What side effects are associated with this type of intervention?

Common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) include immune checkpoint inhibitors like Pembrolizumab and targeted therapies such as Danvatirsen. Pembrolizumab, a PD-1 inhibitor, can cause side effects like severe pneumonitis, vitiligo, alopecia, and other immune-related adverse events. Danvatirsen, an antisense oligonucleotide targeting STAT3, is still under investigation, but similar targeted therapies may cause partial alopecia, hair curling, and dyspigmentation. Both treatments can lead to various cutaneous and systemic immune-related adverse effects.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been approved by the FDA for the treatment of recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). It is often used in combination with other agents or as monotherapy, particularly in patients whose tumors express PD-L1. Other similar immunotherapies, such as nivolumab (another PD-1 inhibitor), have also been approved for HNSCC. These treatments work by enhancing the immune system's ability to fight cancer cells. There is ongoing research into combining these immunotherapies with other agents, such as antisense oligonucleotides like Danvatirsen, to improve efficacy and patient outcomes.

What other types of research exist?

Promising novel alternatives to Danvatirsen and Pembrolizumab for HNSCC patients include the combination of Pembrolizumab with Lenvatinib, which has shown efficacy in heavily pretreated and anti-PD-1 refractory patients. Another potential option is the combination of Panitumumab with chemotherapy (docetaxel/cisplatin) as a first-line treatment.

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Antisense Oligonucleotide

Danvatirsen + Pembrolizumab for Head and Neck Cancer (PEMDA-HN Trial)

Phase 2

Recruiting

Led By Ezra Cohen, MD

Research Sponsored by Flamingo Therapeutics NV

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing danvatirsen with pembrolizumab in patients with head and neck cancer that has returned or spread. Danvatirsen aims to stop cancer growth, and pembrolizumab helps the immune system attack the cancer.

Who is the study for?

This trial is for adults with recurrent or metastatic head and neck squamous cell carcinoma that can't be cured by surgery. They must have a life expectancy of at least 3 months, measurable tumor growth, PD-L1 expression in the tumor, good organ function, and agree to birth control if necessary. Excluded are those with curable disease by local therapy, prior metastatic treatment, certain heart diseases, previous immunotherapy drugs like anti-PD-1/L1/L2 agents.

What is being tested?

The study compares two treatments: Danvatirsen combined with Pembrolizumab versus Pembrolizumab alone for first-line treatment of advanced head and neck cancer. Patients will be randomly assigned to either receive both drugs or just Pembrolizumab in an open-label Phase II trial.

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation in various organs (like pneumonitis), infusion reactions from the drug administration process itself, fatigue due to immune system activation by the drugs, and possibly other common chemotherapy-associated risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Confirmed ORR

Secondary study objectives

Area under the plasma concentration-time curve

DCR & CR Rate

DOR

+9 more

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

Active Control

Group I: Danvatirsen plus pembrolizumabExperimental Treatment2 Interventions

Danvatirsen dosing: Week 1: Danvatirsen intravenously (IV) on Days 1, 3, and 5 Week 2 and subsequent weeks: Danvatirsen IV weekly Pembrolizumab dosing: Pembrolizumab every 3 weeks after the Danvatirsen dose.

Group II: PembrolizumabActive Control1 Intervention

Pembrolizumab IV every 3 weeks after the Danvatirsen dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Danvatirsen

2019

Completed Phase 2

~90

Pembrolizumab

2017

Completed Phase 3

~3130

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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

Danvatirsen, an antisense oligonucleotide targeting STAT3, works by inhibiting a key transcription factor involved in cancer cell survival and immune evasion, thereby reducing tumor growth and enhancing immune response. Pembrolizumab, a PD-1 inhibitor, blocks the PD-1 pathway that cancer cells use to evade immune detection, reactivating T-cells to recognize and destroy cancer cells. These targeted mechanisms are important for HNSCC patients as they disrupt cancer cell survival and boost the immune system's ability to fight the cancer, potentially improving treatment outcomes.