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NCT04902443 · ClinicalTrials.gov registry record · Phase 1
Pomalidomide and Nivolumab in People With Virus-Associated Malignancies With or Without HIV
A Phase 1 study of Kaposi Sarcoma and Viral Associated Malignancies, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT04902443: Recruiting Phase 1 study of Kaposi Sarcoma and Viral Associated Malignancies, sponsored by National Cancer Institute (NCI).
NCT04902443 is a Phase 1 study of Kaposi Sarcoma and Viral Associated Malignancies that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 58 participants, below the 98-participant average among 13 other Kaposi Sarcoma trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04902443, a Phase 1 study of Kaposi Sarcoma and Viral Associated Malignancies, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study 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 dr
Primary Outcome
The fraction of participants with toxicity noted at each dose level will be reported by grade and type of toxicity identified. Maximum tolerated dose will also be reported.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Pomalidomide
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2021-12-10 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 1 |
What NCT04902443 shows while recruiting
NCT04902443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 98-participant average among 13 other Kaposi Sarcoma trials with a reported enrollment target (41% lower).
The record links to 3 conditions, with Kaposi Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT04902443 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04902443 about?
NCT04902443 is a clinical study titled "Pomalidomide and Nivolumab in People With Virus-Associated Malignancies With or Without HIV". 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 cance...
What is the current status of trial NCT04902443?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2021-12-10. Estimated completion is 2027-12-01.
What conditions does trial NCT04902443 study?
This clinical trial studies the following conditions: Kaposi Sarcoma, Viral Associated Malignancies, EBV/KSHV-associated Lymphomas.
What interventions are being tested in trial NCT04902443?
The interventions under investigation include: Nivolumab (DRUG), Pomalidomide (DRUG).
Who is sponsoring clinical trial NCT04902443?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04902443 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kaposi Sarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04902443's enrollment target sits among peer trials
58 8th of 13 higher than 6 of 13 other Kaposi Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kaposi Sarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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