Hackensack

Researchers are evaluating new treatment options for adults with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This study compares the safety and effectiveness of adding calderasib and cetuximab, both targeted therapies, to a standard chemotherapy regimen called mFOLFOX6. The goal is to see if this combination can help patients live longer without their cancer growing or spreading compared to current treatments that may include mFOLFOX6 with or without bevacizumab. The study has two parts. It involves treatment with calderasib taken as an oral tablet, cetuximab given according to standard procedures, and mFOLFOX6 chemotherapy combining oxaliplatin, leucovorin/levofolinate calcium, and 5-fluorouracil. Some participants may receive bevacizumab or a bevacizumab biosimilar as part of the comparison. The treatments are given following approved dosing schedules. This design allows researchers to assess the safety and tolerability of these drug combinations in treating this type of colorectal cancer with the KRAS G12C mutation. Participants will be monitored for side effects, treatment tolerability, and cancer progression over a period that may last up to about 44 months. Researchers will track outcomes such as how many participants experience dose-limiting toxicities or adverse events, how many stop treatment due to side effects, and progression-free survival time. Assessments include health evaluations, laboratory tests, and imaging to observe cancer status. This long-term follow-up aims to understand both safety and effectiveness of the treatment combinations.

Researchers are investigating new treatments for extensive-stage small cell lung cancer (ES-SCLC), a type of lung cancer that has spread within or beyond the lungs. This trial evaluates the safety and effectiveness of combining two study medicines, gocatamig and ifinatamab deruxtecan (I-DXd), with or without standard chemotherapy and immunotherapy. Gocatamig is a T-cell engager therapy that helps the immune system target cancer cells, while I-DXd is an antibody drug conjugate designed to deliver cancer-killing agents directly to tumor cells. Participants will receive different treatment combinations based on the study part and arm to which they are assigned. Treatments include intravenous administration of gocatamig, I-DXd, atezolizumab, carboplatin, and etoposide. Rescue medications may be given as needed to manage side effects such as cytokine release syndrome or infusion reactions. Participants may be assigned to various treatment groups either per investigator choice or randomized, with some receiving maintenance treatments after initial induction therapy. Throughout the study, participants will be monitored for safety, including the occurrence of adverse events and dose-limiting toxicities, for up to about 58 months. Researchers will also assess tumor response by measuring cancer size changes. Other evaluations include biopsies, imaging scans, and clinical assessments to determine how well participants tolerate the treatments and how their cancer responds. The total duration of participation and follow-up will vary depending on the study phase and treatment arm.

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are studying intismeran autogene combined with pembrolizumab to see if it can stop advanced melanoma, a type of skin cancer that has spread and cannot be removed by surgery, from growing or spreading. This Phase 2 study compares this combination to pembrolizumab with a placebo, aiming to find out if the new treatment helps people live longer without cancer progression. Immunotherapy, which helps the immune system fight cancer, is a standard treatment for advanced melanoma, and intismeran autogene is designed to boost the immune response against a person's specific cancer. Participants receive either intismeran autogene or a placebo through intramuscular injection, along with pembrolizumab given as an intravenous infusion. The study is randomized, double-blind, and controlled, meaning neither participants nor researchers know who gets the active treatment or placebo. This design helps to better understand the effects of intismeran autogene when combined with pembrolizumab. During the study, researchers will monitor participants for up to about 36 months to measure progression-free survival, which means the length of time participants live without the cancer worsening. Assessments include imaging scans to track tumor changes, tumor tissue collection for biomarker analysis, and documentation of any side effects. Participants may also have their mutation status checked and will be observed for safety throughout the study period.

Researchers are evaluating treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are evaluating the safety and effectiveness of Alpha DaRT-224, a novel treatment for patients with recurrent cutaneous squamous cell carcinoma who have not responded to standard therapies and are not candidates for surgery or standard radiation. This multicenter, pivotal, single-arm, open-label clinical study aims to determine the objective response rate and duration of response following treatment, as well as assess progression-free survival, overall survival, local tumor control, and quality of life. The treatment involves placing DaRT seeds, which contain a radium-224 source that releases alpha-emitting atoms, directly into the tumor. These seeds remain in the tumor for 14 to 21 days before being removed. The procedure is planned using radiotherapy parameters and monitored with volumetric imaging to ensure proper placement and coverage of the tumor. Participants will undergo evaluations including CT scans and blood tests before and during the study. Researchers will measure tumor response from day 14 through 52 weeks after treatment and monitor safety by tracking adverse events related to the device. The study also includes assessments of quality of life and long-term outcomes over several months. Participants are followed closely to document tumor changes, side effects, and overall health during the study period.

Researchers are evaluating a combination therapy using BNT324, a B7-H3 antibody-drug conjugate, with BNT327, a bispecific antibody targeting PD-L1 and VEGF, in people with advanced or relapsed small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). This two-part Phase Ib/II trial aims to find safe and effective dose levels and to assess the therapy's safety and clinical effects in different lung cancer groups, including treatment-nave and relapsed patients. The study uses a dose escalation design in Part 1 to establish two safe combination dose levels of BNT324 and BNT327. In Part 2, participants receive either the higher or lower recommended dose to determine the optimal dose for further study. Some groups are randomized to one of the two doses, while others receive the highest dose based on prior results. Both drugs are given by intravenous infusion during the treatment period. Participants undergo screening before starting treatment, followed by treatment and safety monitoring. Researchers track dose-limiting toxicities, adverse events, dose adjustments, and treatment discontinuations up to 90 days after treatment ends or until new anticancer therapy starts. They also evaluate objective response rates up to 87 months after the first dose. Ongoing survival follow-up is included to assess long-term outcomes and safety.

Researchers are conducting a Phase 3 clinical trial to study the effects of relutrigine in people with developmental and epileptic encephalopathies (DEEs). The study is designed to evaluate the drug's efficacy, safety, tolerability, and how the body processes it compared to a placebo. This trial includes participants aged 2 to 65 years who have experienced seizure onset before age 12 and have a confirmed diagnosis of DEE. Participants will be randomly assigned to receive one of two doses of relutrigine (1.0 mg/kg/day or 1.5 mg/kg/day) or a placebo. The medication is given once daily either by mouth or through a gastrostomy or jejunostomy tube. After the initial double-blind treatment period, there is an open-label extension where all participants may receive the study drug. During the study, participants will be monitored for changes in seizure frequency over 16 weeks as the primary outcome. Safety and tolerability will also be assessed throughout the trial. Various evaluations, including heart monitoring and seizure tracking, will be conducted to ensure participant well-being. The overall study will track participants from screening through treatment and follow-up phases to gather comprehensive data about relutrigine's effects.

Researchers are evaluating a culturally-tailored, home-based physical activity program designed to improve physical fitness in Hispanic or Latino/Latina adolescent and young adult childhood cancer survivors. These survivors may face long-term effects such as weight gain, fatigue, and reduced fitness after cancer treatment, with Hispanic or Latino/Latina individuals potentially at higher risk. The study aims to increase moderate to vigorous physical activity (MVPA) through a mobile health and social media intervention. The study has two stages. Stage 1 involves developing the intervention using feedback from 20 Latinx survivors who speak either English or Spanish. Stage 2 is a randomized controlled trial comparing the intervention group with a control group that only uses a Fitbit tracker. The intervention group receives Fitbit trackers, weekly reminders, goal-setting sessions, social media peer support 2-3 times a week, badges, monthly Zoom meetings, and may choose a physical activity partner who also receives support. After 12 weeks, a 4-week maintenance phase continues these supports with less structure. The control group wears a Fitbit daily for 12 weeks without additional support. Participants wear Fitbit trackers daily, attend weekly sessions, post on social media, and complete interviews and questionnaires. Researchers measure changes in physical activity levels, sedentary time, quality of life, and cardiometabolic health indicators. Data is collected using Fitbit devices, interviews, and surveys, with follow-up over 12 weeks plus maintenance. Safety and acceptability of the intervention are also assessed throughout the study.