A Phase II Randomized Trial of Immunotherapy Plus Radiotherapy in Metastatic Genitourinary Cancers

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT03115801
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab will be given to patients with renal cell carcinoma on days 1,15, 29, 43 and 57.
  • Atezolizumab — DRUG
    Atezolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.
  • Radiation & immunotherapy — RADIATION
    Radiation is given to one lesion, 30 Gray (Gy) in 3 fractions of 10 Gy each. over a one week interval (with a minimum of 36hrs between each fraction). On the day of radiation (Day 1) immunotherapy is administered and repeated on the scheduled days. Patients will receive radiation on Day 1 and immunotherapy will be given ± 24hr from Day 1.
  • Pembrolizumab — DRUG
    Pembrolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.

Study Details

The trial is open to patients who have metastatic renal cell carcinoma/urothelial (bladder) carcinoma with at least 2 measurable sites of disease. All eligible patients will be randomly assigned to immunotherapy(nivolumab/atezolizumab/pembrolizumab) versus immunotherapy (nivolumab/atezolizumab/pembrolizumab) plus radiotherapy, 10 Gy x3 (conformally or by intensity modulation radiation therapy/Image-guided radiation therapy (IMRT/IGRT) to maximally spare normal tissue), to one of their measurable lesions.

Key Dates

Start date
Nov 30, 2016
Status verified
Aug 2021
Primary completion
Oct 13, 2020
Completion
Oct 13, 2020

Study Design

Enrollment
6 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A - immunotherapy alone
    Patients with Renal Cell carcinoma will receive Nivolumab alone Days 1, 15, 29, 43 and 57. Patients with Urothelial cancer will receive Atezolizumab or Pembrolizumab on Days 1, 22, 43 and 64.
  • Active Comparator: Arm B - Radiation & immunotherapy
    Radiation is given to one lesion, 30 Gy in 3 fractions of 10 Gy, every other day. On the day of radiation (Day 1) immunotherapy is administered and repeated on the scheduled days.

Primary Outcome Measure

Number of Participants With Best Overall Response Rates of Immunotherapy Alone and of Immunotherapy Plus Radiotherapy (to a Single Metastatic Site). [ Time Frame: from 96 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medicine - New York Presbyterian HospitalNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Weill Cornell Medicine - New York Presbyterian Hospital· New York, NY

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