Pomalidomide and Nivolumab in People With Virus-Associated Malignancies With or Without HIV
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNational Cancer Institute (NCI)
About this trial
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 criteria
Qualifiers
Histologically or cytologically proven selected virus-associated tumors that are systemic, metastatic or locally advanced and not amenable to curative treatment options or are relapsed/refractory to first-line therapy as appropriate for each tumor type as outlined below. Also, participants with eligible solid tumors, who after evaluation by an expert in the area are deemed to be potentially curable after extensive surgery, but refuse such surgical procedure due to associated disfigurement and/or morbidity, may be eligible for the study with the necessary informed consent. Pathology confirmation by NCI Laboratory of Pathology is needed for eligibility.
Relapsed or refractory de novo classical Hodgkin lymphoma having failed standard first-line therapy; and
Unresponsive or progressive disease after treatment with brentuximab vedotin or may be brentuximab vedotin na(SqrRoot) ve but is ineligible or unable to receive brentuximab vedotin; and
Unresponsive or progressive disease after checkpoint inhibitor therapy;
Disqualifiers
Participants who have had anticancer treatment within the last 2 weeks, unless the cancer treatment is for a malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial, such as local treatment for carcinoma in situ or hormonal therapy for prostate or breast carcinoma.
Elevated triglyceride attributed to ART and/or HIV (must be <= Grade 2)
Laboratory or clinical abnormalities that are assessed as more likely to be from the underlying tumors, HIV disease, or other non-treatment causes will not be considered an exclusion criterion.
Alopecia, neuropathy and ototoxicity (i.e., AEs that are not expected to improve within the washout period)
Trial design
Treatments tested in this trial
- Pomalidomide
- Nivolumab
Treatment groups
58 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov