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Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors

A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of Combined Bempegaldesleukin (NKTR-214) and Pembrolizumab With or Without Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03138889
Acronym
PROPEL
Enrollment
162
Registered
2017-05-03
Start date
2017-06-09
Completion date
2022-08-24
Last updated
2023-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

NKTR-214, Metastatic Non-Small Cell Lung Cancer, Pembrolizumab, Keytruda®, NSCLC, Bempegaldesleukin

Brief summary

This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®) with or without chemotherapy. The study is comprised of two groups; dose optimization and dose expansion cohorts. Dose Optimization included first-line and second-line advanced or metastatic solid tumors including non-small cell lung cancer (NSCLC) The dose expansion cohort will include first-line NSCLC patients.

Detailed description

NKTR-214 is a cytokine (investigational agent) that is designed to target CD122, a protein which is found on certain immune cells (known as CD8+ T Cells and Natural Killer Cells) to expand these cells to promote their anti-tumor effects. Pembrolizumab is a programmed death receptor -1 (PD-1) blocking, fully humanized, engineered monoclonal antibody of IgG1 isotype that promotes anti-tumor effects. The study will evaluate the clinical benefit, safety and tolerability of combining NKTR-214 with pembrolizumab with or without chemotherapy. Each dose expansion cohort will enroll approximately 100 new patients. Dose Optimization evaluated an every three-week dose regimen (q3w) of NKTR-214 in combination with pembrolizumab given that the optimal dose and dosing schedule of NKTR-214 in combination with pembrolizumab remains unknown. The previously established recommended Phase 2 dose (0.006 mg/kg) of NKTR-214 was studied in combination with nivolumab. Dose Expansion: NKTR-214 in combination with pembrolizumab will be evaluated in first-line non-small cell lung cancer (NSCLC). The NKTR-214 dose to be studied is 0.006 mg/kg q3w. This dose is based on the recommended phase 2 dose noted in the monotherapy trial with NKTR-214 (Study 15-214-01, NCT02869295) and an ongoing combination trial (16-214-02, NCT02983045). Pembrolizumab will be administered at a dose of 200mg q3w. Following data review for safety and efficacy, additional patients may be dosed using the findings from the dose optimization cohorts.

Interventions

DRUGNKTR-214

NKTR-214: The dose will be 0.008 mg/kg intravenous (IV) infusion administered over 30 (± 5) minutes q3w. The maximum dose of NKTR-214 will be 0.012 mg/kg. This will include a fixed 3+3 dose escalation followed by intra-patient step-up dose escalation based on tolerability.

DRUGPembrolizumab

Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.

DRUGCisplatin

Cisplatin will be dosed per the pharmacy manual

DRUGCarboplatin

Carboplatin will be dosed per the pharmacy manual

DRUGNab paclitaxel

Nab-paclitaxel will be dosed per local practice and label

DRUGPaclitaxel

Paclitaxel will be dosed per local practice and label

DRUGPemetrexed

Pemetrexed will be dosed per the pharmacy manual

DRUGAtezolizumab

Atezolizumab will be dosed per current label indication

Sponsors

Nektar Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Dose Optimization and Dose Expansion Inclusion Criteria: * Willing and able to provide written informed consent. * Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF). * Life expectancy \> 12 weeks from the time of enrollment as determined by the Investigator. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Oxygen saturation ≥ 92% on room air for all indications. * Measurable disease per RECIST 1.1. * Patients with brain metastases are eligible if certain criteria are met. * Availability of fresh or archival tumor tissue * Patients must have a minimum of 6 months of response to any nonpalliative cancer-directed treatment Dose Expansion Inclusion Criteria (Non-Small Cell Lung Cancer): * Histologically confirmed diagnosis of stage IV NSCLC. * Patients must have a minimum of 6 months of response to any nonpalliative cancer-directed treatment. * Patients with actionable mutations with approved targeted therapy in NSCLC are excluded. Testing for mutations should be performed per standard of care. * Must not have received anti-cancer therapy for treatment of metastatic lung cancer * Must not have received prior immunotherapy

Exclusion criteria

* Use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug(s). * Females who are pregnant or breastfeeding. * Patients who have an active autoimmune disease * History of allergy or hypersensitivity to study drug components * Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis. * Prior surgery or radiotherapy within 14 days of therapy. * For Dose Optimization Cohort 1 only: Chemotherapy or biological therapy within 28 days of enrollment. Targeted therapy (e.g., tyrosine kinase inhibitors) within 14 days of enrollment. Patients with ongoing AEs related to prior cancer therapies will be excluded. * Participant's inability to adhere to or tolerate protocol or study procedures NOTE: Other protocol defined Inclusion/

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Experiencing Dose-Limiting Toxicities in Dose Optimization Cohort 1aDLTs were assessed at 21 days from Cycle 1DLTs were assesses in the Dose Optimization Cohort 1 a, which had doses of NKTR-214 as 0.008 mg/kg, 0.010 mg/kg, and 0.012 m/kg, I combination with pembrolizumab at 200 mg. A single DLT (hypotension) was reported in 1 patient in dose optimization Cohort 1a.
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.AEs reported starting immediately after first dose of study drug(s) until 100 days after the last dose of all study drugs, up to approximately 28 months.Safety and Tolerability of NKTR-214 (starting at dose of 0.008 mg/kg) in combination with pembrolizumab (Keytruda®) as evaluated by incidence of drug-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to drug discontinuation, and fatal AEs.
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by RECIST 1.1 of NKTR-214 Plus Pembrolizumab for Dose Expansion Cohorts 2 and 3.Until disease progression, death, unacceptable toxicity, symptomatic deterioration, Investigator's decision to discontinue treatment, patient withdrew consent or lost to follow-up, or study terminated by Sponsor; or until maximum of 2 years.ORR per BICR by RECIST 1.1 for the Response Evaluable Population dose expansion Cohorts 2 and 3. ORR is defined as the proportion of enrolled participants who achieved a Best Overall Response (BOR) of CR or PR. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR. The Response Evaluable Population was subjects who received at least 1 dose (or partial dose) of study drug, had measurable disease (per RECIST 1.1) at baseline, and had at least 1 post-baseline assessment of tumor response.
Objective Response Rate (ORR) Per Investigator's Assessment by RECIST 1.1 of NKTR-214 at a Dose of 0.006 mg/kg With Pembrolizumab and Platinum-based Chemotherapy for Dose Expansion Cohorts 4+5.Until disease progression, death, unacceptable toxicity, symptomatic deterioration, Investigator's decision to discont. treatment, patient withdrew consent or lost to follow-up, or study terminated by Sponsor; or until maximum of 2 years.ORR per Investigator's Assessment\* by RECIST 1.1 for the Response Evaluable Population dose expansion Cohorts 4 +5. The Response Evaluable Population was subjects who received at least 1 dose (or partial dose) of study drug, had measurable disease (per RECIST 1.1) at baseline, and had at least 1 post-baseline assessment of tumor response. Objective response is the sum of confirmed complete response and confirmed partial response. \*Efficacy endpoint for Cohort 4 +5 is per Investigator's Assessment due to the early termination of the study and incompleteness of BICR data for these cohorts.

Countries

Australia, France, Germany, Spain, United States

Participant flow

Participants by arm

ArmCount
Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Pembro (200 mg)
NKTR-214 (0.006 mg/kg) every 3 weeks (q3w) + pembrolizumab 200 mg NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
12
Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Atezo (1200 mg)
NKTR-214 (0.006 mg/kg) every 3 weeks (q3w) + atezolizumab 1200 mg NKTR-214: Specified dose on specified days Atezolizumab: Specified dose on specified days
23
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)
NKTR-214 (0.008 mg/kg) q3w + pembrolizumab (200 mg) NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
4
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
NKTR-214 (0.010 mg/kg) q3w + pembrolizumab (200 mg) NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
7
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)
NKTR-214 (0.012 mg/kg) q3w + pembrolizumab (200 mg) NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
7
Dose Expansion Cohort 2: NKTR-214 (0.006 mg/kg) + Pembro (200 mg)
NKTR-214 (0.006 mg/kg) + pembrolizumab (200 mg) NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
75
Dose Expansion Cohort 3: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)
NKTR-214 (0.010 mg/kg) + pembrolizumab (200 mg) NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
17
Dose Expansion Cohorts 4/5: NKTR-214 (0.006 mg/kg) + Pembro (200 mg) + Chemotherapy
NKTR-214 (0.006 mg/kg) + pembrolizumab (200 mg) + chemotherapy NKTR-214: Specified dose on specified days Pembrolizumab: Specified dose on specified days
17
Total162

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007
Overall StudyWithdrawal by Subject55021301

Baseline characteristics

CharacteristicCohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Atezo (1200 mg)Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 (0.006 mg/kg) + Pembro (200 mg)Dose Expansion Cohort 2: NKTR-214 (0.006 mg/kg) + Pembro (200 mg)Dose Expansion Cohort 3: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)Dose Expansion Cohorts 4/5: NKTR-214 (0.006 mg/kg) + Pembro (200 mg) + ChemotherapyTotal
Age, Customized
Age < 65
11 participants2 participants3 participants3 participants5 participants35 participants6 participants9 participants74 participants
Age, Customized
Age 65-84
12 participants2 participants4 participants4 participants6 participants40 participants11 participants8 participants87 participants
Age, Customized
Age 85 and Over
0 participants0 participants0 participants0 participants1 participants0 participants0 participants0 participants1 participants
ECOG
ECOG 0
11 Participants3 Participants2 Participants5 Participants7 Participants33 Participants8 Participants6 Participants75 Participants
ECOG
ECOG 1
12 Participants1 Participants5 Participants2 Participants5 Participants42 Participants9 Participants11 Participants87 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants0 Participants0 Participants0 Participants0 Participants3 Participants0 Participants0 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants4 Participants7 Participants7 Participants11 Participants65 Participants17 Participants14 Participants144 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants0 Participants0 Participants1 Participants7 Participants0 Participants3 Participants13 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
2 Participants0 Participants0 Participants0 Participants1 Participants2 Participants1 Participants1 Participants7 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants1 Participants3 Participants
Race (NIH/OMB)
White
21 Participants4 Participants7 Participants6 Participants10 Participants72 Participants16 Participants15 Participants151 Participants
Region of Enrollment
France
0 participants0 participants0 participants0 participants0 participants1 participants0 participants0 participants1 participants
Region of Enrollment
Germany
0 participants0 participants0 participants0 participants0 participants16 participants2 participants2 participants20 participants
Region of Enrollment
Italy
0 participants0 participants0 participants0 participants0 participants1 participants0 participants0 participants1 participants
Region of Enrollment
Spain
0 participants0 participants0 participants0 participants0 participants32 participants12 participants0 participants44 participants
Region of Enrollment
United States
23 participants4 participants7 participants7 participants12 participants25 participants3 participants15 participants96 participants
Sex: Female, Male
Female
6 Participants2 Participants4 Participants5 Participants5 Participants24 Participants4 Participants7 Participants57 Participants
Sex: Female, Male
Male
17 Participants2 Participants3 Participants2 Participants7 Participants51 Participants13 Participants10 Participants105 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
4 / 1218 / 233 / 42 / 75 / 739 / 755 / 172 / 17
other
Total, other adverse events
12 / 1223 / 234 / 47 / 77 / 774 / 7516 / 1716 / 17
serious
Total, serious adverse events
5 / 1214 / 232 / 44 / 72 / 730 / 7510 / 178 / 17

Outcome results

Primary

Number of Participants Experiencing Dose-Limiting Toxicities in Dose Optimization Cohort 1a

DLTs were assesses in the Dose Optimization Cohort 1 a, which had doses of NKTR-214 as 0.008 mg/kg, 0.010 mg/kg, and 0.012 m/kg, I combination with pembrolizumab at 200 mg. A single DLT (hypotension) was reported in 1 patient in dose optimization Cohort 1a.

Time frame: DLTs were assessed at 21 days from Cycle 1

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)Number of Participants Experiencing Dose-Limiting Toxicities in Dose Optimization Cohort 1aAt least 1 DLT0 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)Number of Participants Experiencing Dose-Limiting Toxicities in Dose Optimization Cohort 1aVascular Disorders: Hypotension0 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)Number of Participants Experiencing Dose-Limiting Toxicities in Dose Optimization Cohort 1aAt least 1 DLT1 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)Number of Participants Experiencing Dose-Limiting Toxicities in Dose Optimization Cohort 1aVascular Disorders: Hypotension1 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)Number of Participants Experiencing Dose-Limiting Toxicities in Dose Optimization Cohort 1aAt least 1 DLT0 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)Number of Participants Experiencing Dose-Limiting Toxicities in Dose Optimization Cohort 1aVascular Disorders: Hypotension0 Participants
Primary

Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.

Safety and Tolerability of NKTR-214 (starting at dose of 0.008 mg/kg) in combination with pembrolizumab (Keytruda®) as evaluated by incidence of drug-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to drug discontinuation, and fatal AEs.

Time frame: AEs reported starting immediately after first dose of study drug(s) until 100 days after the last dose of all study drugs, up to approximately 28 months.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One TEAE4 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One Serious TEAE2 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One TEAE Leading to Death0 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One TEAE Leading to Drug Discontinuation2 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One Serious TEAE4 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One TEAE Leading to Death0 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One TEAE Leading to Drug Discontinuation3 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One TEAE7 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One TEAE Leading to Death0 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One Serious TEAE2 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One TEAE Leading to Drug Discontinuation1 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.012 mg/kg) + Pembro (200 mg)Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One TEAE7 Participants
TotalNumber of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One TEAE Leading to Drug Discontinuation6 Participants
TotalNumber of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One Serious TEAE8 Participants
TotalNumber of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One TEAE18 Participants
TotalNumber of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.Subjects Reporting at Least One TEAE Leading to Death0 Participants
Primary

Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by RECIST 1.1 of NKTR-214 Plus Pembrolizumab for Dose Expansion Cohorts 2 and 3.

ORR per BICR by RECIST 1.1 for the Response Evaluable Population dose expansion Cohorts 2 and 3. ORR is defined as the proportion of enrolled participants who achieved a Best Overall Response (BOR) of CR or PR. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR. The Response Evaluable Population was subjects who received at least 1 dose (or partial dose) of study drug, had measurable disease (per RECIST 1.1) at baseline, and had at least 1 post-baseline assessment of tumor response.

Time frame: Until disease progression, death, unacceptable toxicity, symptomatic deterioration, Investigator's decision to discontinue treatment, patient withdrew consent or lost to follow-up, or study terminated by Sponsor; or until maximum of 2 years.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by RECIST 1.1 of NKTR-214 Plus Pembrolizumab for Dose Expansion Cohorts 2 and 3.13 Participants
Dose Optimization Cohort 1a: NKTR-214 (0.010 mg/kg) + Pembro (200 mg)Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by RECIST 1.1 of NKTR-214 Plus Pembrolizumab for Dose Expansion Cohorts 2 and 3.2 Participants
Primary

Objective Response Rate (ORR) Per Investigator's Assessment by RECIST 1.1 of NKTR-214 at a Dose of 0.006 mg/kg With Pembrolizumab and Platinum-based Chemotherapy for Dose Expansion Cohorts 4+5.

ORR per Investigator's Assessment\* by RECIST 1.1 for the Response Evaluable Population dose expansion Cohorts 4 +5. The Response Evaluable Population was subjects who received at least 1 dose (or partial dose) of study drug, had measurable disease (per RECIST 1.1) at baseline, and had at least 1 post-baseline assessment of tumor response. Objective response is the sum of confirmed complete response and confirmed partial response. \*Efficacy endpoint for Cohort 4 +5 is per Investigator's Assessment due to the early termination of the study and incompleteness of BICR data for these cohorts.

Time frame: Until disease progression, death, unacceptable toxicity, symptomatic deterioration, Investigator's decision to discont. treatment, patient withdrew consent or lost to follow-up, or study terminated by Sponsor; or until maximum of 2 years.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Dose Optimization Cohort 1a: NKTR-214 (0.008 mg/kg) + Pembro (200 mg)Objective Response Rate (ORR) Per Investigator's Assessment by RECIST 1.1 of NKTR-214 at a Dose of 0.006 mg/kg With Pembrolizumab and Platinum-based Chemotherapy for Dose Expansion Cohorts 4+5.2 Participants

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026