A Phase 1/2 interventional study of Tabelecleucel and Pembrolizumab in Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms and Epstein-Barr Virus Infections, sponsored by Atara Biotherapeutics. Terminated at 7 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Atara Biotherapeutics · Phase 1/2, Interventional, and Treatment
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.
683 studies on the registry are indexed under Nasopharyngeal Carcinoma; 270 are open to participants now.
This study's enrollment of 12 is below the median of 100 across 557 interventional studies indexed under Nasopharyngeal Carcinoma.
Browse Nasopharyngeal Carcinoma studies →Atara Biotherapeutics is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 ) 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).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Tabelecleucel · Biological: Pembrolizumab
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.
Biological: Tabelecleucel · Biological: Pembrolizumab
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.
Biological: Tabelecleucel · Biological: Pembrolizumab
Tabelecleucel is an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Also known as: tab-cel®, ATA129, Epstein-Barr Virus-specific Cytotoxic T Lymphocytes (EBV-CTL)
pembrolizumab IV infusion
Also known as: MK-3475
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.
Time frame: 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%
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months)
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.
| Milestone | Cohort 1B: Checkpoint Inhibitor Naïve | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure | Cohort 2: Checkpoint Inhibitor Naïve |
|---|---|---|---|
| Started | 6 | 6 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 6 | 6 | 0 |
| Withdrew: Adverse event | 1 | 1 | 0 |
| Withdrew: Death | 3 | 3 | 0 |
| Withdrew: Study terminated by sponsor | 2 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
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.
| Participants | Cohort 1B: Checkpoint Inhibitor Naïve | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure |
|---|---|---|
| Cohort 1B: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 | 0 |
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%
No measurements were reported for this outcome.
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).
| cells/kg | Cohort 1B: Checkpoint Inhibitor Naïve and PD-1/PD-L1 Failure |
|---|---|
| Cohort 1B: Recommended Phase 2 Dose (RP2D) of Tabelecleucel in Combination With Pembrolizumab | 2000000 |
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.
| Participants | Cohort 1B: Checkpoint Inhibitor Naïve | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure |
|---|---|---|
| Any TEAEs | 6 | 6 |
| TEAEs (worst grade >=3) | 1 | 4 |
| TEAEs fatal | 0 | 0 |
| TEAEs leading to treatment interruption | 0 | 0 |
| TEAEs leading to treatment discontinuation | 4 | 4 |
| Any TESAEs | 1 | 1 |
| TEAEs related or possibly related to study treatment (worst grade >=3) | 0 | 0 |
| TEAEs related or possibly related to study treatment; serious | 0 | 1 |
| TEAEs related or possibly related to study treatment; fatal | 0 | 0 |
| TEAEs related or possibly related to study treatment; leading to treatment interruption | 0 | 0 |
| TEAEs related or possibly related to study treatment; leading to treatment discontinuation | 0 | 0 |
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
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
The OS is defined as the time from the first dose of investigational product to the date of death due to any cause.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
| Percentage of Participants | Cohort 1B: Checkpoint Inhibitor Naïve | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure |
|---|---|---|
| Cohort 1B: Objective Response Rate (ORR) | 0 (0.0 to 45.9) | 0 (0.0 to 45.9) |
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.
| Percentage of Participants | Cohort 1B: Checkpoint Inhibitor Naïve | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure |
|---|---|---|
| Cohort 1B: Clinical Benefit Rate (CBR) | 66.7 (22.3 to 95.7) | 33.3 (4.3 to 77.7) |
Collected over From Day 1 to end of study (1 year after the last dose or until disease progression, whichever occurred first) (approximately 27 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1B: Checkpoint Inhibitor Naïve | 3/6 (50%) | 1/6 (16.7%) | 6/6 (100%) |
| Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure | 3/6 (50%) | 1/6 (16.7%) | 6/6 (100%) |
| Cohort 2: Checkpoint Inhibitor Naïve | — | — | — |
| Event | Cohort 1B: Checkpoint Inhibitor Naïve | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure | Cohort 2: Checkpoint Inhibitor Naïve |
|---|---|---|---|
| ChillsGeneral disorders | 0/6 | 1/6 | — |
| Non-cardiac chest painGeneral disorders | 0/6 | 1/6 | — |
| PyrexiaGeneral disorders | 0/6 | 1/6 | — |
| Cytokine release syndromeImmune system disorders | 0/6 | 1/6 | — |
| HyponatraemiaMetabolism and nutrition disorders | 1/6 | 0/6 | — |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/6 | 1/6 | — |
| Brain oedemaNervous system disorders | 1/6 | 0/6 | — |
| HemiparesisNervous system disorders | 1/6 | 0/6 | — |
| Event | Cohort 1B: Checkpoint Inhibitor Naïve | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure | Cohort 2: Checkpoint Inhibitor Naïve |
|---|---|---|---|
| Disease progressionGeneral disorders | 5/6 | 3/6 | — |
| HypothyroidismEndocrine disorders | 2/6 | 1/6 | — |
| DiarrhoeaGastrointestinal disorders | 2/6 | 1/6 | — |
| NauseaGastrointestinal disorders | 1/6 | 2/6 | — |
| VomitingGastrointestinal disorders | 1/6 | 2/6 | — |
| ChillsGeneral disorders | 2/6 | 0/6 | — |
| FatigueGeneral disorders | 2/6 | 1/6 | — |
| Non-cardiac chest painGeneral disorders | 0/6 | 2/6 | — |
| PyrexiaGeneral disorders | 1/6 | 2/6 | — |
| HyponatraemiaMetabolism and nutrition disorders | 2/6 | 2/6 | — |
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.
| Age, Continuous(Years) | Cohort 1B: Checkpoint Inhibitor Naïve | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure | Cohort 2: Checkpoint Inhibitor Naïve | Total |
|---|---|---|---|---|
| Mean | 49.0 ± 16.97 | 53.0 ± 3.16 | — | 51.0 ± 11.82 |
| Sex: Female, Male(Participants) | Cohort 1B: Checkpoint Inhibitor Naïve | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure | Cohort 2: Checkpoint Inhibitor Naïve | Total |
|---|---|---|---|---|
| Female | 4 | 2 | 0 | 6 |
| Male | 2 | 4 | 0 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1B: Checkpoint Inhibitor Naïve | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure | Cohort 2: Checkpoint Inhibitor Naïve | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 6 | 6 | 0 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1B: Checkpoint Inhibitor Naïve | Cohort 1B: Checkpoint Inhibitor PD-1/PD-L1 Failure | Cohort 2: Checkpoint Inhibitor Naïve | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 4 | 5 | 0 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 1 |
| White | 1 | 1 | 0 | 2 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2019 to primary completion in Aug 2021, 30 months.
Results were first posted in Nov 2024, 3 years 2 months after primary completion. A results delay was requested in Aug 2022.
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Studies of the drug tested here: Tabelecleucel
Atara Biotherapeutics