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Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)

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ClinicalTrials.gov Identifier: NCT03219671
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : December 25, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Alona Zer, Rabin Medical Center

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

Condition or disease Intervention/treatment Phase
Classic Kaposi Sarcoma Drug: Nivolumab Drug: Ipilimumab Phase 2

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Nivolumab Plus Ipilimumab in Previously Treated Classical Kaposi Sarcoma (CKS)
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2022


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




Primary Outcome Measures :
  1. ORR [ Time Frame: 6-months ]
    overall response rate (ORR)


Secondary Outcome Measures :
  1. PFS rate [ Time Frame: 6-months ]
    6-months PFS rate

  2. 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) [ Time Frame: 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).

  3. Tolerability - treatment related adverse events (AEs) that caused study drug interruption and discontinuation [ Time Frame: 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.


Other Outcome Measures:
  1. Exploratory Biomarkers [ Time Frame: 6-months ]
    including, but not limited to proteins and/or genes involved in regulating immune responses (eg PD-L1, IDO1, KYN and MSI status).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219671


Contacts
Contact: Alona Zer, MD +972-3-93780086 alonaz@clalit.org.il

Locations
Israel
Rabin Medical Center Recruiting
Petach Tikva, Israel
Contact: Alona Zer, MD    +972-3-378086    alonaz@clalit.org.il   
Principal Investigator: Alona Zer, MD         
Sponsors and Collaborators
Alona Zer
Bristol-Myers Squibb
Investigators
Principal Investigator: Alona Zer, MD Rabin Medical Center

Responsible Party: Alona Zer, Senior Physician, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03219671     History of Changes
Other Study ID Numbers: CA209-937
0095-17-RMC ( Other Identifier: Rabin Medical Center )
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Kaposi
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Vascular Tissue
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs