NeuroblastomaPhase 1NCT05429502
Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors
A Phase 1 study testing Topotecan, Temozolomide and Ribociclib in people with Neuroblastoma, run by Novartis Pharmaceuticals at 6 sites in 4 countries.
Trial summary
This is a Phase I/II study to assess the efficacy and safety of ribociclib in combination with topotecan and temozolomide (TOTEM) in pediatric patients with relapsed or refractory (r/r) neuroblastoma (NB), and other solid tumors, including medulloblastoma (MB), high-grade glioma (HGG), malignant rhabdoid tumors (MRT)… Read more about this study
- Who is it for?
- Ages 12 months to 21 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- Topotecan, Temozolomide and Ribociclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 27 Dec 2022to 26 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 12 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants and/or guardian have the ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 12 months and ≤ 21 years at the time of signing consent form Note: The first dose level of Phase I - part A (dose finding) will enroll participants ≥ 12 years - 21 years old, and may expand to younger participants (≥ 12 months to < 12 years) as determined by the data.
- Histologically or cytologically confirmed solid tumors listed below that have progressed despite standard therapy or for which no effective standard therapy exists.
- Neuroblastoma (for Phase I and Phase II): Histologically proven neuroblastoma as per International Neuroblastoma Staging System (INSS); Relapsed or refractory disease; Measurable disease per International Neuroblastoma Response criteria (INRC); Bone marrow only disease not eligible; Available MYCN status before screening
- Medulloblastoma (for Phase I) regardless of genetic status (i.e. Groups 3 or 4 WNT-activated or non-WNT, SHH-activated or non-SHH)
- High-grade glioma (for Phase I): including HGG NOS, WHO Grade III or Grade IV; Glioblastoma, IDH-wildtype or IDH-mutant; Anaplastic astrocytoma, IDH-mutant; Anaplastic oligodendroglioma, IDH-mutant; Anaplastic pleomorphic xanthoastrocytoma; Diffuse midline gliomas, H3 K27-altered; Diffuse hemispheric glioma, H3 G34-mutant; Diffuse pediatric-type HGG, H3-wildtype and IDH-wildtype.
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- Malignant rhabdoid tumor (for Phase I) includes diagnoses of atypical teratoid/rhabdoid tumor (AT/RT), and rhabdoid tumor of the kidney (RTK), and other soft tissues as defined by 2 of the 3 following criteria; either (1)+(2) or (1)+(3): (1) Morphology and immunophenotypic panel consistent with rhabdoid tumor; (2) Loss of SMARCB1 confirmed by immunohistochemistry; (3) Molecular confirmation of tumor-specific bi-allelic SMARCB1 loss/mutation is encouraged in cases where SMARCB1 immunohistochemistry is equivocal, and required if SMARCB1 immunohistochemistry is not available
- Rhabdomyosarcoma (for Phase I) independent of fusion status and subtype
- Participants with CNS disease who are on corticosteroids should take stable doses for at least 7 days prior to first dose of ribociclib with no plans for escalation.
- Performance status:
- ≤ 16 years: Lansky Play score ≥ 50%
- >16 years: Karnofsky performance status ≥ 50% or ECOG < 3
- Life expectancy of ≥ 12 weeks at the time of enrollment
- Adequate bone marrow function (bone marrow may be involved with tumor) and organ function
- Adequate hepatic, renal, cardiac function
- Females who are sexually active must agree to use highly effective contraception during and for 6 months after treatment. Additionally, females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study medication. Pregnant or lactating females are not eligible for the study.
- Sexually active males (including those that have had a vasectomy), who do not agree to abstinence, must be willing to use a condom during intercourse while on study treatment and for 6 months after stopping treatment.
Who cannot join
- Known hypersensitivity to any of the excipients of ribociclib or topotecan or temozolomide.
- Not recovered from clinical and laboratory acute toxicities related to prior anti-cancer therapies
- Concurrent severe and/or uncontrolled concurrent medical conditions (serious infections or significant cardiac, pulmonary, hepatic, psychiatric, GI disease, or other organ dysfunction) that in the investigator's judgement could compromise their ability to tolerate or absorb protocol therapy or would interfere with the study procedures or results
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
- History of QTc prolongation; taking medications with a known risk to prolong the QT interval hat cannot be discontinued or replaced by safe alternative medication
- Currently taking medications that are mainly metabolized by CYP3A4/5 with a narrow therapeutic index, strong inducers or inhibitors of CYP3A4/5, herbal preparations/medications and dietary supplements
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- Vaccinated with live, attenuated vaccines within 4 weeks
- Participated in a prior investigational study within 30 days
- Received prior treatment with a CDK4/6 inhibitor
- Received last dose of anticancer therapy (including experimental) within 4 weeks
- Previous myeloablative therapy with autologous hematopoietic stem cell rescue within 8 weeks
- Allogeneic stem cell transplant within 3 months
- Has last fraction of radiation within 4 weeks
- Major surgery within 2 weeks
- Pregnant or nursing (breast feeding) female participant or female participant who plans to become pregnant or breast-feed during the trial.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States3 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
St Jude s Childrens Research Hospital
Memphis, Tennessee, 38105-2794
Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
United Kingdom1 site
Novartis Investigative Site
Sutton, Surrey, SM2 5PT
About this study
Official title: Phase I/II Multicenter Study to Assess Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors
This is a Phase I/II study to assess the efficacy and safety of ribociclib in combination with topotecan and temozolomide (TOTEM) in pediatric patients with relapsed or refractory (r/r) neuroblastoma (NB), and other solid tumors, including medulloblastoma (MB), high-grade glioma (HGG), malignant rhabdoid tumors (MRT), and rhabdomyosarcoma (RMS).
Read the detailed description
The study is structured into two parts: Phase I - Part A (dose finding) and Phase I - Part B (multiple expansion cohorts). Phase II may commence following the evaluation of Phase I data, which includes safety, tolerability, efficacy, pharmacokinetics, and biomarker data. Additionally, other emerging data that could influence the treatment landscape will be considered before initiating Phase II in patients with relapsed or refractory neuroblastoma (NB) and/or other tumors studied in Phase I.
- Phase I - Part A (dose finding): This phase aims to determine the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) of ribociclib in combination with TOTEM.
Due to the early termination of the trial, Phase I - Part B (multiple expansion cohorts) and Phase II (double-blind, randomized, placebo-controlled in relapsed or refractory NB) were not initiated.
- Conditions
- Neuroblastoma
- Being tested
- Topotecan, Temozolomide, Ribociclib
- Keywords
- neuroblastoma, medulloblastoma, high-grade glioma, malignant rhabdoid tumors, rhabdomyosarcoma, relapsed, refractory, pediatric
- Medical subject headings
- Neuroblastoma, Medulloblastoma, Glioma, Rhabdomyosarcoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopotecanDrug
Also called Hycamtin
Starting out dose of topotecan administered at standard dose given to neuroblastoma patients (0.75 mg/m2/day).
TemozolomideDrug
Also called Temodar
Starting out dose of temozolomide for cohort A1 and A2 for Phase 1-Part A: 150mg/m2/day. Starting out dose for subsequent cohorts, Cohort A3 and onwards, in Phase 1-Part A will initiate at 100mg/m2/day.
RibociclibDrug
Also called Kisqali, LEE011
Starting out dose of ribociclib for cohort A1 Phase 1-Part A: 200mg/m2/day. Starting out dose for Cohort A2 and A3 was 100mg/m2/day.
| Study group | Role | What they receive |
|---|---|---|
| Phase I-part A: Ribociclib + Topotecan and Temozolomide | Experimental | Participants with r/r NB, MB, HGG, MRT or RMS will be treated with ribociclib in combination with topotecan and temozolomide to determine MTD and/or RP2D. Ribociclib dose will be escalated with topotecan and temozolomide. Receives: Drug: Topotecan; Drug: Temozolomide; Drug: Ribociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1- Part A: Percentage of participants with Dose Limiting Toxicities (DLTs) in Cycle 1
Percentage of participants with DLTs during first cycle of treatment (each cycle is 28 days) for each dose level associated with administration of ribociclib in combination with topotecan and temozolomide.
A DLT is defined as an adverse event or abnormal laboratory value suspected to be related with study treatment.
Measured: Up to 28 days
Secondary outcomes (5)
Plasma concentrations of ribociclib (Phase I-Part A)
Pharmacokinetic (PK) blood samples will be collected at selected time-points to determine ribociclib plasma concentrations from participants in Phase I-Part A, Phase I-Part B and Phase II
Measured: Cycle 1 day 1 and 15; Cycle 2 Day 15. Cycle=28 days
Area under the plasma concentration-time curve (AUC) of ribociclib (Phase I-Part A)
PK blood samples will be collected at selected time-points to determine AUC of ribociclib from participants in Phase I-Part A, Phase I-Part B and Phase II
Measured: Cycle 1 day 1 and 15; Cycle 2 Day 15. Cycle=28 days
Maximum plasma concentration (Cmax) of ribociclib (Phase I-Part A)
PK blood samples will be collected at selected time-points to determine Cmax of ribociclib from participants in Phase I-Part A, Phase I-Part B and Phase II
Measured: Cycle 1 day 1 and 15; Cycle 2 Day 15. Cycle=28 days
Time of maximum plasma concentration (Tmax) of ribociclib (Phase I-Part A)
PK blood samples will be collected at selected time-points to determine Cmax of ribociclib from participants in Phase I-Part A and Phase I-Part B.
Measured: Cycle 1 day 1 and 15; Cycle 2 Day 15. Cycle=28 days
Percentage of participants with dose interruptions and dose reductions (Phase I-Part A)
Percentage of participants with dose interruptions and dose reductions for participants in Phase I-Part A, Phase I-Part B and Phase II
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start27 Dec 2022
- Primary completion26 Feb 2025
- Study completion26 Feb 2025
Why it stopped: Study halted early due to high toxicity risk (from BHLRM model) in combo treatment and inability to identify recommended Phase 2 dose in initial phase (Phase 1-Part A), making continuation to subsequent phases (Phase 1-Part B and Phase 2) unfeasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Cohort A1 - concurrent regimen Cohort A2 - sequential regimen Cohort A3 (post protocol amendment #2) - concurrent
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovative Therapies For Children with Cancer Consortium
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429502
- Sponsor's protocol ID
- CLEE011Q12101
- Other IDs
- 2024-512095-35-00
- Status last verified
- Oct 2025
- First submitted
- 17 Jun 2022
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Multicenter Study to Assess Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors
- ClinicalTrials.gov ID
- NCT05429502
- Acronym / sponsor ID
- CLEE011Q12101
- Conditions
- Neuroblastoma
- Keywords
- neuroblastoma, medulloblastoma, high-grade glioma, malignant rhabdoid tumors, rhabdomyosarcoma, relapsed, refractory, pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted early due to high toxicity risk (from BHLRM model) in combo treatment and inability to identify recommended Phase 2 dose in initial phase (Phase 1-Part A), making continuation to subsequent phases (Phase 1-Part B and Phase 2) unfeasible.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Innovative Therapies For Children with Cancer Consortium
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 23 Jun 2022 (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.
This is a Phase I/II study to assess the efficacy and safety of ribociclib in combination with topotecan and temozolomide (TOTEM) in pediatric patients with relapsed or refractory (r/r) neuroblastoma (NB), and other solid tumors, including medulloblastoma (MB), high-grade glioma (HGG), malignant rhabdoid tumors (MRT), and rhabdomyosarcoma (RMS).
Detailed description
The study is structured into two parts: Phase I - Part A (dose finding) and Phase I - Part B (multiple expansion cohorts). Phase II may commence following the evaluation of Phase I data, which includes safety, tolerability, efficacy, pharmacokinetics, and biomarker data. Additionally, other emerging data that could influence the treatment landscape will be considered before initiating Phase II in patients with relapsed or refractory neuroblastoma (NB) and/or other tumors studied in Phase I.
- Phase I - Part A (dose finding): This phase aims to determine the maximum tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) of ribociclib in combination with TOTEM.
Due to the early termination of the trial, Phase I - Part B (multiple expansion cohorts) and Phase II (double-blind, randomized, placebo-controlled in relapsed or refractory NB) were not initiated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort A1 - concurrent regimen Cohort A2 - sequential regimen Cohort A3 (post protocol amendment #2) - concurrent
| Arm | Type | Receives |
|---|---|---|
| Phase I-part A: Ribociclib + Topotecan and Temozolomide | Experimental | Drug: Topotecan, Drug: Temozolomide, Drug: RibociclibParticipants with r/r NB, MB, HGG, MRT or RMS will be treated with ribociclib in combination with topotecan and temozolomide to determine MTD and/or RP2D. Ribociclib dose will be escalated with topotecan and temozolomide. |
Who may qualify
- Ages
- 12 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- Participants and/or guardian have the ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 12 months and ≤ 21 years at the time of signing consent form Note: The first dose level of Phase I - part A (dose finding) will enroll participants ≥ 12 years - 21 years old, and may expand to younger participants (≥ 12 months to < 12 years) as determined by the data.
- Histologically or cytologically confirmed solid tumors listed below that have progressed despite standard therapy or for which no effective standard therapy exists.
- Participants with CNS disease who are on corticosteroids should take stable doses for at least 7 days prior to first dose of ribociclib with no plans for escalation.
- Performance status:
Key exclusion criteria (16 listed)
- Known hypersensitivity to any of the excipients of ribociclib or topotecan or temozolomide.
- Not recovered from clinical and laboratory acute toxicities related to prior anti-cancer therapies
- Concurrent severe and/or uncontrolled concurrent medical conditions (serious infections or significant cardiac, pulmonary, hepatic, psychiatric, GI disease, or other organ dysfunction) that in the investigator's judgement could compromise their ability to tolerate or absorb protocol therapy or would interfere with the study procedures or results
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
- History of QTc prolongation; taking medications with a known risk to prolong the QT interval hat cannot be discontinued or replaced by safe alternative medication
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 |
|---|---|---|
| TopotecanAlso: HycamtinStarting out dose of topotecan administered at standard dose given to neuroblastoma patients (0.75 mg/m2/day). | Drug | Phase I-part A: Ribociclib + Topotecan and Temozolomide |
| TemozolomideAlso: TemodarStarting out dose of temozolomide for cohort A1 and A2 for Phase 1-Part A: 150mg/m2/day. Starting out dose for subsequent cohorts, Cohort A3 and onwards, in Phase 1-Part A will initiate at 100mg/m2/day. | Drug | Phase I-part A: Ribociclib + Topotecan and Temozolomide |
| RibociclibAlso: Kisqali, LEE011Starting out dose of ribociclib for cohort A1 Phase 1-Part A: 200mg/m2/day. Starting out dose for Cohort A2 and A3 was 100mg/m2/day. | Drug | Phase I-part A: Ribociclib + Topotecan and Temozolomide |
Primary outcome
Phase 1- Part A: Percentage of participants with Dose Limiting Toxicities (DLTs) in Cycle 1
Time frame: Up to 28 days
Percentage of participants with DLTs during first cycle of treatment (each cycle is 28 days) for each dose level associated with administration of ribociclib in combination with topotecan and temozolomide. A DLT is defined as an adverse event or abnormal laboratory value suspected to be related with study treatment.
5 secondary outcomes
Plasma concentrations of ribociclib (Phase I-Part A)
Time frame: Cycle 1 day 1 and 15; Cycle 2 Day 15. Cycle=28 days
Area under the plasma concentration-time curve (AUC) of ribociclib (Phase I-Part A)
Time frame: Cycle 1 day 1 and 15; Cycle 2 Day 15. Cycle=28 days
Maximum plasma concentration (Cmax) of ribociclib (Phase I-Part A)
Time frame: Cycle 1 day 1 and 15; Cycle 2 Day 15. Cycle=28 days
Time of maximum plasma concentration (Tmax) of ribociclib (Phase I-Part A)
Time frame: Cycle 1 day 1 and 15; Cycle 2 Day 15. Cycle=28 days
Percentage of participants with dose interruptions and dose reductions (Phase I-Part A)
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: Study halted early due to high toxicity risk (from BHLRM model) in combo treatment and inability to identify recommended Phase 2 dose in initial phase (Phase 1-Part A), making continuation to subsequent phases (Phase 1-Part B and Phase 2) unfeasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Link to study resultsLink provided by the sponsor.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Topotecan, Temozolomide and Ribociclib in people with Neuroblastoma, run by Novartis Pharmaceuticals at 6 sites in 4 countries.
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 17 inclusion and 16 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: stopped early, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Germany, Italy, United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study halted early due to high toxicity risk (from BHLRM model) in combo treatment and inability to identify recommended Phase 2 dose in initial phase (Phase 1-Part A), making continuation to subsequent phases (Phase 1-Part B and Phase 2) unfeasible.). Results are not available in the source record.
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?
Phase 1- Part A: Percentage of participants with Dose Limiting Toxicities (DLTs) in Cycle 1 (time frame: Up to 28 days). 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 10 Oct 2025.