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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2026
  • participants needed
    54
  • sponsor
    National Cancer Institute (NCI)
Updated on 21 July 2022
ct scan
aspirin
cancer
edema
lymphoma
vincristine
monoclonal antibodies
measurable disease
carcinoma
antiretroviral therapy
oophorectomy
etoposide
doxorubicin
anthracyclines
cytotoxic chemotherapy
combination chemotherapy
progressive disease
neutrophil count
immunohistochemistry
tumor cells
bevacizumab
nivolumab
AIDS
cancer chemotherapy
bleomycin
herpes
imaging procedure
leiomyosarcoma

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....

Description

Background
  • There is an unmet need for less toxic and more effective treatments for virus-associated malignancies.
  • Pomalidomide induces polyfunctional T cell, NK cell, and dendritic cell activation.
  • Pomalidomide has shown promising activity in Kaposi sarcoma, likely due in part to immune modulation.
  • Downregulation and/or deregulation of immune surface markers by viruses can thwart immunologic therapy, which may be prevented or reversed by pomalidomide.
  • PD-L1 is expressed in virus-associated malignancies and modulation of PD-1 signaling is a promising approach to treatment of virus-associated malignancies.
  • Checkpoint inhibitors used alone have been shown to have some activity in certain virus-induced tumors (e.g. Hodgkin and non-Hodgkin lymphomas, Merkel cell carcinoma, and HPV-associated nasopharyngeal cancer). It is thus rational to explore combination strategies that overcome viral-mediated immune evasion and provide potentially better immunologic anti-tumor activity.
    Objectives

-Assess the safety and tolerability of pomalidomide plus nivolumab (Pom/Nivo) in participants with virus-associated solid malignancies

Eligibility
  • Age greater than or equal to 18 years
  • Histologically or cytologically proven selected virus-associated tumors that are systemic, metastatic or locally advanced and not amenable to curative treatment options or relapsed/refractory to first-line therapy
  • For solid tumors or hematologic malignancies at least one measurable disease
  • At least five measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy to these measurable lesions.
  • ECOG Performance Status (PS) less than or equal to 2
  • Participants must be willing to give informed consent.
  • Participants can be HIV positive or negative.
  • Antiretroviral therapy (ART) for HIV+ patients
  • Participants receiving other investigational agents will not be eligible.
Design
  • This is a Phase I study assessing the safety and efficacy of a fixed dose of nivolumab combined with increasing doses of pomalidomide in participants with viral associated malignancies.
  • Up to 6 participants treated in a 3+3 dose de-escalation schema for pomalidomide using one dose de-escalation and one dose escalation levels.
  • Following identification of an optimal dose, an expansion phase will be initiated through a protocol amendment. Up to 30 participants will be enrolled. Of these 12 participants must have a KS diagnosis and 12 participants must have EBV and/or KSHV-associated lymphomas.
  • 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.
  • Pomalidomide will be administered as an oral planned starting dose of 3 mg daily. Pomalidomide will be given from day 1 to day 21 of each cycle.
  • Participants will receive therapy up to 24 cycles or until unacceptable toxicity, clinical progression, the participant s request to discontinue therapy, or PI decision.

Details
Condition Viral Associated Malignancies, Kaposi Sarcoma, EBV/KSHV-associated Lymphomas
Treatment Pomalidomide, Nivolumab
Clinical Study IdentifierNCT04902443
SponsorNational Cancer Institute (NCI)
Last Modified on21 July 2022

Eligibility

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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