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Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)

NCT ID: NCT03219671

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2022-09-01

Brief Summary

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

Detailed Description

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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).

Conditions

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Classic Kaposi Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nivolumab plus ipilimumab

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

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

nivolumab 240mg every 2 weeks

Ipilimumab

Intervention Type DRUG

ipilimumab 1 mg/kg every 6 weeks

Interventions

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Nivolumab

nivolumab 240mg every 2 weeks

Intervention Type DRUG

Ipilimumab

ipilimumab 1 mg/kg every 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Alona Zer

OTHER

Sponsor Role lead

Responsible Party

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Alona Zer

Senior Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Alona Zer, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

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Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Alona Zer, MD

Role: CONTACT

Phone: +972-3-93780086

Email: [email protected]

Facility Contacts

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Alona Zer, MD

Role: primary

Other Identifiers

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0095-17-RMC

Identifier Type: OTHER

Identifier Source: secondary_id

CA209-937

Identifier Type: -

Identifier Source: org_study_id