NCT03598816

PolyImmune {Durvalumab (MEDI4736) and Tremelimumab} & Vaccine Orchestrated Treatment for Patients With Advanced/Metastatic Renal Cell Carcinoma

A Randomized Phase II PIVOT-RCC (PolyImmune {Durvalumab (MEDI4736) and Tremelimumab} & Vaccine Orchestrated Treatment for Patients With Advanced/Metastatic Renal Cell Carcinoma) Trial

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Reported in the 2018 NEJM (378; 1277) article, the combination of checkpoint inhibitors ipilimumab (anti-CTLA-4 antibody) and nivolumab (anti-PD-1 antibody) phase III trial Checkmate 214 demonstrated statistically significant (P\<0.0001) improvement of overall response rate (ORR) at 42% (95% confidence interval (CI), 37-47%) compared to standard of care (SOC) sunitinib at 27% (95% CI, 22-31%) in treatment naïve advanced or metastatic clear cell renal cell carcinoma (ccRCC). This study also showed increased survival benefit of Ipi+Nivo over sunitinib in the IMDC intermediate-poor risk ccRCC patients. Accordingly, the Ipi+Nivo was just approved by U.S. FDA in April 2018 for treating metastatic ccRCC. Hence, the investigators hypothesized that the combination of durvalumab and tremelimumab is similarly efficacious in advanced or metastatic RCC. Furthermore, the investigators also hypothesize that the administration of personalized neoantigen DNA vaccine will further enhance anti-tumor immune response in RCC.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Durvalumab	-Durvalumab infusion will start approximately 1 hour (maximum 2 hours) after the end of the tremelimumab infusion
DRUG	Tremelimumab	-Tremelimumab will be administered first
DEVICE	TDS-IM v1.0 System	-Integrated electroporation device
BIOLOGICAL	Neoantigen DNA Vaccine	-At each vaccination time point, patients will receive two injections of the neoantigen DNA vaccine, one injection into each deltoid or lateralis.
PROCEDURE	Research blood draw	-Baseline, C2D1, C3D1, C5D1, C7D1, and C9D1

Timeline

• Start date: 2020-08-31
• Primary completion: 2022-12-31
• Completion: 2024-05-31
• First posted: 2018-07-26
• Last updated: 2020-08-13

Regulatory

• FDA-regulated drug study
• FDA-regulated device study