Villejuif

Researchers are evaluating a new treatment approach for meningiomas that continue to grow despite local therapies like surgery and radiotherapy. This trial focuses on the precision medicine concept of combining molecular imaging for patient selection with targeted treatment using a radioligand called 177Lu-DOTATATE. The study builds on evidence showing high expression of somatostatin receptors in meningiomas and prior success of this radioligand therapy in other tumors, aiming to explore its use in refractory meningiomas in a randomized Phase II study. Participants are randomly assigned to receive either the investigational treatment 177Lu-DOTATATE given by intravenous injection or the local standard of care, which may include treatment or observation as decided by their doctor. The trial involves baseline PET imaging to confirm somatostatin receptor positivity and follows patients after treatment. This design allows researchers to compare the effects of the new therapy against current practices in managing recurrent meningioma. During the study, participants undergo assessments including cranial MRI scans to measure tumor status and PET imaging for receptor evaluation. Blood tests are performed to monitor organ function and electrolytes before and during treatment. The main outcome measured is progression-free survival, tracking the time from randomization until disease progression or death, with follow-up for up to two years. Safety and treatment adherence are closely monitored throughout the study period.

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 new treatment options for high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that affects the tissue lining the bladder but has not spread to the muscle or beyond. The study aims to assess the safety and tolerability of MK-3120, a biological treatment given directly into the bladder. This phase 1/2 study focuses on patients who have undergone a surgical procedure called transurethral resection of bladder tumor (TURBT) to remove tumors. Participants receive MK-3120 through intravesical administration, which means the medicine is delivered directly into the bladder at one of three doses as outlined by the study protocol. The treatment is given after TURBT, and the study includes patients who are either new to Bacillus Calmette-Guérin (BCG) therapy or have been previously treated with BCG. The study does not include a control group but monitors participants for side effects and tolerability during treatment. Throughout the study, researchers closely observe participants for any dose-limiting toxicities within about 5 weeks, adverse events up to 24 months, and treatment discontinuation due to side effects for up to 12 months. Participants undergo regular assessments to monitor safety and treatment effects. The total duration of follow-up may extend up to two years to ensure thorough safety monitoring and evaluation of the treatment's impact.

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 evaluating the safety and tolerability of Sacituzumab Tirumotecan when administered directly into the bladder for people with intermediate-risk non-muscle invasive bladder cancer (NMIBC). The study aims to find the highest dose that patients can take without experiencing serious problems and to select a dose level for future studies to assess how well the drug works. This is a Phase 1/2 open-label clinical trial focused on safety and efficacy in this specific bladder cancer population. Participants receive Sacituzumab Tirumotecan through intravesical administration, meaning the drug is given directly into the bladder. The study allows the use of rescue medications and supportive care to manage side effects such as stomatitis, oral mucositis, ocular surface toxicity, and other adverse events. Rescue medications may include antihistamines, steroids, antiemetics, antifungals, analgesics, and growth factors as deemed necessary by the investigator. During the study, researchers monitor participants closely for dose limiting toxicities, adverse events, and treatment discontinuations due to side effects, with primary outcomes assessed up to approximately 6 to 10 weeks. Participants undergo evaluations to assess safety and tolerability throughout the treatment period. The total duration and detailed follow-up procedures are designed to understand the drug’s safety profile and identify the optimal dose for further research.

Researchers are studying TD001, an antibody-drug conjugate (ADC) that targets prostate-specific membrane antigen (PSMA), to evaluate its safety, tolerability, drug levels, and early anti-cancer effects in men with metastatic PSMA-expressing castration-resistant prostate cancer (CRPC). This first-in-human, open-label, multicenter Phase 1/2 trial includes a dose escalation phase to find recommended doses for Phase 2, followed by an expansion phase to further assess the treatment. Participants will receive TD001 through intravenous infusions at doses and schedules defined by the study protocol. Treatment continues until the disease progresses or another reason requires stopping. Multiple dosing schedules may be explored to optimize dose and administration for effectiveness and safety in this patient group. During the study, men will have their disease monitored through measurements of tumor lesions and prostate-specific antigen (PSA) levels. Safety is carefully tracked by recording any adverse events or serious side effects, as well as any treatment modifications or discontinuations due to side effects. The study also evaluates the maximum tolerated dose and recommended Phase 2 doses over estimated follow-up periods of 9 to 21 months to guide future research.

Researchers are evaluating the safety, tolerability, and therapeutic effects of a combination treatment using BNT113 and pembrolizumab compared to pembrolizumab alone for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16+) and expresses the PD-L1 protein with a combined positive score of 1 or higher. This Phase II/III trial includes patients whose cancer cannot be treated with local therapies and who have not received prior systemic anticancer therapy for their current disease condition. The trial consists of two parts. Part A is a non-randomized Safety Run-In Phase to confirm the safety and tolerability of BNT113 combined with pembrolizumab at the selected dose. Part B is a randomized phase that compares BNT113 plus pembrolizumab against pembrolizumab alone as first-line treatment. Patients in Part A continue their treatment without randomization. Treatments are given by intravenous injection or infusion, and patients may receive either combination therapy or monotherapy for up to 24 months. There is also an optional pre-screening phase to test tumor samples for HPV16 DNA and PD-L1 expression before entering the main trial. Participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria confirmed by independent review. Researchers monitor treatment-emergent adverse events for up to 27 months in Part A and evaluate overall survival and progression-free survival for up to 48 months in Part B. Tumor tissue samples are collected before treatment to confirm eligibility. The study involves ongoing safety monitoring and efficacy evaluations throughout the treatment and follow-up periods.

Researchers are evaluating the experimental antibody COM701 in participants with relapsed platinum sensitive ovarian cancer (PSOC). This trial aims to find out if COM701, given as a maintenance treatment, can delay the progression of ovarian cancer, delay the need for new anti-cancer treatments, and to assess its safety. The study is part of an adaptive-platform trial with multiple sub-studies, focusing initially on COM701 alone compared to a placebo. Participants are randomly assigned in a 1:2 ratio to receive either a placebo or COM701 via intravenous infusion every 3 weeks. The trial includes a double-blind, randomized, placebo-controlled design for the first sub-study. Future sub-studies will explore COM701 combined with other anti-cancer drugs. During the study, participants will visit the clinic every three weeks for treatment and monitoring. Health checks include physical exams, vital signs, ECGs, blood and urine tests, and pregnancy tests if applicable. Disease response will be assessed with CT or MRI scans and tumor marker tests using tumor tissue samples. The primary measure is progression-free survival, tracking time from randomization until disease progression or death, assessed up to two years.

Researchers are evaluating BMS-986506 in people with advanced Clear Cell Renal Cell Carcinoma (ccRCC), a type of kidney cancer. This Phase 1/1b open-label study aims to determine if BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC, especially those who have already received prior treatments including immunotherapy and targeted therapies. Participants receive specified doses of BMS-986506 on certain days as part of the treatment. The study includes two parts: part 1 involving participants who have had at least two prior treatment plans including immunotherapy and targeted therapy, and part 2 involving participants who have had at least one standard treatment including both a PD-1/L1 inhibitor and a VEGF-TKI. The treatment is given orally without altering the medication form. During the study, researchers monitor participants for adverse events, serious adverse events, dose-limiting toxicities, events leading to discontinuation, and deaths, using criteria up to about 2 years after the first dose. Participants are assessed for performance status and oxygen levels, and safety is carefully tracked to evaluate the effects of BMS-986506 over time.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMP1734, a PARP1 selective inhibitor, in participants with advanced solid tumors. The study aims to assess preliminary efficacy and find the best dosing for future clinical development. This first-in-human trial is conducted in two parts, focusing on patients with recurrent, advanced, or metastatic solid tumors including metastatic prostate, ovarian, breast, and other solid tumors with specific genetic mutations. The trial has two main phases: Part 1 involves dose escalation of IMP1734 as a monotherapy to determine the maximum tolerated or achievable dose in solid tumors. Part 2 focuses on dose optimization to select the optimal dose for further clinical use. Treatment involves oral administration of IMP1734, with dose escalation steps and combination dose escalations in specific cancers like metastatic prostate cancer, ovarian, and breast cancer. Participants will undergo regular assessments to monitor safety through adverse event tracking, pharmacokinetic and pharmacodynamic evaluations, and tumor response measurements using criteria like RECIST1.1, CA125, or PSA. The study includes monitoring for serious adverse events from consent until 30 plus 7 days after the last dose. Dose-limiting toxicities are assessed during the first treatment cycle. Participants are expected to have adequate organ function, a life expectancy of at least 12 weeks, and will be followed closely during the trial to evaluate the drug's safety and potential anti-tumor activity.