Trial Outcomes & Findings for Phase 2 Study of Nivolumab in Solid Tumors Induced by Prior Radiation Exposure (NCT NCT02864316)

Last Updated: 2019-08-28

Results Overview

Number of participants with response. Response will be assessed at baseline (within 4 weeks prior to starting nivolumab) and then every 8 weeks while on Nivolumab, up to 24 weeks. The best objective response will be assessed at 24 weeks. Response will be defined based on RECIST 1.1 criteria where complete response (CR)= disappearance of all target lesions, partial response (PR) is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Up to 24 weeks

Results posted on

2019-08-28

Participant Flow

2 subjects were screen failures

Participant milestones

Participant milestones
Measure	Radiation-Induced Metastatic Sarcoma a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab	Radiation-Induced Non-Sarcoma Metastatic Solid Tumors a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab
Overall Study STARTED	2	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Radiation-Induced Metastatic Sarcoma a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab	Radiation-Induced Non-Sarcoma Metastatic Solid Tumors a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab
Overall Study Progressive Disease	2	1
Overall Study Adverse Event	0	1

Baseline Characteristics

Phase 2 Study of Nivolumab in Solid Tumors Induced by Prior Radiation Exposure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation-Induced Metastatic Sarcoma n=2 Participants a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab	Radiation-Induced Non-Sarcoma Metastatic Solid Tumors n=2 Participants a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: Data was not collected for 1/2 participants from the non-sarcoma arm since the participant was discontinued from therapy (due to adverse event) before disease re-evaluation for response could be performed.

Outcome measures

Outcome measures
Measure	Radiation-Induced Metastatic Sarcoma n=2 Participants a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab	Radiation-Induced Non-Sarcoma Metastatic Solid Tumors n=1 Participants a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab
Best Objective Response Rate PD	2 Participants	1 Participants
Best Objective Response Rate SD	0 Participants	0 Participants
Best Objective Response Rate PR	0 Participants	0 Participants
Best Objective Response Rate CR	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Data was not collected to assess this outcome measure since no participants remained on the study at 24 weeks.

Disease status at 24 weeks will be compared to disease status at the time of enrollment, and response coded based on RECIST 1.1 criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 22 months

Number of participants alive without progression.

Outcome measures

Outcome measures
Measure	Radiation-Induced Metastatic Sarcoma n=2 Participants a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab	Radiation-Induced Non-Sarcoma Metastatic Solid Tumors n=1 Participants a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab
Progression-free Survival	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 22 months

Population: Data was not collected to assess this outcome measure since none of the participants experienced a response.

The duration of overall response is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, accessed up to 3 years.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 100 days post-intervention

Number of participants with treatment-related adverse events as defined by CTCAE 4.0 criteria.

Outcome measures

Outcome measures
Measure	Radiation-Induced Metastatic Sarcoma n=2 Participants a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab	Radiation-Induced Non-Sarcoma Metastatic Solid Tumors n=2 Participants a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab
Number of Participants With Treatment-related Adverse Events	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 22 months

Overall survival was planned to be measured at 5 years post-intervention as the time from enrollment until death. Instead, due to early termination for low accrual, the number of participants alive at the time of study termination is reported.

Outcome measures

Outcome measures
Measure	Radiation-Induced Metastatic Sarcoma n=2 Participants a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab	Radiation-Induced Non-Sarcoma Metastatic Solid Tumors n=2 Participants a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab
Overall Survival	1 Participants	0 Participants

Adverse Events

Radiation-Induced Metastatic Sarcoma

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Radiation-Induced Non-Sarcoma Metastatic Solid Tumors

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Radiation-Induced Metastatic Sarcoma n=2 participants at risk a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab	Radiation-Induced Non-Sarcoma Metastatic Solid Tumors n=2 participants at risk a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab
Nervous system disorders Presyncope	0.00% 0/2 • up to 100 days after last-dose of therapy	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy
Renal and urinary disorders Acute kidney injury	0.00% 0/2 • up to 100 days after last-dose of therapy	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy
General disorders Fever	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy	0.00% 0/2 • up to 100 days after last-dose of therapy
Respiratory, thoracic and mediastinal disorders Lung Infection	0.00% 0/2 • up to 100 days after last-dose of therapy	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • up to 100 days after last-dose of therapy	50.0% 1/2 • Number of events 2 • up to 100 days after last-dose of therapy
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/2 • up to 100 days after last-dose of therapy	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy
Vascular disorders Hypotension	0.00% 0/2 • up to 100 days after last-dose of therapy	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy

Other adverse events

Additional Information

Patrick Forde, MBBCh

Sidney Kimmel Comprehensive Cancer Center

Phone: 410-955-3974

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Radiation-Induced Metastatic Sarcoma n=2 participants at risk a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab	Radiation-Induced Non-Sarcoma Metastatic Solid Tumors n=2 participants at risk a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression. Nivolumab
Skin and subcutaneous tissue disorders Hyperhhidrosis	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy	0.00% 0/2 • up to 100 days after last-dose of therapy
General disorders Edema - limbs	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy	0.00% 0/2 • up to 100 days after last-dose of therapy
Eye disorders Blurred Vision	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy	0.00% 0/2 • up to 100 days after last-dose of therapy
Gastrointestinal disorders Abdominal Pain	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy	0.00% 0/2 • up to 100 days after last-dose of therapy
Blood and lymphatic system disorders anemia	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy	0.00% 0/2 • up to 100 days after last-dose of therapy
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy	0.00% 0/2 • up to 100 days after last-dose of therapy
Gastrointestinal disorders Constipation	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy	0.00% 0/2 • up to 100 days after last-dose of therapy
Nervous system disorders Headache	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy	0.00% 0/2 • up to 100 days after last-dose of therapy
Respiratory, thoracic and mediastinal disorders Epistaxis	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy	0.00% 0/2 • up to 100 days after last-dose of therapy
Skin and subcutaneous tissue disorders Dry Skin	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy	0.00% 0/2 • up to 100 days after last-dose of therapy
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • up to 100 days after last-dose of therapy	100.0% 2/2 • Number of events 2 • up to 100 days after last-dose of therapy
Metabolism and nutrition disorders Hypokalemia	0.00% 0/2 • up to 100 days after last-dose of therapy	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy
Cardiac disorders Atrial fibrillation	0.00% 0/2 • up to 100 days after last-dose of therapy	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy
Gastrointestinal disorders Vomiting	0.00% 0/2 • up to 100 days after last-dose of therapy	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/2 • up to 100 days after last-dose of therapy	50.0% 1/2 • Number of events 2 • up to 100 days after last-dose of therapy
Renal and urinary disorders Urinary Tract Pain	0.00% 0/2 • up to 100 days after last-dose of therapy	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/2 • up to 100 days after last-dose of therapy	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy
Metabolism and nutrition disorders Hyponatremia	0.00% 0/2 • up to 100 days after last-dose of therapy	50.0% 1/2 • Number of events 1 • up to 100 days after last-dose of therapy