Nanatinostat + Valganciclovir/Pembrolizumab for Nasopharyngeal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for EBV-positive nasopharyngeal carcinoma, a cancer affecting the area behind the nose and above the back of the throat. Researchers combine two drugs, nanatinostat (a potential new drug) and valganciclovir, to evaluate their effectiveness and safety. They also add a third drug, pembrolizumab, to assess whether it improves outcomes. Suitable candidates for this trial have recurrent or metastatic EBV-positive nasopharyngeal carcinoma and have previously tried at least one chemotherapy regimen without success. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this potential new drug.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but you cannot have had anti-tumor treatments like chemotherapy or immunotherapy within 4 weeks before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that patients generally tolerate the combination of nanatinostat and valganciclovir well. In various studies, patients received higher doses than those used for conditions like lymphoma and tolerated them effectively. Some patients even demonstrated signs of tumor reduction, which is promising.
When researchers added pembrolizumab, the treatment remained safe, and some patients experienced partial improvements. This is encouraging, as it suggests the treatment could be effective without additional safety concerns.
As this is a Phase 1 trial, the primary goal is to assess the treatment's safety and manageability. Early results are positive, but monitoring for side effects remains crucial as more data is collected.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Nanatinostat, Valganciclovir, and Pembrolizumab for nasopharyngeal cancer because it offers a multi-faceted approach to treatment. Unlike traditional options that often focus on chemotherapy or radiation, Nanatinostat works by inhibiting specific enzymes that control cancer cell growth, potentially making it more targeted. Valganciclovir adds an antiviral angle, which is unique because certain viral infections are linked to nasopharyngeal cancer. Finally, Pembrolizumab, an immunotherapy drug, empowers the immune system to recognize and attack cancer cells, offering a promising new angle to enhance treatment effectiveness. This combination could improve outcomes by addressing the cancer from multiple biological pathways.
What evidence suggests that this trial's treatments could be effective for nasopharyngeal cancer?
Research has shown that combining nanatinostat and valganciclovir, one of the treatment arms in this trial, may effectively treat cancers linked to the Epstein-Barr virus (EBV). In studies, this combination reduced or eliminated cancer in up to 58% of patients, with about one-third having no detectable cancer afterward. Another treatment arm in this trial adds pembrolizumab, which boosts the immune system, to the nanatinostat and valganciclovir combination. Early results suggest that this triple treatment could be a stronger option for patients with hard-to-treat cancers like nasopharyngeal carcinoma.13456
Who Is on the Research Team?
Darrel P Cohen, MD, PhD
Principal Investigator
Viracta Therapeutics
Are You a Good Fit for This Trial?
This trial is for adults with advanced EBV+ solid tumors, including nasopharyngeal carcinoma, who've tried at least one platinum-based chemotherapy but no more than three treatments. They must have measurable disease and be in good physical condition (ECOG 0 or 1), with proper bone marrow and liver function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1b Dose Escalation
Nanatinostat dose escalation starting at 20 mg orally daily, 4 days per week, and valganciclovir starting at 900 mg orally daily to evaluate safety and determine the recommended Phase 2 dose
Phase 1b Cohort
Patients with other EBV+ solid tumors receive nanatinostat in combination with valganciclovir at the RP2D
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nanatinostat
- Pembrolizumab
- Valganciclovir
Find a Clinic Near You
Who Is Running the Clinical Trial?
Viracta Therapeutics, Inc.
Lead Sponsor