Head and neck cancer – Trials in Disease

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Ongoing Clinical Trials for Head and Neck Cancer

This article provides detailed information about 27 ongoing clinical trials investigating new treatments for head and neck cancer. These studies are testing various medications and treatment combinations, including immunotherapies, targeted therapies, and radiation enhancement techniques. Trials are being conducted across multiple countries in Europe, offering patients with different stages and types of head and neck cancer opportunities to access experimental treatments that may improve outcomes.

Clinical trial locations

Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

This trial evaluates DS-3939a, an investigational treatment delivered through intravenous infusion for patients with advanced cancers that have spread beyond their original location. The study focuses on assessing the safety and effectiveness of this medication in various solid tumor types.

Inclusion criteria: Participants must be adults who have signed informed consent and have adequate organ function. They need a confirmed diagnosis of locally advanced, metastatic, or unresectable cancer affecting specific sites including bladder, lung, breast, ovary, bile duct, or pancreas. Patients must have measurable disease according to standard criteria and an acceptable performance status that allows them to carry out daily activities with minimal restrictions.

Exclusion criteria: Patients with metastatic or advanced solid tumors outside the specified cancer types cannot participate. Those not within the required age range, vulnerable populations, or individuals who do not meet safety and tolerability requirements for the study drug are excluded.

Treatment focus: The trial tests DS-3939a to determine its safety profile and evaluate how well it works in treating advanced solid tumors. The study is conducted in two phases: the first examines safety and tolerability, while the second assesses the medication’s effectiveness at a recommended dose by measuring how tumors respond to treatment.

Investigational drug: DS-3939a targets specific pathways that cancer cells use for growth and spread. The medication is designed to help treat advanced solid tumors by interfering with cancer cell mechanisms, though the exact mechanism is still under investigation.

Study of IPN01194 for Adults with Advanced Solid Tumors, Including Melanoma, Head and Neck Cancer, Pancreatic Cancer, and Colorectal Cancer

This clinical trial examines IPN01194, an oral medication taken as a hard capsule, for treating multiple types of advanced cancers. The study evaluates both safety and effectiveness when used alone in adult patients.

Inclusion criteria: Participants must be at least 18 years old with confirmed diagnosis of metastatic or locally advanced cancer including melanoma, colorectal cancer, pancreatic ductal adenocarcinoma, or head and neck squamous cell carcinoma. Patients need tumors with specific genetic mutations and measurable disease according to standard evaluation criteria. They should have a performance status indicating they can perform most daily activities and must agree to provide tumor tissue samples.

Exclusion criteria: Those with cancer types not specified in the study, individuals outside the age requirements, vulnerable populations, patients with prohibited medical conditions, and those unable to follow study procedures cannot participate.

Treatment focus: The trial proceeds in two phases. The first determines the safest and most effective dose while monitoring side effects. The second phase focuses on evaluating how well the treatment reduces tumor size, with regular assessments of tumor response and patient health status.

Investigational drug: IPN01194 is an ERK1/2 inhibitor that works by blocking proteins involved in cancer cell growth and survival. This oral medication targets the specific pathway that helps cancer cells multiply and spread.

Study of JK06 for Patients with Advanced or Metastatic Cancer

This trial studies JK06, a 5T4 antibody drug conjugate, for patients whose cancer cannot be surgically removed or has spread to other areas. The medication is administered through intravenous infusion every three weeks.

Inclusion criteria: Patients must be at least 18 years old and willing to attend clinic visits and follow study procedures. They need to provide a fresh tumor biopsy if required and have a performance status allowing them to carry out light work activities. Women of childbearing potential must use two forms of effective birth control. Participants should have measurable disease and acceptable laboratory test results including specific levels of blood components.

Exclusion criteria: Those who recently received other cancer treatments, individuals with certain health conditions that could interfere with the study, pregnant or breastfeeding women, people with allergies to study medications, and those with uncontrolled infections cannot participate.

Treatment focus: The study aims to determine the safest and most effective dose of JK06 through dose escalation and expansion phases. Regular monitoring includes assessments of tumor response and evaluation of any side effects or adverse reactions.

Investigational drug: JK06 is an antibody-drug conjugate that combines an antibody targeting the 5T4 protein on cancer cells with a drug designed to kill these cells. This approach aims to deliver treatment directly to cancer cells while minimizing damage to normal cells.

Study of NBTXR3 and Cetuximab for Elderly Patients with Advanced Head and Neck Cancer Ineligible for Platinum Chemotherapy

This trial tests a treatment combining NBTXR3, injected directly into the tumor, with radiotherapy and potentially cetuximab. The study focuses on elderly patients who cannot receive standard platinum-based chemotherapy.

Inclusion criteria: Participants must be 60 years or older with confirmed locally advanced head and neck squamous cell carcinoma. They need one primary tumor suitable for direct injection and must be ineligible for platinum-based chemotherapy due to specific health conditions or age factors. Patients should be candidates for radiation therapy aimed at curing the cancer.

Exclusion criteria: Those with cancer types other than locally advanced head and neck squamous cell carcinoma, individuals who have received certain previous treatments, patients with medical conditions interfering with study participation, and those unable to follow study procedures cannot participate.

Treatment focus: The study evaluates how well NBTXR3 combined with radiotherapy, with or without cetuximab, improves survival outcomes compared to radiotherapy with or without cetuximab alone. The goal is to assess progression-free survival, meaning how long patients live without cancer worsening.

Investigational drugs: NBTXR3 is injected into the tumor to make cancer cells more sensitive to radiation therapy. Cetuximab targets the EGFR receptor to reduce cancer cell growth and spread. Both are used with radiotherapy to enhance treatment effectiveness.

Study of Pucotenlimab with Becotatug Vedotin versus Becotatug Vedotin alone for patients with locally advanced head and neck squamous cell carcinoma

This study compares treatment with MRG003 alone versus MRG003 combined with pucotenlimab for patients with locally advanced disease. Both medications are given through intravenous injection, followed by chemoradiotherapy.

Inclusion criteria: Participants must be between 18 and 75 years old with confirmed diagnosis of previously untreated advanced cancer meeting specific staging criteria. They need measurable tumors by CT scan or MRI and must be able to receive cisplatin treatment. Patients should have adequate blood test results and no previous treatments for their cancer, with no hearing loss beyond mild levels.

Exclusion criteria: Those who previously received EGFR antibody therapy, patients with active or untreated brain metastases, individuals with another cancer in the past 5 years (except certain skin cancers), those with serious heart conditions or active infections, and pregnant or breastfeeding women cannot participate.

Treatment focus: The trial evaluates patient responses when receiving MRG003 alone compared to both medications together, followed by chemoradiotherapy. Doctors monitor treatment responses and side effects throughout the study period.

Investigational drugs: Pucotenlimab is a PD-1 inhibitor that helps the immune system fight cancer cells. MRG003 is an antibody-drug conjugate targeting EGFR on cancer cells, delivering cancer-fighting substances directly to tumors while minimizing damage to healthy cells.

Study on Immunotherapy with Nivolumab and Ipilimumab for Patients with Recurrent Head and Neck Cancer After Surgery

This trial examines two immunotherapy medications given after surgery to remove recurrent cancer. Patients receive either nivolumab alone or a combination of nivolumab and ipilimumab to prevent cancer from returning.

Inclusion criteria: Participants must have undergone salvage surgery for high-risk recurrent head and neck squamous cell carcinoma. They need an ECOG performance status of 0 or 1, indicating good daily functioning. Patients must not be taking high doses of immunosuppressive medications and need specific laboratory test results within required ranges. Both men and women must agree to use appropriate contraception during the study.

Exclusion criteria: Those who have not undergone salvage surgery, patients not at high risk for recurrence, individuals unable to receive adjuvant therapy after surgery, and people not eligible for nivolumab or the combination treatment cannot participate.

Treatment focus: The study aims to determine if immunotherapy after surgery can prevent cancer from returning. Participants receive treatment for up to six months with regular monitoring to assess disease-free survival and overall health outcomes over a two-year period.

Investigational drugs: Nivolumab helps the immune system recognize and attack cancer cells more effectively by blocking the PD-1 receptor. Ipilimumab enhances the immune response by targeting the CTLA-4 receptor. When used together, these medications may improve prevention of cancer recurrence.

Study on Reduced Dose Intensity of Pembrolizumab and Drug Combination for Patients with Advanced or Metastatic Cancer Responding to Standard Immunotherapy

This trial compares continuing standard immunotherapy with reducing the dose frequency for patients who have shown positive response after six months of treatment. The study includes various cancer types and aims to determine if reduced dosing maintains effectiveness.

Inclusion criteria: Patients must be at least 18 years old with confirmed diagnosis of specific cancer types including lung cancer, kidney cancer, and others. They need to be in partial or complete response after 6 months of standard immunotherapy treatment. Participants must have good performance status, adequate organ function, and agree to use effective birth control if applicable.

Exclusion criteria: Those with cancer types not included in the study, individuals who have not shown response to treatment after 6 months, melanoma patients who have not shown partial response, and those treated with certain drug combinations without response cannot participate.

Treatment focus: The study evaluates whether reducing checkpoint inhibitor doses to every three months maintains the same effectiveness as standard dosing in controlling cancer while potentially reducing side effects. Regular assessments monitor pain levels, treatment response, and quality of life.

Investigational drugs: Checkpoint inhibitors block proteins that prevent the immune system from attacking cancer cells, enhancing the body’s immune response against tumors. The reduced dose approach aims to maintain benefits while minimizing potential side effects.

Study on the Impact of Cisplatin and Drug Combination on Speech and Cognition in Cancer Patients

This trial examines how different cancer treatments affect patients’ ability to understand speech in noisy environments, as well as their cognitive functions and quality of life. The study involves multiple medications administered through various routes.

Inclusion criteria: Participants must be between 18 and 75 years old with cancer diagnosis receiving curative treatments. They need normal hearing ability for their age according to international standards, be native Finnish speakers, and able to provide written informed consent.

Exclusion criteria: Those without cancer diagnosis, individuals outside the specified age range, and vulnerable populations requiring special protection cannot participate.

Treatment focus: The study assesses short-term effects of cancer treatments on speech perception in noise, with follow-up visits approximately 3-4 months after initial treatment ends. Researchers conduct regular assessments including hearing tests and cognitive function evaluations.

Investigational drugs: The trial involves various cancer treatment medications including cisplatin, oxaliplatin, gemcitabine, capecitabine, mesna, ifosfamide, etoposide, and bleomycin, administered either intravenously or orally depending on the specific treatment plan.

Study on Using Indocyanine Green for Detecting Residual Disease in Head and Neck Cancer Surgery

This trial uses a special imaging technique during surgery to help doctors identify any remaining cancer cells after removing the main tumor. The technique uses indocyanine green, a fluorescent dye injected into the body that highlights cancer cells under near-infrared light.

Inclusion criteria: Participants must be at least 18 years old with confirmed epidermoid carcinoma in the oral cavity or oropharynx, eligible for surgery aimed at complete tumor removal. They need an ECOG performance status of 0-2 and must provide signed informed consent. Women of childbearing potential require a negative pregnancy test within 14 days before the procedure.

Exclusion criteria: Those with history of epidermoid carcinoma, individuals outside the specified age range, patients not part of specified clinical trial groups, and vulnerable populations cannot participate.

Treatment focus: The study evaluates how well the fluorescence imaging technique detects microscopic residual disease in removed tissue. Regular monitoring includes assessments of adverse events, vital signs, and laboratory results to ensure safety.

Investigational drug: Indocyanine green is a diagnostic agent administered intravenously that absorbs near-infrared light and emits fluorescence, helping highlight cancerous areas during surgery to ensure complete removal of malignant tissue.

Study of Cannabidiol and Nutritional Supplements to Improve Muscle Health in Adults with Head and Neck Cancer Before Surgery

This trial examines how cannabidiol combined with nutritional supplements might improve muscle health before and after cancer treatment. Participants receive either Arvisol tablets containing CBD or placebo tablets along with nutritional supplements.

Inclusion criteria: Participants must be between 18 and 75 years old with diagnosis of squamous cell carcinoma in the head and neck area or high likelihood based on assessment. They need mild to moderate nutritional risk, must provide informed consent, and have a mobile phone for monitoring. Women of childbearing potential must not be pregnant and must use effective birth control.

Exclusion criteria: Those below 18 or above 65 years, individuals with previous allergic reactions to CBD or hemp products, pregnant or breastfeeding women, people with active substance abuse, severe liver problems, or taking medications that interact with CBD cannot participate.

Treatment focus: The study examines how CBD affects muscle health and energy production in muscle cells. Participants take medication for up to 21 days with regular monitoring of muscle strength, mass, overall physical performance, appetite, and digestive issues.

Investigational drugs: Cannabidiol is a non-psychoactive compound from cannabis plants that works by interacting with the endocannabinoid system. Nutritional supplementation provides extra nutrients beyond regular diet to support overall health and muscle function.

Summary

The 27 ongoing clinical trials for head and neck cancer demonstrate a diverse landscape of research efforts across Europe. France leads with the highest concentration of trials (11), followed by Spain (10) and Belgium (9), suggesting strong research infrastructure in these countries. Many trials focus on immunotherapy approaches, with several studying combinations of checkpoint inhibitors like pembrolizumab and nivolumab with other agents. There is particular interest in treatments for patients who cannot tolerate standard platinum-based chemotherapy, with multiple trials testing NBTXR3 combined with cetuximab specifically for elderly patients. Several studies target advanced or recurrent disease, and a notable number examine novel antibody-drug conjugates. The geographic distribution suggests that patients in Western European countries have the most access to these experimental treatments, though some trials extend to Central and Eastern Europe.

Ongoing Clinical Trials on Head and neck cancer

  • Study of zanidatamab in adult patients with HER2-positive solid tumors (endometrial, colorectal, head & neck, sarcoma) or HER2-mutant non-small cell lung cancer

    Recruiting

    2 1 1
    Investigated drugs:
    France
  • Study of Heart and Blood Vessel Side Effects in Cancer Patients Receiving Immune Checkpoint Inhibitor Drug Combination Treatment

    Recruiting

    3 1 1 1
    Hungary
  • Study of Mitazalimab Injection Treatment for Patients with High-Risk Oral Potentially Malignant Disorders

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Italy
  • Study of NBTXR3 and Cetuximab for Elderly Patients with Advanced Head and Neck Cancer Ineligible for Platinum Chemotherapy

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia France Germany Greece +4
  • Study on the Impact of Cisplatin and Drug Combination on Speech and Cognition in Cancer Patients

    Recruiting

    3 1 1 1
    Investigated diseases:
    Finland
  • Study on the Use of Indocyanine Green and Technetium (99mTc) Nanocolloid for Sentinel Node Biopsy in Patients with Melanoma, Oral Cancer, or Penile Cancer

    Recruiting

    2 1 1 1
    The Netherlands
  • Study on Using Perflubutane for Sentinel Node Detection in Patients with Breast Cancer, Melanoma, or Head and Neck Cancer

    Recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands
  • Study of JK06 for Patients with Advanced or Metastatic Cancer

    Recruiting

    2 1 1
    Investigated drugs:
    Belgium Spain
  • Study on Immunotherapy with Nivolumab and Ipilimumab for Patients with Recurrent Head and Neck Cancer After Surgery

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France
  • Study on Using Indocyanine Green for Detecting Residual Disease in Head and Neck Cancer Surgery

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France