Trials / Terminated
TerminatedNCT03115801
A Phase II Randomized Trial of Immunotherapy Plus Radiotherapy in Metastatic Genitourinary Cancers
A Phase II Randomized Controlled Trial of Programmed Death -1/Programmed Death Ligand-1(PD-1/PDL-1) Axis Blockade Versus PD-1/PDL-1 Axis Blockade Plus Radiotherapy in Metastatic Genitourinary (Renal/Urothelial) Malignancies
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Weill Medical College of Cornell University · Academic / Other
- Sex
- All
- Age
- 19 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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 IMRT/IGRT to maximally spare normal tissue), to one of their measurable lesions. For patients assigned to the immunotherapy plus radiotherapy arm, immunotherapy treatment starts with the first radiotherapy fraction. Nivolumab will be given every 2 weeks for patients with metastatic renal cell cancer and atezolizumab/pembrolizumab will be given every 3 weeks for patients with metastatic urothelial cancer. Patients will be re-imaged at 9 week (year 1) or 12 week (years 2-3) intervals and evaluated for response (defined as an objective response of measurable metastatic sites outside the radiation field). This response will be evaluated with CT scans in non-irradiated measurable metastatic sites per RECIST version 1.1. Patients will continue to receive their respective immunotherapies for up to three years or until disease progression or until a dose limiting toxicity is reached.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nivolumab | Nivolumab will be given to patients with renal cell carcinoma on days 1,15, 29, 43 and 57. |
| DRUG | Atezolizumab | Atezolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64. |
| RADIATION | Radiation & immunotherapy | 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. |
| DRUG | Pembrolizumab | Pembrolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64. |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2020-10-13
- Completion
- 2020-10-13
- First posted
- 2017-04-14
- Last updated
- 2021-09-22
- Results posted
- 2021-09-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03115801. Inclusion in this directory is not an endorsement.