Diffuse Intrinsic Pontine Glioma, High Grade Glioma, Refractory Central Nervous System Tumor, Refractory Solid Tumor, Relapsed Central Nervous System Tumor, Relapsed Solid Tumor
Conditions
Keywords
Newly Diagnosed, Recurrent, Refractory
Brief summary
Phase 1: * To confirm the safety and anticipated recommended phase 2 dose (RP2D) of REGN2810 (cemiplimab) for children with recurrent or refractory solid or Central Nervous System (CNS) tumors * To characterize the pharmacokinetics (PK) of REGN2810 given in children with recurrent or refractory solid or CNS tumors Phase 2 (Efficacy Phase): * To confirm the safety and anticipated RP2D of REGN2810 to be given concomitantly with conventionally fractionated or hypofractionated radiation among patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) * To confirm the safety and anticipated RP2D of REGN2810 given concomitantly with conventionally fractionated or hypofractionated radiation among patients with newly diagnosed high-grade glioma (HGG) * To confirm the safety and anticipated RP2D of REGN2810 given concomitantly with re-irradiation in patients with recurrent HGG * To assess PK of REGN2810 in pediatric patients with newly diagnosed DIPG, newly diagnosed HGG, or recurrent HGG when given in combination with radiation * To assess anti-tumor activity of REGN2810 in combination with radiation in improving overall survival at 12 months (OS12) among patients with newly diagnosed DIPG * To assess anti-tumor activity of REGN2810 in combination with radiation in improving progression-free survival at 12 months (PFS12) among patients with newly diagnosed HGG * To assess anti-tumor activity of REGN2810 in combination with radiation in improving overall survival at OS12 among patients with recurrent HGG
Interventions
DRUGcemiplimab (monotherapy)
To be administered intravenously as monotherapy in Phase 1
To be administered intravenously in combination with radiation and then used as maintenance therapy
RADIATIONConventional or hypofractionated
Combined with cemiplimab IV administration
RADIATIONRe-irradiation
Combined with cemiplimab IV administration
Sponsors
Pacific Pediatric Neuro-Oncology Consortium
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 25 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Age 0 to \<18 years of age (Phase 1) 2. Age ≥3 and ≤25 years of age (Efficacy Phase) 3. Karnofsky performance status ≥50 (patients \>16 years) or Lansky performance status ≥50 (patients ≤ 16 years) 4. Life expectancy \>8 weeks 5. Adequate Bone Marrow Function 6. Adequate Renal Function 7. Adequate Liver Function 8. Adequate Neurologic Function Key
Exclusion criteria
1. Patients with bulky metastatic disease of the CNS causing Uncal herniation or symptomatic midline shift, significant, symptomatic mass effect, or uncontrolled neurological symptoms such as seizures or altered mental status 2. Patients with metastatic spine disease and gliomatosis as documented by diffuse involvement of \>2 lobes 3. Patients who are receiving any other investigational anticancer agent(s) 4. Patients on greater than dexamethasone 0.1 mg/kg/day (maximum 4 mg/day) or equivalent dose in alternate corticosteroid, or actively undergoing corticosteroid dose escalation in the last 7 days 5. Patients with a history of allogeneic stem cell transplant 6. Prior treatment with an agent that blocks the PD-1/PD-L1/PD-L2 pathway Note: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Overall Survival (OS) at 12 Months for Participants With ndDIPG and Recurrent HGG (rHGG) | Up to 12 months | OS was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last date that participant was documented to be alive. 95% CI is based on Kaplan-Meier method. |
| Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Up to Week 16 | Ctrough (trough concentration) of functional cemiplimab in serum reported. |
| Percentage of Progression-free Survival (PFS) at 12 Months for Participants With Newly Diagnosed HGG (ndHGG) | At 12 months | PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined per Response Assessment in Neuro-Oncology (RANO)/Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria, or death due to any cause. |
| Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Up to Week 16 | Cmax (peak concentration) of functional cemiplimab in serum reported. |
| Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum | Up to 24 months | — |
| Number of Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months) | TEAEs are AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occur during the post-treatment period but prior to initiation of other anticancer therapy. Number of TEAEs reported. |
| Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs | From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months) | NCI CTCAE version 4.0 was utilized for AE grading of severity: Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (Life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to AE). Number of NCI grade 3/4/5 Treatment-Emergent Adverse Events (AEs) reported |
| Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs) | From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months) | Number of sponsor-identified irAEs (all grades) reported. |
| Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs | From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months) | Number of severe treatment-emergent sponsor-identified irAEs reported. |
| Number of Treatment-emergent AEs of Special Interest (AESI) | From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months) | AEs of special interest (AESI) are AEs required to be monitored, documented, and managed in a pre-specified manner as described in the protocol. Number of treatment-emergent AESI reported. |
| Number of NCI Grade 3/4/5 Treatment-emergent AESI | From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months) | Number of NCI grade 3/4/5 treatment-emergent AESI reported |
| Number of Participants With Any TEAE Resulting in Death | From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months) | Number of participants with any TEAE resulting in death reported |
| Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | Up to 36 months | Number of participants with new or worsened laboratory abnormalities (NCI-CTCAE All Grades) reported in Hematology, Electrolytes, Liver, Chemistry; Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (Life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to AE). |
| Number of Participants Who Developed Dose Limiting Toxicities (DLTs) (Phase 1) | Baseline to 28 days | Number of participants who developed dose limiting toxicities (DLTs) in phase 1 reported |
| Number of Participants Who Developed DLTs (Efficacy Phase) | Up to 4 weeks post radiation therapy | — |
| Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum | Up to 24 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anti-REGN2810 Antibodies (ADA) | 1st follow-up visit, approximately 25 months | ADA status classified as: Positive; Pre-existing (baseline \[BL\] sample positive & all post BL ADA titers reported as \< 9-fold BL titer value); Negative (all samples negative); ADA positive: Treatment-boosted (positive result at BL with ≥1 post BL titer result ≥9-fold BL titer value); Treatment-emergent (TE) (negative result or missing result at BL with ≥1 positive post BL result); TE: Persistent (positive result detected in ≥2 consecutive post BL samples separated by ≥ a 12/16-week post BL period with no ADA-negative results in-between, regardless of any missing samples; Indeterminate (positive result in last collection, regardless of any missing samples); Transient (not persistent or indeterminate, regardless of any missing samples) |
| Objective Response Rate (ORR) for Participants Who Have a Confirmed Complete Response (CR) or Partial Response (PR) | Approximately 24 months | ORR was defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR), as determined per standard criteria between the date of first study treatment and the date of the first objectively documented progression or the date of receiving another anti-cancer systemic therapy, whichever came first. Clopper-Person exact confidence interval |
Countries
United States
Participant flow
Pre-assignment details
65 participants were screened; 57 participants were enrolled and had received at least 1 dose of REGN2810 at time of study termination (Sponsor decision)
Participants by arm
| Arm | Count |
|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg Phase 1 (Cohort A) SOLID TUMOR \< 12 yr REGN2810 3 milligrams/kilogram (mg/kg) every two weeks (Q2W) | 3 |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg Phase 1 (Cohort B) SOLID TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W) | 5 |
| CNS TUMOR <12 yr REGN2810 3mg/kg Phase 1 (Cohort C1) CNS TUMOR \<12 yr REGN2810 3mg/kg (Q2W) | 3 |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg Phase 1 (Cohort C2) CNS TUMOR \<12 yr REGN2810 4.5mg/kg (Q2W) | 9 |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg Phase 1 (Cohort D) CNS TUMOR 12 to \<18 yr REGN2810 3mg/kg (Q2W) | 5 |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy Efficacy Phase (Cohort E) ndDIPG \<12 yr REGN2810 4.5mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy) | 6 |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy Efficacy Phase (Cohort F) ndDIPG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy) | 5 |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy Efficacy Phase (Cohort H) ndHGG \>=12 yr REGN2810 3mg/kg (Q2W) + Radiotherapy (pre-specified to be assessed regardless of which radiation therapy) | 12 |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation Efficacy Phase (Cohort I) rHGG \<12 yr REGN2810 4.5mg/kg (Q2W) + Re-Irradiation | 1 |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation Efficacy Phase (Cohort J) rHGG \>= 12 yr REGN2810 3mg/kg (Q2W) + Re-Irradiation | 8 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Death | 1 | 1 | 1 | 4 | 2 | 5 | 3 | 2 | 0 | 3 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Other Treatment | 1 | 1 | 1 | 2 | 3 | 1 | 2 | 7 | 0 | 3 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Progressive Disease | 1 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Subject Decision | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | CNS TUMOR <12 yr REGN2810 4.5mg/kg | CNS TUMOR <12 yr REGN2810 3mg/kg | SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | SOLID TUMOR < 12 yr REGN2810 3mg/kg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 12.1 years STANDARD_DEVIATION 5.23 | 16.3 years STANDARD_DEVIATION 3.01 | 8.0 years STANDARD_DEVIATION 0 | 16.4 years STANDARD_DEVIATION 3.63 | 15.4 years STANDARD_DEVIATION 2.41 | 4.8 years STANDARD_DEVIATION 1.83 | 15.0 years STANDARD_DEVIATION 1 | 7.1 years STANDARD_DEVIATION 2.26 | 7.7 years STANDARD_DEVIATION 1.53 | 13.4 years STANDARD_DEVIATION 1.95 | 7.0 years STANDARD_DEVIATION 5.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 3 Participants | 1 Participants | 5 Participants | 1 Participants | 3 Participants | 3 Participants | 2 Participants | 0 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 5 Participants | 0 Participants | 6 Participants | 4 Participants | 1 Participants | 2 Participants | 7 Participants | 3 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not reported | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 40 Participants | 4 Participants | 1 Participants | 12 Participants | 4 Participants | 2 Participants | 3 Participants | 5 Participants | 3 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 25 Participants | 2 Participants | 1 Participants | 4 Participants | 4 Participants | 4 Participants | 2 Participants | 4 Participants | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 32 Participants | 6 Participants | 0 Participants | 8 Participants | 1 Participants | 2 Participants | 3 Participants | 5 Participants | 2 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 3 | 4 / 5 | 2 / 3 | 8 / 9 | 3 / 5 | 6 / 6 | 4 / 5 | 7 / 12 | 1 / 1 | 5 / 8 |
| other Total, other adverse events | 3 / 3 | 5 / 5 | 2 / 3 | 8 / 9 | 4 / 5 | 6 / 6 | 5 / 5 | 12 / 12 | 1 / 1 | 8 / 8 |
| serious Total, serious adverse events | 0 / 3 | 0 / 5 | 0 / 3 | 3 / 9 | 0 / 5 | 3 / 6 | 3 / 5 | 7 / 12 | 0 / 1 | 5 / 8 |
Outcome results
Primary
Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum
Time frame: Up to 24 months
Population: Cohorts used for pharmacokinetic endpoints were based on age and/or tumor type; Due to sparse sampling, area under the curve could not be calculated.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum | NA mg*hr/L |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum | NA mg*hr/L |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum | NA mg*hr/L |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum | NA mg*hr/L |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum | NA mg*hr/L |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum | NA mg*hr/L |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum | NA mg*hr/L |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum | NA mg*hr/L |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum | NA mg*hr/L |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Area Under the Concentration-time Curve (AUC) of Functional Cemiplimab (REGN2810) in Serum | NA mg*hr/L |
Primary
Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum
Time frame: Up to 24 months
Population: Cohorts used for pharmacokinetic endpoints were based on age and/or tumor type. Radiation type was collected, but not used for assessment; Due to sparse sampling, elimination half-life could not be calculated.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum | NA milligrams/Liter (mg/L) |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum | NA milligrams/Liter (mg/L) |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum | NA milligrams/Liter (mg/L) |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum | NA milligrams/Liter (mg/L) |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum | NA milligrams/Liter (mg/L) |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum | NA milligrams/Liter (mg/L) |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum | NA milligrams/Liter (mg/L) |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum | NA milligrams/Liter (mg/L) |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum | NA milligrams/Liter (mg/L) |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Elimination Half-life (t1/2) of Functional Cemiplimab (REGN2810) in Serum | NA milligrams/Liter (mg/L) |
Primary
Number of NCI Grade 3/4/5 Treatment-emergent AESI
Number of NCI grade 3/4/5 treatment-emergent AESI reported
Time frame: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Population: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of NCI Grade 3/4/5 Treatment-emergent AESI | 0 Events |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of NCI Grade 3/4/5 Treatment-emergent AESI | 0 Events |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of NCI Grade 3/4/5 Treatment-emergent AESI | 0 Events |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of NCI Grade 3/4/5 Treatment-emergent AESI | 0 Events |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of NCI Grade 3/4/5 Treatment-emergent AESI | 1 Events |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Number of NCI Grade 3/4/5 Treatment-emergent AESI | 2 Events |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of NCI Grade 3/4/5 Treatment-emergent AESI | 2 Events |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of NCI Grade 3/4/5 Treatment-emergent AESI | 4 Events |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Number of NCI Grade 3/4/5 Treatment-emergent AESI | 0 Events |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Number of NCI Grade 3/4/5 Treatment-emergent AESI | 6 Events |
Primary
Number of Participants Who Developed DLTs (Efficacy Phase)
Time frame: Up to 4 weeks post radiation therapy
Population: Only Efficacy Phase participants that were eligible for Dose Limiting Toxicity evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of Participants Who Developed DLTs (Efficacy Phase) | 1 Participants |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants Who Developed DLTs (Efficacy Phase) | 1 Participants |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of Participants Who Developed DLTs (Efficacy Phase) | 0 Participants |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of Participants Who Developed DLTs (Efficacy Phase) | 0 Participants |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants Who Developed DLTs (Efficacy Phase) | 1 Participants |
Primary
Number of Participants Who Developed Dose Limiting Toxicities (DLTs) (Phase 1)
Number of participants who developed dose limiting toxicities (DLTs) in phase 1 reported
Time frame: Baseline to 28 days
Population: Only Phase 1 participants that were eligible for Dose Limiting Toxicity evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of Participants Who Developed Dose Limiting Toxicities (DLTs) (Phase 1) | 0 Participants |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants Who Developed Dose Limiting Toxicities (DLTs) (Phase 1) | 0 Participants |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of Participants Who Developed Dose Limiting Toxicities (DLTs) (Phase 1) | 0 Participants |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of Participants Who Developed Dose Limiting Toxicities (DLTs) (Phase 1) | 0 Participants |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants Who Developed Dose Limiting Toxicities (DLTs) (Phase 1) | 0 Participants |
Primary
Number of Participants With Any TEAE Resulting in Death
Number of participants with any TEAE resulting in death reported
Time frame: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Population: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of Participants With Any TEAE Resulting in Death | 0 Participants |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants With Any TEAE Resulting in Death | 0 Participants |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of Participants With Any TEAE Resulting in Death | 0 Participants |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of Participants With Any TEAE Resulting in Death | 0 Participants |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants With Any TEAE Resulting in Death | 0 Participants |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Number of Participants With Any TEAE Resulting in Death | 0 Participants |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Participants With Any TEAE Resulting in Death | 0 Participants |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Participants With Any TEAE Resulting in Death | 0 Participants |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Number of Participants With Any TEAE Resulting in Death | 0 Participants |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Number of Participants With Any TEAE Resulting in Death | 0 Participants |
Primary
Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry
Number of participants with new or worsened laboratory abnormalities (NCI-CTCAE All Grades) reported in Hematology, Electrolytes, Liver, Chemistry; Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (Life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to AE).
Time frame: Up to 36 months
Population: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Hematology | 3 Participants |
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Electrolytes | 3 Participants |
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Liver | 1 Participants |
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Chemistry | 3 Participants |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Electrolytes | 3 Participants |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Hematology | 4 Participants |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Chemistry | 5 Participants |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Liver | 2 Participants |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Electrolytes | 0 Participants |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Hematology | 3 Participants |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Liver | 0 Participants |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Chemistry | 3 Participants |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Hematology | 7 Participants |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Electrolytes | 5 Participants |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Liver | 5 Participants |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Chemistry | 6 Participants |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Liver | 3 Participants |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Electrolytes | 2 Participants |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Chemistry | 4 Participants |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Hematology | 3 Participants |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Liver | 4 Participants |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Electrolytes | 6 Participants |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Hematology | 6 Participants |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Chemistry | 6 Participants |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Electrolytes | 4 Participants |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Liver | 5 Participants |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Chemistry | 4 Participants |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Hematology | 4 Participants |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Hematology | 11 Participants |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Chemistry | 10 Participants |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Electrolytes | 9 Participants |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Liver | 7 Participants |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Chemistry | 1 Participants |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Hematology | 1 Participants |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Liver | 1 Participants |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Electrolytes | 1 Participants |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Liver | 5 Participants |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Hematology | 8 Participants |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Chemistry | 7 Participants |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Number of Participants With at Least One Lab Abnormality (NCI-CTCAE All Grades) in Hematology, Electrolytes, Liver, Chemistry | ≥ 1 lab abnormality (All Grades) Electrolytes | 7 Participants |
Primary
Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs
NCI CTCAE version 4.0 was utilized for AE grading of severity: Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (Life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to AE). Number of NCI grade 3/4/5 Treatment-Emergent Adverse Events (AEs) reported
Time frame: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Population: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs | 3 Events |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs | 5 Events |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs | 0 Events |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs | 9 Events |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs | 4 Events |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs | 25 Events |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs | 8 Events |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs | 19 Events |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs | 4 Events |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Number of Severe (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Grade 3/4/5) TEAEs | 16 Events |
Primary
Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs
Number of severe treatment-emergent sponsor-identified irAEs reported.
Time frame: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Population: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs | 0 Events |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs | 0 Events |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs | 0 Events |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs | 0 Events |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs | 0 Events |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs | 0 Events |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs | 3 Events |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs | 2 Events |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs | 0 Events |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Number of Severe (NCI CTCAE Grade 3/4/5) Treatment-emergent Sponsor Identified irAEs | 1 Events |
Primary
Number of Treatment-emergent Adverse Events (TEAEs)
TEAEs are AEs that developed or worsened during the on-treatment period and any treatment-related AEs that occur during the post-treatment period but prior to initiation of other anticancer therapy. Number of TEAEs reported.
Time frame: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Population: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of Treatment-emergent Adverse Events (TEAEs) | 19 Events |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Treatment-emergent Adverse Events (TEAEs) | 42 Events |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of Treatment-emergent Adverse Events (TEAEs) | 24 Events |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of Treatment-emergent Adverse Events (TEAEs) | 56 Events |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Treatment-emergent Adverse Events (TEAEs) | 49 Events |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Number of Treatment-emergent Adverse Events (TEAEs) | 108 Events |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Treatment-emergent Adverse Events (TEAEs) | 102 Events |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Treatment-emergent Adverse Events (TEAEs) | 222 Events |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Number of Treatment-emergent Adverse Events (TEAEs) | 28 Events |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Number of Treatment-emergent Adverse Events (TEAEs) | 175 Events |
Primary
Number of Treatment-emergent AEs of Special Interest (AESI)
AEs of special interest (AESI) are AEs required to be monitored, documented, and managed in a pre-specified manner as described in the protocol. Number of treatment-emergent AESI reported.
Time frame: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Population: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of Treatment-emergent AEs of Special Interest (AESI) | 0 Events |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Treatment-emergent AEs of Special Interest (AESI) | 0 Events |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of Treatment-emergent AEs of Special Interest (AESI) | 0 Events |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of Treatment-emergent AEs of Special Interest (AESI) | 0 Events |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Treatment-emergent AEs of Special Interest (AESI) | 1 Events |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Number of Treatment-emergent AEs of Special Interest (AESI) | 5 Events |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Treatment-emergent AEs of Special Interest (AESI) | 2 Events |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Treatment-emergent AEs of Special Interest (AESI) | 4 Events |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Number of Treatment-emergent AEs of Special Interest (AESI) | 0 Events |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Number of Treatment-emergent AEs of Special Interest (AESI) | 8 Events |
Primary
Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs)
Number of sponsor-identified irAEs (all grades) reported.
Time frame: From first dose of study drug up to 90 days after the last dose of study treatment (up to 36 months)
Population: Safety analysis set (SAF): All enrolled participants who have received any study treatment (at least one dose of any component of study treatment in a combination therapy) in each study phase. Participants analyzed according to the study treatment received (as treated).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs) | 0 Events |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs) | 1 Events |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs) | 0 Events |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs) | 0 Events |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs) | 0 Events |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs) | 2 Events |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs) | 5 Events |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs) | 9 Events |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs) | 0 Events |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Number of Treatment-emergent Sponsor Identified Immune-related Adverse Events (irAEs) | 9 Events |
Primary
Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum
Cmax (peak concentration) of functional cemiplimab in serum reported.
Time frame: Up to Week 16
Population: Pharmacokinetic Analysis Set (PKAS): All treated participants who received any amount of study drug (SAF) and had at least 1 non-missing functional cemiplimab measurement following the first dose of cemiplimab (based on actual treatment received \[as treated\]); Cohorts used for pharmacokinetic endpoints were based on age and/or tumor type.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax - after 1st dose | 58.2 mg/L |
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax -Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | NA mg/L |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax - after 1st dose | 73.5 mg/L |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax -Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | NA mg/L |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax - after 1st dose | 92.2 mg/L |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax -Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | NA mg/L |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax - after 1st dose | 68.3 mg/L |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax -Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | NA mg/L |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax -Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | NA mg/L |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax - after 1st dose | 152 mg/L |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax -Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | 221 mg/L |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax - after 1st dose | 95.1 mg/L |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax -Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | 165 mg/L |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax - after 1st dose | 71.8 mg/L |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax - after 1st dose | 88.8 mg/L |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax -Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | 179 mg/L |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax - after 1st dose | 105 mg/L |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax -Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | 209 mg/L |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax - after 1st dose | NA mg/L |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Peak Concentration (Cmax) of Functional Cemiplimab (REGN2810) in Serum | Cmax -Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | NA mg/L |
Primary
Percentage of Overall Survival (OS) at 12 Months for Participants With ndDIPG and Recurrent HGG (rHGG)
OS was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last date that participant was documented to be alive. 95% CI is based on Kaplan-Meier method.
Time frame: Up to 12 months
Population: Only participants with ndDIPG and recurrent HGG (rHGG) were assessed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Percentage of Overall Survival (OS) at 12 Months for Participants With ndDIPG and Recurrent HGG (rHGG) | 0.0 Percentage of Participants |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Percentage of Overall Survival (OS) at 12 Months for Participants With ndDIPG and Recurrent HGG (rHGG) | 40.0 Percentage of Participants |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Percentage of Overall Survival (OS) at 12 Months for Participants With ndDIPG and Recurrent HGG (rHGG) | 0.0 Percentage of Participants |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Percentage of Overall Survival (OS) at 12 Months for Participants With ndDIPG and Recurrent HGG (rHGG) | 35.7 Percentage of Participants |
Primary
Percentage of Progression-free Survival (PFS) at 12 Months for Participants With Newly Diagnosed HGG (ndHGG)
PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined per Response Assessment in Neuro-Oncology (RANO)/Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria, or death due to any cause.
Time frame: At 12 months
Population: Only participants with newly diagnosed HGG (ndHGG) were assessed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Percentage of Progression-free Survival (PFS) at 12 Months for Participants With Newly Diagnosed HGG (ndHGG) | 22.2 Percentage of Participants |
Primary
Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum
Ctrough (trough concentration) of functional cemiplimab in serum reported.
Time frame: Up to Week 16
Population: Pharmacokinetic Analysis Set (PKAS): All treated participants who received any amount of study drug (SAF) and had at least 1 non-missing functional cemiplimab measurement following the first dose of cemiplimab (based on actual treatment received \[as treated\]); Cohorts used for pharmacokinetic endpoints were based on age and/or tumor type.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - after 1st dose | 16.7 mg/L |
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | NA mg/L |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | NA mg/L |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - after 1st dose | 23.9 mg/L |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - after 1st dose | 33.8 mg/L |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - after 1st dose | 28.5 mg/L |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | NA mg/L |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | NA mg/L |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - after 1st dose | 48.3 mg/L |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | 82.4 mg/L |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - after 1st dose | 39.7 mg/L |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | 94.3 mg/L |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - after 1st dose | 26.0 mg/L |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - after 1st dose | 36.3 mg/L |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | 78.5 mg/L |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - after 1st dose | 35.8 mg/L |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | 122 mg/L |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - Week 16 (Cycle 4 Day 1) (4 weeks per cycle) | NA mg/L |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Trough Concentration (Ctrough) of Functional Cemiplimab (REGN2810) in Serum | Ctrough - after 1st dose | NA mg/L |
Secondary
Number of Participants With Anti-REGN2810 Antibodies (ADA)
ADA status classified as: Positive; Pre-existing (baseline \[BL\] sample positive & all post BL ADA titers reported as \< 9-fold BL titer value); Negative (all samples negative); ADA positive: Treatment-boosted (positive result at BL with ≥1 post BL titer result ≥9-fold BL titer value); Treatment-emergent (TE) (negative result or missing result at BL with ≥1 positive post BL result); TE: Persistent (positive result detected in ≥2 consecutive post BL samples separated by ≥ a 12/16-week post BL period with no ADA-negative results in-between, regardless of any missing samples; Indeterminate (positive result in last collection, regardless of any missing samples); Transient (not persistent or indeterminate, regardless of any missing samples)
Time frame: 1st follow-up visit, approximately 25 months
Population: ADA analysis set (AAS): all treated participants who received any amount of cemiplimab (SAF) \& had ≥1 non-missing ADA result following first dose of cemiplimab (based on actual treatment received \[as treated\]).~By design, the study arms were expected to be reflective of tumor type/diagnosis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of Participants With Anti-REGN2810 Antibodies (ADA) | Negative | 16 Participants |
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of Participants With Anti-REGN2810 Antibodies (ADA) | Treatment-emergent (TE) response | 0 Participants |
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Number of Participants With Anti-REGN2810 Antibodies (ADA) | Pre-existing immunoreactivity | 0 Participants |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants With Anti-REGN2810 Antibodies (ADA) | Negative | 5 Participants |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants With Anti-REGN2810 Antibodies (ADA) | Treatment-emergent (TE) response | 0 Participants |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Number of Participants With Anti-REGN2810 Antibodies (ADA) | Pre-existing immunoreactivity | 0 Participants |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of Participants With Anti-REGN2810 Antibodies (ADA) | Pre-existing immunoreactivity | 1 Participants |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of Participants With Anti-REGN2810 Antibodies (ADA) | Negative | 17 Participants |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Number of Participants With Anti-REGN2810 Antibodies (ADA) | Treatment-emergent (TE) response | 1 Participants |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of Participants With Anti-REGN2810 Antibodies (ADA) | Negative | 6 Participants |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of Participants With Anti-REGN2810 Antibodies (ADA) | Treatment-emergent (TE) response | 1 Participants |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Number of Participants With Anti-REGN2810 Antibodies (ADA) | Pre-existing immunoreactivity | 0 Participants |
Secondary
Objective Response Rate (ORR) for Participants Who Have a Confirmed Complete Response (CR) or Partial Response (PR)
ORR was defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR), as determined per standard criteria between the date of first study treatment and the date of the first objectively documented progression or the date of receiving another anti-cancer systemic therapy, whichever came first. Clopper-Person exact confidence interval
Time frame: Approximately 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOLID TUMOR < 12 yr REGN2810 3mg/kg | Objective Response Rate (ORR) for Participants Who Have a Confirmed Complete Response (CR) or Partial Response (PR) | 0 Percentage of Participants |
| SOLID TUMOR 12 to <18 yr REGN2810 3mg/kg | Objective Response Rate (ORR) for Participants Who Have a Confirmed Complete Response (CR) or Partial Response (PR) | 0 Percentage of Participants |
| CNS TUMOR <12 yr REGN2810 3mg/kg | Objective Response Rate (ORR) for Participants Who Have a Confirmed Complete Response (CR) or Partial Response (PR) | 0 Percentage of Participants |
| CNS TUMOR <12 yr REGN2810 4.5mg/kg | Objective Response Rate (ORR) for Participants Who Have a Confirmed Complete Response (CR) or Partial Response (PR) | 0 Percentage of Participants |
| CNS TUMOR 12 to <18 yr REGN2810 3mg/kg | Objective Response Rate (ORR) for Participants Who Have a Confirmed Complete Response (CR) or Partial Response (PR) | 0 Percentage of Participants |
| ndDIPG <12 yr REGN2810 4.5mg/kg + Radiotherapy | Objective Response Rate (ORR) for Participants Who Have a Confirmed Complete Response (CR) or Partial Response (PR) | 0 Percentage of Participants |
| ndDIPG >=12 yr REGN2810 3mg/kg + Radiotherapy | Objective Response Rate (ORR) for Participants Who Have a Confirmed Complete Response (CR) or Partial Response (PR) | 0 Percentage of Participants |
| ndHGG >=12 yr REGN2810 3mg/kg + Radiotherapy | Objective Response Rate (ORR) for Participants Who Have a Confirmed Complete Response (CR) or Partial Response (PR) | 8.3 Percentage of Participants |
| rHGG <12 yr REGN2810 4.5mg/kg + Re-Irradiation | Objective Response Rate (ORR) for Participants Who Have a Confirmed Complete Response (CR) or Partial Response (PR) | 0 Percentage of Participants |
| rHGG >= 12 yr REGN2810 3mg/kg + Re-Irradiation | Objective Response Rate (ORR) for Participants Who Have a Confirmed Complete Response (CR) or Partial Response (PR) | 0 Percentage of Participants |