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Skin Kaposi SarcomaPhase 2NCT04577755

Pomalidomide Treatment in Patients With Kaposi Sarcoma

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Skin Kaposi Sarcoma, run by National Cancer Institute (NCI) at 15 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II trial studies the effect of pomalidomide in treating patients with Kaposi sarcoma. Pomalidomide is a cancer fighting drug that stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Skin Kaposi Sarcoma
What is being tested?
Biopsy Procedure, Biospecimen Collection and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
15 sitesUnited States
Study dates
18 Mar 2022to 4 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Participant is able to understand and willing to sign a written informed consent document
  • Participants must have histologically or cytologically confirmed cutaneous KS. Participants must have measurable disease with a minimum of five bi-dimensionally measurable KS cutaneous marker lesions. If fewer than five bi-dimensionally measurable marker lesions are available, the total surface area of the marker lesion(s) must be >= 700 mm^2
  • Participants must have documentation of HIV status
  • If HIV negative, documentation of a negative HIV rapid test within 21 days before enrollment into OPEN Step-1 (Treatment Assignment - Registration Step).
  • If HIV positive, documentation of HIV-1 infection by means of any one of the following:
  • Documentation of HIV diagnosis in the medical record by a licensed health care provider
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  • Documentation of receipt of antiretroviral therapy (ART) (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis [PrEP]) by a licensed health care provider. Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name
  • Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multi-spot antibody differentiation assay
  • Note: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., United States [U.S.] Food and Drug Administration [FDA])
  • WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an enzyme (E)/carbon immunoassay (CIA) that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 ribonucleic acid (RNA) viral load
  • Age >= 18 years. Because no dosing or adverse event data are currently available on the use of pomalidomide in participants < 18 years of age, children are excluded from this study
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1
  • Life expectancy of greater than 6 months
  • Hemoglobin >= 8 g/dL (within 14 days before enrollment into OPEN Step-1 (Treatment Assignment - Registration Step)
  • Absolute neutrophil count (ANC): >= 1,000/mm^3 (within 14 days before enrollment into OPEN Step-1 (Treatment Assignment - Registration Step)
  • Platelets: >= 75,000/mm^3 (within 14 days before enrollment into OPEN Step-1 (Treatment Assignment - Registration Step)
  • Bilirubin =< 1.5: x upper limit of normal (ULN) unless the patient is receiving an ART drug known to be associated with increased bilirubin, in which case the direct fraction should be =< 2 x ULN (within 14 days before enrollment into OPEN Step-1 (Treatment Assignment - Registration Step)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (within 14 days before enrollment into OPEN Step-1 (Treatment Assignment - Registration Step)
  • Serum creatinine =< 2.0 mg/dL/176.8 umol/L; or estimated creatinine clearance >= 15 mL/minute (1.00 mL/s) (as calculated per the Cockcroft-Gault equation (within 14 days before enrollment into OPEN Step-1 (Treatment Assignment - Registration Step)
  • Females of childbearing potential (FCBP), defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally post menopausal for at least 24 consecutive months, i.e., has had menses at any time in the preceding 24 consecutive months) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All patients must be counseled at a minimum of every 28 (± 2) days about pregnancy precautions and risks of fetal exposure
  • HIV positive participants must be taking stable ART for >= 12 weeks, and have an undetectable HIV viral load within 28 days before enrollment into OPEN Step-1 (Treatment Assignment - Registration Step). Minor fluctuations up to 200 copies/mL are acceptable
  • HIV positive participants must not show recent improvement on ART that may confound response evaluation, within the following parameters:
  • If on ART 12 to 24 weeks, participants must show evidence of KS progression requiring further systemic treatment
  • Evidence of KS progression for eligibility include: Any new lesion(s); spreading of lesions by any measurable degree; development of ulceration; worsening edema documented by circumferential measure of limb or body; increase in symptoms such as pain, including negative psychological impact, requiring; any degree disease worsening by imagining) that would prompt expert assessment to recommend further systemic treatment without delay
  • If on ART for > 24 weeks, must show no evidence of regression in last 8 weeks
  • Evidence of KS regression for eligibility include: Measures of edema, lesion size or number, resolution of ulceration, or 20% improvement by imaging in largest diameter. For purposes of this assessment, if there is 20% reduction in size of any lesion, disappearance of any lesion, this constitutes regression unless there is concomitant increase in size or appearance of new lesions elsewhere
  • Participants must agree to participate in and comply with the mandatory POMALYST Risk Evaluation and Mitigation Strategy (REMS) program
  • Participants must be able to take aspirin 81 mg daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA], may use one of the alternatives
  • For participants with impaired decision-making capacity (IDMC): Participants with IDMC may be eligible for the study provided all other eligibility criteria are satisfied:
  • The participant's legally authorized representative (LAR) is able and willing to sign consent in addition to the study candidate
  • Both participant and LAR agree to follow study parameters and ensure that drug is taken per protocol, recorded in the study drug diary, and returned to clinic with any unused pills

Who cannot join

  • Participant who is receiving any other investigational agents
  • Participant has symptomatic visceral KS involving the lungs or gastrointestinal (GI) tract that requires immediate chemotherapy or radiotherapy. Participants with minimally symptomatic visceral disease not requiring immediate tumor shrinkage are eligible if in provider judgment potential disease progression will not cause a hazard for the participant
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide
  • Use of agents containing zidovudine (including Combivir and Trizivir) are prohibited. Changes to ART therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.). Use of medications or substances that are strong inhibitors of cytochrome P450 (CYP)1A2, which include amiodarone, cimetidine, fluoroquinolones (e.g., ciprofloxacin, enoxacin), fluvoxamine, and ticlopidine is prohibited. Co-administration of efavirenz, an inhibitor of CYP1A2, with strong inhibitors of CYP3A4 and P-glycoprotein (P-gp) is prohibited. Use of erythropoietin is prohibited. Co-administration of corticosteroids greater than doses required for treatment of adrenal insufficiency is prohibited. Because the lists of these agents are constantly changing, it is important to regularly consult frequently updated list; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the informed consent/enrollment procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection for which the participants have not completed at least 14 days of therapy prior to study enrollment into OPEN Step-1 (Treatment Assignment - Registration Step) and/or is not clinically stable
  • Participant has symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
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  • Pregnant women are excluded from this study because pomalidomide is a thalidomide analog with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pomalidomide, breastfeeding should be discontinued if the mother is treated with pomalidomide
  • Participants who have had chemotherapy, radiotherapy, or therapies to target KS lesions within 4 weeks (6 weeks for nitrosoureas or mitomycin C) with the exception of ART, before enrollment into OPEN Step-1 (Treatment Assignment - Registration Step)
  • Participants with high clinical suspicion of concurrent Castleman disease or IL6 related inflammatory disease
  • For a reference of signs and symptoms consistent with IL6 related inflammatory disease or KSHV inflammatory cytokine syndrome (KICS) can refer to publication from Polizzotto Minnesota (MN), et al. Clinical Features and Outcomes of Patients with Symptomatic Kaposi Sarcoma Herpesvirus (KSHV)-associated Inflammation: Prospective Characterization of KICS. Clinical Infectious Diseases, 2016. 62(6):730-8
  • Participants with a history of malignant tumors other than KS, unless:
  • In complete remission for >= 1 year, or
  • Completely resected basal cell or squamous skin carcinoma, or
  • In situ squamous cell carcinoma (SCC) of the cervix or anus
  • Participants with grade >= 3 peripheral neuropathy
  • Participants with a history of venous or arterial thromboembolism, unless line-rated thrombosis without embolus occurring >= 1 year prior to study entry
  • Participants with a known procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency, or antiphospholipid syndrome, but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome
  • Participants with any prior use of pomalidomide, lenalidomide or thalidomide
  • Participants with any condition, including the presence of laboratory abnormalities, which in the opinion of the responsible investigator places the participant at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • University of Illinois

    Chicago, Illinois, 60612

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Thomas Street at Quentin Mease Health Center

    Houston, Texas, 77004

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Mount Sinai Hospital

    New York, New York, 10029

  • NYP/Weill Cornell Medical Center

    New York, New York, 10065

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: A Multicenter Phase II Study of Pomalidomide Monotherapy in Kaposi Sarcoma

This phase II trial studies the effect of pomalidomide in treating patients with Kaposi sarcoma. Pomalidomide is a cancer fighting drug that stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the proportion of participants with Kaposi sarcoma (KS) (with or without human immunodeficiency virus [HIV], regardless of previous treatment status) treated with pomalidomide who respond to treatment with a durable response (i.e., response duration of at least one year).

SECONDARY OBJECTIVES:

  1. To measure the overall response rate (ORR) and report 95% confidence intervals in the overall study population.

Ia. To measure the ORR in the HIV positive study population. Ib. To measure the ORR in the HIV unrelated study population. II. To estimate the ORR in subgroups of KS in regard to HIV and previous treatment status.

III. To assess the safety of pomalidomide therapy. IV. To describe changes in visceral disease among those presenting with evaluable visceral disease.

  1. To assess response duration in participants treated with pomalidomide.

EXPLORATORY OBJECTIVES:

  1. To assess the effect of pomalidomide treatment on the tumor microenvironment and explore the relationship with clinical response.

II. To describe the effects of pomalidomide on CD4 lymphocyte counts and HIV viral load in HIV positive (+) participants.

III. To assess the effect of pomalidomide treatment on serum biomarkers and explore the relationship with clinical response.

IV. To assess Kaposi's sarcoma-associated herpesvirus (KSHV) viral copy number in plasma and explore whether changes correlate with clinical outcome.

  1. To assess the effects of pomalidomide on viral and cellular transcription in KS tumor biopsies and explore the relationship with clinical response.

VI. To biobank clinical samples for future potential studies on the immune phenotype and viral and cellular transcription and to explore the relationship with clinical response.

OUTLINE:

Patients receive pomalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, patients with complete response (CR) or partial response (PR) continue pomalidomide for an additional 12 cycles with the option to continue thereafter in the absence of disease progression or unacceptable toxicity. After 12 cycles, patients with stable disease may continue pomalidomide for an additional 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray imaging throughout the trial. Patients may undergo computed tomography (CT) as clinically indicated. Patients also undergo blood sample collection and may optionally undergo tissue biopsy during screening and on the trial.

After completion of study treatment, patients are followed up every 6 months for up to 5 years.

Being tested
Biopsy Procedure, Biospecimen Collection, Computed Tomography, Pomalidomide, X-Ray Imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo tissue biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • PomalidomideDrug

    Also called 4-Aminothalidomide, Actimid, CC 4047, CC-4047

    Given PO

  • X-Ray ImagingProcedure or surgery

    Also called Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs

    Undergo x-ray imaging

Study groups in NCT04577755
Study groupRoleWhat they receive
Treatment (pomalidomide)ExperimentalPatients receive pomalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, patients with CR or PR continue pomalidomide for an additional 12 cycles with the option to continue thereafter in the absence of disease progression or unacceptable toxicity. After 12 cycles, patients with stable disease may continue pomalidomide for an additional 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo chest x-ray imaging throughout the trial. Patients may undergo CT as clinically indicated. Patients also undergo blood sample collection and may optionally undergo tissue biopsy during screening and on the trial.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Pomalidomide; Procedure: X-Ray Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of response

    The Kaplan-Meier (K-M) method will be used to describe duration of response for all treated participants. The cumulative proportion of study participants still in response at one year will be estimated using the point estimate and the 95% confidence interval using Greenwood's formula for the standard error of the K-M estimate. The proportional hazards model will be used to evaluate the association of human immunodeficiency virus (HIV) status and pretreatment status on duration of response.

    Measured: From the first date at which a partial or complete response is documented until progression or death due to any cause, assessed up to 5 years

Secondary outcomes (4)

  1. Overall response rate (ORR)

    The binomial proportion and its 95% confidence interval will be used to estimate ORR in four groups defined by HIV status and pretreatment status (HIV+, pretreated; HIV+, treatment naive; HIV-, pretreated and HIV-, treatment naive). In addition, the binomial proportion and its 95% confidence interval will be used to describe the ORR for HIV+ and HIV- participants, and those that were pretreated and treatment naïve.

    Measured: Up to 5 years post treatment

  2. Incidence of adverse events

    Will be assessed using version Common Terminology Criteria for Adverse Events 5.0. Adverse events observed on this study will be summarized by organ system, severity grade and relationship to pomalidomide. Frequency and severity of adverse events will be tabulated at the event and person level.

    Measured: Up to 5 years post treatment

  3. Changes in visceral disease

    For those with evaluable visceral disease, changes in visceral disease will be descriptively reported.

    Measured: Baseline up to 5 years post treatment

  4. Response duration in participants treated with pomalidomide

    For deaths unrelated to progressive disease, duration of response will be censored at the date of the last Kaposi sarcoma (KS) evaluation during which the participant was determined to still be in response.

    Measured: From the first date of which a partial or complete response is documented until first date of progression, assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start18 Mar 2022
  3. Primary completion4 Feb 2027 (estimated)
  4. Study completion4 Feb 2027 (estimated)

Resources

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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04577755
Sponsor's protocol ID
NCI-2020-07565
Other IDs
NCI-2020-07565, AMC-108, AMC-108, UM1CA121947
Status last verified
Sep 2026
First submitted
6 Oct 2020
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Skin Kaposi Sarcoma, run by National Cancer Institute (NCI) at 15 sites in United States.

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 31 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of response (time frame: From the first date at which a partial or complete response is documented until progression or death due to any cause, assessed up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04577755.

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 28 Sep 2026.

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