Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)
A Phase 2 Study of Nivolumab Plus Ipilimumab in Previously Treated Classical Kaposi Sarcoma (CKS)
2 other identifiers
interventional
20
1 country
1
Brief Summary
A Phase 2 study of nivolumab plus ipilimumab in previously treated classical Kaposi Sarcoma (CKS)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2018
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2017
CompletedFirst Posted
Study publicly available on registry
July 17, 2017
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedDecember 26, 2018
December 1, 2018
2.4 years
June 26, 2017
December 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
ORR
overall response rate (ORR)
6-months
Secondary Outcomes (3)
PFS rate
6-months
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)
during the study, through study completion, an average of 1 year
Tolerability - treatment related adverse events (AEs) that caused study drug interruption and discontinuation
during the study, through study completion, an average of 1 year
Other Outcomes (1)
Exploratory Biomarkers
6-months
Study Arms (1)
nivolumab plus ipilimumab
EXPERIMENTALnivolumab 240mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Pathologically confirmed KS
- Age \> 18
- ECOG PS \< 2
- At least one prior treatment modality (palliative radiation or chemotherapy)
- Measurable disease as defined by RECIST version 1.1 by physical exam and/or PET-CT (previously irradiated lesions should not be counted as target lesions).
You may not qualify if:
- Patients with HIV-related KS or HIV positive serology.
- Ongoing immunosuppressive therapy
- Active autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alona Zerlead
- Bristol-Myers Squibbcollaborator
Study Sites (1)
Rabin Medical Center
Petah Tikva, Israel
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alona Zer, MD
Rabin Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior Physician
Study Record Dates
First Submitted
June 26, 2017
First Posted
July 17, 2017
Study Start
April 1, 2018
Primary Completion
September 1, 2020
Study Completion
September 1, 2022
Last Updated
December 26, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share