PIVOT IO-001 Enrollment Stops After Trial Failure, But Analyses Continue

In PIVOT IO-001, patients with metastatic melanoma are no longer being enrolled and treatment arms have been unblinded after the combination of bempegaldesleukin and nivolumab did not meet its coprimary end points.

melanoma under microscope

The phase 3 PIVOT IO-001 study has stopped enrolling patients and treatment arms have been unblinded after the combination of bempegaldesleukin (NKTR-214; Bempeg) and nivolumab (Opdivo) did not demonstrate improvements in progression-free survival (PFS) and overall survival (OS), and showed no response benefit compared with nivolumab alone, missing its coprimary end points.1

In the PIVOT IO-001 study (NCT03635983), 781 patients were enrolled to assess the efficacy and safety of the combination. Both ORR and PFS by Blinded Independent Central Review and OS was assessed by investigators.2

The secondary end points of the study include clinical benefit rate, duration of response, time to response, ORR by investigator and in the biomarker population, PFS by investigator and in the biomarker population, and OS in the biomarker population. The study also explores secondary safety end points including, the incidence of adverse events (AEs), incidence of serious AEs, and the incidence of laboratory abnormalities.

Patients enrolled had histologically confirmed stage III (unresectable) or stage IV melanoma and were previously untreated. The patients were all required to have an ECOG performance status of ≤ 1 if 18 years of age or older, or a Lansky Performance Score ≥ 80%, between the ages of 12 and 17 years.

In ongoing analyses of PIVOT IO-001, investigators will look at OS and share findings with the scientific community at a later date. Moreover, the combination of Bempeg and nivolumab continues to be investigated in clinical trials of patients with renal cell carcinoma, and bladder cancer.1

“While we are surprised and deeply disappointed in these results for the melanoma study, we will continue to await initial results from our first two ongoing studies in renal cell carcinoma and urothelial cancer, which are currently expected in the first half of 2022,” said Jonathan Zalevsky, chief research and development officer of Nektar Therapeutics, in the press release.


1. Bristol Myers Squibb and Nektar announce update on phase 3 PIVOT IO-001 trial evaluating bempegaldesleukin (BEMPEG) in combination with Opdivo (nivolumab) in previously untreated unresectable or metastatic melanoma. News release. Bristol Myers Squibb and Nektar. March 14, 2022. Accessed March 14, 2022. https://bit.ly/3MRzSEj

2. A study of NKTR-214 combined with nivolumab vs nivolumab alone in participants with previously untreated inoperable or metastatic melanoma. Clinicaltrials.gov. Updated January 20, 2022. Accessed March 14, 2022.

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