Phase 2
N=26
Pomalidomide in Treating Patients With Kaposi Sarcoma and Human Immunodeficiency Virus Infection
Human Immunodeficiency Virus 1 Positive · Skin Kaposi Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT03601806 ↗Enrolled (actual)
26
Serious AEs
26.9%
Results posted
Feb 2026
Primary outcome: Primary: Overall Response Rate — 0.577 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Laboratory Biomarker Analysis (Other); Pomalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AIDS Malignancy Consortium
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
0.577 | — |
| PRIMARY Complete Response Rate |
— | — |
| PRIMARY Incidence of Adverse Events Defined as Grade 3 or Higher Toxicities Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 |
57.7; 38.5 | — |
| SECONDARY Changes in CD4 T Cell Count |
456; 524.1; 512.6; 587.8; 417.4; 484.6 | — |
| SECONDARY Changes in HIV Viral Load as Measured by HIV Quantitative Polymerase Chain Reaction |
34.9; 31.4; 31.5; 23.2; 27.5; 39.1 | — |
Summary
This phase II clinical trial studies the side effects of pomalidomide and how well it works in treating patients with Kaposi sarcoma and human immunodeficiency virus (HIV) infection. Biological therapies, such as pomalidomide, may stimulate the immune system in different ways and stop tumor cells from growing and it may also block the growth of new blood vessels necessary for tumor growth.
Eligibility Criteria
Inclusion Criteria
- Participants must have measurable cutaneous KS that has been pathologically confirmed by an acquired immunodeficiency syndrome (AIDS) Malignancy Consortium (AMC)-approved pathologist; diagnostic tissue must be available to satisfy the tissue submission requirements for central pathology review
- Participants may not show evidence for ongoing improvement in KS lesions in the 4 weeks prior to enrollment
- HIV positive. Documentation of HIV-1 infection by means of any one of the following:
- HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA copies/mL confirmed by a licensed screening antibody and/or HIV antibody antigen combination assay;
- 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 multispot 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. 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 E/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 RNA viral load.
- Eastern Cooperative Oncology Group (ECOG) performance status = = 50)
- Life expectancy >= 12 weeks
- Hemoglobin >= 8 g/dL
- Absolute neutrophil count (ANC): >= 1,000 cells/mm^3 (1.0 x 10^9/L)
- Platelets: >= 75,000 cells/mm^3 (75.0 x 10^9/L)
- Total bilirubin: = 60 mL/minute (1.00 mL/s) (serum creatinine = = 12 weeks, with HIV viral load = 40 mIU/mL and a history of amenorrhea x >= 1 year
- FCBP 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, including one of the following highly effective, long-acting methods, DepoProvera, an intrauterine device (IUD), an implant*, or bilateral tubal ligation, if it can be verified that the procedure was performed, 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
- NOTE: Implants containing levonorgestrel and etonogestrel are prohibited in women receiving efavirenz, as drug interactions will render the implants ineffective
- Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy
- All participants must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure; serum or urine pregnancy testing will be repeated in FCBP, and must be negative, within 24 hours of starting each new cycle of pomalidomide
- Able to take aspirin (>= 81 mg) daily as prophylactic anticoagulation
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria
- Participants who are receiving any other investigational agents
- Any prior use of thalidomide, lenalidomide, or pomalidomide
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to pomalidomide
- Visceral disease requiring cytotoxic chemotherapy (i.e., pulmonary KS, symptomatic gastrointestinal KS). KS-related lymphedema is permitted.
- Use of agents containing zidovudine (including Combivir and Trizivir) are prohibited; in order to be eligible, participants taking zidovudine must change to a different regimen at least 7 days prior to therapy initiation; changes to antiretroviral therapy
Data sourced from ClinicalTrials.gov (NCT03601806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.