Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors
- Conditions
- Solid Tumor, AdultMelanomaBladder CancerPancreatic CancerVirus-associated TumorsTriple Negative Breast CancerNon Small Cell Lung Cancer
- Interventions
- Drug: Association atezolizumab + BDB001+ RTDrug: Association atezolizumab + BDB001 + RT
- Registration Number
- NCT03915678
- Lead Sponsor
- Institut BergoniƩ
- Brief Summary
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 247
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Population 3: anti-PD-1/L1 refractory non-small lung cancer Association atezolizumab + BDB001+ RT Participants with anti-PD-1/L1 refractory non-small lung cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy. Population 6: Triple negative breast cancer Association atezolizumab + BDB001 + RT Participants with triple negative breast cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy. Population 1: Pancreatic cancer Association atezolizumab + BDB001 + RT Participants with pancreatic cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy. Population 2: Virus-associated tumors Association atezolizumab + BDB001+ RT Participants with virus-associated tumors will be treated with Atezolizumab combined with BDB001 and radiotherapy. Population 4: Soft-tissue sarcoma Association atezolizumab + BDB001 + RT Participants with soft-tissue sarcoma will be treated with Atezolizumab combined with BDB001 and radiotherapy. Population 5: anti-PD-1/L1 refractory bladder cancer Association atezolizumab + BDB001 + RT Participants with anti-PD-1/L1 refractory bladder cancer will be treated with Atezolizumab combined with BDB001 and radiotherapy.
- Primary Outcome Measures
Name Time Method Assessment of the antitumor activity of atezolizumab combined with BDB001 and radiotherapy in patients with pancreatic cancer. 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. 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. 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 virus associated tumors. 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. 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 bladder cancer. 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.
- Secondary Outcome Measures
Name Time Method 6-month objective response rate (ORR) independently for each population. 6 months 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.
6-month Progression-free rate (PFR) in patients with virus-associated tumor. 6 months 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.
6-month Progression-free rate (PFR) in patients with bladder cancer. 6 months 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.
6-month Progression-free rate (PFR) in patients with triple negative breast cancer. 6 months 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.
1-year progression-free survival, independently for each population. 1 year 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.
Safety profile, independently for each population: Common Terminology Criteria for Adverse Events version 5 Throughout the treatment period, an expected average of 6 months Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.
Tumor immune cells levels before treatment onset and cycle 3 day 1 (each cycle is 21 days) Levels of immune cells in tumor will be measured by immunohistochemistry.
6-month Progression-free rate (PFR) in patients with pancreatic cancer. 6 months 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.
6-month Progression-free rate (PFR) in patients with non-small cell lung cancer. 6 months 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.
Blood cytokines levels baseline, cycle 1 day 1, cycle 2 day 1, cycle 3 day 1 and progression (each cycle is 21 days) Levels of cytokines in blood will be measured by ELISA.
Blood kynurenine levels baseline, cycle 1 day 1, cycle 2 day 1, cycle 3 day 1 and progression (each cycle is 21 days) Levels of kynurenine in blood will be measured by ELISA.
Objective response rate (ORR) within 24 weeks of treatment onset, independently for each population. Within 6 months 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.
Best overall response, independently for each population. Throughout the treatment period, an expected average of 6 months 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).
2-year progression-free survival, independently for each population. 2 years 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.
2-year overall survival, independently for each population. 2 years Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).
1-year overall survival, independently for each population. 1 year Overall survival is defined as the delay between the start date of treatment and the date of death (of any cause).
Blood lymphocytes levels baseline, cycle 1 day 1, cycle 2 day 1, cycle 3 day 1 and progression (each cycle is 21 days) Levels of lymphocytes in blood will be measured by flow cytometry.
Trial Locations
- Locations (11)
Chu Brest
š«š·Brest, France
IUCT OncopƓle
š«š·Toulouse, France
Institut BergoniƩ
š«š·Bordeaux, France
Centre FranƧois Baclesse
š«š·Caen, France
Centre Oscar Lambret
š«š·Lille Cedex, France
Centre Georges FranƧois Leclerc
š«š·Dijon, France
HĆ“pital La Timone
š«š·Marseille, France
Institut Paoli Calmettes
š«š·Marseille, France
Institut Curie
š«š·Paris, France
CHU Poitiers
š«š·Poitiers, France
Centre EugĆØne Marquis
š«š·Rennes, France