Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)

Phase 2

• Conditions: Classic Kaposi Sarcoma
• Interventions: Drug: Nivolumab; Drug: Ipilimumab

• Registration Number: NCT03219671
• Lead Sponsor: Alona Zer

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).

Study Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-17
• Study Start: 2018-04-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-23
• Last Update Posted: 2018-12-26
• Primary Completion: 2020-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nivolumab plus ipilimumab	Nivolumab	nivolumab 240mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks
nivolumab plus ipilimumab	Ipilimumab	nivolumab 240mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks

Primary Outcome Measures

Name	Time	Method
ORR	6-months	overall response rate (ORR)

Secondary Outcome Measures

Name	Time	Method
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.
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).

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel