Corona

Researchers are evaluating the effectiveness of amivantamab combined with either lazertinib or platinum-based chemotherapy in treating participants who have epidermal growth factor receptor mutated EGFRm non-small cell lung cancer NSCLC. This study focuses on advanced or metastatic NSCLC cases where standard curative treatments are not suitable. It aims to assess the antitumor activity of these treatment combinations in this patient population. Participants receive either amivantamab with oral lazertinib in 28-day cycles or amivantamab with intravenous chemotherapy consisting of carboplatin and pemetrexed in 21-day cycles. Treatment continues until disease progression, participant withdrawal, death, or investigator decision to stop treatment. The study is designed with two separate groups receiving these distinct treatment combinations. Throughout the study, participants will undergo assessments to monitor treatment effects and safety. Researchers will measure progression-free survival as the primary outcome up to 4 years and 6 months, along with secondary outcomes including dose adjustments, adverse events, overall survival, response rates, and duration of response. Participants are followed regularly during treatment to track these outcomes and manage any side effects until the studys completion.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

Researchers are evaluating whether adding immunotherapy drugs brentuximab vedotin and nivolumab to the standard treatment of chemotherapy with or without radiation improves survival for patients aged 5 to 60 with early stage classical Hodgkin lymphoma. This phase III trial compares progression-free survival and overall survival between the standard therapy and the immunotherapy-enhanced approach, as well as patient-reported outcomes and long-term side effects. Participants initially receive two cycles of ABVD chemotherapy every 28 days and then undergo imaging to classify their early response. Based on risk level and response, patients are assigned to one of eight treatment arms that include either continuing standard chemotherapy, receiving immunotherapy drugs, or combinations with involved-site radiation therapy. Treatments are delivered intravenously or orally in cycles lasting 28 days. Imaging and blood samples are collected throughout the trial. Participants are monitored regularly with PET scans, CT or MRI imaging, and blood tests. Follow-up visits occur every 3 months in the first year, then every 6 months for years two and three, and annually up to 12 years from registration. Researchers assess survival outcomes, adverse events, patient-reported symptoms and quality of life, and metabolic tumor burden. Long-term effects such as cardiovascular and pulmonary health are also evaluated using questionnaires and clinical assessments.

Researchers are evaluating the effectiveness and safety of inavolisib combined with Phesgo compared to a placebo combined with Phesgo as maintenance treatment for participants with previously untreated HER2-positive advanced breast cancer that has a PIK3CA mutation. This Phase 3 study focuses on participants with locally advanced or metastatic breast cancer who have completed induction therapy. Participants first receive induction therapy with Phesgo plus taxane-based chemotherapy. Following this, they enter the maintenance phase where they are randomly assigned to receive either inavolisib tablets taken orally once daily for 21 days of each 21-day cycle along with Phesgo administered subcutaneously every 3 weeks, or a matching placebo tablet with Phesgo on the same schedule. Optional endocrine therapy may be given based on the investigators choice according to standard care. Throughout the study, participants undergo regular monitoring including tumor assessments, quality of life questionnaires, and safety evaluations lasting up to approximately 111 months. Key outcomes measured include progression-free survival assessed by investigators, overall survival, response rates, duration of response, and adverse event rates. Plasma concentrations of inavolisib are also measured at specific timepoints. Participants will be followed closely during and after treatment to assess these outcomes over an extended period.

This research evaluates the combination of pembrolizumab, an immunotherapy drug, with radiation therapy after chemotherapy in patients with muscle invasive bladder cancer. The goal is to prevent the need for surgery to remove the bladder cystectomy following standard chemotherapy that aims to shrink or eliminate the tumor. This phase II trial focuses on bladder preservation and improving survival without bladder removal in this patient group. Participants receive photon beam radiation therapy daily from Monday to Friday for up to 20 treatments. Pembrolizumab is given intravenously on the first day of each 21-day cycle, for up to 18 cycles totaling 12 months, including the prior chemotherapy phase. Before and during treatment, patients undergo tissue collection via transurethral resection of bladder tumor TURBT, imaging scans such as CT, MRI, or PET, as well as cystoscopy and urine and blood tests. Throughout the study, patients are monitored for treatment effects, tumor recurrence, metastasis, and overall survival, with assessments of side effects and patient-reported symptoms related to gastrointestinal, urinary, and sexual function. After treatment, follow-up visits occur every 26 weeks until two years, then annually up to five years. Specimens are also collected for future research. The main outcome measured is bladder intact event-free survival within three years after registration.

Researchers are evaluating the use of biomarkers to predict how patients with stage IIIB-IV non-small cell lung cancer NSCLC will respond to initial PD1 or PD-L1-based immunotherapy and to guide second-line treatment choices. This phase II trial aims to improve understanding of immunotherapy effects on tumor cells and immune response, as well as to develop personalized treatment strategies. The study focuses on patients with advanced NSCLC who have no sensitizing EGFR mutation or ALKROS1 alteration and are starting or have recently started FDA-approved PD1PDL1 immunotherapy with or without chemotherapy. Participants receive PDL1-based immunotherapy every three weeks with or without chemotherapy for up to 12 to 24 months as part of their first-line treatment. Depending on treatment response and circulating tumor DNA ctDNA levels, patients may discontinue or continue therapy and undergo monitoring or surveillance. For those whose cancer progresses, second-line treatments include combinations of tremelimumab and durvalumab given intravenously or adagrasib taken orally with bevacizumab given intravenously, depending on specific genetic mutations. Treatment cycles and durations vary by arm, with careful monitoring for disease progression or toxicity. Throughout the study, patients undergo regular blood sample collections, imaging scans including CT, MRI, or PET, and may have cerebrospinal fluid, ascites, pleural fluid, and tumor biopsies collected during routine care. Safety and treatment response are assessed through these evaluations, along with progression-free survival and overall survival measures. After treatment completion, participants are followed up at 30 days, then every 3 months in the first year, and every 6 months up to two years to monitor long-term outcomes.

Researchers are evaluating treatments for patients with high-risk, locally advanced cervical cancer that has spread to nearby tissue or lymph nodes. This Phase III trial compares adding induction chemotherapy with carboplatin, paclitaxel, and pembrolizumab before standard chemotherapy, radiation, and pembrolizumab maintenance against the standard treatment of chemotherapy, radiation, and pembrolizumab maintenance alone. The study aims to investigate whether this induction approach improves progression-free survival and overall survival, while assessing treatment toxicity and biomarker effects. Participants are randomly assigned to one of two groups. In the standard care group, patients receive weekly cisplatin and pembrolizumab every three weeks alongside daily radiation therapy for 5 weeks, followed by brachytherapy for 4 to 5 treatments, and then pembrolizumab maintenance every six weeks for up to 15 cycles. In the experimental group, patients first receive induction chemotherapy with carboplatin and paclitaxel weekly for 3 weeks, plus pembrolizumab every three weeks for 2 cycles, then receive the same chemoradiation and pembrolizumab maintenance schedule, with radiation delivered in weeks 7 to 13. Treatment is given unless disease progression or unacceptable side effects occur. Throughout the trial, participants undergo imaging scans including PET, CT, chest x-ray, and MRI, along with blood sample collection to monitor disease and biomarkers. After completing treatment, patients are followed every 3 months for 2 years, then every 6 months for up to 3 more years. Researchers measure progression-free survival as the primary outcome and assess overall survival, adverse events, treatment completion, biomarker levels, and radiation quality. Safety and treatment effects are closely monitored during the study period lasting several years.

Researchers are studying patients with stage II-IV colorectal cancer CRC that can be removed by surgery to compare two blood tests, the Haystack MRD test and the Signatera assay, for detecting if the cancer returns after treatment. The study aims to find if the Haystack test can detect cancer recurrence earlier and more sensitively than the currently used Signatera test. Early detection of cancer return is important to improve chances for curative treatment in these patients. Participants will provide tissue and blood samples before surgery and then undergo both Haystack MRD and Signatera ctDNAcfDNA testing several times after surgery. Testing occurs 3 to 10 weeks post-surgery, then every 3 months for the first two years, and every 6 months for years three to five if no disease progression is observed. The study also explores the performance of two additional cancer detection assays under development. Throughout the study, participants will have blood samples collected at regular intervals and archival tissue accessed for personalized testing. Researchers will monitor minimal residual disease rates, the timing of cancer recurrence detection by the tests and imaging, and associations between ctDNA results and recurrence status over a follow-up period of up to five years. This long-term monitoring aims to assess the clinical performance and lead time advantages of the Haystack test compared to Signatera.

Researchers are evaluating the use of botensilimab and balstilimab as neoadjuvant immunotherapy treatments for adults with advanced resectable colorectal cancer that may have spread locally or to nearby lymph nodes but can still be surgically removed. This phase II trial focuses on patients with mismatch repair proficient or microsatellite stable tumors. The study aims to estimate disease-free survival rates and assess tumor responses and safety when these treatments are given before surgery. Participants receive botensilimab intravenously on day 1 and balstilimab intravenously on days 1, 15, 29, and 43, provided there is no disease progression or unacceptable side effects. Surgery to remove the tumor is performed 5 to 16 weeks after starting treatment. Throughout the study, participants undergo CT or MRI scans and blood sample collections to monitor their condition. After completing treatment and surgery, participants are followed up at 2 weeks, 4 weeks, then every 3 months for 2 years, followed by every 6 months for 1 year. Researchers will evaluate outcomes including disease-free survival at 2 and 3 years, pathologic response rates, recurrence-free survival, safety, quality of life, and time to surgery. Exploratory studies include analyzing tumor microenvironment changes and circulating tumor DNA levels to understand treatment effects and disease recurrence.

Researchers are studying the use of Ivonescimab combined with mFOLFOX6 compared to Bevacizumab combined with mFOLFOX6 for patients with metastatic colorectal cancer who have not received previous systemic treatment for their metastatic disease. This phase 3, randomized, double-blind, active-controlled, multicenter trial aims to evaluate first-line treatment options for this condition. Approximately 600 patients will participate in the study, which is sponsored by Summit Therapeutics. Participants will be randomly assigned to receive either Ivonescimab plus mFOLFOX6 or Bevacizumab plus mFOLFOX6 through intravenous infusions every two weeks for up to 8 cycles. Following this initial treatment period, maintenance therapy with Ivonescimab or Bevacizumab combined with Leucovorin and 5-Fluorouracil will be administered on Day 1 of each cycle every two weeks for up to 2 years. Throughout the study, participants will undergo various assessments to monitor their response to treatment, including progression-free survival evaluated by independent review committee using RECIST criteria. Researchers will also track overall survival, objective response rate, duration of response, and adverse events for up to approximately 4 years. The study includes regular infusions and follow-up visits over this treatment and monitoring period.