RecruitingPhase 1NCT04902443

Pomalidomide and Nivolumab in People With Virus-Associated Malignancies With or Without HIV

A Phase I Study of Pomalidomide and Nivolumab in Patients With Virus-Associated Malignancies With or Without HIV


Sponsor

National Cancer Institute (NCI)

Enrollment

58 participants

Start Date

Dec 10, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of pomalidomide and nivolumab (an immune therapy drug) in people with virus-associated cancers — meaning cancers caused by viruses such as EBV, HPV, hepatitis B, hepatitis C, or the Kaposi sarcoma virus — with or without HIV. **You may be eligible if...** - You have been diagnosed with a cancer associated with a virus (such as Kaposi sarcoma, certain lymphomas, cervical or anal cancer, Merkel cell carcinoma, or liver cancer related to hepatitis) - Your cancer is advanced, has spread, or has come back after initial treatment - Your tumor has been confirmed by a pathology laboratory - You are in adequate general health **You may NOT be eligible if...** - Your overall health is too poor to participate - You have uncontrolled serious infections (other than the virus driving your cancer) - You have active autoimmune conditions that required recent treatment - You have recently received certain other immune therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPomalidomide

Pomalidomide will be administered as an oral planned starting dose of 3 mg daily (dose escalation) or at an MTD of 4 mg (dose expansion). Pomalidomide will be given from day 1 to day 21 of each cycle.

DRUGNivolumab

Nivolumab will be administered IV at a dose of 480 mg at day one of each cycle, except for cycle one when it will be administered on day 8. One cycle equals 28 days


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT04902443


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