Spartalizumab and Low-dose PAzopanib in Refractory or Relapsed Solid TumOrs of Pediatric and Adults
NCT ID: NCT05210413
Last Updated: 2026-01-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE1/PHASE2
Total Enrollment
80 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-05-17
Study Completion Date
2027-11-17
Brief Summary
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Immunotherapies have revolutionized medical oncology following the remarkable and, in some cases, unprecedented outcomes observed in certain groups of patients with cancer. However results in adults and mainly in pediatric cancer are still disappointing.
Modulators of angiogenesis, such as VEGF, have a broad range of diverse effects on the immune system and the tumor micro-environment that are mainly immunosuppressive. In patients with early-stage disease, anti-VEGF therapy can lead to antitumor effects by modulating immune mechanisms - provided that therapy is maintained for an adequate length and tumors are sufficiently immunogenic. Nevertheless, blocking angiogenic molecules using a strategy based on a single therapeutic approach is likely insufficient to generate a complete or robust immune response against cancer, especially in patients with advanced-stage disease.
Based on the results of previous studies which evaluated the safety profile of spartalizumab, of pazopanib and the combination of antiangiogenic agents with checkpoint inhibitors, a study combining spartalizumab and low-dose pazopanib in refractory or relapsed solid tumors of pediatric and adults is proposed. This study will include 2 separate cohorts:
* the pediatric cohort will consist of a phase I study (dose-finding and expansion phases) combining pazopanib at a fixed dose of 225 mg/m2 and spartalizumab with four potential candidate doses (2, 3, 4 and 6 mg/kg).
* the adult cohort will consist of a phase II study combining pazopanib at a fixed dose of 400 mg and spartalizumab at the RP2D of 400 mg every 4 weeks.
Modulators of angiogenesis, such as VEGF, have a broad range of diverse effects on the immune system and the tumor micro-environment that are mainly immunosuppressive. In patients with early-stage disease, anti-VEGF therapy can lead to antitumor effects by modulating immune mechanisms - provided that therapy is maintained for an adequate length and tumors are sufficiently immunogenic. Nevertheless, blocking angiogenic molecules using a strategy based on a single therapeutic approach is likely insufficient to generate a complete or robust immune response against cancer, especially in patients with advanced-stage disease.
Based on the results of previous studies which evaluated the safety profile of spartalizumab, of pazopanib and the combination of antiangiogenic agents with checkpoint inhibitors, a study combining spartalizumab and low-dose pazopanib in refractory or relapsed solid tumors of pediatric and adults is proposed. This study will include 2 separate cohorts:
* the pediatric cohort will consist of a phase I study (dose-finding and expansion phases) combining pazopanib at a fixed dose of 225 mg/m2 and spartalizumab with four potential candidate doses (2, 3, 4 and 6 mg/kg).
* the adult cohort will consist of a phase II study combining pazopanib at a fixed dose of 400 mg and spartalizumab at the RP2D of 400 mg every 4 weeks.
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Detailed Description
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Immunotherapies have revolutionized medical oncology following the remarkable and, in some cases, unprecedented outcomes observed in certain groups of patients with cancer. However results in adults and mainly in pediatric cancer are still disappointing. One hypothesis is that the tumor micro-environment (TME) - characterized by hypoxia, a low pH, and a high interstitial fluid pressure - can reduce the effectiveness of virtually all types of anticancer therapies, including immunotherapy. In adults, combination with other therapeutic modalities, including anti-angiogenic agents, is one of the many strategies currently under investigation to improve the response rates and duration of immunotherapies.
Modulators of angiogenesis, such as VEGF, have a broad range of diverse effects on the immune system and the tumor micro-environment that are mainly immunosuppressive. In patients with early-stage disease, anti-VEGF therapy can lead to antitumor effects by modulating immune mechanisms - provided that therapy is maintained for an adequate length and tumors are sufficiently immunogenic. Nevertheless, blocking angiogenic molecules using a strategy based on a single therapeutic approach is likely insufficient to generate a complete or robust immune response against cancer, especially in patients with advanced-stage disease. Therefore, such anti-angiogenic agents will likely need to be used in combination with various immunotherapeutic strategies that boost adaptive immune responses, such as those described in the next sections. For these reasons, the investigators proposed to combine immunotherapy and low dose of pazopanib to enhance the efficacy of immunotherapy in some selected pediatric patients and adults.
PDR001 (also referred to as spartalizumab) is a humanized monoclonal antibody (mAb) directed against human programmed death-1 (PD-1) that blocks the interaction between PD-1 and its ligands (PD-L1 and PD-L2).
Pazopanib is a potent, selective, oral, ATP competitive multitargeted receptor tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, c-kit, and platelet-derived growth factor receptors. It is approved by the US Food and Drug Administration for the treatment of advanced renal cell carcinoma and soft tissue sarcoma (STS) in adults. Based on the results of previous studies which evaluated the safety profile of spartalizumab, of pazopanib and the combination of antiangiogenic agents with checkpoint inhibitors, a study combining spartalizumab and low-dose pazopanib in refractory or relapsed solid tumors of pediatric and adults is proposed. This study will include 2 separate cohorts:
* the pediatric cohort will consist of a phase I study (dose-finding and expansion phases) combining pazopanib at a fixed dose of 225 mg/m2 and spartalizumab with four potential candidate doses (2, 3, 4 and 6 mg/kg).
* the adult cohort will consist of a phase II study combining pazopanib at a fixed dose of 400 mg and spartalizumab at the RP2D of 400 mg every 4 weeks.
Modulators of angiogenesis, such as VEGF, have a broad range of diverse effects on the immune system and the tumor micro-environment that are mainly immunosuppressive. In patients with early-stage disease, anti-VEGF therapy can lead to antitumor effects by modulating immune mechanisms - provided that therapy is maintained for an adequate length and tumors are sufficiently immunogenic. Nevertheless, blocking angiogenic molecules using a strategy based on a single therapeutic approach is likely insufficient to generate a complete or robust immune response against cancer, especially in patients with advanced-stage disease. Therefore, such anti-angiogenic agents will likely need to be used in combination with various immunotherapeutic strategies that boost adaptive immune responses, such as those described in the next sections. For these reasons, the investigators proposed to combine immunotherapy and low dose of pazopanib to enhance the efficacy of immunotherapy in some selected pediatric patients and adults.
PDR001 (also referred to as spartalizumab) is a humanized monoclonal antibody (mAb) directed against human programmed death-1 (PD-1) that blocks the interaction between PD-1 and its ligands (PD-L1 and PD-L2).
Pazopanib is a potent, selective, oral, ATP competitive multitargeted receptor tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, c-kit, and platelet-derived growth factor receptors. It is approved by the US Food and Drug Administration for the treatment of advanced renal cell carcinoma and soft tissue sarcoma (STS) in adults. Based on the results of previous studies which evaluated the safety profile of spartalizumab, of pazopanib and the combination of antiangiogenic agents with checkpoint inhibitors, a study combining spartalizumab and low-dose pazopanib in refractory or relapsed solid tumors of pediatric and adults is proposed. This study will include 2 separate cohorts:
* the pediatric cohort will consist of a phase I study (dose-finding and expansion phases) combining pazopanib at a fixed dose of 225 mg/m2 and spartalizumab with four potential candidate doses (2, 3, 4 and 6 mg/kg).
* the adult cohort will consist of a phase II study combining pazopanib at a fixed dose of 400 mg and spartalizumab at the RP2D of 400 mg every 4 weeks.
Conditions
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Refractory or Recurrent Solid Tumor
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Pediatric cohort:
Multicentre, open-label, non-randomized, phase I clinical study, with dose-finding and expansion phases.
Adult cohort:
Multicenter phase II single-arm open-label clinical trial, with a pre-screening phase to identify patients with mature tertiary lymphoid structure (TLS).
Multicentre, open-label, non-randomized, phase I clinical study, with dose-finding and expansion phases.
Adult cohort:
Multicenter phase II single-arm open-label clinical trial, with a pre-screening phase to identify patients with mature tertiary lymphoid structure (TLS).
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Pediatric cohort
Multicentre, open-label, non-randomized, phase I clinical study, with dose-finding and expansion phases.
Group Type
EXPERIMENTAL
Spartalizumab in Pediatric cohort
Intervention Type
DRUG
Infusion of spartalizumab at four dose escalation levels: 2, 3, 4 and 6 mg/kg in successive cohorts of 3 patients, depending on the number of patients with dose-limiting toxicity (DLT) to maximum tolerated dose (MTD).
Low-dose Pazopanib in Pediatric Cohort
Intervention Type
DRUG
Oral pazopanib treatment at a fixed dose of 225mg/m²/day
Adult cohort
Multicenter phase II single-arm open-label clinical trial, with a pre-screening phase to identify patients with mature tertiary lymphoid structure (TLS).
Group Type
EXPERIMENTAL
Spartalizumab in Adult cohort
Intervention Type
DRUG
Infusion of 400 mg of spartalizumab on Day1 of each cycle.
Low-dose Pazopanib in Adult Cohort
Intervention Type
DRUG
Oral pazopanib treatment with a fixed dose of 400 mg/day
Interventions
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Spartalizumab in Pediatric cohort
Infusion of spartalizumab at four dose escalation levels: 2, 3, 4 and 6 mg/kg in successive cohorts of 3 patients, depending on the number of patients with dose-limiting toxicity (DLT) to maximum tolerated dose (MTD).
Intervention Type
DRUG
Low-dose Pazopanib in Pediatric Cohort
Oral pazopanib treatment at a fixed dose of 225mg/m²/day
Intervention Type
DRUG
Spartalizumab in Adult cohort
Infusion of 400 mg of spartalizumab on Day1 of each cycle.
Intervention Type
DRUG
Low-dose Pazopanib in Adult Cohort
Oral pazopanib treatment with a fixed dose of 400 mg/day
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. For pediatric patients (Cohort 1):
1. Patients should be without standard established therapeutic alternatives at the time of enrollment suffering from the following conditions :
* refractory or recurrent solid tumor, proven histologically,
* any tumor with high mutational load (\> 10 somatic mutations/ Mo) or a high MSI status,
* tumor, whatever the histology, with proven PDL1 expression (≥1%) or presence of mature tertiary lymphoid structure (TLS).
2. Age ≥5 and \<18 years at inclusion, patients 18 years and older may be included after discussion with the Sponsor if they have a pediatric recurrent/refacractory malignancy.
3. Performance status: Karnofsky performance status (for patients \>16 years of age) or Lansky Play score (for patients ≤16 years of age) ≥70%. Patients who are unable to walk because of paralysis or stable neurological disability, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
4. Able to swallow tablets.
5. Evaluable or measurable disease as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1…).
6. Life expectancy ≥ 3 months.
7. Adequate organ function:
* Hematologic criteria :peripheral absolute neutrophil count (ANC) ≥1000/μL (unsupported), platelet count ≥100,000/μL (unsupported), hemoglobin ≥8.0 g/dL (transfusion is allowed)
* Cardiac function: shortening fraction (SF) \>29% (\>35% for children \<3 years) and left ventricular ejection fraction (LVEF) ≥50% at baseline, as determined by echocardiography (mandatory only for patients who have received cardiotoxic therapy), absence of QTc prolongation (QTc \>450 msec on baseline ECG, using the Fridericia correction \[QTcF formula\]) or other clinically significant ventricular or atrial arrhythmia.
* Renal and hepatic function: serum creatinine ≤1.5 x upper limit of normal (ULN) for age, total bilirubin ≤1.5 x ULN, alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 x ULN; aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase/SGOT ≤ 2.5 x ULN except in patients with documented tumor involvement of the liver who must have AST/SGOT and ALT/SGPT ≤ 5 x ULN.
8. Able to comply with scheduled follow-up and with management of toxicity.
9. Females of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 72 hours prior to initiation of treatment. Sexually active women of childbearing potential must agree to use a highly effective contraception during the study and for at least 6 months after the last study treatment administration. Sexually active male patients must agree to use condoms during the study and for at least 6 months after the last study treatment administration.
10. Written informed consent from parents/legal representative and age-appropriate assent before any study-specific screening procedures are conducted according to local, regional or national guidelines.
11. Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
2. For adults patients:
* Pre-screening phase:
1. adults (≥ 18 years old) with refractory or recurrent solid tumor (include rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma and other) and/or tumor with High mutation rate (\>10 somatic mutations/Mb) and/or suffering of Mismatch repair-deficient syndrome.
2. Adult patients with an ECOG score of 0/1. Patients who are unable to walk because of paralysis or stable neurological disability, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
3. Evaluable or measurable disease as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1…).
4. Written informed consent from patient before any study-specific screening procedures are conducted according to local, regional or national guidelines.
* Screening phase (Cohort 2):
1. adults without standard established therapeutic alternatives at the time of enrollment suffering from refractory or recurrent advanced solid tumor characterized by the presence of mature TLS
2. Age ≥ 18 years at inclusion
3. Adult patients with an ECOG score of 0/1. Patients who are unable to walk because of paralysis or stable neurological disability, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
4. Evaluable or measurable disease as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1…).
5. Life expectancy ≥ 3 months
6. Adequate organ function:
* Hematologic criteria :peripheral absolute neutrophil count (ANC) ≥1000/μL (unsupported), platelet count ≥100,000/μL (unsupported), hemoglobin ≥8.0 g/dL (transfusion is allowed)
* Cardiac function: shortening fraction (SF) \>29% and left ventricular ejection fraction (LVEF) ≥50% at baseline, as determined by echocardiography (mandatory only for patients who have received cardiotoxic therapy), absence of QTc prolongation (QTc \>450 msec on baseline ECG, using the Fridericia correction \[QTcF formula\]) or other clinically significant ventricular or atrial arrhythmia.
* Renal and hepatic function: serum creatinine ≤1.5 x upper limit of normal (ULN) for age, total bilirubin ≤1.5 x ULN, alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 x ULN; aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase/SGOT ≤ 2.5 x ULN except in patients with documented tumor involvement of the liver who must have AST/SGOT and ALT/SGPT ≤5 x ULN.
g. Able to comply with scheduled follow-up and with management of toxicity. h. Females of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 72 hours prior to initiation of treatment. Sexually active women of childbearing potential must agree to use a highly effective contraception during the study and for at least 6 months after the last study treatment administration. Sexually active male patients must agree to use condoms during the study and for at least 6 months after the last study treatment administration.
i. Written informed consent from patient before any study-specific screening procedures are conducted according to local, regional or national guidelines.
j. Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
1. Patients should be without standard established therapeutic alternatives at the time of enrollment suffering from the following conditions :
* refractory or recurrent solid tumor, proven histologically,
* any tumor with high mutational load (\> 10 somatic mutations/ Mo) or a high MSI status,
* tumor, whatever the histology, with proven PDL1 expression (≥1%) or presence of mature tertiary lymphoid structure (TLS).
2. Age ≥5 and \<18 years at inclusion, patients 18 years and older may be included after discussion with the Sponsor if they have a pediatric recurrent/refacractory malignancy.
3. Performance status: Karnofsky performance status (for patients \>16 years of age) or Lansky Play score (for patients ≤16 years of age) ≥70%. Patients who are unable to walk because of paralysis or stable neurological disability, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
4. Able to swallow tablets.
5. Evaluable or measurable disease as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1…).
6. Life expectancy ≥ 3 months.
7. Adequate organ function:
* Hematologic criteria :peripheral absolute neutrophil count (ANC) ≥1000/μL (unsupported), platelet count ≥100,000/μL (unsupported), hemoglobin ≥8.0 g/dL (transfusion is allowed)
* Cardiac function: shortening fraction (SF) \>29% (\>35% for children \<3 years) and left ventricular ejection fraction (LVEF) ≥50% at baseline, as determined by echocardiography (mandatory only for patients who have received cardiotoxic therapy), absence of QTc prolongation (QTc \>450 msec on baseline ECG, using the Fridericia correction \[QTcF formula\]) or other clinically significant ventricular or atrial arrhythmia.
* Renal and hepatic function: serum creatinine ≤1.5 x upper limit of normal (ULN) for age, total bilirubin ≤1.5 x ULN, alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 x ULN; aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase/SGOT ≤ 2.5 x ULN except in patients with documented tumor involvement of the liver who must have AST/SGOT and ALT/SGPT ≤ 5 x ULN.
8. Able to comply with scheduled follow-up and with management of toxicity.
9. Females of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 72 hours prior to initiation of treatment. Sexually active women of childbearing potential must agree to use a highly effective contraception during the study and for at least 6 months after the last study treatment administration. Sexually active male patients must agree to use condoms during the study and for at least 6 months after the last study treatment administration.
10. Written informed consent from parents/legal representative and age-appropriate assent before any study-specific screening procedures are conducted according to local, regional or national guidelines.
11. Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
2. For adults patients:
* Pre-screening phase:
1. adults (≥ 18 years old) with refractory or recurrent solid tumor (include rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma and other) and/or tumor with High mutation rate (\>10 somatic mutations/Mb) and/or suffering of Mismatch repair-deficient syndrome.
2. Adult patients with an ECOG score of 0/1. Patients who are unable to walk because of paralysis or stable neurological disability, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
3. Evaluable or measurable disease as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1…).
4. Written informed consent from patient before any study-specific screening procedures are conducted according to local, regional or national guidelines.
* Screening phase (Cohort 2):
1. adults without standard established therapeutic alternatives at the time of enrollment suffering from refractory or recurrent advanced solid tumor characterized by the presence of mature TLS
2. Age ≥ 18 years at inclusion
3. Adult patients with an ECOG score of 0/1. Patients who are unable to walk because of paralysis or stable neurological disability, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
4. Evaluable or measurable disease as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1…).
5. Life expectancy ≥ 3 months
6. Adequate organ function:
* Hematologic criteria :peripheral absolute neutrophil count (ANC) ≥1000/μL (unsupported), platelet count ≥100,000/μL (unsupported), hemoglobin ≥8.0 g/dL (transfusion is allowed)
* Cardiac function: shortening fraction (SF) \>29% and left ventricular ejection fraction (LVEF) ≥50% at baseline, as determined by echocardiography (mandatory only for patients who have received cardiotoxic therapy), absence of QTc prolongation (QTc \>450 msec on baseline ECG, using the Fridericia correction \[QTcF formula\]) or other clinically significant ventricular or atrial arrhythmia.
* Renal and hepatic function: serum creatinine ≤1.5 x upper limit of normal (ULN) for age, total bilirubin ≤1.5 x ULN, alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 x ULN; aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase/SGOT ≤ 2.5 x ULN except in patients with documented tumor involvement of the liver who must have AST/SGOT and ALT/SGPT ≤5 x ULN.
g. Able to comply with scheduled follow-up and with management of toxicity. h. Females of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 72 hours prior to initiation of treatment. Sexually active women of childbearing potential must agree to use a highly effective contraception during the study and for at least 6 months after the last study treatment administration. Sexually active male patients must agree to use condoms during the study and for at least 6 months after the last study treatment administration.
i. Written informed consent from patient before any study-specific screening procedures are conducted according to local, regional or national guidelines.
j. Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
Exclusion Criteria
For pediatric and adult patients (Cohorts 1 and 2):
1. Patients treated with anti-PD1 immunotherapy within 6 months prior to starting study treatment; patients treated with anti-PD1 for more than 6 months remain eligible for inclusion, provided that this treatment has brought the patient clinical benefit (objective response or stable disease \> 4 months).
2. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea or malabsorption syndrome).
3. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmia, e.g. ventricular, supraventricular, nodal arrhythmias, or conduction abnormality), unstable ischemia, congestive heart failure within 12 months of screening).
4. Uncontrolled hypertension
5. Active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
6. Presence of any ≥ CTCAE grade 2 treatment-related toxicity with the exception of alopecia, ototoxicity or peripheral neuropathy.
7. Systemic anticancer therapy within 21 days of the first study dose or 5 times its half-life, whichever is less.
8. Previous myeloablative therapy with autologous hematopoietic stem cell rescue within 8 weeks of the first study drug dose
9. Allogeneic stem cell transplant within 3 months prior to the first study drug dose. Patients receiving any agent to treat or prevent graft-versus host disease (GVHD) post bone marrow transplant are not eligible for this trial.
10. Radiotherapy (non-palliative) within 21 days prior to the first dose of drug (or within 6 weeks for therapeutic doses of MIBG)
11. Major surgery within 21 days of the first dose. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48-hour interval must be maintained before the first dose of the investigational drug is administered.
12. Currently taking medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes
13. High dose chemotherapy followed by peripheral stem cell transplantation within less than 6 months.
14. Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study treatment. The use of physiologic doses of corticosteroids (up to 0.25 mg/kg daily prednisone equivalent) may be approved after consultation with the Sponsor.
15. Diagnosis of prior or active autoimmune disease.
16. Evidence of interstitial lung disease.
17. Unable to taper steroids due to ongoing mass effect; a maximum dexamethasone dose of 0.05 mg/kg/day is allowed, but preferably have been discontinued.
18. Known hypersensitivity to any study drug or component of the formulation.
19. Persons referred to in Articles L. 1121-5, L. 1121-6, L. 1121-8 and L. 11221-1-2 of the Public Health Code (pregnant women, parturient and nursing mothers; persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent and persons admitted to a health or social establishment for purposes other than that of research; adults subject to a legal protection measure or incapacitated express consent; people in emergency situations who cannot give prior consent)
20. Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug.
1. Patients treated with anti-PD1 immunotherapy within 6 months prior to starting study treatment; patients treated with anti-PD1 for more than 6 months remain eligible for inclusion, provided that this treatment has brought the patient clinical benefit (objective response or stable disease \> 4 months).
2. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea or malabsorption syndrome).
3. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmia, e.g. ventricular, supraventricular, nodal arrhythmias, or conduction abnormality), unstable ischemia, congestive heart failure within 12 months of screening).
4. Uncontrolled hypertension
5. Active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
6. Presence of any ≥ CTCAE grade 2 treatment-related toxicity with the exception of alopecia, ototoxicity or peripheral neuropathy.
7. Systemic anticancer therapy within 21 days of the first study dose or 5 times its half-life, whichever is less.
8. Previous myeloablative therapy with autologous hematopoietic stem cell rescue within 8 weeks of the first study drug dose
9. Allogeneic stem cell transplant within 3 months prior to the first study drug dose. Patients receiving any agent to treat or prevent graft-versus host disease (GVHD) post bone marrow transplant are not eligible for this trial.
10. Radiotherapy (non-palliative) within 21 days prior to the first dose of drug (or within 6 weeks for therapeutic doses of MIBG)
11. Major surgery within 21 days of the first dose. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48-hour interval must be maintained before the first dose of the investigational drug is administered.
12. Currently taking medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes
13. High dose chemotherapy followed by peripheral stem cell transplantation within less than 6 months.
14. Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study treatment. The use of physiologic doses of corticosteroids (up to 0.25 mg/kg daily prednisone equivalent) may be approved after consultation with the Sponsor.
15. Diagnosis of prior or active autoimmune disease.
16. Evidence of interstitial lung disease.
17. Unable to taper steroids due to ongoing mass effect; a maximum dexamethasone dose of 0.05 mg/kg/day is allowed, but preferably have been discontinued.
18. Known hypersensitivity to any study drug or component of the formulation.
19. Persons referred to in Articles L. 1121-5, L. 1121-6, L. 1121-8 and L. 11221-1-2 of the Public Health Code (pregnant women, parturient and nursing mothers; persons deprived of their liberty by a judicial or administrative decision, persons hospitalized without consent and persons admitted to a health or social establishment for purposes other than that of research; adults subject to a legal protection measure or incapacitated express consent; people in emergency situations who cannot give prior consent)
20. Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug.
Minimum Eligible Age
5 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Sponsor Role
collaborator
Fondation ARC
OTHER
Sponsor Role
collaborator
Novartis
INDUSTRY
Sponsor Role
collaborator
University Hospital, Bordeaux
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Stéphane DUCASSOU, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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CHU d'Angers - Unité d'Hématologie et d'Oncologie pédiatrique
Angers, , France
Site Status
CHU de Bordeaux - Unité d'Hématologie et d'Oncologie pédiatrique
Bordeaux, , France
Site Status
Institut Bergonié - Oncologie Médicale
Bordeaux, , France
Site Status
Centre Oscar Lambret - Oncologie pédiatrie
Lille, , France
Site Status
Oscar Lambret Center
Lille, , France
Site Status
Centre Léon Bérard - Oncologie Médicale
Lyon, , France
Site Status
Institut d'Hématologie et d'Oncologie Pédiatrique (IHOP) - Oncologie pédiatrique
Lyon, , France
Site Status
APHM Hôpital des Enfants La Timone - Hématologie Oncologie Pédiatrique
Marseille, , France
Site Status
Nantes University Hospital
Nantes, , France
Site Status
Institut Curie - Centre D'Oncologie SIREDO
Paris, , France
Site Status
Curie Institute
Paris, , France
Site Status
Strasbourg University Hospital
Strasbourg, , France
Site Status
Gustave Roussy - Oncologie pédiatrique
Villejuif, , France
Site Status
Countries
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France
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHUBX 2020/31
Identifier Type: -
Identifier Source: org_study_id
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