Guadecitabine + Durvalumab for Kidney Cancer

Recruiting at4 trial locations

Overseen by Ajjai Alva, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Ajjai Alva, MD

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

Ajjai Alva, M.D.

Principal Investigator

University of Michigan

Eligibility Criteria

Inclusion Criteria

You weigh more than 30 kilograms.

Women who could become pregnant must have a negative pregnancy test within 28 days before joining the study.

Written informed consent and HIPAA authorization for release of personal health information

Exclusion Criteria

You are still experiencing moderate or severe side effects from previous cancer treatments, except for hair loss, skin discoloration, and specific lab test results mentioned in the inclusion criteria.

You have received an organ transplant and are taking medicines to lower your immune system.

You have an ongoing infection that needs to be treated with medication throughout your body.

Treatment Details

Interventions

• Durvalumab (PD-L1 Inhibitor)
• Guadecitabine (Anti-metabolites)

Participant Groups

Group I: Single Arm Experimental Treatment 2 Interventions

This is a non-randomized, single arm, open label Phase Ib/II study. Phase Ib: Days 1-5 Guadecitabine: * Dose 0: 60 mg/m\^2 * Dose -1: 45 mg/m\^2 Phase II: Days 1-5 Guadecitabine (at Ph II dose) Day 8 Durvalumab (1500 mg IV) Day 8 Durvalumab (1500 mg IV)

Durvalumab is already approved in Japan for the following indications:

Approved in Japan as Imfinzi for:

• Not specified in provided sources

Who Is Running the Clinical Trial?

Ajjai Alva, MD

Lead Sponsor

Trials

2

Recruited

70+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Big Ten Cancer Research Consortium

Collaborator

Trials

11

Recruited

450+