Trial Outcomes & Findings for Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors (NCT NCT04052204)
NCT ID: NCT04052204
Last Updated: 2021-10-14
Results Overview
DLTs were graded according to NCI- CTCAE version 4.03 and coded using the latest version of Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT) as event category and MedDRA primary system organ class (SOC) body term as Body System category.
TERMINATED
PHASE1/PHASE2
3 participants
Cycle 1 of the treatment period (28 days)
2021-10-14
Participant Flow
4 participants screened for this study, 1 of the 4 participants was a screen failure, 3 participants were enrolled and received study treatment in Combination A.
Participant milestones
| Measure |
Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
|
Avelumab + NKTR-214+ Talazoparib (Combination B)
The dose level for avelumab was fixed at 800 mg Q2W. The starting dose level for NKTR-214 and talazoparib was determined at the completion of the dose finding for Combination A based on available clinical data. The lowest allowed dose for NKTR-214 was 0.003 mg/kg and the lowest allowed dose for talazoparib was 0.5 mg once daily, in which case participants with moderate renal impairment cannot be enrolled. NKTR-214 was administered prior to avelumab. Talazoparib was taken at the clinic after all procedures/assessments completed, before or after the NKTR-214 and avelumab infusions.
Arm was not tested as company terminated this study on 21 May 2021.
|
Avelumab + NKTR- 214 + Enzalutamide (Combination C)
The dose level for avelumab was fixed at 800 mg Q2W. The starting dose level for NKTR-214 and enzalutamide was determined at the completion of the dose finding for Combination A based on available clinical data. The approved label dose for enzalutamide was 160 mg once daily (QD) unless unexpected safety issues requiring it lowering according to the Bayesian Logistic Regression Model (BLRM) recommendation. NKTR-214 was administered prior to avelumab. The daily dose of enzalutamide was taken at the clinic after all procedures/assessments completed, and before or after the avelumab and NKTR-214 infusions.
Arm was not tested as company terminated this study on 21 May 2021.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
|
Avelumab + NKTR-214+ Talazoparib (Combination B)
The dose level for avelumab was fixed at 800 mg Q2W. The starting dose level for NKTR-214 and talazoparib was determined at the completion of the dose finding for Combination A based on available clinical data. The lowest allowed dose for NKTR-214 was 0.003 mg/kg and the lowest allowed dose for talazoparib was 0.5 mg once daily, in which case participants with moderate renal impairment cannot be enrolled. NKTR-214 was administered prior to avelumab. Talazoparib was taken at the clinic after all procedures/assessments completed, before or after the NKTR-214 and avelumab infusions.
Arm was not tested as company terminated this study on 21 May 2021.
|
Avelumab + NKTR- 214 + Enzalutamide (Combination C)
The dose level for avelumab was fixed at 800 mg Q2W. The starting dose level for NKTR-214 and enzalutamide was determined at the completion of the dose finding for Combination A based on available clinical data. The approved label dose for enzalutamide was 160 mg once daily (QD) unless unexpected safety issues requiring it lowering according to the Bayesian Logistic Regression Model (BLRM) recommendation. NKTR-214 was administered prior to avelumab. The daily dose of enzalutamide was taken at the clinic after all procedures/assessments completed, and before or after the avelumab and NKTR-214 infusions.
Arm was not tested as company terminated this study on 21 May 2021.
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Progressive disease
|
1
|
0
|
0
|
|
Overall Study
Other
|
1
|
0
|
0
|
Baseline Characteristics
Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
n=3 Participants
NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
|
|---|---|
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Age, Continuous
|
64.00 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 of the treatment period (28 days)Population: The DLT-evaluable analysis set included all enrolled participants in Phase 1b who receive at least one dose of the combination treatment and either experience DLT during the first cycle (28 days) of treatment, or complete the DLT observation period for the first cycle of treatment without a DLT.
DLTs were graded according to NCI- CTCAE version 4.03 and coded using the latest version of Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT) as event category and MedDRA primary system organ class (SOC) body term as Body System category.
Outcome measures
| Measure |
Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
n=3 Participants
NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
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|---|---|
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Number of Participants With Dose Limiting Toxicities (DLT)
|
1 Participants
|
SECONDARY outcome
Timeframe: Approximately 8 months (246 days).Population: All participants treated in combination A who achieved an OR.
DR was defined, for participants with a confirmed Objective Response (OR), as the time from the first documentation of OR to the date of first documentation of progressive disease (PD) or death due to any cause. The documentation of PD was defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. If a subject had not had an event (PD or death), DR was censored at the date of last adequate tumor assessment. As there were no objective responses in the study, no participant met the definition of analysis population.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 8 months (246 days).Population: All participants treated in combination A who achieved an OR.
TTR was defined, for participants with objective response, as the time from the date of first dose of study treatment to the first documentation of objective response (Complete Response or Partial Response) which was subsequently confirmed. As there were no objective responses in the study, no participant met the definition of analysis population.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 8 months (246 days).Population: All participants treated in Combination A.
Progression-Free Survival (PFS) was defined as the time from the date of first dose of study treatment to the date of the first documentation of PD or death due to any cause, whichever occurred first. PFS data were censored on the date of the last adequate tumor assessment for participants who did not have an event (PD or death), for participants who started new anti-cancer therapy prior to an event, or for participants with an event after two or more missing tumor assessments. Participants who did not have an adequate baseline tumor assessment or who did not have any adequate post-baseline tumor assessments were censored on the date of first dose of study treatment unless death occurred on or before the time of the second planned tumor assessment, in which case the death was considered an event. PFS time was summarized using the Kaplan-Meier method.
Outcome measures
| Measure |
Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
n=3 Participants
NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
|
|---|---|
|
Progression-Free Survival (PFS)
|
1.69752 months
Interval 0.59913 to 1.69752
|
SECONDARY outcome
Timeframe: Approximately 8 months (246 days).Population: All participants treated in Combination A.
Overall survival (OS) was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. OS time was summarized using the Kaplan-Meier method.
Outcome measures
| Measure |
Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
n=3 Participants
NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
|
|---|---|
|
Overall Survival (OS)
|
2.56293 months
Interval 0.59913 to
The upper limit of 95% CI can not be estimated due to small number of events.
|
SECONDARY outcome
Timeframe: Blood samples were collected on Day 1 and Day 15 in Cycle 1 and Cycle 2 for avelumab. Blood samples were collected on Day 1, Day 3, Day 4 and Day 8 in Cycle 1, Day1 and Day 8 in Cycle 2 for NKTR-214.Population: The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least one of the PK parameters of interest for avelumab, NKTR-214, IL-2, talazoparib, enzalutamide, or N-desmethyl-enzalutamide.
Cmax was defined as the maximum observed plasma concentration at the end of infusion. Ctrough was defined as the predose concentration at the end of dosing interval.
Outcome measures
| Measure |
Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
n=3 Participants
NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
|
|---|---|
|
Pharmacokinetic (PK) Parameters - Cmax and Ctrough for Avelumab and NKTR-214
|
NA ug/mL
There were no summaries and interpretations of PK results available, because N\<=3 in the PK analysis set.
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1, 2 and end of treatment (EOT).Population: The immunogenicity analysis set was a subset of the safety analysis set and included participants who had at least one ADA/nAb sample collected for avelumab, NKTR-214, or IL-2.
ADA against avelumab and NKTR-214 in serum samples was determined and reported separately for ADA never-positive, ADA ever-positive participants, baseline ADA positive, treatment-boosted ADA, treatment-induced ADA, transient ADA response, persistent ADA response. For all participants, blood for ADA samples was drawn from the contralateral arm of the avelumab and NKTR-214 infusion.
Outcome measures
| Measure |
Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
n=3 Participants
NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
|
|---|---|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) Results
|
NA Participants
ADA results were not analyzed for this study due to study termination.
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1, 2 and EOTPopulation: The immunogenicity analysis set was a subset of the safety analysis set and included participants who had at least one ADA/nAb sample collected for avelumab, NKTR-214, or IL-2.
nAb in serum samples was determined and reported separately for nAb never-positive, nAb ever-positive, baseline nAb positive, treatment-induced nAb, transient nAb response, persistent nAb response.
Outcome measures
| Measure |
Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
n=3 Participants
NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
|
|---|---|
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Number of Participants With Positive Neutralizing Antibody (nAb) Results
|
NA Participants
NAb results were not analyzed for this study due to study termination.
|
SECONDARY outcome
Timeframe: On-treatment biopsy is required to be collected on Cycle 1 between Days 9 and 14 for participants in Combination A.Population: The biomarker analysis set for biomarkers that were only measured at screening was a subset of the safety analysis set and included participants who had at least one baseline biomarker assessment.
PD-L1 expression level in baseline tumor tissue, and in on-treatment tumor tissue was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and/or inflammatory cells in regions of interest. PD-L1 expression level in baseline tumor tissue and in on-treatment tumor tissue were under pathological analyses, assisted by image analysis. Participants were classified as positive or negative according to scoring algorithms and cut-offs established from internal or external sources.
Outcome measures
| Measure |
Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
n=3 Participants
NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
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|---|---|
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PD-L1 Expression Level in Baseline and On-treatment Tumor Tissue
|
NA Participants
No biomarker data (PD-L1) were analyzed for this study due to early study termination.
|
SECONDARY outcome
Timeframe: Approximately 6 months (190 days)Population: The safety analysis set included all participants who received at least one dose of study drug.
Adverse events (AEs) were any untoward medical occurrences in a participant or clinical study participants, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent adverse events (TEAEs) were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment). A Serious Adverse Event (SAE) was defined as any untoward medical occurrence that, at any dose: a. Results in death, b. Was life-threatening, c. Required inpatient hospitalization or prolongation of existing hospitalization, d. Resulted in persistent disability/incapacity, e. Was a congenital anomaly/birth defect. Causality to study treatment was determined by the investigator.
Outcome measures
| Measure |
Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
n=3 Participants
NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
|
|---|---|
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Number of Participants With Treatment-Emergent Adverse Events(TEAEs), Serious TEAEs, TEAEs Leading to Death and Infusion-Related Reactions (IRRs) During On-treatment Period
Participants with all-causality TEAEs
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs), Serious TEAEs, TEAEs Leading to Death and Infusion-Related Reactions (IRRs) During On-treatment Period
Participants with grade ≥ 3 all-causality TEAEs
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs), Serious TEAEs, TEAEs Leading to Death and Infusion-Related Reactions (IRRs) During On-treatment Period
Participants with treatment-related TEAEs
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs), Serious TEAEs, TEAEs Leading to Death and Infusion-Related Reactions (IRRs) During On-treatment Period
Participants with grade ≥ 3 treatment-related TEAEs
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs), Serious TEAEs, TEAEs Leading to Death and Infusion-Related Reactions (IRRs) During On-treatment Period
Participants with serious all-causality TEAEs
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs), Serious TEAEs, TEAEs Leading to Death and Infusion-Related Reactions (IRRs) During On-treatment Period
Participants with serious treatment-related TEAEs
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs), Serious TEAEs, TEAEs Leading to Death and Infusion-Related Reactions (IRRs) During On-treatment Period
Participants with all-causality TEAEs leading to death
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs), Serious TEAEs, TEAEs Leading to Death and Infusion-Related Reactions (IRRs) During On-treatment Period
Participants with treatment-related TEAEs leading to death
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events(TEAEs), Serious TEAEs, TEAEs Leading to Death and Infusion-Related Reactions (IRRs) During On-treatment Period
Participants with IRRs
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 15 of each treatment cyclePopulation: The safety analysis set included all participants who received at least one dose of study drug.
Liver Function Tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBILI) were used to assess possible drug induced liver toxicity. The number of participants with at least one of the following laboratory results were summarized below: 1. (ALT ≥3 × ULN or AST ≥3 × ULN) post-baseline. 2. TBILI ≥2 × ULN post-baseline. 3. (ALP ≤2 × ULN or missing) post-baseline.
Outcome measures
| Measure |
Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
n=3 Participants
NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
|
|---|---|
|
Number of Participants With Laboratory Abnormalities With NCI-CTCAE Grade >= 3 - Safety Analysis Set
|
3 Participants
|
Adverse Events
Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
Serious adverse events
| Measure |
Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
n=3 participants at risk
NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
|
|---|---|
|
General disorders
Death
|
33.3%
1/3 • Number of events 1 • Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.
|
Other adverse events
| Measure |
Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
n=3 participants at risk
NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
|
|---|---|
|
General disorders
Asthenia
|
33.3%
1/3 • Number of events 4 • Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 7 • Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.
|
|
General disorders
General physical health deterioration
|
33.3%
1/3 • Number of events 1 • Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.
|
|
General disorders
Influenza like illness
|
33.3%
1/3 • Number of events 1 • Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
1/3 • Number of events 1 • Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 1 • Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.
|
|
Investigations
Platelet count increased
|
33.3%
1/3 • Number of events 1 • Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1 • Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
33.3%
1/3 • Number of events 1 • Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • Number of events 5 • Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
33.3%
1/3 • Number of events 1 • Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 6 • Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 2 • Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER