Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer

Phase 1/2 Active not recruiting 57 enrolled Ajjai Alva, MD AstraZeneca · collab Big Ten Cancer Research Consortium · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a single arm, multi-centre (via Big Ten Cancer Research Consortium) phase Ib/II study of patients treated with durvalumab 1500 mg IV q 4 weeks in combination with guadecitabine at the recommended phase 2 dose subcutaneously for 5 consecutive days. Eligible patients will have metastatic RCC with a clear cell component, ECOG performance status of 0-1, have received 0-1 prior therapy but no prior anti-PD-1/PD-L1/CTLA4 (Cohort 1, 36 subjects). Study treatment could potentially continue for up to 13 cycles (52 weeks).

Timeline

Start: 2017-12-19
Primary completion: 2022-12
Completion: 2023-12

Publications

Zakharia Y, Singer EA, Acharyya S, Garje R, Joshi M, Peace D, Baladandayuthapani V, Majumdar A, Li X, Lalancette C, Kryczek I, Zou W, Alva A. Durvalumab and guadecitabine in advanced clear cell renal cell carcinoma: results from the phase Ib/II study BTCRC-GU16-043. Nat Commun. 2024 Feb 1;15(1):972. doi: 10.1038/s41467-024-45216-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Durvalumab	Monoclonal antibody	1500 mg	Intravenous
Subject	Guadecitabine	Oligonucleotide (other)	45 mg/m2	Subcutaneous
Subject	Guadecitabine	Oligonucleotide (other)	60 mg/m2	Subcutaneous

Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer

Summary

Timeline

Publications

Drugs

Indications