Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.

Patrick Forde, MB, BCH

The purpose of this study is to determine whether Nivolumab is effective in the treatment of radiation-induced solid tumors.

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

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.

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.

Number of participants alive without progression.

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.

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

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.

Bristol-Myers Squibb

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

a flat dose of Nivolumab 240 mg will be administered intravenously every 2 weeks until disease progression.

Nivolumab

Radiation-Induced Metastatic Sarcoma

Radiation-Induced Non-Sarcoma Metastatic Solid Tumors

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Patrick Forde, MBBCh

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.

Best Objective Response Rate

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

Percentage of Patients Progression-free at 24 Weeks From the Time of Enrollment

Progression-free Survival

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 2 Study of Nivolumab in Solid Tumors Induced by Prior Radiation Exposure	NCT02864316	Solid Tumors In...	Nivolumab	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase 2 Study of Nivolumab in Solid Tumors Induced by Prior Radiation Exposure	NCT02864316	Solid Tumors In...	Nivolumab	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Spots Global Cancer Trial Database for solid tumors induced by prior radiation exposure