Ipilimumab + Nivolumab w/Thoracic Radiotherapy for Extensive-Stage Small Cell Lung Cancer
The purpose of the safety run in Phase I portion of this study is to confirm the recommended Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard treatment with 4-6 cycles of platinum-based chemotherapy.
The purpose of the Phase II portion of this study is to estimate the 6-month Progression Free Survival (PFS) rate among participants treated with ipilimumab and nivolumab with thoracic radiation therapy (30 Gy in 10 fractions) after standard treatment with 4 to 6 cycles of platinum based chemotherapy.
Small Cell Lung Cancer
Extensive-stage Small Cell Lung Cancer
Radiation: Thoracic Radiation Therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Consolidative Ipilimumab and Nivolumab With Thoracic Radiotherapy After Platinum Based Chemotherapy for Patients With Extensive-Stage Small Cell Lung Cancer|
- Phase I: Confirmation of Recommended Phase II Dose [ Time Frame: 13 weeks ]Recommended Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard treatment with 4-6 cycles of platinum-based chemotherapy. Investigators will initially enroll 6 patients and wait until completion of the 13-week safety observation period following initiation of ipilimumab + nivolumab combination treatment.
- Phase II: Progression Free Survival (PFS) [ Time Frame: 6 months ]PFS is defined as the duration from date of registration to date of first documentation of progression assessed by local investigator or symptomatic deterioration (as defined above) or death due to any cause.
- Overall Survival (OS) [ Time Frame: 1 year ]OS is defined as the duration from date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.
|Actual Study Start Date:||February 13, 2017|
|Estimated Study Completion Date:||April 2021|
|Estimated Primary Completion Date:||April 2021 (Final data collection date for primary outcome measure)|
Experimental: Combination Therapy
Consolidative Ipilimumab and Nivolumab with Thoracic Radiotherapy after Platinum Based Chemotherapy. Radiotherapy, followed by a 14 to 21 day break between radiotherapy and the beginning of study drug treatment.
Radiation: Thoracic Radiation Therapy
All participants will receive radiation therapy (3Gy x 10 fractions) to the chest for 10 days (Monday through Friday for 2 weeks).
Other Name: radiotherapyDrug: Ipilimumab
Ipilimumab 3 mg/kg (90 minute IV infusion) will be administered every 3 weeks for 4 doses.
Other Name: YERVOYDrug: Nivolumab
Nivolumab 1 mg/kg (30 minute IV infusion) will be administered every 3 weeks for 4 doses, followed by nivolumab 480 mg every 4 weeks.
Other Name: OPDIVO
Please refer to this study by its ClinicalTrials.gov identifier: NCT03043599
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Yesenia Artigas 813-745-3931 firstname.lastname@example.org|
|Contact: Bradford A. Perez, M.D. 813-745-4380 email@example.com|
|Principal Investigator: Bradford A. Perez, M.D.|
|Sub-Investigator: Scott Antonia, M.D., Ph.D.|
|Sub-Investigator: Alberto Chiappori, M.D.|
|Sub-Investigator: Benjamin Creelan, M.D.|
|Sub-Investigator: Thomas Dilling, M.D.|
|Sub-Investigator: Jhanelle Gray, M.D.|
|Sub-Investigator: Eric Haura, M.D.|
|Sub-Investigator: Trevor Rose, M.D.|
|Sub-Investigator: Tawee Tanvetyanon, M.D.|
|Sub-Investigator: Charles Williams, M.D.|
|Principal Investigator:||Bradford A. Perez, M.D.||H. Lee Moffitt Cancer Center and Research Institute|