Trial Outcomes & Findings for A Phase II Randomized Trial of Immunotherapy Plus Radiotherapy in Metastatic Genitourinary Cancers (NCT NCT03115801)

NCT ID: NCT03115801

Last Updated: 2021-09-22

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: from 96 weeks
• Results posted on: 2021-09-22

Participant Flow

Participant milestones

Measure	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. 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 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. 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.
Overall Study STARTED	4	2
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm A - Immunotherapy Alone n=4 Participants 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 B - Radiation & Immunotherapy n=2 Participants 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.	Total n=6 Participants Total of all reporting groups
Age, Continuous	56.25 years n=5 Participants	69 years n=7 Participants	60.5 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: from 96 weeks

Outcome measures

Measure	Arm A - Immunotherapy Alone n=4 Participants 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 B - Radiation & Immunotherapy n=2 Participants 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.
Number of Participants With Best Overall Response Rates of Immunotherapy Alone and of Immunotherapy Plus Radiotherapy (to a Single Metastatic Site).	4 Participants	2 Participants

PRIMARY outcome

Timeframe: from 96 weeks

Population: 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.

Outcome measures

Measure	Arm A - Immunotherapy Alone n=1 Participants 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 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. 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.
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).	1 Participants	0 Participants

SECONDARY outcome

Timeframe: from 96 weeks

Outcome measures

Measure	Arm A - Immunotherapy Alone n=4 Participants 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 B - Radiation & Immunotherapy n=2 Participants 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.
Number of Participants With Progression Free Survival	1 Participants	0 Participants

SECONDARY outcome

Timeframe: from 96 weeks

Outcome measures

Measure	Arm A - Immunotherapy Alone n=4 Participants 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 B - Radiation & Immunotherapy n=2 Participants 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.
Number of Participants Who Experienced Toxicities Related to Immunotherapy and Immunotherapy Plus Radiotherapy Treatment Groups	1 Participants	1 Participants

SECONDARY outcome

Timeframe: from 96 weeks

Outcome measures

Measure	Arm A - Immunotherapy Alone n=4 Participants 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 B - Radiation & Immunotherapy n=2 Participants 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.
Participants Will be Measured for Overall Survival	4 Participants	2 Participants

Adverse Events

Arm A - Immunotherapy Alone

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm B - Radiation & Immunotherapy

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A - Immunotherapy Alone n=4 participants at risk 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 B - Radiation & Immunotherapy n=2 participants at risk 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.
Gastrointestinal disorders Abdominal Pain	25.0% 1/4 • Number of events 3 • 2 years	0.00% 0/2 • 2 years
Respiratory, thoracic and mediastinal disorders Dyspnea on Exertion	25.0% 1/4 • Number of events 3 • 2 years	0.00% 0/2 • 2 years
Musculoskeletal and connective tissue disorders Hip Fracture	25.0% 1/4 • Number of events 3 • 2 years	0.00% 0/2 • 2 years
Blood and lymphatic system disorders Hyperglycemia	0.00% 0/4 • 2 years	50.0% 1/2 • Number of events 1 • 2 years

Other adverse events

Measure	Arm A - Immunotherapy Alone n=4 participants at risk 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 B - Radiation & Immunotherapy n=2 participants at risk 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.
Musculoskeletal and connective tissue disorders Back Pain	25.0% 1/4 • Number of events 1 • 2 years	0.00% 0/2 • 2 years
Blood and lymphatic system disorders Elevated Alkaline Phosphate	0.00% 0/4 • 2 years	50.0% 1/2 • Number of events 1 • 2 years
Musculoskeletal and connective tissue disorders Intermittent discomfort in the right buttock	25.0% 1/4 • Number of events 1 • 2 years	0.00% 0/2 • 2 years
Blood and lymphatic system disorders Neutropenia	25.0% 1/4 • Number of events 1 • 2 years	0.00% 0/2 • 2 years

Additional Information

Sharanya Chandrasekhar

Weill Cornell Medicine

Phone: 6469623110

Email: shc2043@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place