Clinical Research Directory

A Study of PF-08046052/SGN-EGFRd2 in Advanced Solid Tumors

This study will test the safety of a drug called PF-08046052/SGN-EGFRd2 in participants with advanced solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. Participants will have cancer that cannot be removed (unresectable) or has spread through the body (metastatic). This study will have three parts. Parts A and B of the study will find out how much PF-08046052/SGN-EGFRd2 should be given to participants. Part C will use the dose found in parts A and B to find out how safe PF-08046052/SGN-EGFRd2 is and if it works to treat solid tumor cancers.

Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC

This trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC). The names of the study drugs used in this research study are: * ficerafusp alfa (a type of bifunctional antibody and recombinant fusion protein) * pembrolizumab (a type of monoclonal antibody)

Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer

Background: Throat cancer is a common tumor that can occur in people infected with the human papilloma virus (HPV). Most people with this cancer survive more than 5 years with standard chemotherapy drugs plus radiation. But radiation can cause serious adverse effects. Researchers believe that adding a vaccine (PRGN-2009) to this drug therapy may improve survival without the need for radiation. Objective: To test a study vaccine combined with standard chemotherapy in patients with HPV-associated throat cancers. Eligibility: People aged 18 years and older with newly diagnosed throat cancer associated with HPV. Design: Participants will be screened. They will have a physical exam and blood tests. They will have imaging scans and tests of their heart function and hearing. They will provide a sample of tissue from their tumor. A recent sample may be used; if none is available, a new sample will be taken. All participants will get two common drugs for treating cancer. These drugs are given through a tube attached to a needle inserted into a vein in the arm. Participants will receive these drugs on the first day of three 3-week cycles. Half of the participants will also get the vaccine. PRGN-2009 is injected under the skin in the arm. They will get these shots 4 times: 7 days before the start of the first cycle and on the 11th day of each cycle. Participants will have standard surgery to remove their tumors 3 to 6 weeks after completing the study treatment. They will have follow-up visits 3, 6, 12, and 24 months after their surgery. ...

Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer

This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer

A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.

Efficacy Study of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Cancer of the Head and Neck

The purpose of this study is to determine whether pembrolizumab, when given after salvage surgery, is effective in increasing the time a person with squamous cell cancer of the head and neck remains disease-free following locoregional disease recurrence.

Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer

The goal of this clinical trial is to assess the safety and tolerability of a virus replicon particle (VRP) encapsulated saRNA encoding IL-12 when injected into in head and neck cancer patients. The main questions being addressed are: The safety and tolerability of intratumoral (IT) injections of VRP-encapsulated saRNA encoding IL-12 (VLPONC-01) The tumor response to IT injections of VLPONC-01 The tumor response due to the combination of IT injections of VLPONC-01 and system IV administration of neoadjuvant pembrolizumab (anti-PD-1) treatment Researchers will compare neoadjuvant pembrolizumab alone to the combination therapy to see if the combination enhances tumor responses.

Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy

This is prospective research study which will include patients with recurrent or metastatic squamous cell carcinoma of the head and neck, esophagus and anal canal starting on first-line platinum based chemotherapy or any line of immunotherapy treatment.This study aims to characterize the dynamic changes in genomic, epigenetic, immune profiling and imaging data during treatment with systemic therapy. Patients will have archived tumor samples requested as well as blood samples collected at up to four time points to analyze these changes. Imaging data will be derived from patients' routine CT scans before and after treatment.

De-Escalation Surgery After Immunotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

This is a multicenter, randomized, open-label, non-inferiority clinical trial designed to evaluate whether downgraded surgery-guided by post-immunotherapy tumor boundaries-can achieve comparable 3-year overall survival (OS) to standard surgery in patients with Stage III-IVa locally advanced head and neck squamous cell carcinoma (HNSCC) who have responded to neoadjuvant immunotherapy. A total of 356 patients will be randomized 1:1 to receive either downgraded or standard surgery, followed by risk-adapted adjuvant therapy. The primary endpoint is 3-year OS, with secondary endpoints including disease-free survival, quality of life, complication rates, and cost-effectiveness. The study hypothesizes that downgraded surgery will preserve organ function and quality of life without compromising survival outcomes.

Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies

This study is a first-in-human (FIH), Phase 1/1b, open-label, multicenter dose escalation and dose expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of JANX008 in adult subjects with advanced or metastatic carcinoma expressing EGFR.

A Randomized, Double-Blind Phase II Study of Adjuvant Pembrolizumab Versus Placebo in Head and Neck Cancers at High Risk for Recurrence- the PATHWay Study

A placebo-controlled, randomized study using adjuvant pembrolizumab treatment for one year in order to potentially improve progression free survival in a squamous cell carcinoma of the head and neck cohort at high-risk for recurrence.

Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer

The main objectives of this study are to assess the safety, tolerability, immunological activity, and preliminary efficacy of the Modi-1 Moditope vaccine, both as monotherapy and in combination with a checkpoint inhibitor (CPI) such as pembrolizumab or nivolumab with or without Ipilimumab (where these are standard of care in a non-neoadjuvant setting), in patients with advanced triple negative breast cancer (TNBC), advanced/unresectable human papillomavirus-negative squamous cell carcinoma of the head and neck (SCCHN), high grade serous ovarian carcinoma (HGSOC), or renal cell carcinoma (RCC). Modi-1 Moditope will also be investigated in the neoadjuvant setting for patients with SCCHN undergoing curative intent surgical resection in combination with pembrolizumab versus the Modi-1 alone.

ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation

The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.

Identification of the Pathogenetic Mechanisms Underlying Squamous Cell Carcinomas

This is a multicentric, retrospective, and prospective biomarker study.

VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer

This phase I trial studies how well anti-semaphorin 4D (SEMA4D) monoclonal antibody VX15/2503 (VX15/2503) with or without ipilimumab and/or nivolumab work in treating patients with stage I-IVA head and neck squamous cell cancer. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread.

Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL \[LN-144/LN-145 (lifileucel)\] in combination with immune checkpoint inhibitors or TIL \[LN-144/LN-145 (lifileucel) and LN-145-S1\] as a single agent therapy.

Neodjuvant Nivolumab and Lirilumab, Followed by Surgery, Followed by Adjuvant Nivolumab and Lirilumab, in SCCHN

This research study is studying a combination of two immunotherapy drugs, as a possible treatment for locoregionally recurrent squamous cell carcinoma of the head and neck. The immunotherapy drugs involved in this study are: * Nivolumab (Opdivo™) * Lirilumab

Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer

The goal of this observational study is to learn about the occurrence of and to identify suitable strategies for screening and monitoring of inner ear damage in patients receiving cisplatin chemoradiotherapy for head and neck cancer. Researchers will compare patients who are receiving cisplatin chemoradiotherapy to patients who are only receiving radiotherapy. Patients will undergo standardized testing for hearing loss, tinnitus and vestibular dysfunction at baseline, during and after treatment. Optional genetic analyses will aim to identify genes known to predispose to cisplatin-induced ototoxicity.

Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC

This is an open-label, randomized, phase II trial to test the efficacy of Ibrutinib in combination with either Nivolumab or Cetuximab in the treatment of recurrent and/or metastatic head an neck squamous cell carcinoma

Needs and Preferences of Patients With Head-neck Cutaneous SCC

The care of patients with high-risk cutaneous squamous cell carcinomas in the head-neck area is complex and requires a multidisciplinary approach. A key component in this care is the need and experience of patients. However, studies on the experiences and needs of patients with high-risk cutaneous squamous cell carcinomas in the head-neck region are lacking.

Safety and Efficacy Trial of TV5M01 for Radiation-Induced Mucositis in Head and Neck Cancer Patients.

This study is a Phase 2, double-blind, randomized controlled trial evaluating the safety and efficacy of TV5M01 (a 5% green tea and 0.1% morphine gel) compared to triple mixture (0.19% lidocaine, 0.29% nystatin, and 5.50% hydroxides) for treating radiation-induced oral mucositis in patients with head and neck squamous cell carcinoma. The trial will enroll 40 patients (20 per group) with stage III-IV head and neck cancer receiving radiotherapy who develop grade 1 or higher mucositis. Participants will apply the assigned mouthwash three times daily from mucositis diagnosis until resolution. Primary outcomes include safety (incidence of infections and adverse events) and efficacy (duration of grade 3-4 mucositis, days with severe pain). Secondary outcomes include quality of life and analgesic use. Randomization will use minimization methodology to balance important prognostic factors. The study design incorporates two interim analyses after 10 and 19 participants, with clear safety monitoring and stopping rules. If successful, this trial could provide an evidence-based treatment option for radiotherapy-induced mucositis, potentially improving treatment completion rates and quality of life for head and neck cancer patients.

Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers

Patients with locally recurrent squamous-cell carcinoma of the head and neck (SCCHN) after Chemotherapy and immunotherapy have a very poor prognosis and limited therapeutic options. Intratumoral chemotherapy (ITC) with cisplatin and epinephrine in order to increase the local cisplatin retention lead to a 50 % response rate in several studies but was given up due to the poor local tolerance with frequent necrosis of the peritumoral tissues. Gemcitabine, carboplatin and paclitaxel (GCP) are used in advanced SCCHN. These chemotherapies seem to be interesting options for intratumoral infusion: their different effect could lead to avoid chemotherapy resistance with a good tolerance profile, without tissue necrosis profile. The other major option for recurrent SCCHN is immunotherapy by Nivolumab, an anti PD-1 with a 13% mediane response rate. Nevertheless, the failure of this treatment stay unclear, but immunosuppressive action of the tumour is suspected. The presence of tumoral antigen could lead to better response to immunotherapy; association of chemotherapy and immunotherapy seems a promosing association to avoid treatment resistance as cytotoxic release tumoral antigen; it could also be associated to an abscopal effect. The aim of the study is to evaluate the efficacy of ITC using GCP in LOCAL recurrent SCCHN treated by nivolumab.

Ipilimumab for Head and Neck Cancer Patients

This study is for patients with squamous cell carcinoma of the head and neck (SCCHN). This study will test the feasibility of the administration of intratumoral injections of ipilimumab prior to surgical resection, and the immune system response to treatment.

Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer

This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1.