Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)

Alona Zer

Status and phase

Unknown

Phase 2

Conditions

Classic Kaposi Sarcoma

Treatments

Drug: Nivolumab

Drug: Ipilimumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03219671

0095-17-RMC (Other Identifier)

CA209-937

Details and patient eligibility

About

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

Full 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).

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.