Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)

Study Overview
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Brief Summary
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A Phase 2 study of nivolumab plus ipilimumab in previously treated classical Kaposi Sarcoma (CKS)

Detailed Description
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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).

Official Title
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A Phase 2 Study of Nivolumab Plus Ipilimumab in Previously Treated Classical Kaposi Sarcoma (CKS)

Conditions
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Classic Kaposi Sarcoma

Intervention / Treatment
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* Drug: Nivolumab
* Drug: Ipilimumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nivolumab plus ipilimumab<br>nivolumab 240mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks | Drug: Nivolumab<br>* nivolumab 240mg every 2 weeks<br>Drug: Ipilimumab<br>* ipilimumab 1 mg/kg every 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | overall response rate (ORR) | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS rate | 6-months 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) | 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). | during the study, through study completion, an average of 1 year | 
| Tolerability - treatment related adverse events (AEs) that caused study drug interruption and discontinuation | Patients will be evaluated for treatment related adverse events (AEs) that caused study drug interrupption and discontinuation. | during the study, through study completion, an average of 1 year |