A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)
This study is designed to compare the antitumor activity of V940 in combination with BCG to BCG monotherapy, and evaluate safety of both treatments, in participants who have high risk NMIBC and are BCG-naïve (Cohort A), and, in an exploratory fashion, eva
A Phase 2 Open-label Study Evaluating Dosimetry Randomized Dose Optimization Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants with PSMA PET-Positive Castration-Resistant Prostate Cancer
This is a three-part study which includes biodistribution (Part 1), dose optimization (Part 2) to determine the optimal dose of Ac-225 rosopatamab tetraxetan to be evaluated in future studies, and dose escalation (Part 3) in post-Lu-177-PSMA-RL participants using the Bayesian optimal interval (BOIN) design. The study will evaluate participants with CRPC previously treated with at least one ARSI with and without prior exposure to Lu-177-PSMA-RL.
A Phase 2 Open-Label Study to Evaluate the Safety and Efficacy of DCR-PHXC in Patients With Primary Hyperoxaluria Type 1 or 2 and Severe Renal Impairment With or Without Dialysis PHYOX7
The aim of this study is to evaluate DCR-PHXC in participants with PH1 or PH2 and severe renal impairment, with or without hemodialysis or peritoneal dialysis.Primary hyperoxaluria is typically diagnosed by measuring oxalate levels in urine. However, as kidney function decreases, the renal excretion of oxalate also decreases and may no longer reflect daily oxalate loads (Perinpam et al., 2017). Decreasing renal excretion of oxalate results in increasing Pox levels (Hoppe et al., 1998, Hoppe et al., 2009). Because a decrease in Pox is reasonably likely to predict clinical benefit due to its causal role in systemic oxalosis in CKD Stages 3b to 5, Pox may be a more relevant endpoint in patients with PH who have severe renal impairment (Milliner et al., 2020).
A Phase 2 Randomized Double-Blind Placebo-Controlled Multicenter Dose Ranging Study Evaluating the Efficacy and Safety of GS-1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)
The study team is evaluating an oral investigational drug to see if it reduces the signs and symptoms of moderately to severely active ulcerative colitis (UC) by blocking certain processes involved in the inflammation pathway. The study is also evaluating if there are any adverse events or other safety issues associated with the investigational drug.
A Phase 2 randomized open-label active-controlled study of JNJ-90301900 in combination with chemoradiation followed by durvalumab in locally advanced and unresectable Stage III non-small cell lung cancer
This is a Phase 2 study testing whether adding a new medicine, JNJ-90301900 (radioenhancer) to the standard treatment of chemotherapy and radiation, followed by a medication called durvalumab (a type of immunotherapy) can be a better treatment option for patients with a type of lung cancer called non-small cell lung cancer (NSCLC). This study will be done in two parts. In Part 1, patients will be enrolled sequentially into two groups to receive a JNJ-90301900 injection at two different dose levels along with standard treatment of chemotherapy and radiation, followed by a medication called durvalumab. In part 2, the patients will be randomly divided into three groups. Patients in Groups A and B will receive the study medicine at two different dose levels along with standard treatment of chemotherapy and radiation, followed by a medication called durvalumab. Patients in Group C will receive the standard chemotherapy and radiation treatment, followed by a medication called durvalumab. The study will compare the effects of this new combination treatment with those of the standard treatment alone. All patients will have blood samples taken to see how their bodies handle the study medicines and how well the cancer responds to this treatment over time. Patients will have special scans taken to monitor how the cancer is changing in response to the study medication. The study team will monitor all patients for side effects and safety concerns throughout the study. All patients will be followed up after their last study dose for up to 24 months.
A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma (mRNA-4157-P201)
This is an open-label, randomized, Phase 2 study. Approximately 150 eligible patients will be randomly assigned in a 2:1 ratio to the combination arm (approximately 100 patients who receive mRNA-4157 and pembrolizumab) and the control arm (approximately 50 patients who receive pembrolizumab alone). Patients with completely resected cutaneous melanoma at one of the following stages: ? Stage IIIB, only if relapsed within 3 months of initial surgery of curative intent. That is, the patient must have relapsed within 3 months of their first surgery of curative intent and subsequently had a second surgery of curative intent before entering this study (as such, newly diagnosed Stage IIIB patients are not eligible).? Stage IIIC.? Stage IIID.? Stage IV.Patients must have had complete resection (surgery of curative intent) within 13 weeks before study enrollment, and must be disease free at study entry (screening). Once a patient is enrolled, they will be randomized and should commence pembrolizumab treatment as soon as possible (ideally within 13 weeks of their surgery of curative intent). For patients randomly assigned to the mRNA-4157 plus pembrolizumab combination arm:? A pembrolizumab run-in period, typically 2 pembrolizumab cycles, will occur while mRNA-4157 is being manufactured.? Once a patient’s mRNA-4157 is available, the combination treatment period will commence. The first dose of mRNA-4157 will be administered with the next dose of pembrolizumab in order to achieve synchronous combination dosing in 21-day cycles.All patients on both arms of the study may continue on pembrolizumab until disease recurrence, unacceptable toxicity, or they undergo 18 total cycles (approximately 1 year of treatment), whichever is sooner. Crossover to the mRNA-4157 and pembrolizumab combination arm is not permitted for patients who relapse following pembrolizumab monotherapy. Recurrence-free survival (RFS) is the primary endpoint of the trial and is defined as the time between the first dose of pembrolizumab and the date of first recurrence (local, regional, or distant metastasis), new primary melanoma or death (from any cause), whichever occurs first. Patients will be assessed for recurrence by radiological imaging.
A Phase 2 Randomized Study of Osimertinib Versus Osimertinib Plus Chemotherapy for Patients with Metastatic EGFR-Mutant Lung Cancers That Have Detectable EGFR-Mutant cfDNA in Plasma After Initiation of Osimertinib
This study is about testing two different treatments for a type of lung cancer called EGFR-mutant lung cancer. The first treatment is a medicine called osimertinib, which patients will take by mouth every day. They'll take it for three rounds, and then the doctors will check their blood to see if themedicine is working. If the medicine is not working, some patients will getanother treatment called chemotherapy along with osimertinib, while otherswill keep taking osimertinib alone. The doctors will monitor how well thetreatments are working by taking pictures of the inside of the body andchecking the blood again if the cancer starts to grow again.
A Phase 2 Study of Darolutamide in Combination with Leuprolide Acetate in Hormone-Therapy Na ve Recurrent and/or Metastatic Androgen Receptor (AR) Positive Salivary Gland Cancer
A Phase 2 Study of Darolutamide in Combination with Leuprolide Acetate in Hormone-Therapy Naïve Recurrent and/or Metastatic Androgen Receptor (AR) Positive Salivary Gland Cancer
A Phase 2 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Patients with Stage 4 Non-Small Cell Lung Cancer
This study aims to see how well a new drug, EIK1001, works when given with pembrolizumab and certain chemotherapies in patients with Stage 4 lung cancer who haven't had other treatments. Patients will getEIK1001 through an IV once a week, and pembrolizumab every three weeks for up to 35 cycles. There are two groups: one will get EIK1001 with pemetrexed and carboplatin, and the other with paclitaxel and carboplatin. At first, a small number of patients will get a low dose of EIK1001 to check for serious side effects. If it’s safe, more patients will get a higher dose. The main goal is to see if the treatment has few side effects. The study will also look at how well the treatment works against the cancer, how long patients live without the cancer getting worse, and other important health markers. Patients will have regular scans to check their cancer and will be watched closely for side effects. The treatment will continue until the cancer worsens, side effects are too severe, or other reasons the study teams decides is good enough for patient withdrawal. After treatment ends, patients will be followed for at least 90 days to monitor their health.
A Phase 2/3 Adaptive Double-blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Subjects Adult and Pediatric subjects With APOL1-mediated Proteinuric Kidney Disease
This is an adaptive Phase 2/3 study of VX-147 in subjects Adult and Pediatric with APOL1-mediated proteinuric kidney disease that is designed to select a dose of VX-147 and establish the efficacy and safety of the selected dose