OncoMatch/Clinical Trials/NCT04902443
Pomalidomide and Nivolumab in People With Virus-Associated Malignancies With or Without HIV
Official title: A Phase I Study of Pomalidomide and Nivolumab in Patients With Virus-Associated Malignancies With or Without HIV
Is NCT04902443 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments including Pomalidomide and Nivolumab for viral associated malignancies.
Treatment: Pomalidomide · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Endocrine / hormonal
Cancer type
Sarcoma
Tumor Agnostic
Biomarker criteria
Required: EBV eber expression
assessing of virus infection of the tumor cells with EBV EBER by in situ hybridization (ISH)
Required: KSHV lana expression
KSHV LANA by immunohistochemistry (IHC)
Required: CDKN2A p16 expression
p16 by immunohistochemistry (IHC) to document the respective viral infection (HPV)
Required: MCPYV large t antigen expression
Merkel cell polyomavirus large T antigen by immunohistochemistry (IHC)
Required: HBV surface antigen or anti-hbv core antibody or elevated hbv dna viral load
detection of serum HBV surface antigen, anti-HBV core antibody, elevated HBV DNA viral load
Required: HCV antibody or elevated hcv rna viral load
positive HCV antibody or elevated HCV RNA viral load
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: investigational agent
Participants who are receiving any other investigational agents
Cannot have received: allogeneic stem cell transplant
Participants who have received prior allogeneic stem cell or organ transplant
Cannot have received: organ transplant
Participants who have received prior allogeneic stem cell or organ transplant
Lab requirements
Blood counts
absolute neutrophil count >=1,000/mcL; platelets >=75,000/mcL
Kidney function
glomerular filtration rate (GFR) >=30 mL/min/1.73 m^2
Liver function
total bilirubin <= institutional ULN (except Gilbert disease or ART-related, must be grade <=2); AST(SGOT)/ALT(SGPT) <=3x institutional ULN
Participants must have adequate organ and marrow function as defined below: absolute neutrophil count >=1,000/mcL; platelets >=75,000/mcL; total bilirubin <= institutional ULN (except for Gilbert disease or ART-related, must be grade <=2); AST(SGOT)/ALT(SGPT) <=3x institutional ULN; GFR >=30 mL/min/1.73 m^2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04902443 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational agent, allogeneic stem cell transplant, organ transplant disqualifies patients from enrollment.
Does this trial require EBV?
Yes, EBV eber expression is a required biomarker for enrollment.
Does this trial require KSHV?
Yes, KSHV lana expression is a required biomarker for enrollment.
Does this trial require CDKN2A?
Yes, CDKN2A p16 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 99 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages