Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)
|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: NCT03219671|
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : December 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Classic Kaposi Sarcoma||Drug: Nivolumab Drug: Ipilimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Nivolumab Plus Ipilimumab in Previously Treated Classical Kaposi Sarcoma (CKS)|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||September 1, 2022|
Experimental: nivolumab plus ipilimumab
nivolumab 240mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks
nivolumab 240mg every 2 weeks
ipilimumab 1 mg/kg every 6 weeks
- ORR [ Time Frame: 6-months ]overall response rate (ORR)
- PFS rate [ Time Frame: 6-months ]6-months PFS rate
- Safety - Incidence of Treatment-Emergent Adverse Events according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 4.0 (CTCAE v4) [ Time Frame: during the study, through study completion, an average of 1 year ]Patients will be evaluated for treatment related adverse events (AEs) on each visit during study participation and toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 4.0 (CTCAE v4).
- Tolerability - treatment related adverse events (AEs) that caused study drug interruption and discontinuation [ Time Frame: during the study, through study completion, an average of 1 year ]Patients will be evaluated for treatment related adverse events (AEs) that caused study drug interrupption and discontinuation.
- Exploratory Biomarkers [ Time Frame: 6-months ]including, but not limited to proteins and/or genes involved in regulating immune responses (eg PD-L1, IDO1, KYN and MSI status).
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): NCT03219671
|Contact: Alona Zer, MDemail@example.com|
|Rabin Medical Center||Recruiting|
|Petach Tikva, Israel|
|Contact: Alona Zer, MD +972-3-378086 firstname.lastname@example.org|
|Principal Investigator: Alona Zer, MD|
|Principal Investigator:||Alona Zer, MD||Rabin Medical Center|