Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)

Classic Kaposi Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03219671
• Other study ID #: CA209-937
• Secondary ID: 0095-17-RMC
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2018
• Est. completion date: September 1, 2022

Study information

• Verified date: December 2018
• Source: Rabin Medical Center
• Contact: Alona Zer, MD
• Phone: +972-3-93780086
• Email: alonaz[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Classic Kaposi Sarcoma
• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• Nivolumab
nivolumab 240mg every 2 weeks
• Ipilimumab
ipilimumab 1 mg/kg every 6 weeks

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Alona Zer	Bristol-Myers Squibb

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Biomarkers	including, but not limited to proteins and/or genes involved in regulating immune responses (eg PD-L1, IDO1, KYN and MSI status).	6-months
Primary	ORR	overall response rate (ORR)	6-months
Secondary	PFS rate	6-months PFS rate	6-months
Secondary	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
Secondary	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