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)

Phase 3 Terminated 623 enrolled Nektar Therapeutics Bristol-Myers Squibb · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to compare the objective response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214: BEMPEG) combined with nivolumab to that of tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in IMDC intermediate- or poor-risk patients and IMDC all-risk patients with previously untreated advanced renal cell carcinoma (RCC).

Timeline

Start: 2018-12-18
Primary completion: 2022-01-07
Completion: 2022-10-19

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor decision”

paper ORR with BEMPEG plus NIVO versus TKI was 23.0% (95% CI, 18.0 to 28.7) versus 30.6% (95% CI, 25.1 to 36.6) PMID 38838287 ↗

paper difference, -7.7 [95% CI, -15.2 to -0.2]; P = .0489 PMID 38838287 ↗

Publications

Tannir NM, Formiga MN, Penkov K, Kislov N, Vasiliev A, Gunnar Skare N, Hong W, Dai S, Tang L, Qureshi A, Zalevsky J, Tagliaferri MA, George D, Agarwal N, Pal S. Bempegaldesleukin Plus Nivolumab Versus Sunitinib or Cabozantinib in Previously Untreated Advanced Clear Cell Renal Cell Carcinoma: A Phase III Randomized Study (PIVOT-09). J Clin Oncol. 2024 Aug 10;42(23):2800-2811. doi: 10.1200/JCO.23.02082. Epub 2024 Jun 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bempegaldesleukin	Protein / enzyme biologic	—	—
Comparator	Cabozantinib	Small molecule	—	—
Subject	Nivolumab	Monoclonal antibody	—	—
Comparator	Sunitinib	Small molecule	—	—