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Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)

Primary Purpose

Classic Kaposi Sarcoma

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Nivolumab

Ipilimumab

About this trial

This is an interventional treatment trial for Classic Kaposi Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Rabin Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nivolumab plus ipilimumab

Arm Description

nivolumab 240mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks

Outcomes

Primary Outcome Measures

ORR

overall response rate (ORR)

Secondary Outcome Measures

PFS rate

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)

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).

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.

Full Information

NCT ID

NCT03219671

First Posted

June 26, 2017

Last Updated

December 23, 2018

Sponsor

Alona Zer

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03219671

Brief Title

Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2018 (Actual)

Primary Completion Date

September 1, 2020 (Anticipated)

Study Completion Date

September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Alona Zer

Collaborators

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Classic Kaposi Sarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

nivolumab plus ipilimumab

Arm Type

Experimental

Arm Description

nivolumab 240mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Intervention Description

nivolumab 240mg every 2 weeks

Intervention Type

Drug

Intervention Name(s)

Ipilimumab

Intervention Description

ipilimumab 1 mg/kg every 6 weeks

Primary Outcome Measure Information:

Title

ORR

Description

overall response rate (ORR)

Time Frame

6-months

Secondary Outcome Measure Information:

Title

PFS rate

Description

6-months PFS rate

Time Frame

6-months

Title

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)

Description

Time Frame

during the study, through study completion, an average of 1 year

Title

Tolerability - treatment related adverse events (AEs) that caused study drug interruption and discontinuation

Description

Patients will be evaluated for treatment related adverse events (AEs) that caused study drug interrupption and discontinuation.

Time Frame

during the study, through study completion, an average of 1 year

Other Pre-specified Outcome Measures:

Title

Exploratory Biomarkers

Description

including, but not limited to proteins and/or genes involved in regulating immune responses (eg PD-L1, IDO1, KYN and MSI status).

Time Frame

6-months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alona Zer, MD

Phone

+972-3-93780086

alonaz@clalit.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alona Zer, MD

Organizational Affiliation

Rabin Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rabin Medical Center

City

Petach Tikva

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alona Zer, MD

Phone

+972-3-378086

alonaz@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Alona Zer, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)

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