Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)

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

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

Study Overview

• Status: Unknown
• Conditions: Classic Kaposi Sarcoma
• Intervention / Treatment: Drug: Nivolumab; Drug: Ipilimumab

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alona Zer, MD; Phone Number: +972-3-93780086; Email: alonaz@clalit.org.il

Study Locations

• Israel
  • Petach Tikva, Israel
    • Recruiting
    • Rabin Medical Center
    • Contact: Alona Zer, MD; Phone Number: +972-3-378086; Email: alonaz@clalit.org.il
    • Principal Investigator: Alona Zer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nivolumab plus ipilimumab; nivolumab 240mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks	Drug: Nivolumab; nivolumab 240mg every 2 weeks; Drug: Ipilimumab; ipilimumab 1 mg/kg every 6 weeks

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Alona Zer
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Alona Zer, MD, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 23, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; DNA Virus Infections; Herpesviridae Infections; Neoplasms, Vascular Tissue; Sarcoma; Sarcoma, Kaposi; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Ipilimumab
• Other Study ID Numbers: CA209-937; 0095-17-RMC (Other Identifier: Rabin Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes