About PIVOT-10, a Phase 2, Randomized, Non-Comparative, Open-Label Study of Bempegaldesleukin in Combination With Nivolumab and of Chemotherapy in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients With Low PD-L1 Expression
The Phase 2 study will evaluate the anti-tumor activity of bempegaldesleukin in combination with nivolumab by assessing the objective response rate (ORR) in approximately 165 cisplatin ineligible, locally advanced or metastatic urothelial cancer patients with low PD-L1 expression. The efficacy will be assessed within the experimental Arm A (bempegaldesleukin + nivolumab), while Arm B will receive a combination of gemcitabine and carboplatin and will serve as a reference arm. Secondary outcome measures include Duration of Response (DOR) and incidence of treatment-related Adverse Events (AEs). For more information, please visit clinicaltrials.gov and search NCT03785925.
About the PIVOT Phase 1/2 Program: Bempegaldesleukin in combination with OPDIVO® (nivolumab)
The PIVOT Phase 1/2 program is a dose escalation and expansion study of bempegaldesleukin when administered in combination with nivolumab in patients with melanoma, renal cell carcinoma, non-small cell lung cancer (NSCLC), urothelial carcinoma, or triple negative breast cancer. The dose escalation stage of the study enrolled 38 patients and evaluated the safety and efficacy profile of the combination and the recommended phase 2 dose was established. The expansion stage of the PIVOT program is underway to evaluate the safety and efficacy of combining bempegaldesleukin with nivolumab in approximately 330 patients who are either immuno-oncology (I-O) therapy naïve or anti-PD-1 or anti-PD-L1 relapsed/refractory. The expansion cohorts in the PIVOT program include five tumor types and thirteen indications, including first and second-line melanoma, first and second-line renal cell carcinoma, first and second-line NSCLC, first and third-line urothelial carcinoma, and first and second-line triple negative breast cancer. For more information, please visit clinicaltrials.gov and search NCT02983045.
Pivot
About the PROPEL Phase 1/2 Program: Bempegaldesleukin in combination with TECENTRIQ® (atezolizumab) or KEYTRUDA® (pembrolizumab)
The dose escalation stage of the PROPEL program will determine the recommended Phase 2 dose of bempegaldesleukin administered in combination with anti-PD-L1 agent, atezolizumab or anti-PD-1 agent, pembrolizumab. The study will evaluate the clinical benefit, safety and tolerability of combining bempegaldesleukin with atezolizumab or pembrolizumab and will enroll patients into two separate arms concurrently. The first arm will evaluate an every three-week dose regimen of bempegaldesleukin in combination with atezolizumab in up to 30 patients with urothelial bladder cancer in approved treatment settings of atezolizumab. The second arm will evaluate an every three-week dose regimen of bempegaldesleukin in combination with pembrolizumab in up to 50 patients with melanoma and non-small cell lung cancer in approved treatment settings of pembrolizumab. For more information, please visit clinicaltrials.gov and search NCT03138889.
Picture15.png
About the REVEAL Phase 1/2 Program: Bempegaldesleukin in combination with NKTR-262
REVEAL is a Nektar-sponsored, open-label, multicenter, dose escalation and dose expansion study of NKTR-262 administered as intratumoral injections in combination with bempegaldesleukin administered as an IV infusion systemically (doublet). The study also may evaluate the doublet combination with nivolumab (triplet). During the dose escalation phases, recommended Phase 2 dose (RP2D) regimens of the doublet and/or triplet combinations will be established. Following dose escalation, the dose expansion phase will evaluate the doublet and/or triplet combinations in up to 350 patients who have been diagnosed with a range of locally advanced or metastatic cancers including: melanoma, Merkel cell carcinoma, triple-negative breast cancer, ovarian cancer, renal cell carcinoma, colorectal cancer, urothelial carcinoma, or sarcoma. For more information, please visit clinicaltrials.gov and search NCT03435640.