Obninsk

Researchers are evaluating the pharmacokinetics, safety, and immune response of two drugs, RPH-030 and Vectibix4, in patients with metastatic colorectal cancer mCRC who have wild-type RAS genes. The study aims to show that these treatments are equivalent in how the body processes them and to compare their safety and immune effects. Additionally, the study will explore how effective these drugs are when used as first-line therapy combined with FOLFIRI chemotherapy. Participants will receive either RPH-030 or Vectibix4 intravenously at 6 mgkg every two weeks along with FOLFIRI chemotherapy, which includes irinotecan, calcium folinate, and fluorouracil. Treatment starts with FOLFIRI for 8 cycles, then continues with a modified de Gramont regimen. The study includes several periods a screening phase, a main period lasting up to 6 months, a continued therapy period up to 1 year where all patients receive RPH-030, and a treatment extension period lasting up to 2 years for patients with stable disease or response. Follow-up visits occur after treatment ends to monitor survival and disease status. Participants will undergo regular tumor assessments approximately every 6 to 8 weeks, hospitalizations for drug administration at specific visits, and blood sampling for pharmacokinetic and safety evaluations. Researchers will monitor drug levels over time, adverse events, immune reactions, and tumor responses. Follow-up includes imaging or phone calls to track overall survival and disease progression. The total study participation can last up to about 2 years with additional follow-up to ensure thorough monitoring of outcomes and safety.

This research aims to gather long-term safety and effectiveness information for people treated with ibrutinib, a medicine taken by mouth that blocks a specific enzyme called brutons tyrosine kinase. The study focuses on participants who previously took part in ibrutinib studies that have finished and are still receiving ibrutinib treatment, continuing to benefit from it. It is an open-label study, meaning both participants and researchers know the treatment being given. Participants will continue taking ibrutinib capsules daily at the dose they were given in their prior study until the doctor decides the treatment is no longer helpful due to disease progression or side effects, the participant chooses to stop, other treatment options become available, or the study ends. Safety will be monitored throughout, and effectiveness data may be combined with previous study results. No formal testing of hypotheses is planned in this extension. During the study, participants will be regularly monitored for safety and disease status. The main outcome is the number of participants experiencing side effects within 30 days after the last ibrutinib dose or before starting another cancer therapy. Participants may continue treatment until alternative access to ibrutinib is arranged or the study ends, which is planned for December 2029. Researchers will collect ongoing data to understand the long-term effects of ibrutinib treatment.

Researchers are studying aggressive high-volume metastatic hormone-sensitive prostate cancer mHSPC in male patients in the Russian Federation. This observational study focuses on treatment patterns and the evaluation of homologous recombination repair mutations HRRm in circulating tumor DNA ctDNA. The study aims to better understand demographic and clinical characteristics along with how patients with different HRR gene statuses are treated. The study enrolls about 400 male patients with high-aggressive Gleason 8-10 and high-volume mHSPC who have known tumor HRRm status from routine tumor samples. No additional procedures beyond routine clinical care are performed. Data are collected during two visits a baseline visit where medical history and treatment approaches since diagnosis are recorded, and a final visit at disease progression or after about 12 months to gather follow-up treatment and progression information. Blood samples for ctDNA and HRRm testing are collected from routine blood draws and analyzed centrally. Participants contribute data through medical record reviews and, if needed, patient interviews. Researchers collect information on treatments received, disease progression, lab tests, and mutation presence. The study evaluates various outcomes including treatment proportions, therapy durations, progression times, and mutation rates over 36 months. Data are entered into electronic forms, and follow-up may occur by phone if in-person visits are not possible. The total study duration is about 38 months or until all data are collected.

Researchers are conducting a national, multi-center, prospective study to collect real-world data on patients in the Russian Federation with advanced and aggressive endometrial cancer, specifically stage III-IV disease. The study focuses on molecular profiling markers such as POLE mutations, dMMRpMMR, p53 abnormalities, HER2 expression, and PD-L1 status, alongside demographic and clinical characteristics. It aims to understand first-line postoperative treatment approaches in these patients. The study involves no additional procedures beyond routine clinical practice. Patients provide archival tumor tissue samples obtained from biopsy or post-operative formalin-fixed paraffin-embedded FFPE blocks for molecular testing. Testing uses immunohistochemistry IHC for certain markers and next-generation sequencing NGS or polymerase chain reaction PCR for POLE mutations. Data will be collected at two visits a baseline visit to gather clinical and demographic information and tissue testing results, and a final visit 6 months later or at disease progression to collect follow-up treatment and progression data. Participants data and outcomes will be recorded in an electronic case report form. The study measures include rates of positive molecular markers and various clinical and treatment-related outcomes over 24 to 33 months. Approximately 500 patients will be enrolled across about 30 sites. The overall study duration is about 27 months or until data collection for all patients is complete.

Researchers are evaluating the efficacy and safety of BCD-248 as a treatment for patients with relapsed or refractory multiple myeloma, a condition where the disease has returned or is resistant to previous therapies. This open-label phase 2 clinical study aims to assess the overall response rate and other important outcomes in this patient population. The study is sponsored by Biocad and focuses on patients who have received multiple prior treatments including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 therapy. Participants will receive BCD-248 administered subcutaneously. The study monitors various outcomes including overall response rate up to 24 weeks and progression-free survival up to 104 weeks, among others, over a total duration extending to about 3.7 years for some measures. Pharmacokinetic parameters like Cmax, Cmin, AUC0-t, and Ctrough will be tracked shortly after administration and up to 6 months. Additional assessments include measurement of soluble BCMA levels and the presence of binding and neutralizing antibodies. During the study, participants will undergo regular evaluations including disease assessments based on International Myeloma Working Group criteria, safety monitoring for adverse events, and laboratory tests. Long-term follow-up will include evaluation of response duration, time to response and progression, and overall survival. The study started in December 2024 and is expected to continue until July 2028, providing extended observation for participant outcomes and safety.

Researchers are evaluating the effectiveness, safety, how the body processes, and immune response to BCD-236 combined with chemotherapy in women with relapsed or metastatic triple negative breast cancer TNBC who have received previous treatments. This is a Phase 2 study that compares BCD-236 plus chemotherapy versus chemotherapy alone in patients whose cancer has returned or progressed after earlier therapies. Participants will be randomly assigned to one of two groups one receiving BCD-236 by intravenous infusion plus chemotherapy chosen by the investigator, and the other receiving chemotherapy alone. Treatment continues until the cancer worsens, side effects become intolerable, or the study ends. During the study, participants will undergo regular assessments including tumor measurements and health evaluations to monitor response and side effects. The main outcome measured is the overall response rate at 24 weeks, with secondary outcomes including progression-free survival, overall survival, disease control rate, time to response, and duration of response assessed at various times up to 102 weeks. Participants will be monitored closely throughout their treatment and follow-up periods.

Researchers are evaluating stereotactic ablative radiation therapy SABR for patients with metastatic cancer who have 6 to 10 metastatic sites in bones and internal organs. This study focuses on patients with persistent or progressive metastatic tumors who continue their current drug therapy. The goal is to assess the safety and effectiveness of radiation treatment for these patients, as current radiation approaches have shown benefits for those with fewer metastases, but less is known for patients with more than five metastatic sites. The study uses stereotactic radiation therapy applied to each metastatic site in ablative doses. Treatment planning involves advanced imaging techniques like three- or four-dimensional computed tomography, fixation devices, and contouring of targets and organs at risk. Various radiation doses and schedules are tailored depending on tumor location, such as lungs, brain, liver, bones, and adrenal glands. Radiation sessions use a linear accelerator with real-time visual control and special breathing techniques when needed. The radiation course lasts between 1 to 8 working days following up to 3 days of preparation. Participants undergo a thorough pre-treatment examination, followed by detailed radiation therapy. After treatment, they are monitored at 3, 6, 9, and 12 months, then every 6 months for up to 5 years. Researchers collect and analyze data on treatment safety and effectiveness, including progression-free survival, local control, overall survival, and timing of changes in chemotherapy. Participants continue their regular cancer care and provide informed consent to join the study.

Researchers are studying if preoperative proton therapy PPT is tolerable and safe for adults with high-grade brain gliomas, including glioblastomas. These aggressive brain tumors have poor survival rates and limited treatment advances. The trial aims to determine the highest safe dose of PPT and its effects on surgery, clinical outcomes, and safety. Participants receive preoperative proton stereotactic radiotherapy targeting the tumor with increasing dose levels in small groups of patients. This is followed by surgical removal of the tumors contrast-enhancing part using advanced imaging and monitoring techniques. After surgery, MRI scans assess tumor removal, and a follow-up evaluation occurs 3-4 weeks later. Then, standard chemoradiotherapy with proton beams and temozolomide chemotherapy begins 4-6 weeks after surgery, followed by maintenance chemotherapy for up to 12 cycles or until disease progression. During the study, participants undergo clinical, radiological, and morphological assessments to evaluate treatment effects and safety. Follow-up exams happen monthly after chemoradiotherapy and then quarterly during the first year. The main outcome measured is radiation-induced toxicity over 12 months, along with clinical effects, maximal irradiation dose, and postoperative safety. The total participation period extends up to several years, including standard treatment and monitoring.

Researchers are evaluating stereotactic radiation therapy as a treatment for patients with oligometastatic cancer, which means having one to five metastatic tumors in bones or internal organs. The study aims to improve treatment effectiveness compared to the usual palliative care, which includes chemotherapy and less intense radiation therapy. This trial includes adult patients with various tumor locations who have completed a current chemotherapy line and have specific cancer stages T1-4, N0-3, M0-1. Participants are randomly assigned to receive either stereotactic ablative radiation therapy targeting each metastatic site or standard palliative radiation therapy or chemotherapy alone. The stereotactic radiation uses detailed imaging and planning to deliver focused, high-dose radiation over several sessions depending on tumor location and size. The study involves pre-treatment imaging and planning, radiation treatment sessions lasting from one to eight working days, and follow-up visits scheduled at 3, 6, 9, 12, 18, and 24 months. During the study, participants undergo comprehensive examinations before treatment, imaging scans, and radiation sessions with precise targeting methods. Researchers will monitor progression-free survival and time before changing chemotherapy lines as primary outcomes, along with side effects, overall survival, metastasis control, and quality of life assessments. Data collection and analysis will continue through follow-up visits extending up to two years after treatment completion.

Researchers are conducting a multicenter observational study in Russia to examine treatment methods and the prevalence of HER2-positive status in various stages of bladder cancer, including PD-L1-positive status in metastatic bladder cancer. The study aims to collect and analyze epidemiologic data without changing routine clinical care. Approximately 600 adult patients with urothelial bladder cancer will be enrolled from about 30 specialized oncology centers, divided into three equal groups based on cancer stage high-risk non-muscle-invasive, muscle-invasive, and metastatic bladder cancer. Participants will be observed during a single routine clinical visit where demographic, clinical, and treatment information will be recorded. Tumor tissue samples collected during standard care will be sent to a central laboratory for testing. No interventions or additional diagnostic procedures will be performed as part of the study. Enrollment is expected to continue for about 18 months or until 600 patients have been included and all necessary data and test results are collected. Participants provide their medical data, including treatment history, during their routine visits, and tumor samples are analyzed centrally. Researchers will measure various outcomes related to treatment patterns and biomarker prevalence over a 24-month period. The study focuses on proportions of patients receiving different treatments, relapse rates, progression timelines, and biomarker status. There is no follow-up planned beyond the single visit, and safety monitoring is not part of this observational study.