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Clinical trial · no report yet · Phase 1/Phase 2
PIVOT-02
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
- NCT02983045 ↗
- Completed
- Nektar Therapeutics
- Focused size, estimated: 1–150 verified statements
We haven't built an HCP commentary report on PIVOT-02 (bempegaldesleukin plus nivolumab; bempegaldesleukin plus nivolumab plus ipilimumab in locally advanced or metastatic solid tumors) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on PIVOT-02 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Indexed so far | |
|---|---|
| 3 posts on X | |
| 1 YouTube video | |
| 1 podcast episode |
The trial
ClinicalTrials.gov- Official title
- A Phase 1/2, Open-label, Multicenter Study of the Combination of NKTR-214 and Nivolumab or the Combination of NKTR-214, Nivolumab, and Other Anti-Cancer Therapies in Patients With Select Locally Advanced or Metastatic Solid Tumor Malignancies
- Phase
- Phase 1/Phase 2
- Status
- Completed
- Conditions
- Melanoma; Renal Cell Carcinoma; Non Small Cell Lung Cancer; Urothelial Carcinoma; Triple Negative Breast Cancer; HR+/HER2- Breast Cancer; Gastric Cancer
- Interventions
- 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; Dose Expansion Triplet: Combination of NKTR-214+ nivolumab+ ipilimumab
- Arms
- Dose Escalation: Combination of NKTR-214 + nivolumab · Experimental
- Dose Expansion: Combination of NKTR-214 + nivolumab · Experimental
- Experimental: Combination of NKTR-214 + nivolumab + ipilimumab · Experimental
- Experimental: Dose Expansion of Part 3 · Experimental
- Enrollment
- 557
- Primary outcomes
- Part 1 Dose Escalation: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window
- Part 3 Schedule Finding: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window
- Part 2 and Part 4: Objective Response Rate (ORR) Per RECIST 1.1 at Recommended Phase 2 Dose (RP2D)
- Sponsor
- Nektar Therapeutics with Bristol-Myers Squibb
- Start
- Dec 19, 2016
- Primary completion
- Apr 28, 2022
- Results posted
- Yes
- Registry record
- NCT02983045 · updated Mar 13, 2023
Publications
linked from the registry- Bautista J, Echeverria CE, Maldonado-Noboa I, Adatty-Molina J, Suarez Urresta S, Coral-Riofrio EC, Araujo-Abad S, Kyriakidis NC, Lopez-Cortes A. Next-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy. J Immunol Res. 2026;2026(1):e7864229. doi: 10.1155/jimr/7864229. PubMed 41811823
- Siefker-Radtke AO, Cho DC, Diab A, Sznol M, Bilen MA, Balar AV, Grignani G, Puente E, Tang L, Chien D, Hoch U, Choudhury A, Yu D, Currie SL, Tagliaferri MA, Zalevsky J, Hurwitz ME, Tannir NM. Bempegaldesleukin plus Nivolumab in First-line Metastatic Urothelial Carcinoma: Results from PIVOT-02. Eur Urol. 2022 Oct;82(4):365-373. doi: 10.1016/j.eururo.2022.05.002. Epub 2022 May 25. PubMed 35643589
- Diab A, Tykodi SS, Daniels GA, Maio M, Curti BD, Lewis KD, Jang S, Kalinka E, Puzanov I, Spira AI, Cho DC, Guan S, Puente E, Nguyen T, Hoch U, Currie SL, Lin W, Tagliaferri MA, Zalevsky J, Sznol M, Hurwitz ME. Bempegaldesleukin Plus Nivolumab in First-Line Metastatic Melanoma. J Clin Oncol. 2021 Sep 10;39(26):2914-2925. doi: 10.1200/JCO.21.00675. Epub 2021 Jul 13. PubMed 34255535
- Veatch JR, Singhi N, Jesernig B, Paulson KG, Zalevsky J, Iaccucci E, Tykodi SS, Riddell SR. Mobilization of pre-existing polyclonal T cells specific to neoantigens but not self-antigens during treatment of a patient with melanoma with bempegaldesleukin and nivolumab. J Immunother Cancer. 2020 Dec;8(2):e001591. doi: 10.1136/jitc-2020-001591. PubMed 33298619