Study of Combination of Ipilimumab and Nivolumab in Patients With Melanoma
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02970981|
Recruitment Status : Active, not recruiting
First Posted : November 22, 2016
Results First Posted : March 11, 2020
Last Update Posted : March 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: Nivolumab Biological: Ipilimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial of Ipilimumab With Nivolumab for Participants With Resected Stages IIIB/IIIC/ IV Melanoma|
|Actual Study Start Date :||November 29, 2016|
|Actual Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2020|
Experimental: Nivolumab and Ipilimumab
Dosing during cycle 1 will consist of: 3 mg/kg of Nivolumab+ Ipilimumab at 1 mg/kg. Each induction treatment cycle is comprised of 4 doses of Nivolumab and 4 doses of Ipilimumab given every three weeks for a total of 12 weeks (cycle 1)
Dosing during cycles 2-5 will consist of flat dose Nivolumab at 480 mg every 4 weeks (Q4W) for 48 weeks.
- Number of Cases of Adverse Events Occurring During Study [ Time Frame: 12 weeks post-treatment start ]The adverse events are evaluated per Common Terminology Criteria for Adverse Events (CTCAE) V4.
- Time to Relapse [ Time Frame: Up to 4 years ]Time to relapse will be reported (in months post-treatment) to assess the preliminary efficacy of the study drugs.
- Immune Response Assessment [ Time Frame: 12 Weeks ]
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): NCT02970981
|United States, New York|
|Laura and Isaac Perlmutter Cancer Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Jeffrey S Weber, MD, PhD||NYU Perlmutter Cancer Center|