- |||||||||| bempegaldesleukin (NKTR-214) / Nektar Therap, BMS, Ono Pharma, NKTR-262 / Nektar Therap
Trial completion date, Trial termination, Combination therapy, Metastases: REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies (clinicaltrials.gov) - Jun 29, 2022
P1/2, N=64, Terminated,
Trial completion date: Oct 2022 --> May 2022 | Active, not recruiting --> 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.
- |||||||||| bempegaldesleukin (NKTR-214) / Nektar Therap, BMS, Ono Pharma, NKTR-262 / Nektar Therap
Trial completion date, Trial primary completion date, Combination therapy, Metastases: REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies (clinicaltrials.gov) - Nov 1, 2021
P1/2, N=64, Active, not recruiting,
A clinical trial of BEMPEG+NKTR-262 for patients with metastatic solid tumors is in progress (NCT03435640). Trial completion date: Dec 2021 --> Oct 2022 | Trial primary completion date: Sep 2021 --> Jul 2022
- |||||||||| Review, Journal: Current status of intralesional agents in treatment of malignant melanoma. (Pubmed Central) - Jul 20, 2021
This review focuses on the current status of IT agents currently under clinical trials in melanoma. Reviewed therapies include T-VEC, T-VEC with immune checkpoint inhibitors including ipilimumab and pembrolizumab or other agents, RP1, OrienX010, Canerpaturev (C-REV, HF10), CAVATAK (coxsackievirus A21, CVA21) alone or in combination with checkpoint inhibitors, oncolytic polio/rhinovirus recombinant (PVSRIPO), MAGE-A3-expressing MG1 Maraba virus, VSV-IFNbetaTYRP1, suicide gene therapy, ONCOS-102, OBP-301 (Telomelysin), Stimulation of Interferon Genes Pathway (STING agonists) including DMXAA, MIW815 (ADU-S100) and MK-1454, PV-10, toll-like receptors (TLRs) agonists including TLR-9 agonists (SD-101, CMP-001, IMO-2125 or tilsotolimod, AST-008 or cavrotolimod, MGN1703 or lefitolimod), CV8102, NKTR-262 plus NKTR-214, LHC165, G100, intralesional interleukin-2, Daromun (L19IL2 plus L19TNF), Hiltonol (poly-ICLC), electroporation including calcium electroporation and plasmid interleukin-12 electroporation (pIL-12 EP), IT ipilimumab, INT230-6 (cisplatin and vinblastine with an amphiphilic penetration enhancer), TTI-621 (SIRPαFc), CD-40 agonistic antibodies (ABBV-927 and APX005M), antimicrobial peptide LL37 and other miscellaneous agents.
- |||||||||| bempegaldesleukin (NKTR-214) / Nektar Therap, BMS, Ono Pharma, NKTR-262 / Nektar Therap
Trial completion date, Combination therapy, Metastases: REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies (clinicaltrials.gov) - May 24, 2021
P1/2, N=64, Active, not recruiting,
Reviewed therapies include T-VEC, T-VEC with immune checkpoint inhibitors including ipilimumab and pembrolizumab or other agents, RP1, OrienX010, Canerpaturev (C-REV, HF10), CAVATAK (coxsackievirus A21, CVA21) alone or in combination with checkpoint inhibitors, oncolytic polio/rhinovirus recombinant (PVSRIPO), MAGE-A3-expressing MG1 Maraba virus, VSV-IFNbetaTYRP1, suicide gene therapy, ONCOS-102, OBP-301 (Telomelysin), Stimulation of Interferon Genes Pathway (STING agonists) including DMXAA, MIW815 (ADU-S100) and MK-1454, PV-10, toll-like receptors (TLRs) agonists including TLR-9 agonists (SD-101, CMP-001, IMO-2125 or tilsotolimod, AST-008 or cavrotolimod, MGN1703 or lefitolimod), CV8102, NKTR-262 plus NKTR-214, LHC165, G100, intralesional interleukin-2, Daromun (L19IL2 plus L19TNF), Hiltonol (poly-ICLC), electroporation including calcium electroporation and plasmid interleukin-12 electroporation (pIL-12 EP), IT ipilimumab, INT230-6 (cisplatin and vinblastine with an amphiphilic penetration enhancer), TTI-621 (SIRPαFc), CD-40 agonistic antibodies (ABBV-927 and APX005M), antimicrobial peptide LL37 and other miscellaneous agents. Trial completion date: Dec 2022 --> Dec 2021
- |||||||||| bempegaldesleukin (NKTR-214) / Nektar Therap, BMS, Ono Pharma, NKTR-262 / Nektar Therap
Enrollment change, Combination therapy, Metastases: REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies (clinicaltrials.gov) - Mar 9, 2021
P1/2, N=64, Active, not recruiting,
Trial completion date: Dec 2022 --> Dec 2021 N=393 --> 64
- |||||||||| bempegaldesleukin (NKTR-214) / Nektar Therap, BMS, Ono Pharma, NKTR-262 / Nektar Therap
Enrollment closed, Combination therapy, Metastases: REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies (clinicaltrials.gov) - Feb 21, 2021
P1/2, N=393, Active, not recruiting,
N=393 --> 64 Recruiting --> Active, not recruiting
- |||||||||| Proleukin (aldesleukin) / Clinigen, Novartis, Prometheus, Opdivo (nivolumab) / Ono Pharma, BMS, NKTR-262 / Nektar Therap
[VIRTUAL] 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 () - Oct 14, 2020 - Abstract #SITC2020SITC_1399;
P1/2
Robust TLR7/8 engagement supported the NKTR-262 mechanism of action, while the minimal toxicity profile underscored the benefit of local delivery of NKTR-262, and the BEMPEG combination induced systemic activation of T and NK cells. These data support the RP2D of NKTR-262 (3.84 mg IT) plus BEMPEG (0.006 mg IV) q3w, and the initiation of the phase 1b dose-expansion phase, which is exploring concurrent dosing, with or without nivolumab, in relapsed/refractory metastatic melanoma patients.
- |||||||||| Proleukin (aldesleukin) / Clinigen, Novartis, Prometheus, Opdivo (nivolumab) / Ono Pharma, BMS, NKTR-262 / Nektar Therap
[VIRTUAL] 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 () - Oct 14, 2020 - Abstract #SITC2020SITC_664;
P1/2
Robust TLR7/8 engagement supported the NKTR-262 mechanism of action, while the minimal toxicity profile underscored the benefit of local delivery of NKTR-262, and the BEMPEG combination induced systemic activation of T and NK cells. These data support the RP2D of NKTR-262 (3.84 mg IT) plus BEMPEG (0.006 mg IV) q3w, and the initiation of the phase 1b dose-expansion phase, which is exploring concurrent dosing, with or without nivolumab, in relapsed/refractory metastatic melanoma patients.
- |||||||||| bempegaldesleukin (NKTR-214) / Nektar Therapeutics, BMS, NKTR-262 / Nektar Therapeutics
NKTR-262: Discovery of a novel TLR 7/8 agonist prodrug that demonstrates synergistic anti-tumor effect in combination with NKTR-214, a CD-122 preferential IL-2 pathway agonist (204B, Pennsylvania Convention Center) - Feb 13, 2020 - Abstract #ACSSp2020ACS_Sp_10556;
We hypothesized that combination treatment with NKTR-262 and NKTR-214 could provide powerful and synergistic anti-tumor effects as NKTR-262 could potentiate the antigen-presenting cells and convert M2 macrophages to M1 macrophages, and NKTR-214 could stimulate expansion of “educated” CD8+ T cells, which then traffic to distant tumor sites resulting in tumor shrinkage.In preclinical studies, a single intratumoral administration of NKTR-262 combined with systemic administration of NKTR-214 produced a complete cure of treated and untreated tumors in multiple syngeneic models. Currently, NKTR-262 is being evaluated in a Phase 1b/2 clinical trial in patients with locally advanced or metastatic solid tumors.
- |||||||||| bempegaldesleukin (NKTR-214) / Nektar Therap, BMS, Ono Pharma, NKTR-262 / Nektar Therap
Trial completion date, Trial primary completion date, Combination therapy, Metastases: REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies (clinicaltrials.gov) - Jul 11, 2019
P1/2, N=393, Recruiting,
Currently, NKTR-262 is being evaluated in a Phase 1b/2 clinical trial in patients with locally advanced or metastatic solid tumors. Trial completion date: Dec 2023 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Sep 2021
- |||||||||| bempegaldesleukin (NKTR-214) / Nektar Therap, BMS, Ono Pharma, NKTR-262 / Nektar Therap
Trial completion date, Trial primary completion date, Combination therapy, Metastases: REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies (clinicaltrials.gov) - Dec 26, 2018
P1/2, N=393, Recruiting,
Trial completion date: Dec 2023 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Sep 2021 Trial completion date: Dec 2019 --> Dec 2023 | Trial primary completion date: Nov 2019 --> Dec 2020
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