Nivolumab With or Without Stereotactic Radiosurgery in Treating Patients With Recurrent, Advanced, or Metastatic Chordoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02989636|
Recruitment Status : Recruiting
First Posted : December 12, 2016
Last Update Posted : December 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chordoma||Other: Laboratory Biomarker Analysis Biological: Nivolumab Radiation: Stereotactic Radiosurgery||Phase 1|
I. To assess the safety profile of nivolumab alone and nivolumab in combination with stereotactic radiosurgery to treat patients with recurrent or advanced chordoma.
I. To evaluate toxicity and tolerability of nivolumab alone and nivolumab in combination with stereotactic radiosurgery.
II. To estimate growth modulation index on target lesion. III. To estimate a clinical response (partial response [PR] + complete response [CR] within 6 month + stable disease [SD] beyond 6 months).
IV. To assess progression-free survival and progression-free survival (PFS) rate at 6 months.
V. To assess overall survival rate at 1 year, 3 years and 5 years.
I. To explore peripheral blood immune response during and after treatment.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 14 days for 2 years in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive nivolumab as in Arm I. Patients undergo stereotactic radiosurgery (SRS) as per standard of care on day 8 of course 1.
After completion of study treatment, patients are followed up at 100 days and every 10 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Safety Study of Stereotactic Radiosurgery With Concurrent and Adjuvant PD-1 Antibody Nivolumab in Subjects With Recurrent or Advanced Chordoma|
|Actual Study Start Date :||March 10, 2017|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2021|
Experimental: Arm I (nivolumab)
Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 14 days for 8 doses, then every 28 days for a total of 2 years in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Experimental: Arm II (nivolumab, SRS)
Patients receive nivolumab as in Arm I. Patients undergo stereotactic radiosurgery (SRS) as per standard of care on day 8 of course 1.
Other: Laboratory Biomarker Analysis
Radiation: Stereotactic Radiosurgery
- Incidence of dose limiting toxicities evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 12 weeks after initial dose of nivolumab ]Proportion of serious adverse events will be estimated using the binomial distribution along with 95% confidence interval (exact method).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989636
|Contact: Emma Gentryfirstname.lastname@example.org|
|Contact: Jessica Wollettemail@example.com|
|United States, Maryland|
|Johns Hopkins University/Sidney Kimmel Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Kelly K. Szajna, RN, BSN 410-502-4081 firstname.lastname@example.org|
|Contact: Whitney Webb, RN, MSN 4109557008 email@example.com|
|Principal Investigator: Michael K. Lim, MD|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Michelle Mehallow 212-639-2739 firstname.lastname@example.org|
|Contact: Emily Gelb 646-888-4592 email@example.com|
|Principal Investigator: Yoshiya (Josh) Yamada, MD|
|Principal Investigator:||Michael Lim||Johns Hopkins University/Sidney Kimmel Cancer Center|