Oropharyngeal Cancer

Researchers are evaluating an imaging test called zirconium Zr89 panitumumab combined with PETCT scans to detect the spread of head and neck squamous cell carcinoma to other parts of the body. This phase I trial aims to assess how well 89Zr panitumumab identifies uncertain metastatic lesions compared to standard imaging methods like MRI, CT, and 18F-FDG PETCT. The study focuses on the sensitivity and specificity of this investigational imaging agent in diagnosing metastatic disease. Participants will receive intravenous infusions of panitumumab and 89Zr panitumumab, followed by a PETCT scan within 1 to 5 days after the infusion. They will also undergo standard care evaluations and treatments for their suspected metastatic lesions. The study compares 89Zr panitumumab PETCT results to those from usual imaging techniques to determine its diagnostic value. During the study, participants will have blood tests to check hemoglobin, white blood cell count, platelet count, and kidney function. Researchers will monitor the imaging results to measure sensitivity and specificity over up to seven years. The study also tracks how often invasive procedures like biopsies are chosen versus observation. Participants will be followed and evaluated for safety and diagnostic accuracy throughout the study period.

Researchers are evaluating 177Lu-RAD204, a radiolabeled antibody targeting PD-L1, in a Phase 01 study involving participants with advanced solid tumors that express PD-L1. The study aims to assess the safety, tolerability, biodistribution, radiation dosimetry, and preliminary anti-tumor effects of this treatment. The main goal is to find the maximum tolerated dose and recommended doses for future studies in participants with cancers such as NSCLC, SCLC, triple-negative breast cancer, melanoma, head and neck cancer, endometrial cancer, and others with specific genetic markers. The study includes a pre-screening period for PD-L1 testing if needed, followed by a screening period lasting up to four weeks. Participants undergo a Phase 0 Imaging Period where a low dose of 177Lu-RAD204 is given to assess imaging quality, safety, and dosimetry over two weeks. This may be followed by a Phase 1 Treatment Period with escalating doses of 177Lu-RAD204 administered in cycles lasting six weeks each. Participants may receive multiple treatment cycles based on clinical benefit and safety evaluations. Dose-limiting toxicity is monitored for six weeks after the first treatment dose, and dosing intervals may be adjusted as agreed by the study team. During the study, participants will have imaging scans, safety evaluations, and laboratory tests to track the distribution and effects of 177Lu-RAD204. Researchers will measure pharmacokinetics, radiation dosimetry, and tumor responses up to 30 weeks. Safety and tolerability are closely monitored throughout. Participants must meet specific health and tumor criteria to join and will be observed for any adverse reactions. The total duration of participation varies depending on treatment response and tolerability.

Researchers are evaluating the diagnostic value of a new protein-specific probe called 18F-T2 in PETCT imaging for people with solid tumors that are likely to express high levels of CAIX protein. The study will also assess how safe and tolerable the 18F-T2 injection is, as well as measure its radiation dosage. This research is important to better understand how well 18F-T2 can detect these tumors compared to standard imaging techniques. Participants with tumors suspected to express high levels of CAIX will receive an intravenous injection of 18F-T2. About an hour after the injection, PETCT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PETCT scan using 18F-FDG, a commonly used imaging agent, to allow comparison between the two imaging methods. During the study, participants will be monitored for any adverse events within 24 hours after the 18F-T2 injection to evaluate safety and tolerability. Researchers will measure the diagnostic sensitivity and specificity of 18F-T2 PETCT for detecting CAIX-positive tumors. They will also assess uptake values in tumors on both 18F-T2 and 18F-FDG scans, analyze the correlation between 18F-T2 uptake and CAIX expression in tissue samples, and evaluate radiation dosimetry. The study will continue until one month after completion for outcome assessments.

Researchers are evaluating advanced radiation treatment techniques, specifically stereotactic body radiation therapy SBRT, for safely delivering a strong dose of radiation to tumors in patients with head and neck squamous cell carcinoma HN SCC who are not eligible for curative treatment. The trial aims to compare local progression-free survival, pain response, symptom burden, toxicity, local control, progression-free survival, and overall survival between SBRT and traditional radiation methods. This Phase II randomized trial explores if SBRT can provide effective palliation in a shorter treatment period than conventional approaches. Participants will be randomly assigned to receive either traditional radiation therapy or SBRT. Both treatments involve radiation delivered according to schedules discussed with the study doctor. The study focuses on comparing these two radiation methods for palliation in patients with HN SCC. Treatment details, including timing and dosage, will be managed individually by the medical team. The trial runs until September 2027, with treatment and follow-up planned over about one year. During the study, participants undergo evaluations such as symptom assessments using the M. D. Anderson Symptom Inventory for head and neck cancer MDASI-HN, pain scoring, quality of life questionnaires, and clinical examinations including imaging like CT, MRI, or PETCT scans. Baseline symptoms, smoking history, and pregnancy status for women of child-bearing age are checked before randomization. Researchers will monitor symptom burden and treatment responses throughout the trial, with data collection continuing for up to one year after treatment. Informed consent and regular clinical assessments support participant safety and data accuracy throughout the study.

Researchers are evaluating the safety and effectiveness of different courses of pembrolizumab combined with carboplatin and albumin-binding paclitaxel as preoperative neoadjuvant therapy in patients with resectable head and neck squamous cell carcinoma stages T3 or T4, N0. This phase II, prospective, randomized study aims to compare four treatment cycles versus two cycles and assess outcomes such as pathological complete response, adverse events, survival rates, and radiological responses. The study also explores various factors that could influence treatment response and prognosis. Participants are randomly assigned to receive either four cycles or two cycles of pembrolizumab 200 mg IV, carboplatin 300 mgm2 IV, and albumin-bound paclitaxel 260 mgm2 IV every 21 days, followed by surgery. Each treatment cycle occurs on day 1, and continuation depends on absence of disease progression or unacceptable toxicity. The study collects clinical, pathological, imaging, and serological data before and after treatment to evaluate the therapies. During the study, participants undergo assessments including imaging, pathology examination of tumor tissues, and laboratory tests. Researchers monitor adverse events for 90 days post-surgery and measure pathological response six weeks after treatment initiation. Longer-term outcomes such as event-free and overall survival are tracked for up to five years. Data on operation delays and radiographic responses are also gathered to assess treatment safety and efficacy throughout the study duration.

Researchers are studying the safety and tolerability of increasing doses of 177LuLu-AKIR001, a drug targeting CD44v6-expressing solid tumors that cannot be surgically removed or have spread. This early phase 1 trial focuses on patients with advanced cancers such as thyroid gland anaplastic carcinoma, poorly differentiated thyroid carcinoma, head and neck cancer, cervix carcinoma, vulvar cancer stage IV, and non-small cell lung cancer stage IV, who have no other reasonable treatment options. The main goal is to understand the toxicity profile of 177LuLu-AKIR001 by monitoring dose-limiting toxicities and serious adverse events.

Researchers are studying tumors that have somatostatin receptors SSTRs on their surface, which include tumors in the lung, head and neck, digestive tract, kidneys, and adrenal glands. This trial tests a drug called 212PbVMT-Alpha-NET, which is designed to target these receptors and potentially help shrink tumors that have spread and cannot be removed surgically. The study focuses on people aged 18 and older with these specific types of tumors and aims to determine the maximum tolerated dose and safety of the drug. Participants receive 212PbVMT-Alpha-NET through a vein on the first day of four 8-week cycles. Some participants will also receive a related imaging drug, 203PbVMT-Alpha-NET, a few days before the first two treatment cycles to allow whole-body scans that track how the drug spreads in the body. After each infusion, participants stay in the hospital for a few nights and have weekly blood tests during each treatment cycle. The study includes dose escalation to find the best dose and then dose expansion at that dose level. Throughout the study, participants undergo physical exams, blood and urine tests, imaging scans including PETCT and SPECTCT, heart function tests, and may provide tumor tissue samples if needed. Follow-up visits occur about 30 days after treatment ends, then every 12 weeks for up to 3 years, with annual check-ins continuing up to 6 years after the last treatment. Researchers monitor safety, response to treatment, and survival outcomes during this time.

Researchers are evaluating the use of 68GaGa-FAPI-46 PETCT imaging in patients with head and neck squamous cell carcinoma HNSCC to improve staging before surgery. The study focuses on cancer-associated fibroblasts CAFs, which contribute to metastasis by remodeling the tumor environment and promoting cancer spread. This trial aims to assess how 68GaGa-FAPI-46 PETCT can identify lymph nodes likely to develop metastases and to enhance tumor delineation in HNSCC patients. Participants will receive an intravenous injection of 68GaGa-FAPI-46 at a dose of 2 MBqkg, with the total dose ranging from 80 to 200 MBq. After about 60 minutes, a low-dose PETCT scan will be performed for approximately 20 minutes. This imaging will be added to the standard pre-surgical imaging protocol, which includes cervical MRI, contrast-enhanced CT, and 18F-FDG PETCT. The study compares PETCT imaging results with the pathology of resected lymph nodes to evaluate the ability of the imaging to detect premetastatic conditions. Participants will undergo standard pre-surgery imaging and lymph node dissection surgery as part of their care. The research team will analyze multiple imaging outcomes at 6 weeks, including tumor size, volume, SUVmax, number and location of lesions, and TNM tumor stage. Secondary outcomes include the ability of 68GaGa-FAPI-46 PETCT to visualize tumor infiltration in lymph nodes after 2 months. The total study duration extends through the surgery and follow-up imaging assessments. Safety and feasibility are monitored throughout the trial.

Researchers are studying patients with locally advanced oral squamous cell carcinoma LA-OSCC or locally advanced oropharyngeal squamous cell carcinoma LA-OPSCC to understand tumor regression patterns and treatment outcomes. This study collects data both retrospectively and prospectively from patients treated with neoadjuvant immunochemotherapy. The focus is on evaluating treatment safety, effectiveness, and survival rates over several years. Participants receive two cycles of neoadjuvant immunochemotherapy using tislelizumab combined with paclitaxel and cisplatin or carboplatin. This single-arm, single-center study tracks treatment outcomes and tumor responses. The study uses a bidirectional design, collecting past and ongoing patient data to analyze results comprehensively. During the study, researchers monitor tumor response at 8 weeks, assessing the objective response rate and tumor regression patterns. They also follow participants for two years to measure progression-free survival and assess 5-year overall survival rates. Participants undergo regular evaluations to track their health, treatment effects, and disease status throughout the study period.

Researchers are studying the safety and initial effects of T3011, given directly into tumors, alone and combined with the intravenous drug pembrolizumab. This Phase 12a open-label study focuses on adults with advanced or metastatic solid tumors, including melanoma, head and neck squamous cell carcinoma HNSCC, sarcoma, cutaneous squamous cell carcinoma cSCC, and non-small cell lung cancer NSCLC. The study aims to find safe dose levels and assess how well these treatments are tolerated and work in these cancer types. The study involves several groups Phase 1 tests increasing doses of T3011 alone to determine a recommended dose. Phase 2a Part 1 evaluates T3011 alone in participants with melanoma, HNSCC, sarcoma, and cSCC. Phase 2a Part 2 studies T3011 with pembrolizumab in NSCLC patients. A rollover arm allows participants whose cancer progresses on T3011 alone to receive the combination treatment. T3011 is given as an intratumoral injection every two weeks, and pembrolizumab is given intravenously every three weeks when combined. Participants will have tumor biopsies, imaging, and laboratory tests to monitor safety, drug levels, and cancer response. Researchers will track side effects and measure outcomes like tumor response and survival for up to two years after the first dose. Safety and tolerability are closely followed throughout, with additional monitoring for immune responses and drug presence in bodily fluids. Participants may be followed for up to one year after their last treatment dose to assess overall survival and long-term effects.