Classic Kaposi SarcomaPhase 2NCT03219671
Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)
A Phase 2 study testing Nivolumab and Ipilimumab in people with Classic Kaposi Sarcoma, run by Alona Zer at 1 site in Israel.
Trial summary
A Phase 2 study of nivolumab plus ipilimumab in previously treated classical Kaposi Sarcoma (CKS) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Classic Kaposi Sarcoma
- What is being tested?
- Nivolumab and Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2018to 1 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Alona Zer, MD, +972-3-378086, alonaz@clalit.org.il
Alona Zer, MD
About this study
Official title: 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)
Read the 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).
- Conditions
- Classic Kaposi Sarcoma
- Being tested
- Nivolumab, Ipilimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
nivolumab 240mg every 2 weeks
IpilimumabDrug
ipilimumab 1 mg/kg every 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| nivolumab plus ipilimumab | Experimental | nivolumab 240mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks Receives: Drug: Nivolumab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
overall response rate (ORR)
Measured: 6-months
Secondary outcomes (3)
PFS rate
6-months PFS rate
Measured: 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).
Measured: 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.
Measured: during the study, through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start1 Apr 2018
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classic Kaposi SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alona Zer
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Alona Zer, Rabin Medical Center
- Investigators
- Alona Zer, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219671
- Sponsor's protocol ID
- CA209-937
- Other IDs
- 0095-17-RMC
- Status last verified
- Dec 2018
- First submitted
- 26 Jun 2017
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Nivolumab Plus Ipilimumab in Previously Treated Classical Kaposi Sarcoma (CKS)
- ClinicalTrials.gov ID
- NCT03219671
- Acronym / sponsor ID
- CA209-937
- Conditions
- Classic Kaposi Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Alona ZerUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nivolumab plus ipilimumab | Experimental | Drug: Nivolumab, Drug: Ipilimumabnivolumab 240mg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumabnivolumab 240mg every 2 weeks | Drug | nivolumab plus ipilimumab |
| Ipilimumabipilimumab 1 mg/kg every 6 weeks | Drug | nivolumab plus ipilimumab |
Primary outcome
ORR
Time frame: 6-months
overall response rate (ORR)
3 secondary outcomes
PFS rate
Time frame: 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)
Time frame: during the study, through study completion, an average of 1 year
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alona Zer, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Ipilimumab in people with Classic Kaposi Sarcoma, run by Alona Zer at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alona Zer, MD (+972-3-93780086, alonaz@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.