Pinehurst

Researchers are evaluating the efficacy and safety of the experimental drug ACR-368 alone or combined with ultra-low dose gemcitabine ULDG sensitization in participants with high-grade endometrial cancer. This Phase 2 open-label study divides participants into groups based on a test called OncoSignature, which predicts tumor sensitivity to ACR-368. Some groups receive ACR-368 alone while others receive it with ULDG, and treatment continues until disease progresses or unacceptable side effects occur. Participants are assigned to four different arms Arm 1 includes OncoSignature Positive tumors treated with ACR-368 alone Arm 2 includes OncoSignature Negative tumors treated with ACR-368 plus ULDG sensitization Arm 3 and Arm 4 include participants without OncoSignature selection, receiving either ACR-368 with ULDG or ACR-368 alone, respectively. Participants in the European Union are only enrolled in the unselected groups Arms 3 and 4. Treatment is administered continuously until progression, toxicity, or withdrawal. During the study, participants undergo tumor assessments every 8 weeks for up to two years or until death to measure anti-tumor activity. Safety is monitored by recording adverse events and pharmacokinetic testing occurs at specific times during the first treatment cycle. Other outcomes include overall survival, duration of response, and progression-free survival. Participants provide tumor tissue samples either from new biopsies or archival tissue depending on their assigned arm. The study runs from screening through treatment and follow-up until study completion in November 2027.

Researchers are evaluating if immunotherapies alone or combined with other drugs can delay or prevent colorectal cancer from returning in patients who test positive for circulating tumor DNA ctDNA after their treatment. The study focuses on patients with colorectal cancer who have minimal residual disease following surgery and chemotherapy. The immunotherapies being studied are cemiplimab, fianlimab, and REGN7075, which work by activating the immune system to target and destroy cancer cells. Participants will receive one of three treatments cemiplimab alone, cemiplimab combined with fianlimab, or cemiplimab combined with REGN7075. Treatments are given intravenously with specific dosing amounts e.g., cemiplimab 350 mg. Eligible patients must have confirmed ctDNA positivity from commercial assays and will have confirmation via a special trial assay. Treatment starts after enrollment, with patients assigned to one of the treatment groups in a parallel design. During the study, participants will have regular assessments including ctDNA testing to monitor clearance and sustainability of clearance over periods ranging from 12 weeks up to 3 years. Researchers will also track recurrence-free survival and safety, including monitoring for toxicities during the treatment and up to 60 days after. Blood tests and imaging will be used to ensure patients meet criteria and to evaluate treatment effects. The total participation may last several years, with ongoing follow-up to observe outcomes.

Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.

Researchers are evaluating the efficacy and safety of the combination of divarasib and pembrolizumab compared with pembrolizumab combined with pemetrexed and either carboplatin or cisplatin. This study focuses on adults with previously untreated, advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The goal is to assess these treatments as first-line options in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group will take divarasib orally once daily and receive pembrolizumab through an intravenous infusion every three weeks. The other group will receive pembrolizumab, pemetrexed, and either carboplatin or cisplatin via intravenous infusions every three weeks. Treatment continues with these schedules, following the study protocol for up to approximately five years of follow-up. During the study, participants will have regular assessments to monitor their health and response to treatment. These include imaging and clinical evaluations to measure progression-free survival and overall survival for up to five years. Researchers will also track quality of life, symptom changes, treatment side effects, and adverse events using questionnaires and patient-reported outcomes. Safety monitoring and detailed evaluations will help understand the effects of the treatments over the study duration.

Researchers are evaluating whether adding the investigational drug JNJ-90301900 to standard concurrent platinum-based doublet chemotherapy with radiation therapy cCRT, followed by consolidation immunotherapy cIT with durvalumab, can improve the objective response rate in participants with locally advanced and unresectable stage III non-small cell lung cancer NSCLC. This Phase 2 study aims to compare the safety and efficacy of JNJ-90301900 in combination with cCRT and cIT against cCRT and cIT alone. The study is sponsored by Johnson & Johnson Enterprise Innovation Inc. Participants will be randomly assigned to one of three groups two experimental arms where JNJ-90301900 is injected intratumorally andor intranodally at different percentages of gross tumor volume 22% or 33% along with cCRT and followed by cIT, and a control arm receiving cCRT followed by cIT without JNJ-90301900. Chemotherapy drugs include carboplatin and paclitaxel administered intravenously, radiation therapy is delivered by intensity modulated radiation therapy IMRT, and consolidation immunotherapy is given as durvalumab through intravenous infusion. During the study, participants will undergo regular assessments to monitor tumor response using objective response rate evaluations up to 2 years and 2 months. Other measures include disease control rate, progression-free survival, duration of response, and safety evaluations such as adverse event monitoring, laboratory tests, physical exams, and vital signs. The total participation duration spans treatment and follow-up to assess long-term outcomes and safety of the treatment combinations.

Researchers are evaluating tolododekin alfa also known as ANK-101 combined with an anti-PD-1PD-L1 antibody in adults with advanced or metastatic non-small cell lung cancer NSCLC. The study includes two groups one with participants who have progressed after standard treatments including anti-PD-1PD-L1 antibodies and chemotherapy, and another with participants who have not previously received treatment for their advanced NSCLC. This Phase 1b study aims to assess how this combination affects the cancer and its safety profile. Participants will receive tolododekin alfa as an injection into the tumor every three weeks, combined either with cetrelimab or an FDA-approved anti-PD-1PD-L1 antibody chosen by the investigator. Treatment will be given for up to eight cycles, lasting up to one year. The study is divided into two experimental cohorts based on prior treatment history, with dosing schedules aligned to these cohorts. Throughout the study, participants will undergo regular assessments including imaging to measure tumor response using RECIST v1.1 criteria, laboratory tests, electrocardiograms, and monitoring for side effects. Researchers will track response rates, duration of response, disease control, progression-free survival, overall survival, and detailed pharmacokinetic measures of tolododekin alfa. The study participation may last at least six months with ongoing safety and efficacy monitoring.

Researchers are evaluating whether combining tucatinib with trastuzumab and mFOLFOX6 works better than standard treatments for people with HER2 positive colorectal cancer that has spread or cannot be removed by surgery. This Phase 3 study also aims to learn about the side effects that may occur when taking this combination of drugs. Participants have metastatic or unresectable colorectal cancer and are randomly assigned to different treatment groups. Participants are randomly placed in one of two study groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every 3 weeks and mFOLFOX6 chemotherapy every 2 weeks. The other group receives standard care, which may be mFOLFOX6 alone or combined with bevacizumab or cetuximab, both given intravenously on different schedules. Tissue samples and biopsies are collected before treatment to confirm HER2 positivity and other markers. During the study, participants will have regular evaluations including imaging scans to measure cancer progression, blood tests, and assessments of side effects and quality of life. Progression-free survival is the primary outcome measured for up to about 3 years, with other outcomes like overall survival and response rate also tracked. Safety monitoring continues for about one year after the last treatment. The study lasts several years, with ongoing follow-up to understand long-term effects and benefits.

Researchers are evaluating the use of Vedolizumab in adults with moderate to severely active Ulcerative Colitis UC or Crohns Disease CD, which are chronic gut conditions causing symptoms such as diarrhea, inflammation, bleeding, and abdominal pain. The study aims to measure how many participants achieve remission, meaning their symptoms disappear, after 14 weeks of treatment. This is a Phase 4 treatment study sponsored by Takeda, focusing on the effectiveness of Vedolizumab administered in a community setting. Participants with either UC or CD will receive Vedolizumab intravenously IV during the first 6 weeks, with doses given at Weeks 0 and 2, and possibly an additional IV dose at Week 6. After this initial period, participants may switch to subcutaneous under the skin injections of Vedolizumab every two weeks from Week 6 until Week 50. If the treatment does not appear effective by Week 14, participants may stop Vedolizumab and switch to another therapy. Additional required visits occur at 26 weeks and 52 weeks, with a final check 18 weeks after the last Vedolizumab dose. Throughout the study, participants will visit the clinic multiple times for treatment and monitoring. Assessments include patient-reported symptom measures at Weeks 6, 14, and 52, clinical response evaluations, and endoscopic examinations to observe mucosal healing. Blood and stool tests will measure inflammation markers like C-reactive protein and fecal calprotectin. Safety monitoring will track serious infections up to 72 weeks. Overall, participants are involved for about one year of treatment plus follow-up to evaluate the long-term effects of Vedolizumab.

Ovarian cancer is a serious disease with a high number of new cases and deaths worldwide. This study evaluates the safety and disease activity changes of mirvetuximab soravtansine combined with carboplatin, bevacizumab, or bevacizumab alone in female participants with ovarian cancer confirmed to express folate receptor alpha FR. The trial is a Phase 2 study involving approximately 400 participants worldwide, assessing different treatment combinations given by intravenous infusion. Participants will be assigned to one of three substudies and receive treatment in groups called arms. Substudy 1 includes arms where participants receive one of two doses of mirvetuximab soravtansine with bevacizumab or bevacizumab alone. Substudy 2 involves mirvetuximab soravtansine with carboplatin followed by mirvetuximab soravtansine alone. Substudy 3 combines mirvetuximab soravtansine, bevacizumab, and carboplatin followed by mirvetuximab soravtansine with bevacizumab. Treatments are given by intravenous infusion, and the study duration ranges up to approximately 40 months depending on the substudy. Participants will attend regular visits at hospitals or clinics where they will receive infusions and undergo medical assessments including blood tests and scans. Researchers will monitor treatment-emergent adverse events, ocular events, overall response, progression-free survival, and other outcomes up to about 40 months. The study includes careful safety monitoring and evaluation of disease activity during and after treatment to assess the effects and safety of these drug combinations.

Non-small cell lung cancer NSCLC is a condition where cancer cells grow uncontrollably in the lung tissues. This study evaluates the safety of an investigational drug called telisotuzumab vedotin in adults with previously treated NSCLC that overexpresses c-Met. The trial also monitors changes in disease activity and side effects over time. Participants will be randomly assigned to receive one of three different doses of telisotuzumab vedotin through intravenous IV infusion. Each dose group receives treatment as part of a study lasting up to three years. The study involves approximately 150 adults with c-Met positive NSCLC across many sites worldwide. Throughout the study, participants will attend regular hospital or clinic visits where they undergo medical assessments, blood tests, and complete questionnaires to evaluate how the drug affects their disease and any side effects experienced. The study measures treatment-related adverse events, disease response, and survival outcomes over the three-year period.