Head and Neck Cancer, Head and Neck Neoplasms, Head and Neck Squamous Cell Carcinoma
Conditions
Brief summary
This is a Phase 2 study of enoblituzumab combined with either retifanlimab or tebotelimab administered as first-line treatment to patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
Interventions
BIOLOGICALEnoblituzumab
Anti-B7-H3 antibody
BIOLOGICALRetifanlimab
Anti-PD-1 antibody
BIOLOGICALTebotelimab
PD-1 X LAG-3 bispecific DART molecule
Sponsors
MacroGenics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Enrollment into each cohort will occur independently in a non-randomized fashion, based on PD-L1 expression results. Patients may not crossover between cohorts.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) not curable by local therapy * No prior systemic therapy for SCCHN in the recurrent or metastatic setting (with the exception of systemic therapy completed \> 6 months prior if given as part of multimodal treatment for locally advanced disease) * Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Patients may not have a primary tumor site of upper esophagus, salivary gland, or nasopharynx (any histology) * Availability of formalin-fixed, paraffin embedded tumor specimen or contemporary biopsy for immunohistochemical evaluation of pharmacodynamic markers of interest * Willing to consent for baseline and on-treatment biopsy. * Performance status 0 or 1 * Life expectancy of 6 months or more * Adequate end organ function * At least one radiographically measurable lesion * PD-L1 expression level that is either 1. Positive (combined positive score \[CPS\] ≥ 1) for the retifanlimab cohort, or 2. Negative (CPS \< 1) for the tebotelimab cohort * Results available from human papilloma virus p16 status for oropharyngeal cancer * Acceptable laboratory results
Exclusion criteria
* Disease suitable for local therapy administered with curative intent * Progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced SCCHN * Radiation or other non-systemic therapy within 2 weeks prior to the first dose of study drug * Prior therapy with an anti-B7-H3, anti-PD-1, anti-PD-L1, or anti-LAG-3 agent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) of Enoblituzumab Plus Retifanlimab | Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months. | Investigator-assessed ORR. defined as the percentage of patients in the response evaluable population who achieve the best overall response of complete response (CR) or partial response (PR),per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria.. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions |
| Number of Patients With Adverse Events (AEs) Receiving Enoblituzumab Plus Tebotelimab | Throughout the study, up to 16.5 months. | — |
| ORR of Enoblituzumab Plus Tebotelimab | Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months | Investigator-assessed ORR. ORR, defined as the percentage of patients in the response evaluable population who achieve the a best overall response of complete response (CR) or partial response (PR), per RECIST, version 1.1 criteria. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | up to 16.5 months | Time from the first dose date to the date of death from any cause, evaluated by cohort |
| Best Overall Response (BOR) | Tumor assessment is conducted 6 weeks after first dose, then every 9 weeks until disease progression, up to 16.5 months | The participants best response to treatment during their study participation. Responses are categorized as CR, PR, stable disease (SD), progressive disease (PD), or not evaluated (NE), per RECIST 1.1 criteria CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions, and non-PD in non-target lesions PD is defined as at least a 20% increase from nadir in the sum of diameters of target lesions or unequivocal progression in non-target lesions SD is defined as non-PD in target and non-target lesions |
| Number of Patients With AEs Receiving Enoblituzumab Plus Retifanlimab | Throughout the study, up to 16.5 months. | — |
| Maximum Drug Concentration or Drug Concentration of Enoblituzumab at the End of Infusion of Enoblituzumab (Cmax) | Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [2 hours]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days) | The highest measured concentration of enoblituzumab in the bloodstream. |
| Maximum Drug Concentration or Drug Concentration of Tebotelimab at the End of Infusion of Tebotelimab (Cmax) | Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days) | The highest measured concentration of tebotelimab in the bloodstream. |
| Maximum Drug Concentration or Drug Concentration of Retifanlimab at the End of Infusion of Enoblituzumab (Cmax) | Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days) | The highest measured concentration of retifanlimab in the bloodstream. |
| Progression-free Survival (PFS) | Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months | Time from the first dose date to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort |
| Trough Concentration of Tebotelimab (Ctrough or Cmin) | Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days) | The amount of tebotelimab left in the bloodstream before the next dose is given. |
| Trough Concentration of Retifanlimab (Ctrough or Cmin) | Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days) | The amount of retifanlimab left in the bloodstream before the next dose is given. |
| Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. | Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months | — |
| Number of Patients Who Develop ADA to Tebotelimab | Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months | — |
| Number of Patients Who ADA to Retifanlimab | Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months | — |
| Trough Concentration of Enoblituzumab (Ctrough or Cmin) | Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [2 hours]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days | The amount of enoblituzumab left in the bloodstream before the next dose is given. |
| Disease-control Rate (DCR) | Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months | Percentage of response-evaluable patients with CR, PR, or stable disease (SD) for at least 3 months, evaluated by cohort |
| Duration of Response | Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months | Time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort |
Countries
Australia, Bulgaria, Hungary, Poland, Spain, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Retifanlimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus retifanlimab 375 mg every 3 weeks | 48 |
| Tebotelimab Cohort Enoblituzumab 15 mg/kg every 3 weeks plus tebotelimab 600 mg every 3 weeks | 14 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 10 | 3 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Study terminated by sponsor | 35 | 11 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Tebotelimab Cohort | Retifanlimab Cohort | Total |
|---|---|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 6.8 | 61.2 years STANDARD_DEVIATION 11.31 | 62.0 years STANDARD_DEVIATION 10.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 47 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 42 Participants | 56 Participants |
| Region of Enrollment Australia | 1 participants | 6 participants | 7 participants |
| Region of Enrollment Bulgaria | 2 participants | 0 participants | 2 participants |
| Region of Enrollment Hungary | 1 participants | 3 participants | 4 participants |
| Region of Enrollment Poland | 1 participants | 6 participants | 7 participants |
| Region of Enrollment Spain | 6 participants | 9 participants | 15 participants |
| Region of Enrollment Ukraine | 2 participants | 12 participants | 14 participants |
| Region of Enrollment United States | 1 participants | 12 participants | 13 participants |
| Sex: Female, Male Female | 3 Participants | 10 Participants | 13 Participants |
| Sex: Female, Male Male | 11 Participants | 38 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 48 | 3 / 14 |
| other Total, other adverse events | 40 / 48 | 12 / 14 |
| serious Total, serious adverse events | 14 / 48 | 6 / 14 |
Outcome results
Primary
Number of Patients With Adverse Events (AEs) Receiving Enoblituzumab Plus Tebotelimab
Time frame: Throughout the study, up to 16.5 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retifanlimab Cohort | Number of Patients With Adverse Events (AEs) Receiving Enoblituzumab Plus Tebotelimab | 12 Participants |
Primary
ORR of Enoblituzumab Plus Tebotelimab
Investigator-assessed ORR. ORR, defined as the percentage of patients in the response evaluable population who achieve the a best overall response of complete response (CR) or partial response (PR), per RECIST, version 1.1 criteria. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions
Time frame: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retifanlimab Cohort | ORR of Enoblituzumab Plus Tebotelimab | 2 Participants |
Primary
Overall Response Rate (ORR) of Enoblituzumab Plus Retifanlimab
Investigator-assessed ORR. defined as the percentage of patients in the response evaluable population who achieve the best overall response of complete response (CR) or partial response (PR),per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria.. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions
Time frame: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retifanlimab Cohort | Overall Response Rate (ORR) of Enoblituzumab Plus Retifanlimab | 3 Participants |
Secondary
Best Overall Response (BOR)
The participants best response to treatment during their study participation. Responses are categorized as CR, PR, stable disease (SD), progressive disease (PD), or not evaluated (NE), per RECIST 1.1 criteria CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions, and non-PD in non-target lesions PD is defined as at least a 20% increase from nadir in the sum of diameters of target lesions or unequivocal progression in non-target lesions SD is defined as non-PD in target and non-target lesions
Time frame: Tumor assessment is conducted 6 weeks after first dose, then every 9 weeks until disease progression, up to 16.5 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Retifanlimab Cohort | Best Overall Response (BOR) | Partial Response | 3 Participants |
| Retifanlimab Cohort | Best Overall Response (BOR) | Not Evaluable | 10 Participants |
| Retifanlimab Cohort | Best Overall Response (BOR) | Stable Disease | 20 Participants |
| Retifanlimab Cohort | Best Overall Response (BOR) | Progressive Disease | 15 Participants |
| Retifanlimab Cohort | Best Overall Response (BOR) | Complete Response | 0 Participants |
| Tebotelimab Cohort | Best Overall Response (BOR) | Progressive Disease | 2 Participants |
| Tebotelimab Cohort | Best Overall Response (BOR) | Not Evaluable | 5 Participants |
| Tebotelimab Cohort | Best Overall Response (BOR) | Partial Response | 2 Participants |
| Tebotelimab Cohort | Best Overall Response (BOR) | Stable Disease | 5 Participants |
| Tebotelimab Cohort | Best Overall Response (BOR) | Complete Response | 0 Participants |
Secondary
Disease-control Rate (DCR)
Percentage of response-evaluable patients with CR, PR, or stable disease (SD) for at least 3 months, evaluated by cohort
Time frame: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retifanlimab Cohort | Disease-control Rate (DCR) | 19 Participants |
| Tebotelimab Cohort | Disease-control Rate (DCR) | 5 Participants |
Secondary
Duration of Response
Time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort
Time frame: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Retifanlimab Cohort | Duration of Response | NA months |
| Tebotelimab Cohort | Duration of Response | NA months |
Secondary
Maximum Drug Concentration or Drug Concentration of Enoblituzumab at the End of Infusion of Enoblituzumab (Cmax)
The highest measured concentration of enoblituzumab in the bloodstream.
Time frame: Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [2 hours]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days)
Population: Participants who received Enoblituzumab and had at least 1 end of infusion PK sample. As pre-specified in the PK analysis plan, Enoblituzumab PK data from both arms of the study were combined for analysis since Enoblituzumab dose was schedule were consistent across both arms.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retifanlimab Cohort | Maximum Drug Concentration or Drug Concentration of Enoblituzumab at the End of Infusion of Enoblituzumab (Cmax) | 505.3 mcg/mL | Standard Deviation 130.5 |
Secondary
Maximum Drug Concentration or Drug Concentration of Retifanlimab at the End of Infusion of Enoblituzumab (Cmax)
The highest measured concentration of retifanlimab in the bloodstream.
Time frame: Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days)
Population: Participants who received retifanlimab and had at least 1 end of infusion PK sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retifanlimab Cohort | Maximum Drug Concentration or Drug Concentration of Retifanlimab at the End of Infusion of Enoblituzumab (Cmax) | 113.1 mcg/mL | Standard Deviation 26.9 |
Secondary
Maximum Drug Concentration or Drug Concentration of Tebotelimab at the End of Infusion of Tebotelimab (Cmax)
The highest measured concentration of tebotelimab in the bloodstream.
Time frame: Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days)
Population: Participants who received tebotelimab and had at least 1 End of Infusion PK sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retifanlimab Cohort | Maximum Drug Concentration or Drug Concentration of Tebotelimab at the End of Infusion of Tebotelimab (Cmax) | 196.5 mcg/mL | Standard Deviation 74.8 |
Secondary
Number of Patients Who ADA to Retifanlimab
Time frame: Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months
Population: Only participants receiving retifanlimab were analyzed for the presence of retifanlimab ADA.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Retifanlimab Cohort | Number of Patients Who ADA to Retifanlimab | Not done at baseline, negative post baseline | 3 Participants |
| Retifanlimab Cohort | Number of Patients Who ADA to Retifanlimab | negative at baseline, not done post baseline | 8 Participants |
| Retifanlimab Cohort | Number of Patients Who ADA to Retifanlimab | negative at baseline, negative post baseline | 37 Participants |
Secondary
Number of Patients Who Develop ADA to Tebotelimab
Time frame: Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months
Population: Only participants receiving tebotelimab were analyzed for the presence of tebotelimab ADA.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Retifanlimab Cohort | Number of Patients Who Develop ADA to Tebotelimab | not done at baseline, positive at least once post baseline | 1 Participants |
| Retifanlimab Cohort | Number of Patients Who Develop ADA to Tebotelimab | negative at baseline, not done post baseline | 2 Participants |
| Retifanlimab Cohort | Number of Patients Who Develop ADA to Tebotelimab | negative at baseline, negative post baseline | 7 Participants |
| Retifanlimab Cohort | Number of Patients Who Develop ADA to Tebotelimab | negative at baseline, positive at least once post baseline | 3 Participants |
| Retifanlimab Cohort | Number of Patients Who Develop ADA to Tebotelimab | positive at baseline, negative post baseline | 1 Participants |
Secondary
Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab.
Time frame: Prior to treatment (baseline) and at the beginning of every 3-week cycle of treatment (post baseline) up to 16.5 months
Population: As pre-specified in the PK analysis plan, enoblituzumab ADA data from both arms of the study were combined for analysis since enoblituzumab dose and schedule were consistent across both arms.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Retifanlimab Cohort | Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. | Not done at baseline, negative post baseline | 3 Participants |
| Retifanlimab Cohort | Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. | Not done at baseline, positive at least once post baseline | 1 Participants |
| Retifanlimab Cohort | Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. | negative at baseline, not done post baseline | 6 Participants |
| Retifanlimab Cohort | Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. | negative at baseline, negative post baseline | 37 Participants |
| Retifanlimab Cohort | Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. | negative at baseline, positive at least once post baseline | 5 Participants |
| Retifanlimab Cohort | Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. | positive at baseline, not done post baseline | 4 Participants |
| Retifanlimab Cohort | Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. | positive at baseline, negative post baseline | 4 Participants |
| Retifanlimab Cohort | Number of Patients Who Develop Antidrug Antibodies (ADA) to Enoblituzumab. | positive at baseline, positive at least once post baseline | 2 Participants |
Secondary
Number of Patients With AEs Receiving Enoblituzumab Plus Retifanlimab
Time frame: Throughout the study, up to 16.5 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retifanlimab Cohort | Number of Patients With AEs Receiving Enoblituzumab Plus Retifanlimab | 40 Participants |
Secondary
Overall Survival
Time from the first dose date to the date of death from any cause, evaluated by cohort
Time frame: up to 16.5 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Retifanlimab Cohort | Overall Survival | NA months |
| Tebotelimab Cohort | Overall Survival | NA months |
Secondary
Progression-free Survival (PFS)
Time from the first dose date to the date of first documented progression or death from any cause, whichever occurs first, evaluated by cohort
Time frame: Tumor assessment is conducted 6 weeks after the first dose, then every 9 weeks until disease progression, up to 16.5 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Retifanlimab Cohort | Progression-free Survival (PFS) | NA months |
| Tebotelimab Cohort | Progression-free Survival (PFS) | NA months |
Secondary
Trough Concentration of Enoblituzumab (Ctrough or Cmin)
The amount of enoblituzumab left in the bloodstream before the next dose is given.
Time frame: Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [2 hours]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days
Population: Participants who received enoblituzumab and had at least 1 pre-infusion PK sample. As pre-specified in the PK analysis plan, enoblituzumab PK data from both arms of the study were combined for analysis since enoblituzumab dose and schedule were consistent across both arms.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retifanlimab Cohort | Trough Concentration of Enoblituzumab (Ctrough or Cmin) | 165.7 mcg/mL | Standard Deviation 88.8 |
Secondary
Trough Concentration of Retifanlimab (Ctrough or Cmin)
The amount of retifanlimab left in the bloodstream before the next dose is given.
Time frame: Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days)
Population: Participants who received retifanlimab and had at least 1 pre-infusion PK sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retifanlimab Cohort | Trough Concentration of Retifanlimab (Ctrough or Cmin) | 31.2 mcg/mL | Standard Deviation 15.5 |
Secondary
Trough Concentration of Tebotelimab (Ctrough or Cmin)
The amount of tebotelimab left in the bloodstream before the next dose is given.
Time frame: Cycle 1 Day 1: Pre-infusion, end of infusion (EOI [1 hour]), 4 hours after EOI; Cycle 1 Days 2, 3, 8 and 15 at any time; On Day 1 of Cycles 2, 3, 4, 5 and 6: Pre-infusion and EOI (each cycle is 21 days)
Population: Participants who received tebotelimab and had at least 1 pre-infusion PK sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Retifanlimab Cohort | Trough Concentration of Tebotelimab (Ctrough or Cmin) | 20.1 mcg/mL | Standard Deviation 6.1 |