Halted Phase I and Phase II (Integrated)- Other Refractory or Recurrent Solid Tumor

Spartalizumab and low-dose PAzopanib in Refractory or Relapsed solid TumOrs of pediatric and adults SPARTO

EU CTIS ID: 2024-513535-24-00

What this study is testing

To identify the recommended dose for phase II study (RP2D) of spartalizumab in association with a fixed dose of pazopanib in the pediatric cohort To estimate the efficacy of the combination of spartlizumab and pazopanib on the 6-month disease control rate in the adult cohort

Phase I and Phase II (Integrated)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

For pediatric patients, 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 - a Mismatch repair-deficient syndrome. - tumor, whatever the histology, with proven PDL1 expression (≥1%) or presence of mature tertiary lymphoid structure (TLS).
For adults patients: - Pre-screening phase: adults (≥ 18 years old) with 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.
For adults patients: - Pre-screening phase: 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.
For adults patients: - Pre-screening phase: Evaluable or measurable disease as defined by standard imaging criteria for the patient’s tumor type (RECIST v1.1…).
For adults patients: - Pre-screening phase: Written informed consent from patient before any study-specific screening procedures are conducted according to local, regional or national guidelines.
For adults patients : - Screening phase (Cohort 2): 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

You likely can't join if

Patients treated with anti-PD1/anti-PDL1 immunotherapy within 6 months prior to starting study treatment; patients treated with anti-PD1/anti-PDL1 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).
Radiotherapy (non-palliative) within 21 days prior to the first dose of drug (or within 6 weeks for therapeutic doses of MIBG)
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.
Currently taking medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes
High dose chemotherapy followed by peripheral stem cell transplantation within less than 6 months.
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.

See the full eligibility criteria

Who can join

For pediatric patients, 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 - a Mismatch repair-deficient syndrome. - tumor, whatever the histology, with proven PDL1 expression (≥1%) or presence of mature tertiary lymphoid structure (TLS).
For adults patients: - Pre-screening phase: adults (≥ 18 years old) with 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.
For adults patients: - Pre-screening phase: 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.
For adults patients: - Pre-screening phase: Evaluable or measurable disease as defined by standard imaging criteria for the patient’s tumor type (RECIST v1.1…).
For adults patients: - Pre-screening phase: Written informed consent from patient before any study-specific screening procedures are conducted according to local, regional or national guidelines.
For adults patients : - Screening phase (Cohort 2): 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
For adults patients : - Screening phase (Cohort 2): Age ≥ 18 years at inclusion
For adults patients : - Screening phase (Cohort 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.
For adults patients : - Screening phase (Cohort 2): Evaluable or measurable disease as defined by standard imaging criteria for the patient’s tumor type (RECIST v1.1…).
For adults patients : - Screening phase (Cohort 2): Life expectancy ≥ 3 months
For adults patients : - Screening phase (Cohort 2): 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.
For pediatric patients, 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.
For adults patients : - Screening phase (Cohort 2): Able to comply with scheduled follow-up and with management of toxicity.
For adults patients : - Screening phase (Cohort 2): 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.
For adults patients : - Screening phase (Cohort 2): Written informed consent from patient before any study-specific screening procedures are conducted according to local, regional or national guidelines.
For adults patients : - Screening phase (Cohort 2): Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.
For pediatric patients, 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.
For pediatric patients, able to swallow tablets.
For pediatric patients, evaluable or measurable disease as defined by standard imaging criteria for the patient’s tumor type (RECIST v1.1…).
For pediatric patients, life expectancy ≥ 3 months.
For pediatric patients, 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.
For pediatric patients, 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.
For pediatric patients, Patient affiliated to a social security regimen or beneficiary of the same according to local requirements.

What rules you out

Patients treated with anti-PD1/anti-PDL1 immunotherapy within 6 months prior to starting study treatment; patients treated with anti-PD1/anti-PDL1 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).
Radiotherapy (non-palliative) within 21 days prior to the first dose of drug (or within 6 weeks for therapeutic doses of MIBG)
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.
Currently taking medications with a known risk of prolonging the QT interval or inducing Torsades de Pointes
High dose chemotherapy followed by peripheral stem cell transplantation within less than 6 months.
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.
Diagnosis of prior or active autoimmune disease.
Evidence of interstitial lung disease.
Unable to type steroids due to ongoing mass effect; a maximum dexamethasone dose of 0.05 mg/kg/day is allowed, but preferably have been discontinued.
Known hypersensitivity to any study drug or component of the formulation.
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)
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).
Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug.
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).
Uncontrolled hypertension
Active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
Presence of any ≥ CTCAE grade 2 treatment-related toxicity with the exception of alopecia, ototoxicity or peripheral neuropathy.
Systemic anticancer therapy within 21 days of the first study dose or 5 times its half-life, whichever is less.
Previous myeloablative therapy with autologous hematopoietic stem cell rescue within 8 weeks of the first study drug dose
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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.