TerminatedNCT03435640REVEALUpdated Mar 8, 2023Results posted

REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies

A Phase 1/2 interventional study of NKTR-262 and bempegaldesleukin in Melanoma, Merkel Cell Carcinoma and Triple Negative Breast Cancer, sponsored by Nektar Therapeutics. Terminated at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by Nektar Therapeutics · Phase 1/2, Interventional, and Treatment

Why this study was terminated

Based on the overall results from the Phase 1 part of the study the sponsor decided to end the study. The decision was not due to safety reasons.

Phase: Phase 1/2
Study type: Interventional
Enrollment: 64
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

Patients received intratumoral (IT) injections of NKTR-262 in 3-week cycles for up to 3 cycles; bempegaldesleukin with or without nivolumab was administered every 3 weeks (q3w), and treatment continued until unacceptable toxicity, death, or disease progression per RECIST 1.1. Based on Phase 1 results of the study, the decision was made not to start the Phase 2 part of the study and the study was terminated.

Read the detailed description

Cancer treatments that couple pharmacological activation of tumor antigen presentation with activation and expansion of CD8+ T and natural killer (NK) cells in the tumor environment have the potential to induce an effective anti-tumor immune response in patients. NKTR-262 is a small molecule agonist of toll-like receptors (TLRs) 7/8 designed to be retained in the tumor micro-environment in order to activate antigen-presenting cells (APC), such as dendritic cells, to create new antigen-specific cytotoxic T cells. As a CD122-biased agonist, bempegaldesleukin monotherapy increases newly proliferative CD8+ T cells in tumors. NKTR-262 plus bempegaldesleukin is expected to increase expansion of antigen-specific CD8+ T cells. In preclinical studies, a single IT injection of NKTR-262 plus IV bempegaldesleukin resulted in complete abscopal effects in tumor models. Preliminary clinical data show bempegaldesleukin plus nivolumab enhances immune-stimulatory responses. The REVEAL trial will assess safety and anti-tumor activity of NKTR-262 with bempegaldesleukin +/- nivolumab for the treatment of selected cancers.

Melanoma (1st-line and relapsed/refractory)
Merkel Cell Carcinoma (2nd-line and relapsed/refractory)
Triple Negative Breast Cancer (1st- and 2nd-line and relapsed/refractory)
Renal Cell Carcinoma (1st-line and relapsed/refractory)
Colorectal Cancer (2nd-line and relapsed/refractory; MSI non-high)
Colorectal Cancer (2nd 3rd-line+, I-O therapy naive; relapsed/refractory; MSI high)
Head and Neck Squamous Cell Carcinoma (2nd-line and relapsed/refractory)
Sarcoma (2nd-line and relapsed/refractory)

Conditions studied

Melanoma
Merkel Cell Carcinoma
Triple Negative Breast Cancer
Head and Neck Squamous Cell Carcinoma
Renal Cell Carcinoma
Colorectal Cancer
Sarcoma

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Keywords

Bempegaldesleukin (NKTR-214)
NKTR-262
Nivolumab
Opdivo®
Metastatic
Locally advanced
Relapsed/Refractory
TLR7/8
CD122

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

Histologically confirmed diagnosis of a locally advanced (not amenable to curative therapy such as surgical resection) metastatic cancer of the following histologies: melanoma (MEL), Merkel cell carcinoma (MCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC), colorectal cancer, head and neck squamous cell carcinoma (HNSCC), or sarcoma.
Life expectancy > 12 weeks as determined by the Investigator.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Measurable disease per RECIST 1.1.
Patients enrolled in Cohorts 1-10, Cohort A, Cohort B and Phase 2 Doublet must be refractory to all therapies known to confer clinical benefit to their disease.
Fresh tumor tissue available for cellular characterization and programmed cell death protein 1 (PD-L1) status.
Injected lesions (up to two) must be between 20 mm and 90 mm in diameter for IT injection; lesions must be accessible for baseline and on-treatment biopsies. Any liver lesion targeted for injection must not exceed 50 mm at the time of injection.
Demonstrated adequate organ function within 14 days of Cycle 1 Day 1 (C1D1).

Key Exclusion Criteria:

Use of an investigational agent or an investigational device within 21 days before administration of first dose of study drug(s).
Patients treated with prior interleukin-2 (IL-2).
Patients who have been previously treated with a toll-like receptor (TLR) agonist (excluding topical agents) and patients who have received experimental cancer vaccines.
Patients who have received systemic interferon (IFN)α within the previous 6 months prior to enrollment to the study.
Other active malignancy, except non-melanomic skin cancer
Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
Prior surgery or radiotherapy within 14 days of initiating study drug(s). Patients must have recovered from all radiation-related toxicities, not required corticosteroids and have not had radiation pneumonitis.
Prolonged Fridericia's corrected QT interval (QTcF) > 450 ms for men and > 470 ms for women at Screening.

History of unstable or deteriorating cardiac disease within the previous 6 months prior to screening including but not limited to the following:

Unstable angina or myocardial infarction.
Congestive heart failure (NYHA Class III or IV).
Uncontrolled clinically significant arrhythmias.
Patients with a history of any retinal disorders (e.g., retinal detachment, diabetic retinopathy, retinal hemorrhage, macular degeneration).
Uveal melanoma will be excluded
Patients with tumor that invade the superior vena cava or other major blood vessels.

Additional general and tumor specific inclusion and exclusion criteria will apply.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 64 participants (actual)

Study arms

Experimental
NKTR-262 + bempegaldesleukin or + bempegaldesleukin with nivolumab
Phase 1: NKTR-262 in escalating doses, combined with bempegaldesleukin. The goal of this dose escalation part of the study is to establish a recommended Phase 1b dose for NKTR-262 + bempegaldesleukin with nivolumab, followed by a dose-confirmation cohort.
Drug: NKTR-262 · Drug: bempegaldesleukin · Drug: nivolumab

Interventions

DrugNKTR-262
During Phase 1 Doublet: Patients receive escalating doses of NKTR-262 IT (starting dose 0.03 mg) in 3-week treatment cycles. During Phase 1 Doublet (Cohort A), Phase 2 Doublet: Patients were to receive the RP2D of NKTR-262. During Phase 1 Triplet (Cohort B), and Phase 2 Triplet: Patients receive the RP2D of NKTR-262.
Drugbempegaldesleukin
During Phase 1 Doublet (Cohort A), and proposed Phase 2 Doublet: Patients receive 0.006 mg/kg bempegaldesleukin administered in 3-week treatment cycles. During Phase 1 Triplet (Cohort B), and proposed Phase 2 Triplet: Patients receive 0.006 mg/kg bempegaldesleukin administered in 3-week treatment cycles.
Also known as: NKTR-214
Drugnivolumab
During Phase 1 Triplet (Cohort B), and proposed Phase 2 Triplet: Patients receive a nivolumab flat dose of 360 mg administered in 3-week treatment cycles.
Also known as: Opdivo®

What researchers measure

Primary outcomes

Number of Participants Experiencing Dose-Limiting Toxicities (DLTS)
DLTs were assessed in Cohort 1 through Cohort 9, which had dose levels of NKTR-262 as 0.03mg, 0.06mg, 0.06mg, 0.12mg, 0.24mg, 0.48mg, 0.96mg, 1.92mg, and 3.84mg in combination with bempegaldesleukin (bempeg). There was only 1 DLT that occurred in one of the Cohort 9 patients. Therefore, the maximum tolerated dose (MTD) of NKTR 262 was not reached.
Time frame: The DLT window is 21 days following NKTR-262 single agent administration (Cycle 1) and an additional 9 days when combined with bempeg for staggered dosing administration (Cohorts 1 and 2), or 7 days for the same day administration (Cohort 3 and higher).
Objective Response Rate (ORR) Per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D)
Objective Response Rate (ORR) per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by Blinded Independent Central Review (BICR).
Time frame: From Cycle 1 Day 1 to 100 days after the last dose of study drug or the date for new anti-cancer therapy, whichever is earlier.

Results

Posted Mar 8, 2023

Participant flow

Participant flow — Overall Study
Milestone	Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
Started	3	3	4	3	4	4	4	3	8	14	14
Completed	3	2	3	1	4	4	1	3	8	12	11
Not completed	0	1	1	2	0	0	3	0	0	2	3
Withdrew: Withdrawal by subject	0	1	0	2	0	0	3	0	0	2	3
Withdrew: Lost to follow-up	0	0	1	0	0	0	0	0	0	0	0

Outcome measures

PrimaryNumber of Participants Experiencing Dose-Limiting Toxicities (DLTS)

DLTs were assessed in Cohort 1 through Cohort 9, which had dose levels of NKTR-262 as 0.03mg, 0.06mg, 0.06mg, 0.12mg, 0.24mg, 0.48mg, 0.96mg, 1.92mg, and 3.84mg in combination with bempegaldesleukin (bempeg). There was only 1 DLT that occurred in one of the Cohort 9 patients. Therefore, the maximum tolerated dose (MTD) of NKTR 262 was not reached.

Time frame:: The DLT window is 21 days following NKTR-262 single agent administration (Cycle 1) and an additional 9 days when combined with bempeg for staggered dosing administration (Cohorts 1 and 2), or 7 days for the same day administration (Cohort 3 and higher).
Reported as:: Count of participants · Participants

Number of Participants Experiencing Dose-Limiting Toxicities (DLTS)
Participants	Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
Number of Participants Experiencing Dose-Limiting Toxicities (DLTS)	0	0	0	0	0	0	0	0	1	0	0

PrimaryObjective Response Rate (ORR) Per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D)

Objective Response Rate (ORR) per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by Blinded Independent Central Review (BICR).

Time frame:: From Cycle 1 Day 1 to 100 days after the last dose of study drug or the date for new anti-cancer therapy, whichever is earlier.
Reported as:: Number · percentage of participants

Objective Response Rate (ORR) Per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D)
percentage of participants	Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
Objective Response Rate (ORR) Per RECIST 1.1 in Cohort A and Cohort B at Recommended Phase 2 Dose (RP2D)	0 (0.0 to 23.2)	14.3 (1.8 to 42.8)

Adverse events

Collected over 4 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)	2/3 (66.7%)	1/3 (33.3%)	3/3 (100%)
Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)	2/3 (66.7%)	1/3 (33.3%)	3/3 (100%)
Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)	3/4 (75%)	1/4 (25%)	4/4 (100%)
Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)	1/3 (33.3%)	1/3 (33.3%)	3/3 (100%)
Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)	4/4 (100%)	1/4 (25%)	4/4 (100%)
Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)	4/4 (100%)	1/4 (25%)	4/4 (100%)
Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)	1/4 (25%)	1/4 (25%)	4/4 (100%)
Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)	2/3 (66.7%)	3/3 (100%)	3/3 (100%)
Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	5/8 (62.5%)	3/8 (37.5%)	8/8 (100%)
Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	9/14 (64.3%)	2/14 (14.3%)	14/14 (100%)
Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab	5/14 (35.7%)	5/14 (35.7%)	14/14 (100%)

Most frequent serious events

Showing 10 of 33

Most frequent serious events
Event	Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
SyncopeNervous system disorders	0/3	0/3	0/4	0/3	0/4	0/4	0/4	1/3	0/8	1/14	0/14
Cerebral infarctionNervous system disorders	0/3	0/3	0/4	0/3	0/4	0/4	0/4	1/3	0/8	0/14	0/14
Haemorrhage intracranialNervous system disorders	1/3	0/3	0/4	0/3	0/4	0/4	0/4	0/3	0/8	0/14	0/14
Upper gastrointestinal haemorrhageGastrointestinal disorders	0/3	1/3	0/4	0/3	0/4	0/4	0/4	0/3	0/8	0/14	0/14
AnaemiaBlood and lymphatic system disorders	1/3	0/3	0/4	0/3	0/4	0/4	0/4	0/3	0/8	0/14	1/14
PneumothoraxRespiratory, thoracic and mediastinal disorders	0/3	0/3	0/4	0/3	0/4	0/4	0/4	1/3	0/8	0/14	0/14
Cytokine release syndromeImmune system disorders	0/3	0/3	0/4	0/3	0/4	0/4	0/4	1/3	0/8	0/14	0/14
Amylase increasedInvestigations	0/3	0/3	0/4	1/3	0/4	0/4	0/4	0/3	0/8	0/14	0/14
Lipase increasedInvestigations	0/3	0/3	0/4	1/3	0/4	0/4	0/4	0/3	0/8	0/14	0/14
NephrolithiasisRenal and urinary disorders	0/3	0/3	0/4	0/3	0/4	0/4	0/4	1/3	0/8	0/14	0/14

Most frequent other events

Showing 10 of 245

Most frequent other events
Event	Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab
FatigueGeneral disorders	2/3	3/3	2/4	1/3	3/4	2/4	3/4	1/3	4/8	8/14	6/14
PyrexiaGeneral disorders	0/3	2/3	2/4	1/3	2/4	2/4	2/4	3/3	2/8	2/14	9/14
NauseaGastrointestinal disorders	0/3	3/3	2/4	1/3	2/4	2/4	2/4	3/3	5/8	8/14	8/14
ChillsGeneral disorders	0/3	1/3	1/4	1/3	3/4	1/4	0/4	0/3	1/8	1/14	5/14
Oedema peripheralGeneral disorders	0/3	1/3	0/4	0/3	2/4	3/4	0/4	0/3	0/8	1/14	2/14
ArthralgiaMusculoskeletal and connective tissue disorders	2/3	1/3	1/4	0/3	0/4	3/4	1/4	0/3	3/8	4/14	5/14
DizzinessNervous system disorders	0/3	0/3	0/4	0/3	0/4	3/4	0/4	1/3	2/8	2/14	1/14
Influenza like illnessGeneral disorders	2/3	0/3	2/4	1/3	2/4	2/4	0/4	1/3	5/8	8/14	6/14
DiarrhoeaGastrointestinal disorders	2/3	0/3	1/4	1/3	2/4	2/4	1/4	1/3	3/8	7/14	6/14
VomitingGastrointestinal disorders	0/3	2/3	0/4	2/3	1/4	1/4	0/4	1/3	5/8	4/14	5/14

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab	Total
<=18 years	0	0	0	0	0	0	0	0	0	0	0	0
Between 18 and 65 years	1	3	2	2	2	1	3	3	8	10	8	43
>=65 years	2	0	2	1	2	3	1	0	0	4	6	21

Age, Continuous
Age, Continuous(years)	Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab	Total
Mean	66.0 (63 to 69)	53.0 (39 to 64)	51.5 (32 to 71)	56.3 (39 to 73)	57.0 (41 to 74)	68.0 (58 to 79)	55.3 (40 to 72)	59.0 (58 to 61)	49.0 (35 to 63)	57.7 (30 to 81)	60.3 (28 to 79)	57.4 (28 to 81)

Sex: Female, Male
Sex: Female, Male(Participants)	Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab	Total
Female	1	1	2	1	2	2	1	0	5	4	7	26
Male	2	2	2	2	2	2	3	3	3	10	7	38

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab	Total
Hispanic or Latino	0	0	0	1	0	0	0	0	0	1	1	3
Not Hispanic or Latino	3	3	4	2	3	4	4	3	8	13	13	60
Unknown or Not Reported	0	0	0	0	1	0	0	0	0	0	0	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	1	0	1
Asian	0	0	0	0	1	0	1	0	0	1	0	3
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0	0
Black or African American	0	0	0	0	0	0	0	0	0	1	0	1
White	3	3	4	3	3	4	3	3	8	11	14	59
More than one race	0	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab	Total
United States	3	3	4	3	4	4	4	3	8	14	14	64

ECOG Performance Status
ECOG Performance Status(Participants)	Cohort 1 NKTR-262 (0.03 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 2 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered Staggered)	Cohort 3 NKTR-262 (0.06 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 4 NKTR-262 (0.12 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 5 NKTR-262 (0.24 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 6 NKTR-262 (0.48 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 7 NKTR-262 (0.96 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 8 NKTR-262 (1.92 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort 9 NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort A NKTR-262 (3.84 mg) + Bempegaldesleukin (Administered the Same Day)	Cohort B NKTR-262 (3.84 mg) + Bempegaldesleukin + Nivolumab	Total
ECOG 0	2	1	2	1	2	2	3	3	6	7	5	34
ECOG 1	1	2	2	2	2	2	1	0	2	7	9	30

Study locations

14 sites

HonorHealth
Scottsdale, Arizona 85258, United States
UC San Diego Moores Cancer Center
La Jolla, California 92093, United States
Moffitt Cancer Center
Tampa, Florida 33612, United States
Winship Cancer Center, Emory University Hospital
Atlanta, Georgia 30322, United States
University of Kansas Research Center
Fairway, Kansas 66205, United States
Henry Ford Health System
Detroit, Michigan 48202, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota 55455, United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065, United States
Duke University Medical Center
Durham, North Carolina 27710, United States
Cleveland Clinic
Cleveland, Ohio 44195, United States
Providence Portland Medical Center
Portland, Oregon 97213, United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390, United States
MD Anderson Cancer Center
Houston, Texas 77030, United States
Seattle Cancer Care Alliance
Seattle, Washington 98109, United States

References and documents

Publications

Rolig AS, Rose DC, McGee GH, Rubas W, Kivimae S, Redmond WL. Combining bempegaldesleukin (CD122-preferential IL-2 pathway agonist) and NKTR-262 (TLR7/8 agonist) improves systemic antitumor CD8+ T cell cytotoxicity over BEMPEG+RT. J Immunother Cancer. 2022 Apr;10(4):e004218. doi: 10.1136/jitc-2021-004218. PubMed 35444059 ↗

Study documents

Study protocol · Apr 9, 2020
Statistical analysis plan · Feb 10, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03435640
Lead sponsor: Nektar Therapeutics
Responsible party: Sponsor
First posted: Feb 19, 2018
Start date: Mar 15, 2018
Primary completion: May 9, 2022
Completion: May 9, 2022
Results posted: Mar 8, 2023
Last update: Mar 8, 2023

Study contacts

Study Director

study director · Nektar Therapeutics

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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