-1/L1 refractory bladder cancer | Experimental | Participants with anti-PD-1/L1 refractory bladder cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy. Receives: Drug: Association atezolizumab + BDB001 + RT |
| Population 6: Triple negative breast cancer | Experimental | Participants with triple negative breast cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy. Receives: Drug: Association atezolizumab + BDB001 + RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with pancreatic cancer.
Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.
Measured: Within 6 months of treatment onset
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with virus associated tumors.
Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.
Measured: Within 6 months of treatment onset
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with non-small cell lung cancer.
Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.
Measured: Within 6 months of treatment onset
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with soft-tissue sarcoma.
Antitumor activity will be assessed in terms of 6-month progression-free rat (PFR) and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed at 6 months following treatment onset and more than 24 weeks, based on RECIST 1.1 criteria.
Measured: 6 months of treatment onset
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with bladder cancer.
Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.
Measured: Within 6 months of treatment onset
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with triple negative breast cancer.
Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.
Measured: Within 6 months of treatment onset
Secondary outcomes (17)
6-month Progression-free rate (PFR) in patients with pancreatic cancer.
Progression-free rate is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST 1.1 criteria.
Measured: 6 months
6-month Progression-free rate (PFR) in patients with virus-associated tumor.
Progression-free rate is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST 1.1 criteria.
Measured: 6 months
6-month Progression-free rate (PFR) in patients with non-small cell lung cancer.
Progression-free rate is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST 1.1 criteria.
Measured: 6 months
6-month Progression-free rate (PFR) in patients with bladder cancer.
Progression-free rate is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST 1.1 criteria.
Measured: 6 months
6-month Progression-free rate (PFR) in patients with triple negative breast cancer.
Progression-free rate is defined as the rate of complete or partial response (CR, PR) or stable disease (SD), as per RECIST 1.1 criteria.
Measured: 6 months
6-month objective response rate (ORR) independently for each population.
Objective response is defined as the proportion of patients with complete response (CR) or partial response (PR) observed at 6 months, based on RECIST 1.1 criteria.
Measured: 6 months
Objective response rate (ORR) within 24 weeks of treatment onset, independently for each population.
Objective response is defined as the proportion of patients with complete response (CR) or partial response (PR) observed within 24 wekks after treatment onset, based on RECIST 1.1 criteria.
Measured: Within 6 months
Best overall response, independently for each population.
Best overall response is defined as the best response across all time points (RECIST 1.1). The best overall response is determined once all the data for the patient is known (RECIST 1.1).
Measured: Throughout the treatment period, an expected average of 6 months
1-year progression-free survival, independently for each population.
Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first.
Measured: 1 year
2-year progression-free survival, independently for each population.
Progression-free survival is defined as the delay between the start date of treatment and the date of progression (as per RECIST 1.1) or death (from any cause), whichever occurs first.
Measured: 2 years
1-year overall survival, independently for each population.
Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).
Measured: 1 year
2-year overall survival, independently for each population.
Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).
Measured: 2 years
Safety profile, independently for each population: Common Terminology Criteria for Adverse Events version 5
Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.
Measured: Throughout the treatment period, an expected average of 6 months
Tumor immune cells levels
Levels of immune cells in tumor will be measured by immunohistochemistry.
Measured: before treatment onset and cycle 3 day 1 (each cycle is 21 days)
Blood cytokines levels
Levels of cytokines in blood will be measured by ELISA.
Measured: baseline, cycle 1 day 1, cycle 2 day 1, cycle 3 day 1 and progression (each cycle is 21 days)
Blood lymphocytes levels
Levels of lymphocytes in blood will be measured by flow cytometry.
Measured: baseline, cycle 1 day 1, cycle 2 day 1, cycle 3 day 1 and progression (each cycle is 21 days)
Blood kynurenine levels
Levels of kynurenine in blood will be measured by ELISA.
Measured: baseline, cycle 1 day 1, cycle 2 day 1, cycle 3 day 1 and progression (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start31 Mar 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 6 independent single-arm, multicenter, phase II trials, based on 2-stage Simon's optimal design (Simon R, Controlled Clinical Trials 1989): * Population 1: pancreatic cancer * Population 2: virus-associated tumors * Population 3: non-small lung cancer * Population 4: soft-tissue sarcoma * Population 5: bladder cancer * Population 6: triple negative breast cancer
- Masking
- None (open label)
- Enrolment
- 247 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, National Cancer Institute, France, Eikon Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915678
- Sponsor's protocol ID
- IB 2019-01
- Other IDs
- 2019-000850-78, 2019
- Acronym
- AGADIR
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2019
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03915678
- Acronym / sponsor ID
- AGADIR / IB 2019-01
- Conditions
- Solid Tumor, Adult, Pancreatic Cancer, Virus-associated Tumors, Non Small Cell Lung Cancer, Melanoma, Bladder Cancer
- Keywords
- Immunotherapy, Radiotherapy, Oncology, Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 247 participants (estimated)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Roche Pharma AG, National Cancer Institute, France, Eikon Therapeutics
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 6 independent single-arm, multicenter, phase II trials, based on 2-stage Simon's optimal design (Simon R, Controlled Clinical Trials 1989): * Population 1: pancreatic cancer * Population 2: virus-associated tumors * Population 3: non-small lung cancer * Population 4: soft-tissue sarcoma * Population 5: bladder cancer * Population 6: triple negative breast cancer
| Arm | Type | Receives |
|---|---|---|
| Population 1: Pancreatic cancer | Experimental | Drug: Association atezolizumab + BDB001 + RTParticipants with pancreatic cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy. |
| Population 2: Virus-associated tumors | Experimental | Drug: Association atezolizumab + BDB001+ RTParticipants with virus-associated tumors will be treated with Atezolizumab combined with BDB001 and radiotherapy. |
| Population 3: anti-PD-1/L1 refractory non-small lung cancer | Experimental | Drug: Association atezolizumab + BDB001+ RTParticipants with anti-PD-1/L1 refractory non-small lung cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy. |
| Population 4: Soft-tissue sarcoma | Experimental | Drug: Association atezolizumab + BDB001 + RTParticipants with soft-tissue sarcoma will be treated with Atezolizumab combined with BDB001 and radiotherapy. |
| Population 5: anti-PD-1/L1 refractory bladder cancer | Experimental | Drug: Association atezolizumab + BDB001 + RTParticipants with anti-PD-1/L1 refractory bladder cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy. |
| Population 6: Triple negative breast cancer | Experimental | Drug: Association atezolizumab + BDB001 + RTParticipants with triple negative breast cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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,
Key exclusion criteria (23 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Association atezolizumab + BDB001 + RTA treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg). BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks. Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy. | Drug | Population 1: Pancreatic cancer |
| Association atezolizumab + BDB001+ RTA treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg). BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks. Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy. | Drug | Population 2: Virus-associated tumors |
| Association atezolizumab + BDB001+ RTA treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg). BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks. Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy. | Drug | Population 3: anti-PD-1/L1 refractory non-small lung cancer |
| Association atezolizumab + BDB001 + RTA treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg). BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks. Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy. | Drug | Population 4: Soft-tissue sarcoma |
| Association atezolizumab + BDB001 + RTA treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg). BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks. Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy. | Drug | Population 5: anti-PD-1/L1 refractory bladder cancer |
| Association atezolizumab + BDB001 + RTA treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg). BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks. Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy. | Drug | Population 6: Triple negative breast cancer |
Primary outcome
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with pancreatic cancer.
Time frame: Within 6 months of treatment onset
Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with virus associated tumors.
Time frame: Within 6 months of treatment onset
Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with non-small cell lung cancer.
Time frame: Within 6 months of treatment onset
Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with soft-tissue sarcoma.
Time frame: 6 months of treatment onset
Antitumor activity will be assessed in terms of 6-month progression-free rat (PFR) and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed at 6 months following treatment onset and more than 24 weeks, based on RECIST 1.1 criteria.
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with bladder cancer.
Time frame: Within 6 months of treatment onset
Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with triple negative breast cancer.
Time frame: Within 6 months of treatment onset
Antitumor activity will be assessed in terms of disease control rate within 24 weeks of treatment onset and is defined as the proportion of patients with complete response (CR), partial response (PR) or stable disease (SD) observed within 24 weeks of treatment onset (while treated with the investigational product), based on RECIST 1.1 criteria.
17 secondary outcomes
6-month Progression-free rate (PFR) in patients with pancreatic cancer.
Time frame: 6 months
6-month Progression-free rate (PFR) in patients with virus-associated tumor.
Time frame: 6 months
6-month Progression-free rate (PFR) in patients with non-small cell lung cancer.
Time frame: 6 months
6-month Progression-free rate (PFR) in patients with bladder cancer.
Time frame: 6 months
6-month Progression-free rate (PFR) in patients with triple negative breast cancer.
Time frame: 6 months
6-month objective response rate (ORR) independently for each population.
Time frame: 6 months
Objective response rate (ORR) within 24 weeks of treatment onset, independently for each population.
Time frame: Within 6 months
Best overall response, independently for each population.
Time frame: Throughout the treatment period, an expected average of 6 months
1-year progression-free survival, independently for each population.
Time frame: 1 year
2-year progression-free survival, independently for each population.
Time frame: 2 years
1-year overall survival, independently for each population.
Time frame: 1 year
2-year overall survival, independently for each population.
Time frame: 2 years
Safety profile, independently for each population: Common Terminology Criteria for Adverse Events version 5
Time frame: Throughout the treatment period, an expected average of 6 months
Tumor immune cells levels
Time frame: before treatment onset and cycle 3 day 1 (each cycle is 21 days)
Blood cytokines levels
Time frame: baseline, cycle 1 day 1, cycle 2 day 1, cycle 3 day 1 and progression (each cycle is 21 days)
Blood lymphocytes levels
Time frame: baseline, cycle 1 day 1, cycle 2 day 1, cycle 3 day 1 and progression (each cycle is 21 days)
Blood kynurenine levels
Time frame: baseline, cycle 1 day 1, cycle 2 day 1, cycle 3 day 1 and progression (each cycle is 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Association atezolizumab + BDB001 + RT and Association atezolizumab + BDB001+ RT in people with Solid Tumor, Adult and Pancreatic Cancer, run by Institut Bergonié at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with pancreatic cancer. (time frame: Within 6 months of treatment onset). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.