Anzahl der Treffer: 6 Studien
| Kurztitel | CA052-002 |
| EudraCT-Nr | 2021-001188-26 |
| Titel | Eine Phase-1/2-Studie mit BMS-986340 als Monotherapie und in Kombination mit Nivolumab oder Docetaxel bei Teilnehmern mit fortgeschrittenen soliden TumorenEine Studie zu BMS-986340 als Monotherapie und in Kombination mit Nivolumab oder Docetaxel bei Teilnehmern mit fortgeschrittenen soliden Tumoren |
| Studiendesign | Interventionsstudie , nicht randomisiert , Phase I/II |
| Strategie | 2nd line , 3rd line |
| Einschlusskriterien |
1) Signed Written Informed Consent a) Participants or their legally acceptable representatives (see Appendix 2), must have signed and dated an (IRB)/Independent Ethics Committee (IEC)–approved written ICF in accordance with regulatory, local, and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal patient care. b) Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study. 2) Type of Participant and Target Disease Characteristics a) A fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarkeranalysis. Participants must have a tumor that can be biopsied at an acceptable clinical risk as judged by the investigator to be eligible. An unsuccessful fresh tumor biopsy at screening will not exclude participants from receiving study treatment. For participants in Parts 2A and 2B, a repeat biopsy at screening or on-treatment from the same or an alternative site will be required if clinically feasible (at the discretion of the investigator), and the initial attempt was unsuccessful in obtaining adequate tissue for biomarker analysis. Only 1 repeat attempt may be performed at each time point, if clinically feasible. An unsuccessful fresh tumor biopsy at screening (whether or not repeat is clinically feasible) will not exclude participants from receiving study treatment. Please refer to the laboratory manual for additionaldetails. The biopsy must be a core biopsy, an excisional biopsy, or a surgical specimen. b) Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Appendix 5) and, in addition, have at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable. c) Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1 (Appendix 6). d) Participants must have experienced radiographically documented progressive disease on or after the most recent therapy. e) Study participants will be expected to have received standard-of-care therapies (except forPart 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available PD-(L)1 inhibitor known to be effective in the tumor type for which they are being evaluated. f) Participants must have advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant to existing therapy(ies) known to provide clinical benefit for the condition of the participant. Eligible tumor types for each Part are listed below: - Parts 1A and 1B: NSCLC, SCCHN, MSS-CRC, gastric/GEJ adenocarcinoma, cervical cancer (SCC or adenocarcinoma), RCC, UC, PDAC, melanoma, OC, orTNBC. - Parts2A and 2B: NSCLC, SCCHN, gastric/GEJadenocarcinoma, orup to 3 additional tumor types from Parts 1A and 1B may be considered based on emerging data. - Part 1C: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, OC, or TNBC. g) Participants with NSCLC: i) Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or recurrent disease. ii) Participants must have recurrent or progressive disease during or after platinum doublet-based chemotherapy for advanced or metastatic disease, OR must have recurrent or progressive disease within 6 months after completing platinum-based chemotherapy for local disease. iii) Participants must have received and progressed on or after anti-PD-(L)1 therapy, if available. iv) Status for actionable mutations (eg, epidermal growth factor [EGFR], anaplastic lymphoma kinase [ALK], ROS oncogene 1 [ROS1], rearranged during transfection [RET], etc.) must be known (when testing is available as per country/region standard of care practices); participants with actionable mutations must have received and progressed on, have been intolerant to, or not be a candidate for standard tyrosine kinase inhibitors (as available per country/region standard-of-care practices) h) Participants with SCCHN: i) Participants must have histologically confirmed, recurrent, or metastatic SCCHN (oral cavity, pharynx, larynx), andnot amenable to local therapy with curative intent. Any other cancers of the head and neck, including nasopharyngeal cancer, salivary gland, and neuroendocrine tumors, are excluded. ii) Participants must have progressed on or after, or been intolerant to a platinum containing regimen. iii) Prior curative radiation therapy must have been completed at least 4 weeks prior to first study drug administration. Prior focal palliative radiotherapy must have been completed at least 2 weeks before study drug administration. iv) Historical human papillomavirus (HPV) status for oropharyngeal cancers must be documented. HPV status should have been determined using p16 immunohistochemistry (IHC) or HPV polymerase chain reaction (PCR). v) Participants must have received and progressed on or after anti-PD-(L)1 therapy, if available. i) Participants with MSS-CRC: i) Participants must have received and then progressed on or after, or have been intolerant or refractory to at least 1 standard systemic therapy for metastatic and/or unresectable disease (or have progressed within 6 months of adjuvant therapy). (1) Prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan given as a single regimen or over multiple regimens is required. (2) Prior treatment with an anti-angiogenic therapy (eg, bevacizumab) is required. ii) Participants must have known MSI status or mismatch repair status. (1) If the MSI molecular test and MMR IHC test results are both available, then both MSS and MMR proficiency will be required for study entry. Patients with MSIhigh or MSI-low or MMR deficiency will not be eligible. iii) KRAS, NRAS and BRAF status, if known, should be documented. (1) If RAS wild-type, prior treatment with an anti-EGFR therapy (eg, cetuximab or panitumumab) is required. j) Participants with gastric/GEJ adenocarcinoma: i) Participants must have received and then progressed, relapsed, or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (or have progressed within 6 months of adjuvant therapy). ii) Participants with known human epidermal growth factor receptor 2 (HER2)-positive gastric cancer must have received prior treatment with a HER2 inhibitor (eg, trastuzumab). iii) If available, MSI status or mismatch repair status should be documented. k) Participants with cervical cancer (SCC or adenocarcinoma): i) Must have received and then progressed, relapsed, or been intolerant to platinum-based chemotherapy with or without bevacizumab in the advanced or metastatic setting. ii) If available, MSI status or mismatch repair status should be documented. l) Participants with renal cell carcinoma (RCC): i) Participants must have histologically confirmed, recurrent, or metastatic RCC, and not amenable to local therapy with curative intent. ii) Participant had progression or refractory disease during or after at least 2 lines of therapy, including a prior anti-PD-(L)1 therapy. m) Participants with urothelial carcinoma (UC): i) Participants must have histologically confirmed, recurrent, or metastatic UC, and not amenable to local therapy with curative intent. ii) Must have received and then progressed, relapsed, been intolerant to, or ineligible for at least 1 platinum-containing chemotherapy regimen OR be within 12 months of perioperative (neo-adjuvant or adjuvant) treatment with a platinum agent in the setting of cystectomy for localized muscle-invasive UC. iii) Must be resistant or refractory to anti-PD-(L)1-based immunotherapy. n) Participants with pancreatic adenocarcinomas (PDAC): i) Participants must have histologically confirmed, recurrent, unresectable or metastatic PDAC, and not amenable to local therapy with curative intent. ii) Participants must have received and progressed or been intolerant to (or not be a candidate for) at least 1 prior standard chemotherapy. o) Participants with melanoma: i) Participants must have cutaneous, acral, mucosal, or unknown primary melanoma.Participants with uveal/ocular melanoma are not eligible. ii) Participants must have histologically confirmed, recurrent, or metastatic melanoma, and not amenable to local therapy with curative intent. iii) Participants must have received and then progressed, relapsed, or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting, including a prior anti-PD-(L)1 therapy, if available. iv) Participants must have known BRAF status. If indicated, participants must have been offered mutation-directed therapy that has proven survival benefit. p) Participants with ovarian carcinomas (OC): i) Participants must have histologically or cytologically confirmed, recurrent, or metastatic epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube cancer, and not amenable to local therapy with curative intent. ii) Participants must have received and then progressed, relapsed, or been intolerant to platinum-based chemotherapy, OR must have recurrent or progressive disease within 6 months after completing platinum-based chemotherapy. iii) Participants with BRCA1/2 mutation must have received treatment with a PARP inhibitor, if available. q) Participants with triple negative breast cancer (TNBC): i) Participants must have histologically confirmed, recurrent, or metastatic TNBC, and not amenable to local therapy with curative intent. ii) Must have progression or refractory disease during or after at least 1 chemotherapy regimen for the treatment of locally advanced or metastatic disease. iii) Participants with BRCA1/2 mutation must have received treatment with a platinum-containing regimen (if eligible) and a PARP inhibitor, if available. iv) If PD-L1 positive (defined as combined positive score = 10), prior treatment with immune checkpoint inhibitor is required. 3) Age and Reproductive Status Investigators shall counsel women of childbearing potential (WOCBP) on the importance of pregnancy prevention, the implications of an unexpected pregnancy, and the potential of fetal toxicity occurring due to transmission of study drug to a developing fetus. - The investigator shall evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment. - Local laws and regulations may require the use of alternative and/or additional contraception methods. a) Female Participants i) Females, ages = 18 or local age of majority at the time of consent. ii) Women who are not of childbearing potential are exempt from contraceptive requirements. iii) Women participants must have documented proof that they are not of childbearing potential. iv) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior to the start of study treatment. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24-hour window. v) Additional requirements for pregnancy testing during and after study treatment are located in Section 2, Schedule of Activities. vi) The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. vii) WOCBP must agree to follow instructions for method(s) of contraception defined in Appendix 4 and as described below and included in the ICF. viii) WOCBP are permitted to use hormonal contraception methods (as described in Appendix 4). ix) A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: (1) Is not a WOCBP OR (2) Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, as described in Appendix 4 during the treatment period and for at least 3 months after the last treatment with BMS-986340 monotherapy or for at least 6 months after the last dose of study treatment if receiving BMS 986340 in combination with nivolumab or with docetaxel and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period. b) Male Participants i) Males, age = 18 years or local age of majority at the time of consent. ii) Male participants receiving BMS-986340 monotherapy and BMS-986340 in combination with nivolumab should maintain their usual practice with regard to contraception (if any); however, no specific contraceptive measures are required. iii) Male participants receiving BMS-986340 in combination with docetaxel who are sexually active with a WOCBP must agree to follow instructions for method(s) of contraception as defined in Appendix 4 and as described below. (1) Male participants will be required to always use latex or other synthetic condom during any sexual activity (eg, vaginal, anal, oral) with WOCBP, even if the participants have undergone a successful vasectomy or if their partner is already pregnant or breastfeeding. Males should continue to use a condom during the intervention period and for at least 3 months after the last dose of study intervention. (2) Female partners of males participating in the study should be advised to use highly effective methods of contraception during the intervention period and for at least 3 months after the last dose of study intervention in the male participant. (3) Male participants must refrain from donating sperm during the intervention period and for at least 3 months after the last dose of study intervention. (4) Breastfeeding partners should be advised to consult their health care providers about using appropriate highly effective contraception during the time participant is required to use condoms. |
| Ausschlusskriterien |
1) Medical Conditions a) Women who are pregnant or breastfeeding. 2) Medical History and Concurrent Diseases a) Primary central nervous system (CNS) malignancy. b) Untreated CNS metastases. Participants are eligible if CNS metastases have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment). In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of = 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to the first dose of study treatment. Imaging performed within 28 days prior to the first dose of study treatment must document radiographic stability of CNS lesions and be performed after completion of any CNS-directed therapy c) Leptomeningeal metastases. d) Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before the first dose of study treatment and the participant has no evidence of disease). Participants with history of prior early-stage basal/squamous cell skin cancer or noninvasive or in situ cancers who have undergone definitive treatment at any time are also eligible. e) Participants with an active, known, or suspected autoimmune disease. Participants with type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. f) Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. g) Prior organ or tissue allograft. h) Toxicity (except for alopecia) related to prior anti-cancer therapy and/or surgery, unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible. i) Any major surgery within 4 weeks of study drug administration. Participants must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study treatment. j) Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following: i) Myocardial infarction or stroke/transient ischemic attack within the past 6 months. ii) Uncontrolled angina within the past 3 months. iii) Any history of clinically significant arrhythmias (such as ventricular tachycardia,ventricular fibrillation, or torsades de pointes). iv) History of other clinically significant heart disease (eg, cardiomyopathy, congestiveheart failure with New York Heart Association functional classification III to IV pericarditis or significant pericardial effusion). v) Cardiovascular disease-related requirement for daily supplemental oxygen therapy. vi) QT interval corrected for heart rate using Fridericia’s formula (QTcF) prolongation> 480 msec, except for right bundle branch block. vii) History of myocarditis, regardless of etiology. k) History of or with active interstitial lung disease or pulmonary fibrosis. l) Evidence of active infection that requires systemic antibacterial, antiviral, or antifungal therapy = 7 days prior to the first dose of study treatment (except for viral infections that are presumed to be associated with the underlying tumor type required for study entry). m) Known human immunodeficiency virus (HIV) positive with an acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within the last year, or a current CD4 count <350 cells/µL. Participants with HIV are eligible if: i)They have received antiretroviral therapy for at least 4 weeks prior to the first dose of study treatment, as clinically indicated, while enrolled on study. ii) They continue on antiretroviral therapy as clinically indicated while enrolled on study. iii) CD4 counts and viral load are monitored per standard of care by a local health care provider. NOTE: Testing for HIV must be performed at sites where mandated locally. HIV positive participants must be excluded where mandated locally. n) Participants with serious or uncontrolled medical disorders. o) Receipt of packed red blood cells or platelet transfusion within 2 weeks of the first dose of study treatment. p) Any significant acute or chronic medical illness which would interfere with study treatment or follow-up. q) Any known or underlying medical or psychiatric condition and/or social reason that, in the opinion of the Investigator or Sponsor, could make the administration of studytreatment hazardous to the participants or could adversely affect the ability of the participant to comply with or tolerate the study. r) Any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. s) Previous SARS-CoV-2 infection within 10 days for mild or asymptomatic infections or 20 days for severe/critical illness prior to Cycle 1 Day 1. i) Acute symptoms must have resolved, and, based on investigator assessment in consultation with the Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving study treatment. 3) Prior/Concomitant Therapy a) Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and prior to the first administration of study drug. b) Non-cytotoxic agents, unless at least 4 weeks or 5 half-lives (whichever is shorter) have elapsed from the last dose of prior anti-cancer therapy and prior to the first administration of study drug. If 5 half-lives is shorter than 4 weeks, agreement with the Sponsor/Medical Monitor (or designee) is mandatory. c) Prior immune therapy treatments, unless at least 4 weeks or 5 half-lives (whichever is shorter) have elapsed from the last dose of immune therapy and initiation of study therapy. See Section 6.1 for additional requirements for prior immunotherapy treatments. d) Treatment with any live / attenuated vaccine within 30 days of first study treatment. e) Previous SARS-CoV-2 vaccine within 7 days of Cycle 1 Day 1. For vaccines requiring more than 1 dose, the full series (eg, both doses of a 2-dose series) should be completed prior to Cycle 1 Day 1, when feasible, and when a delay in Cycle 1 Day 1 would not put the study participant at risk. f) Has participated in a study of an investigational agent and has received study therapy or has used an investigational device within 28 days or 5 half-lives (whichever is shorter) of administration of BMS-986340. g) Treatment with complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks prior to first study treatment. Refer to Section 7.7.1 for prohibited therapies. h) Prior radiation therapy within 2 weeks prior to first study treatment. Participants must have recovered (ie, Grade = 1 or at baseline) from radiation-related toxicities prior to first study treatment. i) Prior therapy with an anti-CCR8 antibody. j) For Part 1C only: Participants must not have been previously treated with docetaxel in the unresectable or metastatic setting. 4) Physical and Laboratory Test Findings a) White blood cells (WBC) < 2000/µL. b) Neutrophils < 1500/µL (stable off any growth factor within 4 weeks of first study treatment administration). c) Platelets < 100 x 10^3/µL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration). d) Hemoglobin < 9.0 g/dL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration). e) Serum creatinine > 1.5 x ULN, unless creatinine clearance = 40 mL/min (measured or calculated using the Cockroft-Gault formula). f) Aspartate aminotransferase (AST)/alanine aminotransferase (ALT): > 3.0 x ULN. For participants in Part 1C receiving docetaxel: AST and/or ALT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN. g) Total bilirubin > 1.5 x ULN (except participants with Gilbert’s syndrome, who must have a total bilirubin level of < 3.0 x ULN). For participants in Part 1C receiving docetaxel: total bilirubin > 1 x ULN. h) Any positive test result for hepatitis B virus (HBV) indicating presence of virus; eg, hepatitis B surface antigen (HBsAg, Australia antigen) positive. i) Any positive test result for hepatitis C virus (HCV) indicating presence of active viral replication (detectable HCV-RNA). Note: Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll 5) Allergies and Adverse Drug Reaction a) History of allergy, hypersensitivity, or serious adverse reaction to monoclonal antibodies or related compounds. b) History of life-threatening toxicity related to prior immune therapy (eg, anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg, hypothyroidism). c) History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) except for history of infusion reaction to paclitaxel or oxaliplatin. d) History of allergy or hypersensitivity to study drug components. 6) Other Exclusion Criteria a) Prisoners or participants who are involuntarily incarcerated. (Note: Under specific circumstances and only in countries where local regulations permit, a person who has been imprisoned may be included as a participant. Strict conditions apply and BMS approval is required.) b) Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. Eligibility criteria for this study have been carefully considered to ensure the safety of the study participants and that the results of the study can be used. It is imperative that participants fully meet all eligibility criteria. |
| Weitere Info | ClinicalTrials.gov EU Clinical Trials Register ICH GCP NETWORK |
| Ansprechpartner | Email: ectu.cooperation@uniklinik-ulm.de , Tel. 0731 500 56066 |
| Klinik | ECTU (Early Clinical Trials Unit) |
| Kurztitel | DISCUSS Pilot |
| Titel | Transabdominale Thoraxdrainagen zur Reduktion postoperativer Schmerzen bei der minimalinvasiven Ösophagektomie – DISCUSS Pilot |
| Studiendesign | Interventionsstudie , nicht randomisiert |
| Einschlusskriterien |
- Age >= 18 years - Indication for elective robotic assistend minimal invasive esophagectomy - ASA I-III - Verbal and written consent - Ability to understand the content and scope of the course and to be able to implement it. |
| Ausschlusskriterien |
- Emergency Operation - Participation in another study that interferes with the outcome of the study - > ASA III - ECOG > II - chronic pain syndromes that require routine analgesic therapy - Participation in an interventional study |
| Weitere Info | Deutsches Register Klinischer Studien - DRKS |
| Ansprechpartner | PD Dr. Benjamin-Moritz Müssle |
| Klinik | Chirurgie I |
| Kurztitel | NeoART |
| EudraCT-Nr | 2024-518841-12-00 |
| Titel | Eine Phase Ib/II-Plattformstudie zur Bewertung der Sicherheit und Wirksamkeit von neoadjuvanten Trastuzumab-Deruxtean-haltigen Kombinationstherapien bei HER2+, resektablem Adenokarzinom des Magens und des gastroösophagealen ÜbergangsPlattformstudie zur Bewertung der Behandlung neoadjuvanter Trastuzumab-Deruxtecan-haltiger Kombinationstherapien für HER2+, resektables ösophagogastrisches Adenokarzinom - NeoART |
| Studiendesign | Interventionsstudie , nicht randomisiert , Phase I/II |
| Strategie | 1st line , neoadjuvant |
| Einschlusskriterien |
The following criteria must be met to be eligible for the study: 1. Patient* has given written informed consent. 2. Patient is = 18 years of age at time of signing the written informed consent. 3. Patient has histologically proven locally advanced (cT2-4, any cN, M0 OR any cT, cN+, M0 stage) gastric, esophagogastric junction or lower esophageal adenocarcinoma that: a. Is considered technically resectable b. Does not involve distant sites of the peritoneal cavity - confirmed by diagnostic laparoscopy for all patients with tumors located in the stomach and those with type 2 and 3 GEJ adenocarcinomas according to guideline recommendations [Lordick et al. 2022]. - Type 1 GEJ and lower esophageal tumors can be enrolled without diagnostic laparoscopy (which is in line with guidelines and the current routine practice in Germany) 4. Patient has a HER2 positive tumor (by local testing) defined by HER2 IHC 3+ or IHC 2+ plus ISH positive with a HER2:CEP17 ratio of = 2 according to classically used criteria for defining HER2 positivity [Lordick et al. 2017]. 5. Patient has a ECOG performance status 0 or 1. 6. Patient has adequate blood count, liver-enzymes, and renal function: 1. ANC > 1,500 cells/µL without the use of hematopoietic growth factors 2. Platelet count = 100 x 10^9/L (>100,000 per mm^3)** 3. Hemoglobin = 9 g/dL**, 4. Serum total bilirubin = 1.5 x institutional upper normal limit (ULN) 5. AST (SGOT)/ALT (SGPT) = 2.5 x institutional ULN 6. Patients not receiving therapeutic anticoagulation must have an INR = 1.5 ULN and aPTT = 1.5 ULN. The use of full dose anticoagulants is allowed as long as the INR or PTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least three weeks at the time of inclusion 7. Serum Creatinine = 1.5 x ULN and a calculated creatinine clearance rate = 50 mL/min 7. Female patients defined as women of childbearing potential (WOCBP) must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for 6 months after last dose of chemotherapy or 7 months after the last dose of T-DXd, whatever is later. 8. Male patients with WOCBP partners must agree to remain abstinent (refrain from heterosexual intercourse) or use barrier contraceptive during the treatment period as well as up to 4 months after last dose of T-DXd or up to 6 months after last dose of chemotherapy, whatever is later. Male patients must refrain from donating sperm during this same period * There are no data that indicate special gender distribution. Therefore, patients will be enrolled gender independently in this trial ** Transfusion (red blood cell or platelet) is not allowed within 14 days prior to the day on which bone marrow function is assessed, or at any time after this day and prior to treatment initiation |
| Ausschlusskriterien |
Patients who meet at least one of the following criteria are ineligible: 1. Patient received previous (radio)chemotherapy or HER2-targeted therapy for the same condition or within the past five years for any other cancerous condition. 2. Patient received prior partial or complete esophagogastric tumor resection. 3. Patient has known hypersensitivity to any component of the T-DXd formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein and/or any known contraindication (including hypersensitivity) to one of the study drugs. 4. Patient has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. 5. Patient has lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within three months of the study enrolment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.). 6. Patient received a prior complete pneumonectomy. 7. Patient has inadequate cardiac function (LVEF value < 50 %) as determined by echocardiography. 8. Patient has a known complete absence of dihydropyrimidine dehydrogenase (DPD) activity. 9. Patient received treatment with brivudine, sorivudine or their chemically related analogues within 28 days prior to stud enrollment. 10. Patient has pernicious anemia or other megaloblastic anemia due to vitamin B12 deficiency 11. Patient has peripheral sensitive neuropathy with functional deficits. 12. Patient has a medical history of myocardial infarction (MI) within 6 months before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any MI related symptoms should have a cardiologic consultation during screening to rule out MI. 13. Patient has a corrected QT interval (QTc) prolongation to > 470 ms (females) or > 450 ms (males) based on average of the screening triplicate12-lead ECG. 14. Patient has a history of malignancy other than EGA except for: a. Malignancy treated with curative intent and with no known active disease = 5 years before the first dose of study treatment and of low potential risk for recurrence. b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. c. Adequately treated carcinoma in situ without evidence of disease. 15. Patient has an uncontrolled infection requiring IV antibiotics, antivirals or antifungals within 14 days prior to enrolment. 16. Patient has active primary immunodeficiency, known uncontrolled active HIV infection or active hepatitis B or C (HBV/HCV) infection. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA. Subjects with past or resolved HBV infection are eligible only if they meet all of the following criteria: - HBsAg(-) (for > 6 months off anti-viral treatment) - Anti-HBc(+) (IgG or total Ig) - HBV DNA undetectable - Absence of cirrhosis or fibrosis on prior imaging or biopsy - Absence of HCV co-infection or history of HCV co-infection - Access to a local hepatitis B expert during and after the study 17. Patient has any autoimmune, connective tissue or inflammatory disorders (e.g., Rheumatoid arthritis, Sjogren's, sarcoidosis etc.) with a documented or suspected pulmonary involvement 18. Patient received live, attenuated vaccine within 30 days prior initiation of study drug 19. Patient has any other serious concomitant or medical condition that, in the opinion of the investigator, presents a high risk of complications to the patient or reduces the likelihood of clinical effect. 20. Patient participated in another interventional clinical study within 28 days prior to study enrollment or participation in a clinical study at the same time as this study, unless it is an observational/ noninterventional study or during the follow-up period of an interventional study. 21. Patient has taken an investigational drug within 28 days prior to initiation of study drug. 22. Female patients, who are pregnant or breast feeding or planning to become pregnant within or up to 7 months after the end of treatment. Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study treatment. |
| Weitere Info | ClinicalTrials.gov ICH GCP NETWORK |
| Ansprechpartner | Dr. med. Thomas Ettrich |
| Klinik | Innere Medizin I |
| Kurztitel | PRIME-DC (Online/Präsenz) |
| Titel | Tagesklinik zur integrativen Prähabilitation komplementär zur neoadjuvanten Tumortherapie in zwei Settings (Präsenz vs. Online) - PRIME-DC (Online/Präsenz) - Folgeprojekt der PRIME-DC |
| Studiendesign | Interventionsstudie , nicht randomisiert |
| Strategie | neoadjuvant |
| Einschlusskriterien |
1. Patients diagnosed with cancer 2. Patients planned to undergo or undergoing neoadjuvant treatment before planned curative resection 3. Adult patients (>= 18 years of age) 4. Written informed consent 5. Ability to understand character and individual consequences of the clinical trial Additional for the online program 6. Stable internet connection 7. Laptop of similar 8. Poultieces utensils and utensils for the other applications 9. Sports mat or similar |
| Ausschlusskriterien |
1. Participation in another interventional trial with interference on intervention and outcome of this trial 2. Immobility or inability to walk unaided 3. Expected lack of compliance |
| Weitere Info | Deutsches Register Klinischer Studien - DRKS |
| Ansprechpartner | Prof. Dr. med. Klaus Kramer |
| Klinik | Chirurgie I |
| Kurztitel | PRIMETIME |
| Titel | Patienten-Empowerment in der gastrointestinalen, onkologischen Chirurgie – eine randomisierte kontrollierte Studie zum Einsatz von digitalen perioperativen Informationsmaterialien zur Patientenedukation - PRIMETIME |
| Studiendesign | Interventionsstudie , randomisiert |
| Einschlusskriterien |
- Patientinnen und Patienten, die eine viszeralchirurgische Operation mit kurativer In-tention aufgrund eines primären oder sekundären Malignom erhalten - vorliegender Tumorboardbeschluss - Alter = 18 Jahre - Mündliche und schriftliche Einwilligungserklärung |
| Ausschlusskriterien |
- Schwangerschaft - ASA = 4 - Geistige Einschränkung, welche eine Erfassung von Wesen, Art und Umfang des For-schungsprojekt verhindert - Zu erwartende fehlende Wahrnehmung der Empfehlungen - Fehlende Einwilligungsfähigkeit - Teilnahme an einer anderen Studie, die das Studienergebnis beeinträchtigt |
| Weitere Info | Deutsches Register Klinischer Studien - DRKS |
| Ansprechpartner | Prof. Dr. med. Emrullah Birgin |
| Klinik | Chirurgie I |
| Kurztitel | TATRA |
| EudraCT-Nr | 2023-509970-43-01 |
| Titel | Tranexamsäure zur Reduktion des intra- und postoperativen Transfusionsbedarfs in der elektiven Visceralchirurgie: randomisiert-kontrollierte Studie - TATRA |
| Studiendesign | Phase IV , Interventionsstudie , randomisiert , doppelt , plazebokontrolliert |
| Ansprechpartner | PD Dr. med. Patrick Téoule |
| Klinik | Chirurgie I |
