9 completed, 8 terminated, 2 withdrawn, 1 active not recruiting. 12 Phase 1, 12 Phase 2, 5 Phase 3.
By phase and status
Follow bempegaldesleukin: new trials by email Literature Review of bempegaldesleukin trials Research Report on bempegaldesleukin
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
A Prospective, Single-arm, Multicenter Exploratory Clinical Study of Anlotinib Combined With Bempegaldesleukin and Conventional Chemoradiotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Soft Tissue Sarcoma. Anlotinib and bempegaldesleukin - Locally Advanced Soft Tissue Sarcoma | Phase 2 | Not yet recruiting | 46 | 2025-10-01 | 2025-09-05 |
BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36) Bempegaldesleukin, Pembrolizumab - Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer | Phase 2 / Phase 3 | Terminated | 1 | 2022-03-09 | 2023-01-12 |
Bempegaldesleukin (NKTR-214) With Radiation and Anti-PD-1 Immunotherapy for Head and Neck Squamous Cell Carcinoma NKTR-214, anti-PD-1 therapy, Palliative Radiation - Head and Neck Cancer | Phase 2 | Terminated | 5 | 2021-08-05 | 2024-04-04 |
A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer Nivolumab, NKTR-214 - Ependymoma, Ewing Sarcoma | Phase 1 / Phase 2 | Terminated | 15 | 2021-06-03 | 2023-03-24 |
A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19 Bempegaldesleukin, Standard of Care, Placebo - Covid-19, Coronavirus Disease 2019 | Phase 1 | Completed | 30 | 2020-11-13 | 2024-03-12 |
Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence Bempegaldesleukin, Nivolumab - Melanoma, Melanoma Stage III | Phase 3 | Terminated | 765 | 2020-07-27 | 2023-04-21 |
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 Nivolumab, Radical cystectomy (RC), Bempegaldesleukin - Bladder Cancer, Bladder Tumor | Phase 3 | Completed | 114 | 2020-02-05 | 2024-06-27 |
Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors avelumab, Bempegaldesleukin, talazoparib - Squamous Cell Carcinoma of the Head and Neck (SCCHN), Metastatic Castration Resistant Prostate Cancer (mCRPC) | Phase 1 / Phase 2 | Terminated | 3 | 2019-12-30 | 2021-10-14 |
A CD8 Positron Emission Tomography With Computed Tomography (PET/CT) Study Using ⁸⁹Zr Df-IAB22M2C in Patients With Metastatic Melanoma Receiving Bempegaldesleukin (NKTR-214) and Nivolumab Bempegaldesleukin (NKTR-214), Nivolumab, ⁸⁹Zr-Df-IAB22M2C - Metastatic Melanoma | Phase 1 | Withdrawn | | 2019-08-01 | 2021-07-08 |
Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations NKTR-214 (Cohort A), Nivolumab (Cohort A, B and C), Stereotactic body radiation therapy (SBRT) (Cohort B) - Metastatic Castration-resistant Prostate Cancer | Phase 1 | Completed | 43 | 2019-06-21 | 2024-04-12 |
A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer Bempegaldesleukin, Nivolumab - Urinary Bladder Neoplasm, Neoplasm Metastasis | Phase 2 | Completed | 192 | 2019-04-29 | 2023-03-28 |
An Investigational Study of NKTR-214 Combined With Nivolumab in Japanese Participants With Advanced Solid Tumors NKTR-214, Nivolumab - Advanced Cancer | Phase 1 | Completed | 3 | 2019-04-09 | 2021-10-04 |
A Study of TAK-659 in Combination With NKTR-214 in Participants With Advanced Non-Hodgkin Lymphoma (NHL) TAK-659, NKTR-214 - Lymphoma, Non-Hodgkin | Phase 1 | Withdrawn | | 2019-04-03 | 2023-02-08 |
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) bempegaldesleukin, sunitinib, nivolumab - Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma | Phase 3 | Terminated | 623 | 2018-12-18 | 2023-04-11 |
A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma NKTR-214, Nivolumab - Melanoma | Phase 3 | Completed | 783 | 2018-09-21 | 2025-04-01 |
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 VB10.NEO, Bempegaldesleukin - Locally Advanced or Metastatic Solid Tumours | Phase 1 / Phase 2 | Completed | 41 | 2018-04-04 | 2023-04-21 |
REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies NKTR-262, bempegaldesleukin, nivolumab - Melanoma, Merkel Cell Carcinoma | Phase 1 / Phase 2 | Terminated | 64 | 2018-03-15 | 2023-03-08 |
A Study of NKTR-214 in Combination With Nivolumab in Patients With Metastatic and/or Locally Advanced Sarcoma NKTR-214, Nivolumab - SARCOMA | Phase 2 | Active not recruiting | 88 | 2017-09-12 | 2026-07-22 |
Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors NKTR-214, Pembrolizumab, Cisplatin - Non-Small Cell Lung Cancer | Phase 1 / Phase 2 | Terminated | 162 | 2017-06-09 | 2023-03-10 |
A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors Dose Escalation Doublet: Combination of NKTR-214 + nivolumab, Dose Expansion Doublet: Combination of NKTR-214 + nivolumab, Schedule Finding Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab - Melanoma, Renal Cell Carcinoma | Phase 1 / Phase 2 | Completed | 557 | 2016-12-19 | 2023-03-13 |
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Conditions studied
Melanoma (7) · Carcinoma, Renal Cell (4) · Neoplasm Metastasis (3) · Squamous Cell Carcinoma of Head and Neck (3) · Carcinoma, Non-Small-Cell Lung (2) · Carcinoma, Transitional Cell (2) · Colorectal Neoplasms (2) · Head and Neck Neoplasms (2) · Lymphoma, Non-Hodgkin (2) · Recurrence (2) · Sarcoma (2) · Triple Negative Breast Neoplasms (2) · Urinary Bladder Neoplasms (2) · COVID-19 (1) · Carcinoma, Merkel Cell (1)
Sponsors
Nektar Therapeutics (10) · Bristol-Myers Squibb (4) · Calithera Biosciences, Inc (1) · Memorial Sloan Kettering Cancer Center (1) · Nykode Therapeutics ASA (1) · Parker Institute for Cancer Immunotherapy (1) · Pfizer (1) · The First Affiliated Hospital with Nanjing Medical University (1) · University of Wisconsin, Madison (1)
Countries
United States (18) · Spain (8) · Australia (7) · France (7) · Germany (7) · Italy (7) · Belgium (5) · Canada (5) · Greece (5) · Poland (5) · Russia (5) · United Kingdom (5) · Argentina (4) · Austria (4) · Israel (4)
Top investigators
Adam Burr, MD, PhD (1) · Justine Bruce, MD (1) · Paul Harari, MD (1) · Sandra D'Angelo, MD (1) · Sheng Zhang (1) · Zachary Morris, MD, PhD (1)
Results publications
PMID 41811823, PMID 30988166, PMID 32723187, PMID 33298619, PMID 34255535, PMID 34311780, PMID 35073733, PMID 35444059, PMID 35643589, PMID 35710741, PMID 37651676, PMID 38838287
NIH funding
2018 (4), 2016 (1), 2019 (1)