Office of Research
Clinical Trials

Study of BNT327 and Chemotherapy for Lung Cancer Treatment

This study is exploring a new drug, BNT327, combined with chemotherapy to treat people with advanced non-small cell lung cancer (NSCLC). The study has two parts (Phase 2 and Phase 3) that compare different doses of BNT327 to find the best option. Participants are split into groups based on the type of lung cancer they have. The study will look at how safe the treatments are and if they work better than current options. It's a global trial where researchers want to see if using BNT327 can improve survival rates and reduce tumor size better than just using chemotherapy alone. It's ongoing, so more participants who fit the requirements are being recruited.

This study may be appropriate for those with: Metastatic Cancer

Combining Iadademstat with Immunotherapy for Advanced Lung Cancer

This clinical research study is investigating if adding iadademstat to traditional immunotherapy drugs, atezolizumab or durvalumab, can improve outcomes for people with small cell lung cancer that has spread extensively. The study aims to determine the safest dose of iadademstat, examine any side effects, and see how well it works in combination with the other drugs. In phase I, the study is testing different doses of iadademstat with either atezolizumab or durvalumab to find the safest and most effective amount. Phase II will test the chosen dose against the use of immunotherapy alone in maintaining cancer control after the initial treatment. Participants will continue treatment in cycles and will be monitored through various exams including scans and blood tests. The goal is to see if this combination can stabilize the cancer longer compared to using only traditional immunotherapy. This large and carefully monitored trial allows participants who meet specific health criteria, like confirmed extensive-stage small cell lung cancer diagnosis, a stable condition on immunotherapy, and ability to take oral medication. While the study is an opportunity for advanced treatment options, it comes with specific inclusion and exclusion criteria based on health conditions and earlier treatments to ensure safety.

This study may be appropriate for those with: Newly Diagnosed Cancer

Testing a New Combination Therapy for Advanced Lung Cancer

This study is looking at a new treatment combination for people with advanced lung cancer who have stopped responding to typical immune checkpoint inhibitors. The new combination includes the drugs N-803, tislelizumab, and docetaxel vs. just docetaxel alone, to see which is more effective in extending patients' lives. Adults 18 or older with this specific type of cancer could participate if they meet certain health requirements. Key aspects include the ability to follow the study procedures, managing contraception requirements, and having a specific level of health for various bodily functions. Some individuals will not qualify if they have recent treatments that conflict with the new drugs, have severe allergies to study drugs, or other significant health concerns.

This study may be appropriate for those with: Metastatic Cancer

Pembrolizumab Study for Non-Small Cell Lung Cancer Treatment

This study is investigating whether a combination of two medications, pembrolizumab with or without V940, can help keep patients with a specific kind of lung cancer (non-small cell lung cancer) cancer-free for a longer period after surgery. Participants in this study have lung cancer that surgery can remove but haven't fully responded to drug therapy before surgery. Researchers will compare how long patients remain disease-free and their overall survival when treated with pembrolizumab alone versus with the addition of V940. The study considers various outcomes like survival rates, occurrence of new metastases, and changes in patients' quality of life. However, people with certain medical conditions or those who have received particular treatments in the past won't be eligible to join. The study may last up to 129 months, monitoring people's health outcomes as they receive the treatment to make sure it's working and to identify any side effects or adverse events caused by the medications.

This study may be appropriate for those with: Recurrent Cancer

Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer

This is a prospective, open-label, multi-cohort, non-randomized, multicenter phase 2 study evaluating LN-145 in patients with metastatic NSCLC. All patients are infused with their autologous TIL (LN-145) followed by IL-2 administration between 3-24 hours after every 8-12 hours for a total of 6 doses. Cohort 1 will consist of patients whose tumors did not express PD-L1 (tumor proportion score [TPS] < 1%) prior to their CPI treatment. Cohort 2 will consist of those who do express PD-L1. Cohort 3 will consist of patients whose tumors do not express PD-L1 (TPS < 1%) prior to their CPI treatment and who are unable to safely undergo a surgical harvest for TIL generation. The primary outcome measured will be objective response rate.

This study may be appropriate for those with: Metastatic Cancer

Neladalkib vs Alectinib in ALK NSCLC

This is a global Phase 3 study that will randomly assign people with ALK-positive advanced non-small cell lung cancer (who have not had prior systemic treatment for their lung cancer) to one of two first-line treatments: neladalkib (NVL-655) or alectinib. About 450 participants will be split evenly between the two drugs. The main goal is to see which drug keeps the cancer from getting worse for a longer time, using independent radiology review. Other goals include overall survival, brain (intracranial) outcomes, tumor response rates, safety and side effects, and patient-reported quality of life. Treatment continues until the cancer progresses or side effects prevent further treatment. Participants will be followed with regular scans and visits, and some measures will be collected for up to five years after the first patient is dosed.

This study may be appropriate for those with: Metastatic Cancer

BBO 11818 in KRAS Mutant Cancer

This is an early stage (Phase 1a/1b) open study testing a new oral drug called BBO 11818, which targets KRAS mutations found in many solid tumors. The study will enroll adults with advanced unresectable or metastatic cancers that carry specific KRAS mutations (G12A, G12C, G12D, G12S, or G12V), including lung, colorectal, and pancreatic cancers. The main goals are to find safe dose levels, watch for side effects, measure how the drug behaves in the body, and get a first look at whether the drug can shrink tumors or slow their growth. The study includes a dose-finding stage and a later expansion stage. BBO 11818 will be tested alone and with other approved cancer treatments such as pembrolizumab (an immune therapy), various chemotherapy combinations, and cetuximab. Participants will be seen regularly for tests, scans, and safety checks and followed over time to record responses and any side effects.

This study may be appropriate for those with: Metastatic Cancer

Study on IOV-4001 for Advanced Melanoma and NSCLC

This study is the first-in-human study of IOV-4001, a genetically modified autologous tumor- infiltrating lymphocytes (TIL) product. IOV-4001 is expected to have antitumor activity through its capacity to directly target and kill tumor cells in a manner that is similar to non-genome-edited TIL, but with the potential for enhanced antitumor activity due to disruption of PDCD1, the gene for programmed cell death protein-1 (PD-1).

This study may be appropriate for those with: Metastatic Cancer

Effect of a Virtual Reality Cognitive Training Intervention for Brain Cancer Survivors

You will either be assigned to a group that uses the virtual reality training system or a group that will complete paper word search puzzles. At the start of the study all participants will be asked to complete three short cognitive tests to check your current memory and thinking skills. You will take the same tests again at the end of the study to see if anything has changed or improved. You will receive a schedule based on your start and end dates that explains which days you will need to complete the study-related tasks. You will complete the tasks at home for 4 weeks, 6 days a week. It will start at 15 minutes a day in week one and increase by 5 minutes each week, ending at 30 minutes a day in week four. You will receive either a VR headset and hand controllers for use with VR-CRT (and portable WI-FI hotspot if you do not have WI-FI at home) or a notebook for use with paper word-search puzzles (WSP). The research study will provide the technology to you free of charge, but with a technology sign-out consent to confirm your agreement to return the VR and WI-FI equipment once the study is completed. If you are in the VR group, you will be trained on how to use the equipment and how to connect the VR equipment to WIFI. Off-the-shelf VR equipment (Meta Quest 3/128 GB with WIFI) will be used.

Trastuzumab Deruxtecan Endometrial Study

This global Phase 3 study is testing whether a targeted treatment called trastuzumab deruxtecan (T-DXd) given after surgery can help people with HER2-positive endometrial cancer live longer without the cancer returning. Participants who have newly diagnosed Stage IIC or Stage III endometrial cancer and whose tumors show HER2 will be randomly placed into one of two groups: T-DXd or standard chemotherapy (with or without radiotherapy as decided by the treating doctor). The main goal is to compare the time until cancer returns or the person dies. Doctors will also track overall survival and side effects. T-DXd is a drug that seeks out cancer cells carrying the HER2 protein and delivers a chemotherapy payload directly to them. The study is open-label, which means doctors and patients will know which treatment is given. People will be followed for several years to monitor benefit and safety, including watching for lung inflammation and heart problems, which can be serious with these kinds of treatments.

This study may be appropriate for those with: Newly Diagnosed Cancer

TRI611 in ALK Positive NSCLC

This is a Phase 1/2 study testing an oral drug called TRI-611 in adults with ALK-positive non-small cell lung cancer. The study has two parts. Part 1 finds the safest dose by giving increasing doses to small groups of participants. Part 2 tests how well the chosen dose works in three groups: people who had no prior ALK drugs, people who had several prior ALK drugs including lorlatinib and neladalkib, and people with intermediate prior treatment histories. Participants take TRI-611 daily as long as it helps and side effects are tolerable. They will visit the clinic about seven times in the first three months, then once at the start of each 28-day treatment cycle, and will keep a diary of doses. Main goals are to assess safety and side effects, pick a recommended dose, and measure tumor response and how long responses last. Some outcomes (like survival and duration of response) will be followed for up to about five years.

This study may be appropriate for those with: Metastatic Cancer

DB 1311 Combination Trial

This is an open-label Phase 2 study testing DB-1311 given with either BNT327 or DB-1305 in people with advanced or metastatic solid tumors that have not responded to prior treatments. The study aims to check safety, side effects, how the body processes the drugs, and early signs of benefit like tumor shrinkage and longer time without disease growth. Eligible participants have one of several cancer types (liver cancer, cervical cancer, melanoma, head and neck cancer, platinum-resistant ovarian cancer, or non-small cell lung cancer) and meet basic health and lab criteria. People who previously received certain similar antibody-drug treatments, have serious uncontrolled illnesses, active brain metastases, autoimmune disease, or unresolved severe side effects are not allowed. Participants will receive study drugs in repeated treatment cycles and be seen regularly for safety checks, scans, and blood tests. The study may follow participants for up to about 6 years to collect long-term safety and outcome data.

This study may be appropriate for those with: Metastatic Cancer

New Treatments for Recurrent Glioblastoma

This clinical trial studies new drug combinations for treating people with recurrent glioblastoma, a type of brain cancer that has returned. The trial is testing whether the combination of two monoclonal antibodies, relatlimab and nivolumab, can be as effective or more effective than the current standard treatment, lomustine. These drugs work by potentially interfering with the ability of tumor cells to grow and spread. Participants will be randomly assigned to receive either the experimental drug combination or the standard chemotherapy drug. They will undergo regular checks, including MRI scans and biopsies, to track their response to treatment. The study will compare survival times and patient health outcomes between the two treatment groups over various periods up to 5 years to understand the effectiveness and safety of these treatments.

This study may be appropriate for those with: Recurrent Cancer

DAY301 in Advanced Solid Tumors

This is a Phase 1 study testing DAY301, an experimental antibody-drug medicine that targets PTK7 on cancer cells. The trial has two parts. In the first part (dose escalation) small groups of patients get increasing doses to find a safe dose and the recommended dose for further study. In the second part (dose expansion) that dose is given to larger groups of patients with specific tumor types to see how well it works. The study will track side effects, any serious adverse events, how often doses are interrupted or reduced, how the drug moves through the body (blood levels and half-life), and early measures of tumor response. Participants must have advanced or metastatic solid tumors, provide a tumor sample, have measurable disease, and be well enough to participate. Treatment and assessments continue for up to about 12 months or until the cancer progresses or side effects prevent further treatment.

This study may be appropriate for those with: Metastatic Cancer

Safety and Effectiveness of PYX-201 in Solid Tumors

This study is testing a new drug called PYX-201 in adults with advanced solid tumors that have not responded to usual treatments or for whom there are no suitable treatment options. The goal is to find out what dose of the drug is safe and can be tolerated well. Researchers will monitor participants to see how their bodies react to the drug, including any side effects and how the drug moves through their system. Participants must be adults with certain cancers, such as breast, lung, or ovarian cancer, who meet health criteria like having normal kidney and liver function. The study aims to explore both the safety and preliminary effectiveness of PYX-201 over approximately 3 years. It is open-label, meaning all participants receive the drug, and no placebo is involved. Measurements will focus on potential toxicities and adverse events as well as biological markers from blood samples. Participants must not have severe infections or other active cancers. The research hopes to pave the way for further clinical development if results are promising.

This study may be appropriate for those with: Recurrent Cancer