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Bempegaldesleukin

DRUG9 trials

Sponsors

Nektar Therapeutics, Nykode Therapeutics ASA, Pfizer, Bristol-Myers Squibb

Conditions

Bladder CancerBladder TumorColorectal CancerCoronavirus Disease 2019Covid-19Head and Neck Squamous Cell CarcinomaLocally Advanced or Metastatic Solid TumoursMelanoma

Phase 1

REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies
TerminatedNCT03435640
Nektar TherapeuticsColorectal Cancer, Head and Neck Squamous Cell Carcinoma, Melanoma +4
Start: 2018-03-15End: 2022-05-09Updated: 2023-03-08
A Study to Evaluate Safety and Efficacy of Multiple Dosing With VB10.NEO and Bempegaldesleukin (NKTR-214) Immunotherapy in Patients With Locally Advanced or Metastatic Cancer
CompletedNCT03548467
Nykode Therapeutics ASALocally Advanced or Metastatic Solid Tumours
Start: 2018-04-04End: 2023-01-30Updated: 2023-04-21
Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors
TerminatedNCT04052204
PfizerMetastatic Castration Resistant Prostate Cancer (mCRPC), Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Start: 2019-12-30End: 2020-09-29Updated: 2021-10-14
A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19
CompletedNCT04646044
Nektar TherapeuticsCoronavirus Disease 2019, Covid-19
Start: 2020-11-13End: 2021-05-18Updated: 2024-03-12

Phase 2

A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer
CompletedNCT03785925
Nektar TherapeuticsNeoplasm Metastasis, Urinary Bladder Neoplasm
Start: 2019-04-29End: 2022-06-30Updated: 2023-03-28
BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)
TerminatedNCT04969861
Nektar TherapeuticsMetastatic Head and Neck Cancer, Recurrent Head and Neck Cancer
Start: 2022-03-09End: 2022-04-22Updated: 2023-01-12

Phase 3

A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)
TerminatedNCT03729245
Nektar TherapeuticsMetastatic Renal Cell Carcinoma, Renal Cell Carcinoma
Start: 2018-12-18End: 2022-10-19Updated: 2023-04-11
A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer
CompletedNCT04209114
Bristol-Myers SquibbBladder Cancer, Bladder Tumor, Muscle-Invasive Bladder Cancer
Start: 2020-02-05End: 2023-06-07Updated: 2024-06-27
Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence
TerminatedNCT04410445
Nektar TherapeuticsMelanoma, Melanoma (Skin), Melanoma Stage III +1
Start: 2020-07-27End: 2022-09-22Updated: 2023-04-21

Related Papers

Combining bempegaldesleukin (CD122-preferential IL-2 pathway agonist) and NKTR-262 (TLR7/8 agonist) improves systemic antitumor CD8<sup>+</sup> T cell cytotoxicity over BEMPEG+RT
Journal for ImmunoTherapy of Cancer2022-04-0129 citations
PIVOT IO 009: A phase 3, randomized study of neoadjuvant and adjuvant nivolumab (NIVO) plus bempegaldesleukin (BEMPEG; NKTR-214) versus NIVO alone versus standard of care (SOC) in patients (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin (cis)-ineligible.
Journal of Clinical Oncology2022-02-168 citations
596 Combining Bempegaldesleukin (CD122-preferential IL-2 pathway agonist) and NKTR-262 (TLR7/8 agonist) pairs local innate activation with systemic CD8+ T cell expansion to enhance anti-tumor immunity
Regular and Young Investigator Award Abstracts2021-11-01
PrE0807: A phase Ib feasibility trial of neoadjuvant nivolumab (N) without or with lirilumab (L) in cisplatin-ineligible patients (pts) with muscle-invasive bladder cancer (MIBC).
Journal of Clinical Oncology2021-05-2017 citations
368 REVEAL: Phase 1 dose-escalation study of NKTR-262, a novel TLR7/8 agonist, plus bempegaldesleukin: local innate immune activation and systemic adaptive immune expansion for treating solid tumors
Regular and Young Investigator Award Abstracts2020-11-0115 citations
451 Combining Bempegaldesleukin (CD122-preferential IL-2 pathway agonist) and NKTR-262 (TLR7/8 agonist) pairs local innate activation with systemic CD8+ T cell expansion to enhance anti-tumor immunity
Regular and Young Investigator Award Abstracts2020-11-01
PIVOT-10: Phase II study of bempegaldesleukin plus nivolumab in cisplatin-ineligible advanced urothelial cancer
Future Oncology2020-09-177 citations
PIVOT-09: A phase III randomized open-label study of bempegaldesleukin (NKTR-214) plus nivolumab versus sunitinib or cabozantinib (investigator's choice) in patients with previously untreated advanced renal cell carcinoma (RCC).
Journal of Clinical Oncology2020-02-1919 citations
PIVOT-10: A phase II study of bempegaldesleukin (NKTR-214) in combination with nivolumab (NIVO) in cisplatin (cis) ineligible patients with previously untreated locally advanced or metastatic urothelial cancer (mUC).
Journal of Clinical Oncology2020-02-192 citations
Abstract CT217: An open-label, Phase I/IIa study of VB10.NEO (DIRECT-01) in combination with checkpoint blockade in patients with locally advanced or metastatic solid tumors including melanoma, NSCLC, renal cell carcinoma, urothelial cancer or SSCHN
Cancer Research2019-07-015 citations
Abstract CT217: An open-label, Phase I/IIa study of VB10.NEO (DIRECT-01) in combination with checkpoint blockade in patients with locally advanced or metastatic solid tumors including melanoma, NSCLC, renal cell carcinoma, urothelial cancer or SSCHN
Clinical Trials2019-07-01
A phase III randomized open label study comparing bempegaldesleukin (NKTR-214) plus nivolumab to sunitinib or cabozantinib (investigator's choice) in patients with previously untreated advanced renal cell carcinoma.
Journal of Clinical Oncology2019-05-204 citations
Phase Ib: Preliminary clinical activity and immune activation for NKTR-262 [TLR 7/8 agonist] plus NKTR-214 [CD122-biased agonist] in patients (pts) with locally advanced or metastatic solid tumors (REVEAL Phase Ib/II Trial).
Journal of Clinical Oncology2019-03-1021 citations