Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON). (NCT05012098) | Clinical Trial Compass
CompletedPhase 2
Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON).
United States11 participantsStarted 2022-06-21
Plain-language summary
Background:
Olfactory neuroblastoma (ONB) is a rare cancer of the nasal cavity. At diagnosis, it is usually locally advanced. It tends to spread to the neck. Sometimes it spreads to the lungs and bones. Researchers want to find a better way to treat it.
Objective:
To learn if giving immunotherapy drug bintrafusp alfa can help ONB shrink or disappear.
Eligibility:
People aged 18 years and older diagnosed with recurrent or metastatic ONB that has not responded to standard treatment.
Design:
Participants will be screened with a medical history, blood and urine tests, and physical exam. Their ability to perform their normal activities will be assessed. They will have an electrocardiogram to evaluate their heart. They will have imaging scans and/or a nuclear bone scan, as needed. For some scans, they may receive a contrast dye.
Some screening tests will be repeated during the study.
Participants will receive bintrafusp alfa once every 2 weeks for 26 doses. They will get it intravenously over 60 minutes. They may get other medicines to prevent side effects. They will complete health questionnaires. Visits will last 4-6 hours.
Participants may have optional tumor biopsies.
Participants will have an end of treatment visit within 7 days after they stop taking the study drug. About 28 days after treatment ends, they will have a safety visit. They will have follow-up visits every 3 months for the first year, then every 6 months for years 2-5, and then once a year after that for the rest of their life. If their disease progresses, they may be eligible for re-treatment with the study drug
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed recurrent or metastatic olfactory neuroblastoma (ONB) not amenable to potentially curative local therapies. Review of tissue samples by Pathology at the National Institutes of Health (NIH) is preferred.
✓. Participants must have measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. A previously treated lesion by radiotherapy can be chosen as the target lesion only if progression in the respective lesion has been demonstrated during or following radiotherapy.
✓. Participants should have received at least one line of systemic therapy including a platinum agent, with evidence of disease progression clinically or radiographically.
✓. Men or Women \>=18 years of age on day of signing informed consent. Because no dosing or adverse event data are currently available on the use of bintrafusp alfa in participants \<18 years of age, children are excluded from this study.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\<2.
✓. Participants must have adequate organ and marrow function as defined below:
✓. The effects of immunotherapy on the developing human fetus are unknown. Therefore, participants must use effective methods of contraception (such as implants, injectables, combined oral contraceptives, intrauterine device (IUDs), sexual abstinence or vasectomized partner).
What they're measuring
1
Percentage of Participants With an Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
✓. Participants with bone metastases or hypercalcemia on intravenous bisphosphonate treatment, zolendronic acid, denosumab, or similar agents are eligible to participate and may continue this treatment.
Exclusion criteria
✕. Anticancer treatment, concurrent or prior (chemotherapy, monoclonal antibody, cytokine therapy, immune therapy, targeted small molecule therapy) or any investigational drug, within 4 weeks or 5 half-lives (whichever shorter) prior to the first drug administration. All residual treatment-related toxicities must have resolved or be minimal and not constitute a safety risk. Note: Palliative radiotherapy is permitted concurrently or within the pretreatment period. Subjects receiving bisphosphonates or denosumab are eligible provided treatment was initiated at least 14 days before treatment.
✕. Participants who received prior checkpoint blockade therapy and were taken off treatment for serious adverse events related to immuno-therapy are excluded.
✕. Major surgery within 4 weeks prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted).
✕. Active or prior documented autoimmune or inflammatory diseases that might deteriorate on immunostimulatory agent (including colitis or Crohn's disease, systemic lupus erythematosus, sarcoidosis, vasculitis, Grave's disease, hypophysitis, uveitis, rheumatoid arthritis etc.), except the following:
✕. Current use of immunosuppressive medication within 14 days before the first dose of the study medication, except the following:
✕. Uncontrolled intercurrent chronic or acute illness including, but not limited to the following, that may limit interpretation of results or increase risk to the participant in the judgment of the investigator:
✕. Subjects unwilling to accept blood products as medically indicated.
✕. Vaccination with live vaccines within 4 weeks of the first dose of treatment and while on study is prohibited. Inactivated vaccines may be administered.