Trial · NCT02684058
Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors
NCT02684058, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2023-05-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors. Trials, record NCT02684058. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02684058
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors
- NCT number
- NCT02684058
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 151 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
Diffuse Astrocytoma, Anaplastic Astrocytoma, Astrocytoma, Oligodendroglioma, Childhood, Anaplastic Oligodendroglioma, Glioblastoma, Pilocytic Astrocytoma, Giant Cell Astrocytoma, Pleomorphic Xanthoastrocytoma, Anaplastic Pleomorphic Xanthoastrocytoma, Angiocentric Glioma, Chordoid Glioma of Third Ventricle, Gangliocytoma, Ganglioglioma, Anaplastic Ganglioglioma, Dysplastic Gangliocytoma of Cerebrellum, Desmoplastic Infantile Astrocytoma and Ganglioglioma, Papillary Glioneuronal Tumor, Rosette-forming Glioneurona Tumor, Central Neurocytoma, Extraventricular Neurocytoma, Cerebellar Iponeurocytoma
- Interventions
- Dabrafenib, trametinib, Carboplatin, Vincristine
- First posted
- 2016-02-17
- Last updated
- 2023-12-13
- Other registries' IDs
- eudract:2015-004015-20
- Results first posted
- 2023-05-19
Source ClinicalTrials.gov
Registered outcomes48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | LGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using Response Assessment in Neuro-Oncology (RANO) Criteria | Up to approximately (approx.) 3 years | Percentage of participants in the LGG cohort with a best overall confirmed Complete Response (CR) or Partial Response (PR) as assessed per RANO criteria by central independent assessment. The 95% confidence intervals (CIs) were computed using two-sided exact binomial method. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically. |
| Primary | HGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria | Up to approx. 3.2 years | Percentage of participants in the HGG cohort with a best overall confirmed CR or PR as assessed per RANO criteria by central independent assessment. The 95% CIs were computed using two-sided exact binomial method. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically. |
| Secondary | LGG Cohort: ORR by Investigator Assessment Using RANO Criteria | Up to approx. 3 years and up to approx 4.2 years | Percentage of participants in the LGG cohort with a best overall confirmed CR or PR as assessed per RANO criteria by investigator assessment. The 95% CIs were computed using two-sided exact binomial method. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically. |
| Secondary | LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Central Independent Assessment Using RANO Criteria | Up to approx. 3 years and up to approx 4.2 years | Time from first documented response (PR or CR) until disease progression or death as per RANO criteria. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy, were censored at the date of the last adequate tumor evaluation. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically. |
| Secondary | LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Investigator Assessment Using RANO Criteria | Up to approx. 3 years and up to approx 4.2 years | Time from first documented response (PR or CR) until disease progression or death as per RANO criteria. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy, were censored at the date of the last adequate tumor evaluation. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically. |
| Secondary | LGG Cohort: Kaplan-Meier Progression-Free Survival (PFS) as Per Central Independent Assessment Using RANO Criteria | Up to approx. 3 years and up to approx 4.2 years | Time from the date of randomization to the date of first documented disease progression as per central independent review assessment using RANO criteria or death due to any cause. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation. |
| Secondary | LGG Cohort: Kaplan-Meier Progression-Free Survival (PFS) as Per Investigator Assessment Using RANO Criteria | Up to approx. 3 years and up to approx 4.2 years | Time from the date of randomization to the date of first documented disease progression as per investigator assessment using RANO criteria or death due to any cause. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation. |
| Secondary | LGG Cohort: Kaplan-Meier Estimates of Time to Response (TTR) as Per Central Independent Assessment Using RANO Criteria | Up to approx. 4.2 years | Time from randomization to first documented response of CR or PR as per central independent assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients without an event were censored either at the maximum follow-up time (if they experienced disease progression or death), or at their last tumor assessment date. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically. |
| Secondary | LGG Cohort: Kaplan-Meier Estimates of Time to Response (TTR) as Per Investigator Assessment Using RANO Criteria | Up to approx. 4.2 years | Time from randomization to first documented response of CR or PR as per investigator assessment using RANO criteria. CIs were estimated using the Brookmeyer Crowley method. Patients without an event were censored either at the maximum follow-up time (if they experienced disease progression or death), or at their last tumor assessment date. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically. |
| Secondary | LGG Cohort: Clinical Benefit Rate (CBR) by Central Independent Assessment Using RANO Criteria | Up to approx. 4.2 years | Percentage of participants with a best overall response of CR or PR, or stable disease (SD) which lasts for 24 weeks or longer. CR: Complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; no new lesions; and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be off steroids or only on physiologic replacement doses. PR: ≥ 50% reduction, compared to baseline, in the sum of products of the perpendicular diameters for all measurable lesions for at least 4 weeks, no progression of nonmeasureable disease, no new lesions, and stable or improved nonenhancing (T2/FLAIR) lesions. Patient must be on a corticosteroid dose not greater than the dose at the time of baseline scan and be stable or improving clinically. SD: Partient did not qualify for CR, PR, or progressive disease and has stable nonenhancing (T2/FLAIR) lesions on same or lower doses of corticosteroids compared with baseline scan and clinically stable status. |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 registered outcomesOutcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | LGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using Response Assessment in Neuro-Oncology (RANO) Criteria | Up to approximately (approx.) 3 years | All participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure. | Percentage of participants | NUMBER |
| PRIMARY | HGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria | Up to approx. 3.2 years | All participants on the HGG cohort to whom study treatment had been assigned and who received at least one dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | LGG Cohort: ORR by Investigator Assessment Using RANO Criteria | Up to approx. 3 years and up to approx 4.2 years | All participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure. | Percentage of participants | NUMBER |
| SECONDARY | LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Central Independent Assessment Using RANO Criteria | Up to approx. 3 years and up to approx 4.2 years | Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered with a confirmed CR or PR as per central independent review assessment using RANO criteria. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure. | Months | MEDIAN |
| SECONDARY | LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Investigator Assessment Using RANO Criteria | Up to approx. 3 years and up to approx 4.2 years | Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered with a confirmed CR or PR as per investigator review assessment using RANO criteria. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure. | Months | MEDIAN |
| SECONDARY | LGG Cohort: Kaplan-Meier Progression-Free Survival (PFS) as Per Central Independent Assessment Using RANO Criteria | Up to approx. 3 years and up to approx 4.2 years | Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure. | Months | MEDIAN |
| SECONDARY | LGG Cohort: Kaplan-Meier Progression-Free Survival (PFS) as Per Investigator Assessment Using RANO Criteria | Up to approx. 3 years and up to approx 4.2 years | Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure. | Months | MEDIAN |
| SECONDARY | LGG Cohort: Kaplan-Meier Estimates of Time to Response (TTR) as Per Central Independent Assessment Using RANO Criteria | Up to approx. 4.2 years | Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure. | Months | MEDIAN |
| SECONDARY | LGG Cohort: Kaplan-Meier Estimates of Time to Response (TTR) as Per Investigator Assessment Using RANO Criteria | Up to approx. 4.2 years | Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure. | Months | MEDIAN |
| SECONDARY | LGG Cohort: Clinical Benefit Rate (CBR) by Central Independent Assessment Using RANO Criteria | Up to approx. 4.2 years | All participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure. | Percentage of participants | NUMBER |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 outcomesResults by group401
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| LGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using Response Assessment in Neuro-Oncology (RANO) Criteria | LGG Cohort: Dabrafenib and Trametinib | 46.6 | 95% Confidence Interval 34.8 to 58.6 | Percentage of participants | |
| LGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using Response Assessment in Neuro-Oncology (RANO) Criteria | LGG Cohort: Carboplatin and Vincristine | 10.8 | 95% Confidence Interval 3.0 to 25.4 | Percentage of participants | |
| HGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria | HGG Cohort: Dabrafenib and Trametinib | 56.1 | 95% Confidence Interval 39.7 to 71.5 | Percentage of participants | |
| LGG Cohort: ORR by Investigator Assessment Using RANO Criteria | LGG Cohort: Dabrafenib and Trametinib | Up to approx. 3 years | 54.8 | 95% Confidence Interval 42.7 to 66.5 | Percentage of participants |
| LGG Cohort: ORR by Investigator Assessment Using RANO Criteria | LGG Cohort: Carboplatin and Vincristine | Up to approx. 3 years | 13.5 | 95% Confidence Interval 4.5 to 28.8 | Percentage of participants |
| LGG Cohort: ORR by Investigator Assessment Using RANO Criteria | LGG Cohort: Dabrafenib and Trametinib | Up to approx. 4.2 years | 58.9 | 95% Confidence Interval 46.8 to 70.3 | Percentage of participants |
| LGG Cohort: ORR by Investigator Assessment Using RANO Criteria | LGG Cohort: Carboplatin and Vincristine | Up to approx. 4.2 years | 18.9 | 95% Confidence Interval 8.0 to 35.2 | Percentage of participants |
| LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Central Independent Assessment Using RANO Criteria | LGG Cohort: Dabrafenib and Trametinib | Up to approx. 3 years | 20.3 | 95% Confidence Interval 12.0 to NA | Months |
| LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Central Independent Assessment Using RANO Criteria | LGG Cohort: Carboplatin and Vincristine | Up to approx. 3 years | NA | 95% Confidence Interval 6.6 to NA | Months |
| LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Central Independent Assessment Using RANO Criteria | LGG Cohort: Dabrafenib and Trametinib | Up to approx 4.2 years | 30.0 | 95% Confidence Interval 16.6 to NA | Months |
1 to 10 of 401Source ClinicalTrials.gov
See all 401 results by groupParticipant flow39
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | LGG Cohort: Dabrafenib and Trametinib | 73 | |
| Treatment Period | STARTED | LGG Cohort: Carboplatin and Vincristine | 37 | |
| Treatment Period | STARTED | HGG Cohort: Dabrafenib and Trametinib | 41 | |
| Treatment Period | Treated | LGG Cohort: Dabrafenib and Trametinib | 73 | |
| Treatment Period | Treated | LGG Cohort: Carboplatin and Vincristine | 33 | |
| Treatment Period | Treated | HGG Cohort: Dabrafenib and Trametinib | 41 | |
| Treatment Period | COMPLETED | LGG Cohort: Dabrafenib and Trametinib | 56 | |
| Treatment Period | COMPLETED | LGG Cohort: Carboplatin and Vincristine | 14 | |
| Treatment Period | COMPLETED | HGG Cohort: Dabrafenib and Trametinib | 17 | |
| Treatment Period | NOT COMPLETED | LGG Cohort: Dabrafenib and Trametinib | 17 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 participant flowAdverse events2,072
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | HGG Cohort: Dabrafenib and Trametinib (On-treatment) | 4 | 41 | |
| other | Anaemia | Blood and lymphatic system disorders | HGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up) | 0 | ||
| other | Anaemia | Blood and lymphatic system disorders | LGG Cohort: Dabrafenib and Trametinib (On-treatment) | 14 | 73 | |
| other | Anaemia | Blood and lymphatic system disorders | LGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up) | 0 | ||
| other | Anaemia | Blood and lymphatic system disorders | LGG Cohort: Carboplatin and Vincristine (On-treatment) | 20 | 33 | |
| other | Anaemia | Blood and lymphatic system disorders | LGG Cohort: Carboplatin and Vincristine (Post-treatment Follow-up) | 0 | ||
| other | Anaemia | Blood and lymphatic system disorders | LGG Cohort: Carboplatin and Vincristine (Crossover On-treatment) | 0 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | LGG Cohort: Carboplatin and Vincristine (Crossover Post-treatment Follow-up) | 0 | ||
| other | Leukopenia | Blood and lymphatic system disorders | HGG Cohort: Dabrafenib and Trametinib (On-treatment) | 3 | 41 | |
| other | Leukopenia | Blood and lymphatic system disorders | HGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up) | 0 |
1 to 10 of 2,072Source ClinicalTrials.gov
See all 2,072 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HGG Cohort: Dabrafenib and Trametinib (On-treatment) | 6 | 41 |
| Total, all-cause mortality | HGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up) | 11 | 13 |
| Total, all-cause mortality | LGG Cohort: Dabrafenib and Trametinib (On-treatment) | 0 | 73 |
| Total, all-cause mortality | LGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up) | 0 | 11 |
| Total, all-cause mortality | LGG Cohort: Carboplatin and Vincristine (On-treatment) | 0 | 33 |
| Total, all-cause mortality | LGG Cohort: Carboplatin and Vincristine (Post-treatment Follow-up) | 0 | 16 |
| Total, all-cause mortality | LGG Cohort: Carboplatin and Vincristine (Crossover On-treatment) | 1 | 12 |
| Total, all-cause mortality | LGG Cohort: Carboplatin and Vincristine (Crossover Post-treatment Follow-up) | 0 | 0 |
| Total, other adverse events | HGG Cohort: Dabrafenib and Trametinib (On-treatment) | 41 | 41 |
| Total, other adverse events | HGG Cohort: Dabrafenib and Trametinib (Post-treatment Follow-up) | 0 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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