Actively Recruiting
Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors
Led by Institut Bergonié · Updated on 2025-10-06
247
Participants Needed
11
Research Sites
348 weeks
Total Duration
On this page
Sponsors
I
Institut Bergonié
Lead Sponsor
R
Roche Pharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.
CONDITIONS
Official Title
Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of pancreatic cancer, virus-associated tumors (including papillomavirus-related cancers, Epstein-Barr virus-related cancers, and Kaposi's sarcoma-associated herpes virus), non-small cell lung cancer, soft-tissue sarcoma (confirmed by the RRePS Network as recommended by the French NCI), bladder cancer, or triple negative breast cancer
- Metastatic disease present
- Age 18 years or older
- ECOG performance status of 0 or 1
- At least two lesions: one extracerebral lesion treatable by radiotherapy and one measurable lesion (≥ 10 mm) not treated by radiotherapy
- Life expectancy greater than 6 months
- At least one tumor site eligible for biopsy for research purposes
- Availability of archived paraffin-embedded tumor tissue for research
- Advanced disease with no suitable approved therapeutic regimen offering significant clinical benefit
- For non-small cell lung cancer and bladder cancer patients previously treated with anti-PD-1/L1 therapy: must have had disease progression while on therapy and meet specific treatment and progression criteria
- Adequate hematological, renal, metabolic, and hepatic function
- No prior or concurrent malignant disease requiring active treatment
- At least three weeks since last chemotherapy, immunotherapy, pharmacological treatment, or radiotherapy
- Recovery to grade ≤ 1 from any adverse events related to previous treatments, except alopecia and certain neuropathies
- Negative pregnancy test within 7 days prior to inclusion for women of childbearing potential
- Agreement to use effective contraception during treatment and for 5 months after
- Signed informed consent
- Social security compliant with French law
You will not qualify if you...
- Previous treatment with a TLR agonist
- Progressive or symptomatic central nervous system or leptomeningeal metastases
- Pregnancy or breastfeeding
- Participation in another medical or therapeutic study within the last 30 days
- Known allergy to study drug components or CHO cell products
- History of severe allergic reactions to chimeric, human, or humanized antibodies or fusion proteins
- Use of systemic immunosuppressive medications within 2 weeks prior to inclusion
- Major surgery, open biopsy, or significant trauma within 28 days before inclusion
- Certain cardiac conditions including congestive heart failure NYHA class ≥ 2, unstable angina, recent myocardial infarction, uncontrolled arrhythmias, low left ventricular ejection fraction, or pericardial disorders
- Legal guardianship or deprivation of liberty
- Prior organ or allogeneic stem cell transplantation
- Significant liver disease
- Recent intra-abdominal inflammatory conditions within the last 12 months
- History of autoimmune diseases such as lupus, rheumatoid arthritis, multiple sclerosis, and others
- History or evidence of active pneumonitis or related lung conditions
- Poorly controlled type II diabetes (fasting plasma glucose ≥ 160 mg/dL)
- Severe infections within 2 weeks prior to inclusion
- Use of therapeutic oral or IV antibiotics within 2 weeks prior to inclusion
- Untreated or unstable spinal cord compression
- Live attenuated vaccine administered within 4 weeks before study medication
- Known active hepatitis B or C, HIV/AIDS, or tuberculosis
- Current retinal disorders or inability to replace contact lenses with glasses
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
2
Chu Brest
Brest, France, 29200
Actively Recruiting
3
Centre François Baclesse
Caen, France, 14076
Actively Recruiting
4
Centre Georges François Leclerc
Dijon, France, 21079
Actively Recruiting
5
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
6
Hôpital La Timone
Marseille, France, 13005
Not Yet Recruiting
7
Institut Paoli Calmettes
Marseille, France, 13273
Actively Recruiting
8
Institut Curie
Paris, France, 75005
Not Yet Recruiting
9
CHU Poitiers
Poitiers, France, 86000
Actively Recruiting
10
Centre Eugène Marquis
Rennes, France, 35042
Actively Recruiting
11
IUCT Oncopôle
Toulouse, France, 31052
Actively Recruiting
Research Team
A
Antoine ITALIANO, MD, PhD
CONTACT
S
Simone MATHOULIN-PELISSIER, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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