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Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer

NCT03308396 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2022-02-17

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Guadecitabine

Days 1-5 Dose 0: 60 mg/m\^2 Dose -1: 45 mg/m\^2

DRUG

Durvalumab

Day 8 Durvalumab (1500 mg IV)

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Big Ten Cancer Research Consortium

    collaborator OTHER

  • Ajjai Alva, MD

    lead OTHER

Principal Investigators

  • Ajjai Alva, M.D. · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-19
Primary Completion
2022-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03308396 on ClinicalTrials.gov