What side effects are associated with this type of intervention?

Common treatments for carcinoma, particularly those involving HDAC inhibitors, antivirals, and PD-1 inhibitors, have several known side effects. HDAC inhibitors can cause fatigue, nausea, vomiting, diarrhea, and hematologic toxicities such as thrombocytopenia and neutropenia. Antivirals like Valganciclovir may lead to bone marrow suppression, resulting in neutropenia, anemia, and thrombocytopenia, along with gastrointestinal issues like nausea and diarrhea. PD-1 inhibitors such as Pembrolizumab are associated with immune-related adverse events, including colitis, hepatitis, pneumonitis, endocrinopathies, and skin reactions. Combining these treatments may increase the risk of overlapping toxicities, particularly hematologic and gastrointestinal side effects.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has received FDA approval for several carcinomas, including melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma, due to its immune-enhancing properties. HDAC inhibitors such as vorinostat have been approved for cutaneous T-cell lymphoma, demonstrating their role in altering gene expression to inhibit cancer growth. Although antivirals like Valganciclovir are mainly used for viral infections, their combination with other cancer treatments is being explored for potential synergistic benefits.

What other types of research exist?

Promising alternatives to Nanatinostat, Valganciclovir, and Pembrolizumab for carcinoma patients include: 1) Azacitidine plus Gilteritinib, which has shown a higher overall response rate in AML patients. 2) Vorinostat combined with R-EPOCH for high-risk HIV-associated Non-Hodgkin's Lymphoma, which enhances anti-tumor effects and reactivates latent viruses. 3) Lenvatinib plus Pembrolizumab, which has demonstrated efficacy in advanced renal cell carcinoma and other selected advanced solid tumors.

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HDAC inhibitor

Nanatinostat + Valganciclovir/Pembrolizumab for Nasopharyngeal Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Viracta Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase 1b exploratory proof-of-concept cohort only: Advanced/metastatic EBV+ non-NPC solid tumors with no available curative therapies

ECOG performance status 0 or 1

Must not have

Active autoimmune disease that has required systemic therapy with modifying agents, corticosteroids, or immunosuppressive agents

Active CNS disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of nanatinostat, valganciclovir, and pembrolizumab in patients with certain EBV-related cancers. Nanatinostat makes cancer cells more vulnerable, allowing valganciclovir to kill them, while pembrolizumab boosts the immune system to fight the cancer.

Who is the study for?

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.

What is being tested?

The study tests nanatinostat combined with valganciclovir for EBV+ solid tumors, and adds pembrolizumab for recurrent/metastatic nasopharyngeal carcinoma. It aims to assess the safety and effectiveness of these combinations.

What are the potential side effects?

Potential side effects may include gastrointestinal issues due to oral medication absorption challenges, immune system reactions from autoimmune diseases being triggered or worsened, liver problems from hepatitis B/C infections, and complications related to CNS disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have an advanced cancer linked to EBV with no cure.

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I am fully active or can carry out light work.

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I have EBV+ nasopharyngeal cancer that has returned or spread, and I've had 1-3 treatments already.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an autoimmune disease treated with strong medication.

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I have an active brain or spinal cord disease.

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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Nanatinostat in combination with valganciclovir and pembrolizumabExperimental Treatment3 Interventions

Group II: Nanatinostat in combination with valganciclovirExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Valganciclovir

2019

Completed Phase 4

~2160

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for carcinoma, such as those involving Nanatinostat, Valganciclovir, and Pembrolizumab, work through distinct but complementary mechanisms. Nanatinostat, an HDAC inhibitor, modifies gene expression to promote cancer cell death. Valganciclovir, an antiviral, targets viral infections that may contribute to cancer progression. Pembrolizumab, a PD-1 inhibitor, enhances the immune system's ability to recognize and attack cancer cells. These mechanisms are significant for carcinoma patients as they offer a comprehensive treatment strategy that targets the cancer cells directly, addresses potential viral contributions, and strengthens the body's immune response, potentially improving treatment efficacy and patient outcomes.

Combination of molecular-targeted drugs with endocrine therapy for hormone-resistant breast cancer.Combination of HDAC and topoisomerase inhibitors in small cell lung cancer.Assays for pharmacodynamic analysis of histone deacetylase inhibitors.