Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Ajjai Alva, MD
Study ID
NCT03308396
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Kidney Cancer
  • Clear Cell Renal Cell Carcinoma
  • Kidney Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guadecitabine — DRUG
    Days 1-5 Dose 0: 60 mg/m\^2 Dose -1: 45 mg/m\^2
  • Durvalumab — DRUG
    Day 8 Durvalumab (1500 mg IV)

Study Details

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).

Key Dates

Start date
Dec 19, 2017
Status verified
Feb 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2023

Study Design

Enrollment
57 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    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)

Primary Outcome Measure

Phase Ib: Dose limiting toxicities will be assessed to determine if the trial is stopped before the Phase II portion. [ Time Frame: 28 days/First cycle ]

Locations (5)

FacilityCityStateZIPSite coordinators
Univerisity of Illinois Cancer CenterChicagoIllinois60612-
University of Iowa Hosptials and ClinicsIowa CityIowa52242-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Penn State Cancer InstituteHersheyPennsylvania17033-

Find similar trials in Chicago, IL

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Univerisity of Illinois Cancer Center· Chicago, ILUniversity of Iowa Hosptials and Clinics· Iowa City, IAUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MIRutgers Cancer Institute of New Jersey· New Brunswick, NJPenn State Cancer Institute· Hershey, PA

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