Classic Kaposi Sarcoma
Conditions
Brief summary
A Phase 2 study of nivolumab plus ipilimumab in previously treated classical Kaposi Sarcoma (CKS)
Detailed description
A prospective, single arm, interventional study. All patients will receive IV nivolumab 3mg/kg every two weeks and ipilimumab 1mg/kg every 6 weeks. Patients will be treated until disease progression or intolerable toxicity for a maximal period of two years, with an option to re-initiate therapy upon progression in patients with prior documented response to investigational therapy (unless treatment was held for progression of disease).
Interventions
DRUGNivolumab
nivolumab 240mg every 2 weeks
DRUGIpilimumab
ipilimumab 1 mg/kg every 6 weeks
Sponsors
Bristol-Myers Squibb
Alona Zer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 6-months | overall response rate (ORR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS rate | 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) | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Biomarkers | 6-months | including, but not limited to proteins and/or genes involved in regulating immune responses (eg PD-L1, IDO1, KYN and MSI status). |
Countries
Israel
Contacts
Primary ContactAlona Zer, MD
Outcome results
None listed