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| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE PN597 | Other Identifier | Merck Sharp & Dohme Corp. |
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Phase 1B part was completed with review of DLTs and cumulative safety data by Safety Data Review Committee and identification of a safe RP2D. Post-internal review, sponsor decided to terminate the study, and hence, Phase 2 part was not conducted.
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This is a multicenter, open-label, single-arm Phase 1B/2 study to assess the safety and efficacy of tabelecleucel in combination with pembrolizumab for the treatment of subjects with platinum-pretreated, recurrent/metastatic Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC).
This is a multicenter, open-label, single-arm Phase 1B/2 study to assess the safety and efficacy of tabelecleucel in combination with pembrolizumab for the treatment of subjects with platinum-pretreated, recurrent/metastatic EBV+ NPC.
Tabelecleucel will be selected for each subject from the bank of available tabelecleucel cell products based on matching ≥ 2 human leukocyte antigen (HLA) alleles, at least one of which is a restricting HLA allele, shared between the tabelecleucel donor and the subject's EBV+ NPC. Sites will provide high resolution HLA typing of the subject and other information as required by the protocol.
Phase 1B will identify the maximum tolerated dose (MTD) and characterize the dose limiting toxicity (DLT) for tabelecleucel in combination with pembrolizumab in up to 24 subjects. In the absence of an MTD, the recommended Phase 2 dose (RP2D) will be identified. Phase 2 will evaluate the safety and efficacy of the combination in 36 subjects at the recommended dose level from Phase 1B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1B: Checkpoint Inhibitor Naïve | Experimental | Checkpoint inhibitor naive subjects during the treatment phase will receive intravenous (IV) infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to < 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 × 10^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first. |
|
| Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure | Experimental | Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase will receive IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to < 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 × 10^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles).). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first. |
|
| Cohort 2: Checkpoint Inhibitor Naïve |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tabelecleucel | Biological | Tabelecleucel is an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1B: Number of Participants With Dose-Limiting Toxicities (DLTs) | The occurrence of any of the following toxicities during Treatment Cycle 1 will be considered a DLT, if assessed by the investigator to be possibly related or related to investigational product administration (either tabelecleucel and/or pembrolizumab): Grade (G) 4 nonhematologic toxicity; G4 hematologic toxicity lasting >=7 days, except thrombocytopenia; any nonhematologic AE >=G3, except G3 fatigue lasting =<3 days; G3 diarrhea, nausea, or vomiting; G3 rash; Any G3/4 non-hematologic laboratory value if clinically significant medical intervention is required to treat the participant, abnormality leads to hospitalization, abnormality persists for > 1 week, abnormality results in a Drug-induced Liver Injury (DILI); G3/4 febrile neutropenia; > 2 weeks delay in initiating Cycle 2; discontinue treatment during Cycle 1; missing > 25% of study drugs doses as a result of investigational product-related AEs during the first cycle;G5 toxicity. | From Day 1 through Day 21 of Cycle 1 |
| Cohort 1B: Maximum Tolerated Dose (MTD) | The MTD is defined as the highest dose level at which the subject incidence of a DLTs during the first 21-day cycle of investigational product dosing is < 33% | From Day 1 through Day 21 of Cycle 21 |
| Cohort 1B: Recommended Phase 2 Dose (RP2D) of Tabelecleucel in Combination With Pembrolizumab | The RP2D is no higher than the maximum tolerated dose (highest dose level at which the number of participants with a DLTs during the first 21-day cycle of investigational product dosing is < 33%) and is based on optimal benefit-risk, as determined by the Safety Data Review Committee (SDRC). | From Day 1 through Day 21 of Cycle 1 |
| Cohort 1B: Characterization of the Safety Profile: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as any AE occurring after initiation of the first dose of study treatment through 30 days after the last administration of study drugs or any pre-existing AE (ie, started prior to the first dose of study drugs) that worsened after the first dose through 30 days after the last administration of study drugs or any related AE on or after first dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 2: Complete Response (CR) Rate | The CR rate is defined as percentage of participants with complete response. Per RECIST v1.1, CR is defined as disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased < 10 mm in short axis. | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
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Inclusion Criteria:
Male or female ≥ 12 years of age.
Incurable, locally recurrent or metastatic Epstein-Barr virus (EBV)+NPC (World Health Organization type II/III) in whom the EBV nucleic acid or antigens have been demonstrated in tissue biopsy samples.
Subjects must have had prior receipt of platinum-containing regimen either:
Phase 1B (Cohort 1):
i. Received at least 2 doses of anti-PD-1 or anti-PD-L1 monoclonal antibody at a local regulatory agency-approved dose and schedule. ii. Have progressive disease after anti-PD-1 or anti-PD-L1 monoclonal antibody as defined according to Response Evaluation Criteria in Solid Tumors) RECIST 1.1. The initial evidence of progressive disease is to be confirmed by a second assessment, no less than 4 weeks from the date of the first documented progressive disease, in the absence of rapid clinical progression. (The eligibility determination will be made by the investigator and then the sponsor will collect for retrospective analysis at a central vendor. Once progressive disease is confirmed, the initial date of progressive disease documentation will be considered the date of disease progression).
iii. Documented disease progression within 24 weeks of the last dose of anti-PD-1 or anti-PD-L1 monoclonal antibody. A subject who was re-treated with anti-PD-1 or anti-PD-L1 monoclonal antibody and a subject who was on maintenance with an anti-PD-1 or anti-PD-L1 monoclonal antibody will be allowed to enter the study as long as there is documented PD within 24 weeks of the last treatment date (with the anti-PD-1 or anti-PD-L1 monoclonal antibody).
Phase 1B (Cohort 1): If PD-1/PD-L1 failure (ie, refractory to or relapsed after PD-1/PD-L1 treatment), must have a lesion that can be biopsied after administration of tabelecleucel with acceptable clinical risk (as judged by the investigator) and must agree to undergo biopsy before Cycle 1 Day 1.
Phase 2 (Cohort 2): Checkpoint inhibitor naïve (have never received pembrolizumab or any other anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX40 or anti-CTLA-4 antibodies).
For all subjects: Agree to submit prior biopsy material, if available, for biomarker assessment.
Life expectancy ≥ 4 months at time of screening.
Measurable disease using RECIST 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been documented in such lesions.
Eastern Cooperative Oncology Group (ECOG) performance status of < 2 for subjects aged > 16 years; Lansky score ≥ 70 for subjects aged 12 to 16 years.
Adequate organ function per the protocol.
Willing and able to provide written informed consent (pediatric subjects 12 to < 18 years of age must provide assent along with consent from the subject's legally authorized representative).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aditi Mehta, DO | Atara Biotherapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Stanford Hospital and Clinics |
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A total of 12 participants were enrolled in phase 1b (cohort 1). No participants were enrolled in phase 2 (cohort 2) due to early study termination.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1B: Checkpoint Inhibitor Naïve | Checkpoint inhibitor naive subjects during the treatment phase received intravenous (IV) infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to < 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 9, 2018 | May 22, 2024 |
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Checkpoint inhibitor naive subjects during the treatment phase will receive IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to < 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 × 10^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first. |
|
|
| Pembrolizumab | Biological | pembrolizumab IV infusion |
|
|
| From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
| Cohort 2: Characterization of the Safety Profile: Number of Participants With TEAEs and TESAEs | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as any AE occurring after initiation of the first dose of study treatment through 30 days after the last administration of study drugs or any pre-existing AE (ie, started prior to the first dose of study drugs) that worsened after the first dose through 30 days after the last administration of study drugs or any related AE on or after first dose | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
| Cohort 2: Objective Response Rate (ORR) | For this study, radiographic tumor assessment was performed by computed tomography (CT) or magnetic resonance imaging (MRI) scan based on Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) and immune RECIST (iRECIST) criteria. Per RECIST v1.1, ORR is defined as percentage of participants with complete response (CR) (disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis) or partial response (PR) (at least a 30% decrease in sum of the longest diameters of target lesions taking as reference baseline sum diameters). Per iRECIST, immune complete response (iCR) is defined as resolution of all lesions and immune partial response (iPR) is defined as the target lesion sum of diameters (initial target lesions) not above initial progressive disease threshold, no significant growth in non-target lesion overall, and no new lesion or appearance of any new factor. | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
| Cohort 2: Duration of Response (DOR) | Per RECIST v1.1, the DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death in the absence of disease progression. | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
| Cohort 2: Progression Free Survival (PFS) | The PFS is defined as the time from the first dose of investigational product until the date of RECIST v1.1 defined progression or death due to any cause, whichever occurred first. | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
| Cohort 2: Overall Survival (OS) | The OS is defined as the time from the first dose of investigational product to the date of death due to any cause. | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
| Cohort 2: Immune Response Rate (iRR) | iRR is iCR + iPR. Per iRECIST, iCR is defined as resolution of all lesions and iPR is defined as the target lesion sum of diameters (initial target lesions) not above initial progressive disease threshold, no significant growth in non-target lesion overall, and no new lesion or appearance of any new factor. | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
| Cohort 2: Duration of Immune Response (DOiR) | DOiR is duration of iCR + iPR. Per iRECIST, iCR is defined as resolution of all lesions and iPR is defined as the target lesion sum of diameters (initial target lesions) not above initial progressive disease threshold, no significant growth in non-target lesion overall, and no new lesion or appearance of any new factor. | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
| Palo Alto |
| California |
| 94305 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Atlantic Health System / Morristown Medical Center | Morristown | New Jersey | 07962 | United States |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | 10016 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Pennsylvania (Adults and Pediatrics) | Philadelphia | Pennsylvania | 19104 | United States |
| FG001 | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure | Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to < 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first. |
| FG002 | Cohort 2: Checkpoint Inhibitor Naïve | Checkpoint inhibitor naive subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to < 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Full analysis set included all participants who received at least 1 dose of investigational products (tabelecleucel or pembrolzumab). No participants were enrolled in Phase 2 (Cohort 2) due to early study termination.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1B: Checkpoint Inhibitor Naïve | Checkpoint inhibitor naive subjects during the treatment phase received intravenous (IV) infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to < 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first. |
| BG001 | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure | Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to < 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first. |
| BG002 | Cohort 2: Checkpoint Inhibitor Naïve | Checkpoint inhibitor naive subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to < 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cohort 1B: Number of Participants With Dose-Limiting Toxicities (DLTs) | The occurrence of any of the following toxicities during Treatment Cycle 1 will be considered a DLT, if assessed by the investigator to be possibly related or related to investigational product administration (either tabelecleucel and/or pembrolizumab): Grade (G) 4 nonhematologic toxicity; G4 hematologic toxicity lasting >=7 days, except thrombocytopenia; any nonhematologic AE >=G3, except G3 fatigue lasting =<3 days; G3 diarrhea, nausea, or vomiting; G3 rash; Any G3/4 non-hematologic laboratory value if clinically significant medical intervention is required to treat the participant, abnormality leads to hospitalization, abnormality persists for > 1 week, abnormality results in a Drug-induced Liver Injury (DILI); G3/4 febrile neutropenia; > 2 weeks delay in initiating Cycle 2; discontinue treatment during Cycle 1; missing > 25% of study drugs doses as a result of investigational product-related AEs during the first cycle;G5 toxicity. | Full analysis set included all participants who received at least one dose of investigational products (tabelecleucel or pembrolizumab) and were observed during the first 21 days of the first cycle. | Posted | Count of Participants | Participants | From Day 1 through Day 21 of Cycle 1 |
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| Primary | Cohort 1B: Maximum Tolerated Dose (MTD) | The MTD is defined as the highest dose level at which the subject incidence of a DLTs during the first 21-day cycle of investigational product dosing is < 33% | The study was terminated before the outcome measure data were collected, refer to the Limitations and Caveats section for additional information. | Posted | From Day 1 through Day 21 of Cycle 21 |
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| Primary | Cohort 1B: Recommended Phase 2 Dose (RP2D) of Tabelecleucel in Combination With Pembrolizumab | The RP2D is no higher than the maximum tolerated dose (highest dose level at which the number of participants with a DLTs during the first 21-day cycle of investigational product dosing is < 33%) and is based on optimal benefit-risk, as determined by the Safety Data Review Committee (SDRC). | Full analysis set included all participants who received at least one dose of investigational products (tabelecleucel or pembrolizumab) and were observed during the first 21 days of the first cycle. | Posted | Number | cells/kg | From Day 1 through Day 21 of Cycle 1 |
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| Primary | Cohort 1B: Characterization of the Safety Profile: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as any AE occurring after initiation of the first dose of study treatment through 30 days after the last administration of study drugs or any pre-existing AE (ie, started prior to the first dose of study drugs) that worsened after the first dose through 30 days after the last administration of study drugs or any related AE on or after first dose. | Full analysis set included all participants who received at least one dose of investigational products (tabelecleucel or pembrolizumab). | Posted | Count of Participants | Participants | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
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| Primary | Cohort 2: Characterization of the Safety Profile: Number of Participants With TEAEs and TESAEs | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as any AE occurring after initiation of the first dose of study treatment through 30 days after the last administration of study drugs or any pre-existing AE (ie, started prior to the first dose of study drugs) that worsened after the first dose through 30 days after the last administration of study drugs or any related AE on or after first dose | The study did not proceed to Cohort 2 (Phase 2) and data were not collected. | Posted | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
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| Primary | Cohort 2: Objective Response Rate (ORR) | For this study, radiographic tumor assessment was performed by computed tomography (CT) or magnetic resonance imaging (MRI) scan based on Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) and immune RECIST (iRECIST) criteria. Per RECIST v1.1, ORR is defined as percentage of participants with complete response (CR) (disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis) or partial response (PR) (at least a 30% decrease in sum of the longest diameters of target lesions taking as reference baseline sum diameters). Per iRECIST, immune complete response (iCR) is defined as resolution of all lesions and immune partial response (iPR) is defined as the target lesion sum of diameters (initial target lesions) not above initial progressive disease threshold, no significant growth in non-target lesion overall, and no new lesion or appearance of any new factor. | The study did not proceed to Cohort 2 (Phase 2) and data were not collected. | Posted | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
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| Secondary | Cohort 2: Complete Response (CR) Rate | The CR rate is defined as percentage of participants with complete response. Per RECIST v1.1, CR is defined as disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased < 10 mm in short axis. | The study did not proceed to Cohort 2 (Phase 2) and data were not collected. | Posted | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
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| Secondary | Cohort 2: Duration of Response (DOR) | Per RECIST v1.1, the DoR is defined as the time from the date of first documented confirmed response until date of documented progression or death in the absence of disease progression. | The study did not proceed to Cohort 2 (Phase 2) and data were not collected. | Posted | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
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| Secondary | Cohort 2: Progression Free Survival (PFS) | The PFS is defined as the time from the first dose of investigational product until the date of RECIST v1.1 defined progression or death due to any cause, whichever occurred first. | The study did not proceed to Cohort 2 (Phase 2) and data were not collected. | Posted | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
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| Secondary | Cohort 2: Overall Survival (OS) | The OS is defined as the time from the first dose of investigational product to the date of death due to any cause. | The study did not proceed to Cohort 2 (Phase 2) and data were not collected. | Posted | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
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| Secondary | Cohort 2: Immune Response Rate (iRR) | iRR is iCR + iPR. Per iRECIST, iCR is defined as resolution of all lesions and iPR is defined as the target lesion sum of diameters (initial target lesions) not above initial progressive disease threshold, no significant growth in non-target lesion overall, and no new lesion or appearance of any new factor. | The study did not proceed to Cohort 2 (Phase 2) and data were not collected. | Posted | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
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| Secondary | Cohort 2: Duration of Immune Response (DOiR) | DOiR is duration of iCR + iPR. Per iRECIST, iCR is defined as resolution of all lesions and iPR is defined as the target lesion sum of diameters (initial target lesions) not above initial progressive disease threshold, no significant growth in non-target lesion overall, and no new lesion or appearance of any new factor. | The study did not proceed to Cohort 2 (Phase 2) and data were not collected. | Posted | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
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| Post-Hoc | Cohort 1B: Objective Response Rate (ORR) | For this study, radiographic tumor assessment was performed by CT or MRI scan based on RECIST v1.1 and iRECIST criteria. Per RECIST v1.1, ORR is defined as percentage of participants with CR (disappearance of all extranodal target lesions and all pathological lymph nodes must have decreased to <10 mm in short axis) or PR (at least a 30% decrease in sum of the longest diameters of target lesions taking as reference baseline sum diameters). Per iRECIST, iCR is defined as resolution of all lesions and iPR is defined as the target lesion sum of diameters (initial target lesions) not above initial progressive disease threshold, no significant growth in non-target lesion overall, and no new lesion or appearance of any new factor. Refer also to the Limitations and Caveats section. | Full analysis set included all participants who received at least one dose of investigational products (tabelecleucel or pembrolizumab). Cohort 1B (Phase 1b) was not powered for efficacy. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
| ||||||||||||||||||||||||||||||
| Post-Hoc | Cohort 1B: Clinical Benefit Rate (CBR) | The CBR is defined as the proportion of subjects who achieved BOR of CR or PR or SD. CR and PR are defined in outcome measure of ORR. The SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For this study, radiographic tumor assessment was performed by CT scan or MRI scan based on RECIST v1.1 and immune-based RECIST criteria. Refer also to the Limitations and Caveats section. | Full analysis set included all participants who received at least one dose of investigational products (tabelecleucel or pembrolizumab). Cohort 1B (phase 1b) was not powered for efficacy. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months) |
|
From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
No participants were enrolled in phase 2 (cohort 2) due to early study termination, so, number of participants at risk for All-cause mortality, serious adverse events, and other (not including serious) adverse events are zero.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1B: Checkpoint Inhibitor Naïve | Checkpoint inhibitor naive subjects during the treatment phase received intravenous (IV) infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to < 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first. | 3 | 6 | 1 | 6 | 6 | 6 |
| EG001 | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure | Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to < 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first. | 3 | 6 | 1 | 6 | 6 | 6 |
| EG002 | Cohort 2: Checkpoint Inhibitor Naïve | Checkpoint inhibitor naive subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to < 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84- day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first. | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Blindness unilateral | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Serum ferritin increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Facial motor skill dysfunction | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Skin tightness | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
Post-Hoc efficacy outcomes (ORR and CBR) were analyzed for Cohort 1B (phase 1); however, Cohort 1B was not powered for efficacy. The study was deprioritized and terminated early, and did not proceed to Cohort 2 (Phase 2).
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Atara Biotherapeutics | 650-278-8930 | 1 | clinicalstudies@atarabio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2021 | May 22, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| D009303 | Nasopharyngeal Neoplasms |
| D020031 | Epstein-Barr Virus Infections |
| D009669 | Nose Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D012888 | Skull Neoplasms |
| D001859 | Bone Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure | Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to < 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first. |
|
|
|
|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| OG001 | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure | Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to < 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first. |
|
|
| OG001 | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure | Checkpoint inhibitor PD-1/PD-L1 failure subjects during the treatment phase received IV infusion of pembrolizumab at 200 mg for adults (≥ 18 years of age) or 2 mg/kg for adolescents (12 to < 18 years of age) prior to the administration of tabelecleucel on Day 1; and IV infusion of tabelecleucel (tab-cel) at 2 x 10^6 T-cells/kg on Days 1, 8, and 15 of each 21-day treatment/consolidation cycles (at least 2 cycles or up to 4 cycles). From the Maintenance Phase, subjects with stable disease or better will receive tabelecleucel on Day 1 and pembrolizumab on Day 1, Day 21, Day 42, and Day 63 of each 84-day maintenance cycle, which was continued until disease progression, unacceptable toxicity, or a total of 35 pembrolizumab infusions (including for treatment, consolidation, and maintenance) had been administered, whichever occurred first. |
|
|