Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)

Last updated: December 23, 2018
Sponsor: Alona Zer
Overall Status: Active - Recruiting

Phase

2

Condition

Sarcoma

Kaposi's Sarcoma

Treatment

N/A

Clinical Study ID

NCT03219671
CA209-937
0095-17-RMC
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patients with HIV-related KS or HIV positive serology.

  • Ongoing immunosuppressive therapy

  • Active autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism onlyrequiring hormone replacement, skin disorders (such as vitiligo, psoriasis, oralopecia) not requiring systemic treatment, or conditions not expected to recur in theabsence of an external trigger are permitted to enroll.

Study Design

Total Participants: 20
Study Start date:
April 01, 2018
Estimated Completion Date:
September 01, 2022

Study 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).

Connect with a study center

  • Rabin Medical Center

    Petach Tikva,
    Israel

    Active - Recruiting

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