Trial Outcomes & Findings for NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC (NCT NCT04984811)
NCT ID: NCT04984811
Last Updated: 2026-06-11
Results Overview
The percentage of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR), per RECIST 1.1 and iRECIST as determined by the investigator. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Furthermore, the appearance of one or more new lesions is also considered progression). Under iRECIST, tumor response is classified as immune Complete Response (iCR) or immune Partial Response (iPR) using the same size thresholds as RECIST 1.1.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
Results posted on
2026-06-11
Participant Flow
A total of 33 participants were enrolled in the United States from November 2021 to March 2024 due to early termination decision.
This was a multicenter, open-label, single-arm Phase 2 study.
Participant milestones
| Measure |
NT-I7 and Atezoliaumab (Phase 2, Single Arm)
Participants received NT-I7 in combination with atezolizumab.
1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1, and 1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. On days where both drugs are given, atezolizumab was given prior to NT-I7. The treatment continued up to a maximum of 35 cycles (approximately 2 years).
One treatment cycle is defined as 21 days (3 weeks).
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
Baseline characteristics by cohort
| Measure |
NT-I7 and Atezoliaumab (Phase 2, Single Arm)
n=33 Participants
Participants received NT-I7 in combination with atezolizumab.
1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1, and 1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. On days where both drugs are given, atezolizumab was given prior to NT-I7. The treatment continued up to a maximum of 35 cycles (approximately 2 years).
One treatment cycle is defined as 21 days (3 weeks).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
|
Weight
|
68.1 killograms
n=20 Participants
|
PRIMARY outcome
Timeframe: The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).Population: Efficacy Evaluable Population: Subjects were required to complete at least Cycle 1 treatment and at least one post-baseline tumor scan to be considered evaluable.
The percentage of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR), per RECIST 1.1 and iRECIST as determined by the investigator. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Furthermore, the appearance of one or more new lesions is also considered progression). Under iRECIST, tumor response is classified as immune Complete Response (iCR) or immune Partial Response (iPR) using the same size thresholds as RECIST 1.1.
Outcome measures
| Measure |
NT-I7 and Atezoliaumab (Phase 2, Single Arm)
n=25 Participants
Participants received NT-I7 in combination with atezolizumab.
1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1, and 1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. On days where both drugs are given, atezolizumab was given prior to NT-I7. The treatment continued up to a maximum of 35 cycles (approximately 2 years).
One treatment cycle is defined as 21 days (3 weeks).
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|---|---|
|
Objective Response Rate (ORR)
Objective Response Rate (ORR) RECIST 1.1
|
6 Participants
|
|
Objective Response Rate (ORR)
Objective Response Rate (ORR) iRECIST
|
6 Participants
|
SECONDARY outcome
Timeframe: The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).Population: Efficacy Evaluable Population: Subjects were required to complete at least Cycle 1 treatment and at least one post-baseline tumor scan to be considered evaluable.
Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST 1.1 and iRECIST as determined by the investigator. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Furthermore, the appearance of one or more new lesions is also considered progression). Under iRECIST, tumor response is classified as immune Complete Response (iCR) or immune Partial Response (iPR) using the same size thresholds as RECIST 1.1.
Outcome measures
| Measure |
NT-I7 and Atezoliaumab (Phase 2, Single Arm)
n=6 Participants
Participants received NT-I7 in combination with atezolizumab.
1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1, and 1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. On days where both drugs are given, atezolizumab was given prior to NT-I7. The treatment continued up to a maximum of 35 cycles (approximately 2 years).
One treatment cycle is defined as 21 days (3 weeks).
|
|---|---|
|
Duration of Response (DoR)
DoR per RECIST 1.1
|
15.6 months
Interval 4.1 to
The median and/or its confidence intervals could not be estimated due to the limited number of events among responders.
|
|
Duration of Response (DoR)
DoR per iRECIST
|
23.7 months
Interval 10.3 to
The median and/or its confidence intervals could not be estimated due to the limited number of events among responders.
|
SECONDARY outcome
Timeframe: The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).Population: Efficacy Evaluable Population: Subjects were required to complete at least Cycle 1 treatment and at least one post-baseline tumor scan to be considered evaluable.
The proportion of subjects with a best overall response of CR, PR or SD, per RECIST 1.1 and iRECIST as determined by the investigator.
Outcome measures
| Measure |
NT-I7 and Atezoliaumab (Phase 2, Single Arm)
n=25 Participants
Participants received NT-I7 in combination with atezolizumab.
1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1, and 1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. On days where both drugs are given, atezolizumab was given prior to NT-I7. The treatment continued up to a maximum of 35 cycles (approximately 2 years).
One treatment cycle is defined as 21 days (3 weeks).
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|---|---|
|
Disease Control Rate (DCR)
Disease Control Rate (DCR) by RECIST 1.1
|
20 Participants
|
|
Disease Control Rate (DCR)
Disease Control Rate (DCR) by iRECIST
|
20 Participants
|
SECONDARY outcome
Timeframe: The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).Population: Efficacy Evaluable Population: Subjects were required to complete at least Cycle 1 treatment and at least one post-baseline tumor scan to be considered evaluable.
The time from the first study treatment (Cycle 1, Day 1) to the first occurrence of progression or death from any cause, whichever occurs first, per RECIST 1.1 and iRECIST as determined by the investigator. Progression is defined using RECIST 1.1 as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Furthermore, the appearance of one or more new lesions is also considered progression. Under iRECIST, initial progression is classified as immune unconfirmed progressive disease (iUPD). Progression is confirmed as immune confirmed progressive disease (iCPD) if a subsequent assessment (proportionately 4-8 weeks later) shows a further increase in tumor burden (an additional 5 mm increase in the sum of diameters of target or new lesions, or further progression of non-target lesions) or the appearance of additional new lesions.
Outcome measures
| Measure |
NT-I7 and Atezoliaumab (Phase 2, Single Arm)
n=25 Participants
Participants received NT-I7 in combination with atezolizumab.
1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1, and 1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. On days where both drugs are given, atezolizumab was given prior to NT-I7. The treatment continued up to a maximum of 35 cycles (approximately 2 years).
One treatment cycle is defined as 21 days (3 weeks).
|
|---|---|
|
Progression Free Survival (PFS)
PFS per RECIST 1.1
|
6.3 months
Interval 1.8 to 7.3
|
|
Progression Free Survival (PFS)
PFS per iRECIST
|
10.0 months
Interval 5.5 to 22.3
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Efficacy Evaluable Population: Subjects were required to complete at least Cycle 1 treatment and at least one post-baseline tumor scan to be considered evaluable.
The time from first study treatment (Cycle 1, Day 1) to death from any cause.
Outcome measures
| Measure |
NT-I7 and Atezoliaumab (Phase 2, Single Arm)
n=25 Participants
Participants received NT-I7 in combination with atezolizumab.
1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1, and 1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. On days where both drugs are given, atezolizumab was given prior to NT-I7. The treatment continued up to a maximum of 35 cycles (approximately 2 years).
One treatment cycle is defined as 21 days (3 weeks).
|
|---|---|
|
Overall Survival (OS)
|
22.3 months
Interval 6.8 to
The median and/or its confidence intervals could not be estimated due to the limited number of events.
|
Adverse Events
NT-I7 and Atezoliaumab (Phase 2, Single Arm)
Serious events: 24 serious events
Other events: 32 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
NT-I7 and Atezoliaumab (Phase 2, Single Arm)
n=33 participants at risk
Participants received NT-I7 in combination with atezolizumab.
1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1, and 1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. On days where both drugs are given, atezolizumab was given prior to NT-I7. The treatment continued up to a maximum of 35 cycles (approximately 2 years).
One treatment cycle is defined as 21 days (3 weeks).
Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Cardiac disorders
Acute myocardial infarction
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Cardiac disorders
Atrial fibrillation
|
6.1%
2/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Cardiac disorders
Cardiac arrest
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Cardiac disorders
Myocardial infarction
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Cardiac disorders
Myocarditis
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
General disorders
Death
|
9.1%
3/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
General disorders
Injection site erythema
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
General disorders
Injection site pain
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
General disorders
Injection site pruritus
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
General disorders
Injection site swelling
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
General disorders
Injection site warmth
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
General disorders
Non-cardiac chest pain
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
General disorders
Sudden death
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Infections and infestations
COVID-19 pneumonia
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Infections and infestations
Intervertebral discitis
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Infections and infestations
pneumonia
|
9.1%
3/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Infections and infestations
Pyelonephritis acute
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
12.1%
4/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Nervous system disorders
Ischaemic stroke
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Nervous system disorders
Neurotoxicity
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Nervous system disorders
Toxic encephalopathy
|
4.2%
1/24 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Nervous system disorders
Oliguria
|
4.2%
1/24 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
3/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Vascular disorders
Peripheral artery occlusion
|
3.0%
1/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
Other adverse events
| Measure |
NT-I7 and Atezoliaumab (Phase 2, Single Arm)
n=33 participants at risk
Participants received NT-I7 in combination with atezolizumab.
1200 μg/kg NT-I7 administered intramuscularly (IM) once every 6 weeks (Q6W) starting on Cycle 1, and 1200 mg atezolizumab administered intravenously (IV) once every 3 weeks (Q3W) starting on Cycle 1. On days where both drugs are given, atezolizumab was given prior to NT-I7. The treatment continued up to a maximum of 35 cycles (approximately 2 years).
One treatment cycle is defined as 21 days (3 weeks).
Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
18.2%
6/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Gastrointestinal disorders
Dry mouth
|
6.1%
2/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
2/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
3/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
6/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
General disorders
Chills
|
6.1%
2/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
General disorders
Fatigue
|
51.5%
17/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
General disorders
Influenza like illness
|
12.1%
4/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
General disorders
Injection site pruritus
|
12.1%
4/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
General disorders
Injection site rash
|
9.1%
3/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
General disorders
Oedema peripheral
|
9.1%
3/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Infections and infestations
Oral candidiasis
|
9.1%
3/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Infections and infestations
Urinary tract infection
|
12.1%
4/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
9.1%
3/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Investigations
Alanine aminotransferase increased
|
15.2%
5/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Investigations
Aspartate aminotransferase increased
|
15.2%
5/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.1%
3/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Investigations
Weight decreased
|
6.1%
2/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.1%
4/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.1%
2/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.1%
2/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.1%
2/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.1%
2/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.2%
5/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.1%
4/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.1%
3/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.1%
2/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Nervous system disorders
Dizziness
|
6.1%
2/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Nervous system disorders
Dysgeusia
|
6.1%
2/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Nervous system disorders
Headache
|
9.1%
3/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Psychiatric disorders
Insomnia
|
6.1%
2/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.2%
5/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
27.3%
9/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.1%
2/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.1%
4/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.1%
3/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.1%
2/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.1%
3/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.3%
10/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
3/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
24.2%
8/33 • Up to 2 years and 3 months
TEAEs are defined as AEs that start on or after the first administration of the study treatment and up to 90 days following the last administration of the study treatment. Note: Regarding the AE term "Death," sites were asked to update it to the corresponding adverse event leading to death. The sites reported they were unable to provide additional details, as no further information was available.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place