Clinical Research Directory

A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer

The purpose of this study is to compare anti-tumor activity of amivantamab in addition to pembrolizumab and carboplatin versus pembrolizumab, 5-fluorouracil (FU), and platinum therapy (carboplatin or cisplatin) in participants with refractory/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). HNSCC is a type of cancer that develops in the head and neck regions, including the outer tissue layer of the mouth and throat. This study will focus on participants with HNSCC who are treatment-naive (have not received prior treatment) in the R/M setting.

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).

A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

This global, open-label, single arm, phase 1b study aims to learn more about whether a treatment called JNJ-90301900 is safe and effective when injected directly into tumors, along with standard chemotherapy and radiation therapy, for participants with head and neck squamous cell cancer (HNSCC; a type of solid tumor that begins in outer tissue layer of the mouth \& throat).

HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers

This is a single centre prospective exploratory study of effects of delayed radiation therapy on adaptive immune response in patients with newly diagnosed (head and neck squamous cell carcinoma) HNSCC receiving curative radiotherapy. This research is part 2 of the HN-BIO study.

A Beta-only IL-2 ImmunoTherapY Study

This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.

A Study of MGC026 in Participants With Advanced Solid Tumors

The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of vobramitamab tavatecan (MGC026) in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion in Module A of the study. Combination therapy with pembrolizumab will occur in Module B of the study Participants will receive vobramitamab tavatecan by intravenous (IV) infusion. The dose of vobramitamab tavatecan will be assigned at the time of enrollment. Pembrolizumab will be administered at 200 mg every 3 weeks. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood and tumor samples collected for research purposes.

TMV Vaccine Alone or With Toripalimab-tpzi for Recurrent Head and Neck Squamous Cell Carcinoma

The goal of this clinical trial is to learn if an experimental, personalized cancer vaccine called TMV vaccine is safe and to find the best dose to study in future trials. The study includes adults with head and neck squamous cell carcinoma that has come back in or near the same area after earlier treatment, and who are planning to have surgery to remove it. The study will also test the vaccine together with toripalimab-tpzi, an approved immunotherapy drug. The TMV vaccine is made from each participant's own tumor tissue. Small particles taken from the surface of the tumor cells have 2 immune-boosting proteins added to them, to help the immune system recognize and attack the cancer. The main questions it aims to answer are: * Is the TMV vaccine safe, and what medical problems do participants have after receiving it? * What is the best dose of the TMV vaccine to use in future studies? * Is the TMV vaccine safe when given together with toripalimab-tpzi before and after surgery? The study has 2 parts. In Part 1 (Phase 1a), participants will: * Have tumor tissue collected during their planned surgery, which is used to make their personal vaccine * Receive the vaccine as small injections into the skin every 2 weeks for 3 doses, starting after they recover from surgery * Visit the clinic about once a week for 8 weeks for checkups, blood tests, and safety monitoring * Have scans every 3 months and be followed for up to 3 years The first participants will receive the lowest dose. Later groups will receive higher doses only if the lower dose is found to be safe. In Part 2 (Phase 1b), participants whose tumors test positive for a marker called PD-L1 will: * Have a biopsy to collect tumor tissue for their personal vaccine * Before surgery, receive 2 doses of the vaccine and up to 2 doses of toripalimab-tpzi through a vein * After surgery, receive 1 more dose of the vaccine and continue toripalimab-tpzi every 3 weeks for up to 1 year * Have regular checkups, blood tests, and scans, and be followed for up to 3 years Researchers will also study blood and tumor samples to learn how the immune system responds to the vaccine.

A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers

The purpose of this study is to characterize the safety and tolerability of KFA115 and KFA115 in combination with pembrolizumab in patients with select advanced cancers, and to identify the maximum tolerated dose and/or recommended dose.

Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence

This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin. It is designed to show the efficacy and safety of a 7-dose regimen of Candin over a two-year period in terms of reducing cancer recurrence rate by comparing the recurrence rates between the Candin and the placebo arm. The ratio of the number of subjects who will receive Candin versus placebo will be 3:1. Up to 100 subjects will be screened until 80 subjects are eligible for injection.

Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.

Quad Shot Versus Split Course Radiotherapy in Incurable Head and Neck Cancer

Head and neck cancer in its advanced, incurable stage causes severe symptoms such as pain, trouble swallowing, and bleeding. Palliative radiation therapy is frequently used to relieve these symptoms and improve the patient's quality of life. Currently, a standard treatment approach is the "Split Course" regimen, which takes several weeks and can cause side effects that are difficult for patients to tolerate. This study aims to evaluate a shorter, alternative radiation treatment called "Quad Shot." The hypothesis of this study is that the Quad Shot regimen will be as effective as the Split Course regimen in shrinking the tumor and controlling local symptoms, but will offer a better quality of life by reducing the overall treatment time and the severity of side effects. To test this, researchers will assign participants by chance to receive either the Quad Shot or the Split Course regimen. The research team will closely monitor tumor response, treatment side effects, and patients' quality of life for up to six months.

A Trial Evaluating the Addition of Nivolumab to Cisplatin-RT for Treatment of Cancers of the Head and Neck

The purpose of this study is to determine the efficacy of nivolumab + cisplatin-RT relative to standard of care (SOC) cisplatin-RT alone, using the disease-free survival (DFS by investigator imaging assessment) as primary endpoint )

Cetuximab Combined With Pembrolizumab or Finotonlimab and Chemotherapy in R/M HNSCC

This is an open-label, randomized, prospective, multicenter phase III trial to evaluate the efficacy and safety of the combination therapy of cetuximab with either pembrolizumab or finotonlimab, alongside chemotherapy, as a first-line treatment, compared with pembrolizumab or finotonlimab with chemotherapy for R/M HNSCC.

Pilot Study of Imatinib Cetuximab Combo for H & N Cancer

The goal of this clinical trial is to find if levels of a protein called AXL in tumor cells relate to how tumors respond to cetuximab (CTX) combined with imatinib in participants with head and neck cancer. This interventional study will occur in the time between diagnosis of your cancer and surgery to remove your tumor or radiation or chemoradiation treatment of your primary cancer. Participants will undergo a research blood draw and a research biopsy as part of the screening process, and will be in this research study for approximately 13 to 16 months.

MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.

TBio-4101 and Pembro wi/ or w/o Chemo in Recurrent/Metastatic HNSCC

Phase 1b open-label study to evaluate the safety of selected TIL (TBio-4101) delivered after lymphodepleting chemotherapy and followed by intravenous (IV) bolus aldesleukin (IL-2) and pembrolizumab for patients with advanced HNSCC who have initially progressed on pembrolizumab or pembrolizumab/platinum chemotherapy.

Reduction in the Number of Chemotherapy Cycles in Combination With Pembrolizumab in First-line Treatment of PD-L1-positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinomas

This is a phase II, prospective, non-randomized, single-arm, multicentric study to evaluate the activity and safety of treatment with 4 cycles (instead of 6) of chemotherapy (platinum (cisplatin or carboplatin) and 5-Fluorouracil) in combination with pembrolizumab for the first-line treatment of CPS PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma. A total of 86 patients will have to be enrolled in this study.

Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination

Study to evaluate the use of confocal microscopy for detecting resection margins in patients undergoing surgery for basal cell carcinoma of skin and squamous Cell Carcinoma of Head and Neck

A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma

Phase Ib: To observe the safety and tolerability of SI-B001+SI-B003 in combination and to identify RP2D in locally advanced or metastatic head and neck squamous cell carcinoma indications. Initial efficacy, pharmacokinetic characteristics and immunogenicity were evaluated. Phase II: To evaluate the efficacy of SI-B001+SI-B003 two-drug combination chemotherapy. Safety and tolerance, PK/PD, immunogenicity were evaluated.

A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

A Study of DM005 in Patients With Advanced Solid Tumors

The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM005 for patients with the advanced solid tumors. DM005 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. For each participant, there will be a screening period of up to 28 days, a treatment period consisting of 21-day cycles, an end of treatment (EOT) Visit (+7 days), and a Follow-up Visit at 30 days (±7 days) after the EOT Visit. Participants with advanced solid malignant tumors will be treated with DM005 on Day 1 of each cycle (every 3 weeks, Q3W). An initial dose of DM005 will be infused intravenously (IV) into each participant for approximately 60 minutes (±10) on Cycle1 Day 1. If there is no infusion-related reaction (IRR) during or after the initial dose, with the Investigator's confirmation and supervision, the subsequent dosing of DM005 in the following cycles maybe infused IV for approximately 30 minutes ( ±5). A 21-day observation period (Cycle 1) will then occur, at the end of which all relevant safety data will be reviewed.

A Study of Head and Neck MRI and Tumor Microenvironment Biomarkers

The purpose of this study is to explore biomarker development in patients with newly diagnosed Head and neck squamous cell carcinoma (HNSCC) receiving curative therapy.

App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy

Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition.

Study on the Efficacy of Treatment by Radiotherapy and Pembrolizumab in Newly Diagnosed Metastatic Head & Neck Cancers

Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head \& neck cancers