Trial Outcomes & Findings for SBRT (Stereotactic Body Radiation Therapy) in Combination With Nivolumab/Ipilimumab in Renal Cell Carcinoma (RCC) / Kidney Cancer Patients (NCT NCT03065179)

NCT ID: NCT03065179

Last Updated: 2021-03-30

Results Overview

An adverse event (AE) will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: up to 35 months
• Results posted on: 2021-03-30

Participant Flow

There were 4 participants who signed the informed consent and went through the screening process as part of the protocol and were screen failures.

Participant milestones

Measure	Nivolumab/Ipilimumab Plus SBRT Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy Nivolumab/Ipilimumab: IV immunotherapy SBRT: SBRT will be delivered in conjunction with immunotherapy
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SBRT (Stereotactic Body Radiation Therapy) in Combination With Nivolumab/Ipilimumab in Renal Cell Carcinoma (RCC) / Kidney Cancer Patients

Baseline characteristics by cohort

Measure	Nivolumab/Ipilimumab Plus SBRT n=25 Participants Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy Nivolumab/Ipilimumab: IV immunotherapy SBRT: SBRT will be delivered in conjunction with immunotherapy
Age, Continuous	57 years n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	23 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	23 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: up to 35 months

An adverse event (AE) will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Outcome measures

Measure	Nivolumab/Ipilimumab Plus SBRT n=25 Participants Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy Nivolumab/Ipilimumab: IV immunotherapy SBRT: SBRT will be delivered in conjunction with immunotherapy
Number of Participants With Treatment-related Adverse Events Grade 3 or Higher as Assessed by CTCAE v4.0	9 Participants

PRIMARY outcome

Timeframe: up to 35 months

Outcome measures

Measure	Nivolumab/Ipilimumab Plus SBRT n=25 Participants Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy Nivolumab/Ipilimumab: IV immunotherapy SBRT: SBRT will be delivered in conjunction with immunotherapy
Number of Participants Needing Corticosteroids	10 Participants

PRIMARY outcome

Timeframe: up to 35 months

The ORR is defined as the number of participants with a BOR of CR (Complete response) or PR (Partial response) divided by the number of treated participants. The BOR (Best overall response) is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of first subsequent anti-cancer therapy including radiotherapy, tumor-directed surgery, or systemic anticancer therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment

Outcome measures

Measure	Nivolumab/Ipilimumab Plus SBRT n=25 Participants Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy Nivolumab/Ipilimumab: IV immunotherapy SBRT: SBRT will be delivered in conjunction with immunotherapy
Objective Response Rate (ORR)	56 percentage of participants Interval 38.7 to 78.9

Adverse Events

Nivolumab/Ipilimumab Plus SBRT

Serious events: 9 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nivolumab/Ipilimumab Plus SBRT n=25 participants at risk Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy Nivolumab/Ipilimumab: IV immunotherapy SBRT: SBRT will be delivered in conjunction with immunotherapy
Gastrointestinal disorders Diarrhea	4.0% 1/25 • Up to 35 months
Gastrointestinal disorders Colitis	4.0% 1/25 • Up to 35 months
Gastrointestinal disorders ALT (Alanine Transaminase)	4.0% 1/25 • Up to 35 months
Gastrointestinal disorders AST (Aspartate transaminase)	4.0% 1/25 • Up to 35 months
Gastrointestinal disorders Amylase	24.0% 6/25 • Up to 35 months
Gastrointestinal disorders Lipase	24.0% 6/25 • Up to 35 months

Other adverse events

Measure	Nivolumab/Ipilimumab Plus SBRT n=25 participants at risk Induction Dual Immune Checkpoint Inhibition with nivolumab and ipilimumab plus SBRT to 1-2 metastatic sites, followed by nivolumab monotherapy Nivolumab/Ipilimumab: IV immunotherapy SBRT: SBRT will be delivered in conjunction with immunotherapy
General disorders Fatigue	100.0% 25/25 • Up to 35 months
Skin and subcutaneous tissue disorders Rash	32.0% 8/25 • Up to 35 months
Skin and subcutaneous tissue disorders Pruritus	24.0% 6/25 • Up to 35 months
Respiratory, thoracic and mediastinal disorders Pneumonitis	8.0% 2/25 • Up to 35 months
Respiratory, thoracic and mediastinal disorders Radiation Pneumonitis	8.0% 2/25 • Up to 35 months
Gastrointestinal disorders Diarrhea	56.0% 14/25 • Up to 35 months
Gastrointestinal disorders Colitis	4.0% 1/25 • Up to 35 months
Gastrointestinal disorders ALT	12.0% 3/25 • Up to 35 months
Gastrointestinal disorders AST	12.0% 3/25 • Up to 35 months
Gastrointestinal disorders Amylase	20.0% 5/25 • Up to 35 months
Renal and urinary disorders Creatinine	4.0% 1/25 • Up to 35 months
Endocrine disorders Hypothyroidism	32.0% 8/25 • Up to 35 months
Endocrine disorders Hyperthyroidism	12.0% 3/25 • Up to 35 months
Endocrine disorders Adrenal Insufficiency	16.0% 4/25 • Up to 35 months
Endocrine disorders Hypophysitis	4.0% 1/25 • Up to 35 months
Musculoskeletal and connective tissue disorders Arthritis	8.0% 2/25 • Up to 35 months

Additional Information

Dr. Hans Hammers

UT Southwestern Medical Center

Phone: 214/645-7445

Email: Hans.Hammers@UTSouthwestern.edu

Results disclosure agreements

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