Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Carcinoma, Transitional Cell

Death

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Immunomodulating Agents

Nivolumab

Atezolizumab

Immunologic Factors

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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.

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.

Nivolumab will be given to patients with renal cell carcinoma on days 1,15, 29, 43 and 57.

Atezolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.

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.

Radiation & immunotherapy

Pembrolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.

Himanshu Nagar, M.D.

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.

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.

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

Weill Medical College of Cornell University

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.

Nivolumab: Nivolumab will be given to patients with renal cell carcinoma on days 1,15, 29, 43 and 57.

Atezolizumab: Atezolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.

Pembrolizumab: Pembrolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.

Arm A - Immunotherapy Alone

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.

Nivolumab: Nivolumab will be given to patients with renal cell carcinoma on days 1,15, 29, 43 and 57.

Atezolizumab: Atezolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.

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.

Arm B - Radiation & Immunotherapy

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

The clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.

Sharanya Chandrasekhar

Number of Participants With Best Overall Response Rates of Immunotherapy Alone and of Immunotherapy Plus Radiotherapy (to a Single Metastatic Site).

3 participants on ARM A and 2 participants on ARM B could not be analyzed because they were withdrawn from the trial for disease progression.

Assess the Difference in Participants for the Best Overall Response Between the Two Groups, Immunotherapy Alone and of Immunotherapy Plus Radiotherapy(to a Single Metastatic Site).

Number of Participants With Progression Free Survival

Number of Participants Who Experienced Toxicities Related to Immunotherapy and Immunotherapy Plus Radiotherapy Treatment Groups

Participants Will be Measured for Overall Survival

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Randomized Trial of Immunotherapy Plus Radiotherapy in Metastatic Genitourinary Cancers	NCT03115801	Metastatic Rena... Metastatic Urot...	Nivolumab Atezolizumab Radiation & imm... Pembrolizumab	19 Years - 90 Years	Weill Medical College of Cornell University
A Phase II Randomized Trial of Immunotherapy Plus Radiotherapy in Metastatic Genitourinary Cancers	NCT03115801	Metastatic Rena... Metastatic Urot...	Nivolumab Atezolizumab Radiation & imm... Pembrolizumab	19 Years - 90 Years	Weill Medical College of Cornell University
A Phase II Randomized Trial of Immunotherapy Plus Radiotherapy in Metastatic Genitourinary Cancers	NCT03115801	Metastatic Rena... Metastatic Urot...	Nivolumab Atezolizumab Radiation & imm... Pembrolizumab	19 Years - 90 Years	Weill Medical College of Cornell University

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