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New treatment option for Viral Associated Malignancies
Official title Pomalidomide and Nivolumab in People With Virus-Associated Malignancies With or Without HIV
ClinicalTrials.gov ID: NCT04902443
What this study is testing
What is Pomalidomide?
Pomalidomide is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for viral associated malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Histologically or cytologically proven selected virus-associated tumors that are systemic, metastatic or locally advanced and not amenable to...
- 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...
- Unresponsive or progressive disease after checkpoint inhibitor therapy; and
- Unresponsive or progressive disease after or is ineligible for autologous stem cell transplant (auto-SCT) --EBV-positive aggressive non-Hodgkin...
You likely can't join if
- Participants who have had anticancer treatment within the last 2 weeks, unless the cancer treatment is for a malignancy whose natural history or...
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the...
- 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...
- Alopecia, neuropathy and ototoxicity (i.e., AEs that are not expected to improve within the washout period)
- Participants who are receiving any other investigational agents.
See the full eligibility criteria
Who can join
- 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...
- 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; and
- Unresponsive or progressive disease after or is ineligible for autologous stem cell transplant (auto-SCT) --EBV-positive aggressive non-Hodgkin lymphomas meeting the following criteria:
- Relapsed/refractory disease after standard first-line chemotherapy; and
- Relapsed disease after autologous stem cell transplant if indicated for histology (i.e diffuse large B-cell lymphoma relapsed more than one year after first line treatment) or autologous stem cell transplant is not...
- Relapsed after CAR-T cell therapy for HIV-negative participants only if indicated for histology (i.e., diffuse large B-cell lymphoma) or CAR-T cell therapy is not feasible
- EBV-positive nasopharyngeal cancer unresponsive or progressive disease on or after platinum-containing chemotherapy and/or radiotherapy
- EBV-positive gastric cancer that is unresponsive or progressive disease on or after first-line chemotherapy
- EBV-positive leiomyosarcomas that is unresponsive or progressive disease on or after 2 systemic regimens (CCRT/platinum-taxane)
- Kaposi sarcoma impairing physical wellbeing (for example, tumor edema, pain, skin ulceration or breakdown, oral disease impairing function), no active KSHV-associated multicentric Castleman disease in past 12 months...
- Inadequate tumor response after 6 or more cycles of liposomal doxorubicin or paclitaxel or other active cytotoxic agents (i.e. etoposide, bleomycin, anthracyclines, vincristine, vinblastine); or
- Progressive disease while receiving liposomal doxorubicin or paclitaxel or other active cytotoxic agents (i.e. etoposide, bleomycin, anthracyclines, vincristine, vinblastine); or
- Intolerant of liposomal doxorubicin and paclitaxel
- Primary effusion lymphoma unresponsive or progressive disease on or after first-line combination chemotherapy
- HPV-positive head and neck cancer that is unresponsive or progressive on or after first-line combination chemotherapy +/- radiotherapy
- HPV-positive cervical cancer that is unresponsive or progressive on at least one systemic regimen for recurrent (does not include initial CCRT) or metastatic disease. Tumor HPV testing will not be a requirement for...
- HPV-positive anal cancer that is unresponsive or progressive on or after first-line combination chemotherapy +/- radiotherapy
- HPV-positive vaginal cancer that is unresponsive or progressive on or after first-line chemotherapy
- HPV-positive penile cancer that is unresponsive or progressive on or after surgery and first-line chemotherapy
- HPV-positive vulvar cancer that is unresponsive or progressive on or after first- line combination chemotherapy
- MCPyV-positive Merkel cell carcinomas that is relapsed or refractory after prior checkpoint inhibitor therapy
- HBV- or HCV-associated hepatocellular carcinoma that is not amenable to local therapy or liver transplant and has progressed on first-line therapy with sorafenib or levatinib or atezolizumab+bevacizumab
- For solid tumors, participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis...
- For hematologic malignancies, participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (lymph nodes must measure \>=15 mm in the short axis and...
- For KS, participants must have measurable disease, defined as at least five measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response...
- Prior immunomodulatory therapy and checkpoint inhibitor therapy is allowed if previously tolerated without severe toxicities. Participants may not have received chemotherapy, radiotherapy, monoclonal antibody therapy...
- Age \>=18 years. Because no dosing or adverse event data are currently available on the use of pomalidomide in combination with nivolumab in participants \<18 years of age, children are excluded from this study.
- ECOG performance status \ =60%).
- Participants must have adequate organ and marrow function as defined below:
- leukocytes no lower limit
- absolute neutrophil count \>=1,000/mcL
- platelets \>=75,000/mcL
- total bilirubin \<= institutional upper limit of normal (ULN), except for participants with Gilbert disease or in whom the elevated bilirubinemia is due to ART (must be grade \<= 2)
- AST(SGOT)/ALT(SGPT) \<=3x institutional ULN
- glomerular filtration rate (GFR) \>=30 mL/min/1.73 m\^2 -Participants with any HIV status are eligible; for HIV-positive participants:
- Must be on antiretroviral therapy (ART) \>4 weeks and with evidence of viral suppression defined as HIV viral load \< 400 copies/mL
- Must have no major (e.g. AIDS-defining) opportunistic infections within the last 6 months except for the following which will be allowed:
- Esophageal candidiasis treated within last 6 months or currently improving with antifungal treatment
- Oral and/or genital HSV treated within last 6 months or currently improving with antiviral treatment
- Mycobacterium avium infection in last 6 months or that has been treated for at least 1 month
- For participants with evidence of chronic hepatitis B virus (HBV) infection, participants must be on suppressive therapy.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral...
- Able to take aspirin 81mg daily or a substitute thromboprophylaxis such as low molecular weight heparin at a prophylactic dose.
- Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
- Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is...
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- Participants may not have cardiac or pulmonary abnormalities severe enough that they would pose a danger to receive treatment. To mitigate risks for cardiac AEs, screening EKG, echocardiogram, CPK, and troponin will be...
- Current or history of systemic autoimmune disease requiring systemic immunosuppressive therapy will not be allowed. Note: the following will not be exclusionary: 1) the presence of laboratory evidence of autoimmune...
- Persons of childbearing potential (PCBP), defined as a woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months, i.e., has...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- 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 how...
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the following exceptions:
- 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)
- Participants who are receiving any other investigational agents.
- Participants will be excluded if they are on systemic steroid therapy that cannot be discontinued, with the exception of the use of prednisone or equivalent \<0.125mg/kg/day as replacement therapy. Inhaled or topical...
- History of allergic reactions attributed to pomalidomide and/or nivolumab or compounds of similar chemical or biologic composition to pomalidomide and/or nivolumab.
- Participants who have received prior allogeneic stem cell or organ transplant.
- Participants with severe uncontrolled intercurrent illness.
- Cirrhosis with Child-Pugh score of B or C
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and nursing persons are excluded from this study because pomalidomide is a thalidomide analog. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. These potential...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.