Oropharyngeal Cancer

Researchers are evaluating an imaging test called zirconium Zr89 panitumumab combined with PET/CT 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 PET/CT. 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 PET/CT 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 PET/CT 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 0/1 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 PET/CT 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, PET/CT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PET/CT 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 PET/CT 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 methods called stereotactic body radiotherapy (SBRT) to see if they can safely deliver a stronger dose of radiation to tumors in patients with head and neck squamous cell carcinoma (HN SCC) who are not eligible for curative treatment. The study compares SBRT with traditional radiation methods to understand differences in local tumor control, symptom relief, side effects, and survival outcomes. Participants are randomly assigned to receive either traditional palliative radiation or SBRT, with radiation schedules determined by the study doctor. This Phase II trial aims to deliver radiation in fewer sessions with SBRT, potentially shortening treatment time compared to standard fractionated radiation. During the study, participants will undergo symptom assessments using the M. D. Anderson Symptom Inventory for head and neck cancer over about one year. Researchers will monitor pain response, symptom burden, tumor progression, and overall safety. The trial includes regular clinical evaluations and imaging to assess treatment effects, and participation may last up to approximately one year or more depending on individual follow-up.

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 mg/m2 IV), and albumin-bound paclitaxel (260 mg/m2 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 [177Lu]Lu-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 [177Lu]Lu-AKIR001 by monitoring dose-limiting toxicities and serious adverse events.

Researchers are studying a new cancer treatment called [212Pb]VMT-Alpha-NET for tumors that have somatostatin receptors (SSTRs) on their surface. These tumors include those found in the lungs, head and neck, digestive tract, kidneys, and adrenal glands. The study focuses on people with tumors that have spread and cannot be removed by surgery. The goal is to find the highest safe dose of this drug and evaluate its safety and effects on these cancers. The treatment involves giving [212Pb]VMT-Alpha-NET through a vein on the first day of each 8-week cycle, for a total of four cycles. Some participants will also receive a related imaging drug, [203Pb]VMT-Alpha-NET, a few days before the first two cycles to track where the drug travels in the body using scans. After each dose, participants will stay in the hospital for a few nights and have weekly blood tests during each cycle. Participants will have physical exams, blood and urine tests, heart function tests, and imaging scans before and during the study. Researchers will monitor safety, drug effects, and tumor response through scans, lab tests, and questionnaires. Follow-up visits will continue for up to six years after the last treatment to check on long-term outcomes and overall health.

Researchers are evaluating the use of [68Ga]Ga-FAPI-46 PET/CT 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 [68Ga]Ga-FAPI-46 PET/CT can identify lymph nodes likely to develop metastases and to enhance tumor delineation in HNSCC patients. Participants will receive an intravenous injection of [68Ga]Ga-FAPI-46 at a dose of 2 MBq/kg, with the total dose ranging from 80 to 200 MBq. After about 60 minutes, a low-dose PET/CT 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 PET/CT. The study compares PET/CT 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 [68Ga]Ga-FAPI-46 PET/CT 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 1/2a 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.