Maple Grove

Researchers are evaluating petosemtamab compared with investigator's choice monotherapy in patients with incurable, metastatic or recurrent head and neck squamous cell carcinoma (HNSCC) who have previously received treatment. This phase 3 open-label, randomized, controlled, multicenter study focuses on patients whose disease progressed after anti-PD-1 and platinum-containing therapies. The study aims to assess treatment options for second- and third-line therapy in this challenging condition. Participants will be randomly assigned to receive either petosemtamab or one of several investigator-chosen monotherapies, including cetuximab, methotrexate, or docetaxel. The study compares these treatment approaches without masking, allowing patients and researchers to know the assigned therapies. Treatments will be provided according to the study protocol, with follow-up to monitor effects and safety. During the study, participants will undergo assessments including radiologic evaluations to measure tumor response, laboratory tests to monitor organ function, and quality of life questionnaires. The main outcome is overall survival tracked for up to about three years, with additional measures such as response rate, progression-free survival, and treatment-related side effects observed for up to two years. Safety will be closely monitored, including adverse events and antibody responses, ensuring comprehensive evaluation throughout the study period.

Researchers are studying ART0380, an investigational oral drug that blocks ATR kinase, in people with advanced or metastatic solid tumors, including cancers with DNA repair defects and certain ovarian, peritoneal, fallopian tube, endometrial, colorectal, and pancreatic cancers. This open-label Phase I/IIa study aims to find safe dosing, understand side effects, and assess how well ART0380 works alone or combined with chemotherapy drugs gemcitabine or irinotecan. Participants may receive ART0380 alone or with gemcitabine or irinotecan in 21-day treatment cycles. The study includes multiple parts: initial dose testing of ART0380 alone or with chemo, expansion cohorts targeting tumors with ATM gene alterations, and randomized comparison of ART0380 plus gemcitabine versus gemcitabine alone in ovarian-related cancers. ART0380 dosing schedules vary between continuous daily or intermittent dosing. Some parts evaluate ART0380 with irinotecan in different cancers, including colorectal and pancreatic types. During the trial, participants will have regular assessments such as imaging scans to measure tumor response using RECIST 1.1 criteria, blood tests for tumor markers and drug levels, and safety monitoring for side effects. Pharmacokinetics of ART0380 will be measured at various points. Follow-up visits will track progression-free survival, overall survival, and duration of response. The study lasts up to about 24 months, with ongoing evaluations every 6 to 9 weeks depending on the part of the study.

Researchers are evaluating the combination of fruquintinib and FOLFIRI as a second-line treatment for participants with metastatic colorectal cancer (mCRC) who have previously been treated with FOLFOX and Bevacizumab-based first-line therapy. This open-label Phase II study aims to assess the effectiveness and safety of this combination in controlling the disease and improving progression-free survival. Participants will receive fruquintinib orally on days 1 through 21 of each 28-day cycle alongside FOLFIRI given by intravenous infusion every two weeks. The FOLFIRI treatment includes irinotecan, leucovorin, and fluorouracil administered according to standard dosing schedules. Up to 60 participants will be enrolled to receive this combined treatment regimen. During the study, participants will be monitored every two cycles with evaluations including progression-free survival, overall response rate, duration of response, disease control rate, overall survival, and treatment-emergent adverse events. These assessments will continue for up to two years or until disease progression or death. Safety follow-up will extend up to one year after treatment ends, with regular clinical visits and tests to evaluate response and side effects.

Researchers are evaluating the efficacy and safety of Iza-bren, a bi-specific antibody-drug conjugate targeting EGFR and HER3 with a topoisomerase inhibitor payload, compared to treatment chosen by the physician for patients with first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, HER2-negative breast cancer (BC) who cannot receive anti-PD(L)1 or endocrine therapies. This study focuses on patients with locally advanced, recurrent inoperable, or metastatic disease who meet specific eligibility criteria related to their cancer status and prior treatments. Participants will be randomly assigned to receive either Iza-bren or one of several chemotherapy options such as paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, or capecitabine. These treatments are given at specified doses on scheduled days. The study includes Phase 2 and Phase 3 stages and will last approximately up to 57 months from the first participant's randomization, with ongoing assessments during this period. During the trial, participants will undergo regular imaging tests like CT or MRI to measure disease progression using RECIST v1.1 criteria. Researchers will monitor progression-free survival, overall survival, response rates, quality of life measures, adverse events, and other health indicators. The study aims to track participants for up to nearly five years to evaluate long-term outcomes and treatment tolerability under medical supervision.

Researchers are evaluating whether adding tucatinib to trastuzumab and mFOLFOX6 works better than the current standard treatments for people with HER2 positive metastatic colorectal cancer. This study focuses on participants whose cancer has spread or cannot be removed by surgery. The trial also monitors side effects that might occur from taking these drug combinations. Participants are randomly assigned to one of two groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every three weeks and mFOLFOX6 chemotherapy every two weeks. The other group receives standard care, which includes mFOLFOX6 alone or combined with bevacizumab or cetuximab given by intravenous infusion. The study treatments continue as per the assigned schedule. During the study, participants undergo regular scans and evaluations to measure progression-free survival and other outcomes up to approximately three years. Researchers also assess overall survival, response rates, duration of response, quality of life, and side effects for up to about six years. Safety monitoring continues for around one year after the last treatment. Participants are closely followed to understand the impact of these treatments on their cancer and well-being.

Researchers are evaluating treatments for patients with BRAF-V600 mutant melanoma that has spread to the brain. This phase II trial compares two combinations: encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab. The study aims to determine which approach is more effective at shrinking and controlling brain metastases, and it also examines survival, response rates, and treatment safety. Patients are randomly assigned to one of two treatment groups. One group takes encorafenib daily by mouth, binimetinib twice daily by mouth, and receives nivolumab through an intravenous (IV) infusion every 28 days. The other group receives nivolumab IV every cycle and ipilimumab IV over 30 minutes during the first four cycles, with cycles repeating every 21 days initially, then every 28 days. Treatment continues unless disease worsens or side effects become unacceptable. Participants undergo brain MRI scans before enrollment and throughout the study to assess tumor response using specific criteria. After completing treatment, patients are followed every six months for two years, then yearly up to three years. The study collects tissue, blood, spinal fluid, and stool samples for future research. Researchers monitor progression-free survival as the main outcome, along with overall survival, response rates, and treatment side effects.

Researchers are evaluating two surgical procedures to reduce the risk of ovarian cancer in women with BRCA1 gene mutations. This trial compares bilateral salpingectomy, which removes the fallopian tubes, with bilateral salpingo-oophorectomy, which removes both fallopian tubes and ovaries. The study aims to see if the less extensive surgery is nearly as effective at lowering cancer risk and assesses effects on quality of life, menopausal symptoms, sexual function, and medical decision making. Participants choose between two groups: one undergoing bilateral salpingectomy with possible delayed removal of ovaries, and the other undergoing immediate removal of both fallopian tubes and ovaries. Before surgery, patients have pelvic or transvaginal ultrasounds or pelvic MRIs and blood samples collected. Follow-up visits occur at 10 to 60 days, 6, 12, and 24 months after surgery, then annually for up to 20 years. During the study, researchers will monitor the development of ovarian, primary peritoneal, or fallopian tube cancers over 20 years. They will also assess quality of life, cancer-related distress, menopausal and estrogen deprivation symptoms, sexual dysfunction, medical decision making, and adverse events up to 24 months after surgery. Blood samples and tissue are collected for future research. The long-term follow-up helps understand both cancer risk and patient well-being after surgery.

Researchers are evaluating the safety and effectiveness of standard chemotherapy with or without the drug INCB161734 in adults with metastatic pancreatic ductal adenocarcinoma (PDAC) that has the KRAS G12D mutation. This Phase 3 study focuses on participants who have not previously received treatment for metastatic disease. The purpose is to understand whether adding INCB161734 improves outcomes compared to chemotherapy alone. Participants will be randomly assigned to one of two groups: one group will receive INCB161734 tablets along with an investigator's choice of chemotherapy (either mFOLFIRINOX or GemNabP), while the other group will receive placebo tablets with the same chemotherapy options. Both treatments follow specific protocol-defined schedules and doses. The study is double-blind, meaning neither the participants nor the researchers know which treatment is given to which participant. During the study, participants will be monitored for overall survival, progression-free survival, and tumor response for up to approximately three years. Additional measurements include duration of response, disease control, adverse events, and quality of life assessments using questionnaires. Safety and treatment tolerability will also be carefully tracked. The total participation time may vary, with key evaluations occurring over two to three years.

Researchers are evaluating Pumitamig compared to Durvalumab in people with unresectable stage III non-small cell lung cancer (NSCLC) who have completed platinum-based concurrent chemoradiation therapy without disease progression. This phase 3, randomized study aims to compare these treatments in participants with good performance status after prior therapy. The trial is sponsored by Bristol-Myers Squibb and focuses on progression-free survival as the main outcome. Participants will receive either Pumitamig or Durvalumab at specified doses on certain days as part of the study treatment. The study is open-label, meaning both the researchers and participants know which treatment is given. Treatment will follow completion of at least two cycles of platinum-based chemoradiation with a radiation dose of at least 54 Gy and no disease progression after that therapy. Throughout the study, participants will be regularly monitored with scans and assessed for progression-free survival by blinded independent central review using standard criteria. Other outcomes include overall survival, objective response, disease control rate, and duration of response, observed for up to approximately nine years. Safety and disease status will be closely followed to evaluate the treatments over time.

Researchers are evaluating the safety and effectiveness of pumitamig combined with chemotherapy compared to bevacizumab combined with chemotherapy in adults with untreated, unresectable, or metastatic colorectal cancer. This study focuses on participants who have not received prior treatment and aims to provide important information about these treatment combinations in this serious cancer type. The study is a randomized, double-blind Phase 2/3 trial sponsored by Bristol-Myers Squibb. Participants will receive either pumitamig or bevacizumab along with one of several chemotherapy regimens, including FOLFOX, FOLFIRI, or CAPOX. The treatments are given in specified doses on scheduled days. The study includes multiple experimental and comparator arms, with participants randomly assigned to one of these groups. This design allows comparison of the different drug combinations over the course of the trial. During the study, participants will be regularly evaluated using imaging and clinical assessments to measure tumor response by RECIST criteria and other key outcomes such as progression-free survival and overall survival. These assessments will continue for up to five years to monitor treatment effects and safety. The study will also track the duration and timing of tumor responses. Participants will have visits for evaluations and safety monitoring throughout the trial period.