Actively Recruiting
Pomalidomide and Nivolumab in People With Virus-Associated Malignancies With or Without HIV
Led by National Cancer Institute (NCI) · Updated on 2026-04-28
58
Participants Needed
1
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Less toxic and more effective treatments are needed for cancers caused by viruses. These cancers include Hodgkin and non-Hodgkin lymphoma, hepatocellular carcinoma, head and neck cancer, nasopharyngeal carcinoma, gastric cancer, anal cancer, cervical cancer, vaginal cancer, vulvar cancer, penile cancer, Merkel cell carcinoma, Kaposi sarcoma, and leiomyosarcoma. Researchers want to see if a combination of drugs can help. Objective: To find a safe dose of pomalidomide plus nivolumab in people with cancers caused by viruses. Eligibility: Adults ages 18 or older who have cancers caused by Epstein Barr virus (EBV), human herpes virus 8/Kaposi sarcoma herpesvirus (HHV8/KSHV), human papilloma virus (HPV), hepatitis B or C virus (HBV/HCV), and Merkel cell polyomavirus (MCPyV) that have not responded to previous treatments or have relapsed, or in adults who do not want to have surgery because of disfigurement or other risks. Adults who have HIV with any CD4 T cell count are eligible. Design: Participants will be screened with blood and urine tests, scans, and heart tests. They will have a physical exam. Their ability to perform normal daily activities will be assessed. They may have a tumor biopsy. Treatment will be given in 28-day cycles. Participants will take pomalidomide as a tablet by mouth for 21 days of each cycle, for up to 24 cycles. They will get nivolumab by intravenous infusion once each cycle. They will take an aspirin each day until 30 days after their last dose of the study drugs. Participants will keep a pill diary. They will bring it to their study visit at the end of each cycle. At these visits, some screening tests will be repeated. Participants with Kaposi sarcoma will have pictures taken of their lesions. Participants will give blood and saliva samples for research. They may have optional anal and/or cervical swabs. They may have optional biopsies. Participants will have a follow-up visit 30 days after they stop taking the study drugs, then every month for 100 days. Some screening tests will be repeated. Then they may by contacted by phone every 3 months for 9 months, and then every 6 months thereafter.
CONDITIONS
Official Title
Pomalidomide and Nivolumab in People With Virus-Associated Malignancies With or Without HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed virus-associated tumors that are systemic, metastatic, or locally advanced and not curable or relapsed/refractory to first-line therapy
- Measurable disease in solid tumors or hematologic malignancies
- At least five measurable cutaneous Kaposi sarcoma lesions without prior local radiation or intralesional therapy
- ECOG performance status of 0 to 2
- Willingness to provide informed consent
- HIV-positive or negative status; HIV-positive must be on antiretroviral therapy
- No other investigational agents being taken
- Adequate organ and marrow function
- Ability to take daily aspirin or similar thromboprophylaxis
- For women of childbearing potential, negative pregnancy tests and commitment to effective birth control
- Treated brain metastases allowed if stable
- No severe cardiac or pulmonary abnormalities
- No systemic autoimmune disease requiring immunosuppressive therapy
- No recent major opportunistic infections in HIV-positive participants
You will not qualify if you...
- Anticancer treatment within the last 2 weeks, except for certain local or hormonal therapies
- Unresolved toxicities greater than Grade 1 from prior cancer treatments, except some exceptions
- Taking systemic steroids that cannot be discontinued, except low-dose replacement therapy
- Allergic reactions to pomalidomide or nivolumab or similar compounds
- Prior allogeneic stem cell or organ transplant
- Severe uncontrolled illness
- Cirrhosis with Child-Pugh score B or C
- Psychiatric or social issues limiting study compliance
- Pregnant or nursing persons due to risk of birth defects
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
I
Irene B Ekwede, R.N.
CONTACT
R
Ramya M Ramaswami, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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