국소 진행성 또는 전이성 비소세포폐암 환자를 대상으로 도세탁셀 화학요법 전 트릴라시클리브의 골수 보호 효과를 평가하는 시험입니다.

Trilaciclib: 240 mg/m2 as a 30-min iv. infusion, completed ≤4h prior to chemotherapy.

Docetaxel: 75mg/m2, iv. infusion for 1 hour on days 1 of each 21-day cycle, totaling 4 cycles of medication.

Trilaciclib combined with Docetaxel

The First Affiliated Hospital of Xiamen University

A supervised 12-week cycling-based aerobic exercise intervention performed twice per week.

Exercise

염증성 장질환 환자를 대상으로 GSK4528287의 안전성과 체내 작용을 살펴보는 초기 시험입니다.

Participants will be administered Dose 1 of GSK4528287.

GSK4528287

Participants will be administered Dose 2 of GSK4528287.

Participants will be administered Dose 3 of GSK4528287.

Participants will be administered Dose 4 of GSK4528287.

Participants will be administered Dose 5 of GSK4528287.

Participants will be administered Dose 6 of GSK4528287.

Placebo

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Centre

Michalis S Kostapanos

Participants will receive selexipag based on the body weight on Day 1 and will continue thereafter with twice daily dosing. Selexipag will be uptitrated during the first 12 weeks until the participants reaches the individual maximum tolerated dose (iMTD) or until a maximum dose corresponding to their baseline body-weight category is achieved. Uptitration is followed by a maintenance period after Week 12 until end of treatment (EOT), at the maximum tolerated dose.

Selexipag tablet will be administered orally.

Selexipag

Participants will receive matching placebo based on the body weight on Day 1 and will continue thereafter with twice daily dosing.

Matching placebo tablets will be administered orally.

식도암 환자를 대상으로, 면역치료와 화학요법을 병행해 생존율 향상과 안전성을 평가하는 임상시험입니다.

Patients receive induction therapy with sintilimab plus 3-weekly paclitaxel/carboplatin for 2 cycles, followed by concurrent chemoradiotherapy (weekly paclitaxel/carboplatin plus radiotherapy).

200mg, once every three weeks, administered before concurrent chemoradiotherapy.

Sintilimab

Three-weekly induction chemotherapy regimen: Paclitaxel (135 mg/m², d1) + Carboplatin (AUC=5, d1), administered every 21 days.

3-Weekly Paclitaxel plus Carboplatin (TC) Chemotherapy

Paclitaxel (50 mg/m², intravenous infusion on Day 1 of each week) combined with Carboplatin (AUC 2, intravenous infusion on Day 1 of each week), administered for 5 consecutive weeks as part of concurrent chemoradiotherapy.

Weekly TC Chemotherapy

Definitive radiotherapy administered at a total dose of 50.4 Gy in 28 daily fractions (1.8 Gy per fraction) over approximately 5.5 weeks, delivered concurrently with weekly chemotherapy.

Definitive Radiotherapy

Patients receive concurrent chemoradiotherapy (weekly paclitaxel/carboplatin with radiotherapy), followed by 2 cycles of consolidation chemotherapy (4-weekly paclitaxel/carboplatin).

Four-weekly consolidation chemotherapy regimen: Paclitaxel (175 mg/m², intravenous infusion on Day 1) combined with Carboplatin (AUC 5, intravenous infusion on Day 1), administered every 28 days for 2 cycles following concurrent chemoradiotherapy.

Four-Weekly TC Consolidation Chemotherapy

환자들은 신틸리맙과 3주 간격으로 파클리탁셀/카보플라틴을 2주기 투여하는 유도 요법을 받은 후, 동시 항암방사선 요법(매주 파클리탁셀/카보플라틴 투여 및 방사선 치료)을 받습니다.

신틸리맙

3주 간격 파클리탁셀+카보플라틴(TC) 화학요법

주간 TC 화학요법

확정적 방사선 치료

환자들은 동시 항암방사선 치료(주 1회 파클리탁셀/카보플라틴 투여 및 방사선 치료)를 받은 후, 2주기의 강화 항암화학요법(주 4회 파클리탁셀/카보플라틴 투여)을 받습니다.

4주 간격 TC 강화 항암화학요법

식도암에 대한 신틸리맙과 화학요법 유도 후 동시항암방사선요법 병용 치료와 동시항암방사선요법 단독 치료의 비교: 무작위 대조 3상 임상 연구

In patients with NCCN high or unfavorable intermediate risk prostate cancer - radical prostatectomy with limited lymph node dissection (incl. obturator + / - external iliac lymph nodes bilaterally). In patients with NCCN low or favorable intermediate risk prostate cancer - radical prostatectomy with no lymph nodes dissection bilaterally.

Radical prostatectomy with limited / no lymph node dissection

In patients with NCCN high or unfavorable intermediate risk prostate cancer - radical prostatectomy with extended lymph node dissection (incl. external iliac, obturator, internal iliac and common iliac nodes up to ureter bilaterally).

In patients with NCCN low or favorable intermediate risk prostate cancer - radical prostatectomy with limited lymph node dissection (incl. obturator + / - external iliac lymph nodes bilaterally).

Radical prostatectomy with extended / limited lymph node dissection

Alexander I Rolevich, Dr.

Maxim V Trunin

Corneal wavefront guided therapeutic PRK (50 µm) with Schwind AMARIS, followed by accelerated epi-off CXL. Intensity: 30 mW/cm² (pulsed 1 s on / 1 s off; 50% duty cycle). Total energy (fluence): 5.4 J/cm². Total time (elapsed): 6 minutes \[equivalent to 3 minutes "on" time\].

Used for corneal wavefront guided PRK therapeutic ablation (50 µm) or for PTK epithelial removal, according to arm assignment.

Schwind AMARIS excimer laser

Riboflavin-UVA crosslinking performed after epithelial removal (corneal wavefront guided PRK arm via PRK; comparator arm via PTK). Intensity: 30 mW/cm² (pulsed 1 s on / 1 s off; 50% duty cycle). Total energy (fluence): 5.4 J/cm². Total time (elapsed): 6 minutes \[equivalent to 3 minutes "on" time\].

Corneal collagen crosslinking epi-off accelerated

Epithelial removal by PTK using Schwind AMARIS, followed by accelerated epi-off CXL. Intensity: 30 mW/cm² (pulsed 1 s on / 1 s off; 50% duty cycle). Total energy (fluence): 5.4 J/cm². Total time (elapsed): 6 minutes \[equivalent to 3 minutes "on" time\].

Instituto de Oftalmología Fundación Conde de Valenciana

José Carlos JC Guerrero Acosta, MD

Participants received a single intravenous (IV) infusion of 40 international units per kilogram (IU/kg) rADAMTS13 manufactured in Orth, Austria (TAK-755 ORT), every 2 weeks (Q2W) for 6 months in Period 1 followed by standard of care (SoC) for 6 months in Period 2. Thereafter participants received rADAMTS13 manufactured in Singapore (TAK-755 SIN), dose IV infusion of 40 IU/kg Q2W for 6 months in Period 3. TAK-755 ORT could be replaced with TAK-755 SIN and vice versa depending on availability and other criteria.

Participants in prophylaxis cohort will receive IV infusions of 40 IU/kg TAK-755 ORT during Period 1 and Period 2 and switch to TAK-755 SIN during Period 3 for six months once in a week or twice in a week. In On-demand cohort participants will receive daily IV dose of TAK-755.

TAK-755

Participants will receive Investigator-recommended Standard of care (SoC).

Standard of care

Participants received SoC for 6 months in Period 1 followed by IV infusions of 40 IU/kg dose of TAK-755 ORT Q2W in Period 2 for the next 6 months. Thereafter participants received TAK-755 SIN dose IV infusions of 40 IU/kg Q2W for another 6 months in Period 3. TAK-755 ORT could be replaced with TAK-755 SIN and vice versa depending on availability and other criteria.

Participants experiencing an acute TTP event who met all other inclusion criteria and entered the study through the TAK-755 cohort of the Urgent Treatment Period received initial dose of IV infusion 40 IU/kg \[+/- 4 IU/kg\] TAK-755 ORT or TAK-755 SIN on Day 1 followed by a subsequent dose IV infusions of 20 IU/kg \[+/- 2 IU/kg\] TAK-755 ORT or TAK-755 SIN on Day 2 and an additional daily dose IV infusions of 15 IU/kg \[+/- 1.5 IU/kg\] TAK-755 on Day 3 until 2 days after the acute event was resolved. Upon resolution of the acute TTP event, participants had the option to either move to the prophylaxis cohort of the study or discontinue entirely.

Participants experiencing an acute TTP event who met all other inclusion criteria and entered the study through the SoC cohort of the Urgent Treatment Period received the investigator-recommended SoC and dosing regimen until the acute event was resolved. Upon resolution of the acute TTP event, participants had the option to either move to the prophylaxis cohort of the study or discontinue entirely.

Patients receiving the fecal microbiota transplantation (FMT) in 3 times after inclusion and randomisation

The colonoscopy for FMT will be planned as soon as possible and never more than 5 weeks after inclusion visit.

After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anesthesia.

The patient will then receive either FMT (frozen preparation of 50g of stools in 300ml of physio, see donor section for details) or sham transplantation (FMT vehicle) in the cecum.

Fecal Microbiota Transplantation (FMT)

Patients receiving the sham-transplantation in 3 times after inclusion and randomisation

The sham-transplantation will be planned as soon as possible and never more than 5 weeks after inclusion visit.

After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anesthesia.

The patient will then sham transplantation (FMT vehicle) in the cecum.

Sham-transplantation Placebo

VRd: subjects will receive VRd for induction and consolidation, followed by lenalidomide (R) maintenance until disease progression or unacceptable toxicity.

Bortezomib will be given at a dose of 1.3 mg/m2 SC twice a week (Days 1, 4, 8, and 11) in Cycles 1-6; four 28-day induction cycles (Cycles 1 to 4), and two 28-day consolidation cycles (Cycles 5-6). Subjects will not receive bortezomib after Cycle 6. On treatment days when both bortezomib and daratumumab are administered, bortezomib must be administered after the daratumumab administration.

Velcade

Lenalidomide will be administered PO at 25 mg on Days 1 to 21 in Cycles 1-6; four 28-day induction cycles and two 28-day consolidation cycles. Following consolidation, subjects will then start maintenance therapy, during which they will receive lenalidomide 10 mg daily PO on Days 1 to 28 (continuously) of each 28-day cycle until disease progression or unacceptable toxicity. After 3 cycles of maintenance therapy, if well tolerated, the lenalidomide dose may be increased to 15 mg daily, at the discretion of the investigator.

Lenalidomide

Dexamethasone will be administered PO at 40 mg daily on Days 1-4 and Days 9-12 of each 28-day cycle during induction and consolidation (Cycles 1-6). On daratumumab administration days, during induction/consolidation, dexamethasone may be administered intravenously 1 hour before the daratumumab administration. On days when daratumumab is not administered, dexamethasone is administered PO. Dexamethasone tablets are to be taken with or immediately after a meal or snack, preferably in the morning.

dexamethasone

D-VRd: Subjects will receive D-VRd for induction and consolidation followed by daratumumab and lenalidomide maintenance until disease progression or unacceptable toxicity. Minimal residual disease (MRD)-negative subjects in Arm B will stop therapy with daratumumab after sustained MRD negativity for 12 months and after a minimum of 24 months of maintenance therapy. These subjects will continue lenalidomide maintenance therapy until disease progression or unacceptable toxicity. After stopping daratumumab therapy, subjects with sustained MRD negativity should restart therapy with daratumumab if there is a recurrence of MRD or a confirmed loss of Complete Response (CR) without International Myeloma Working Group (IMWG)-defined disease progression. After reinitiating daratumumab, the subject will continue daratumumab and lenalidomide therapy until disease progression or unacceptable toxicity.

Daratumumab will be given at a dose of 1800 mg SC weekly in Cycles 1 and 2, then every 2 weeks in Cycles 3-6. In maintenance Cycles 7+, subjects will receive daratumumab once every 4 weeks until disease progression or unacceptable toxicity. MRD-negative subjects will stop daratumumab after sustained MRD negativity for 12 months \& after a min. of 24 months of maintenance. Daratumumab should be restarted at recurrence of MRD or confirmed loss of CR without disease progression.

Daratumumab

PD-1/PD-L1 항체와 백금 기반 화학요법 실패 후 재발성 또는 전이성 식도암 환자에게 BL-B01D1의 효과와 안전성을 평가하는 3상 시험입니다.

Participants receive BL-B01D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

BL-B01D1

Participants receive Irinotecan or paclitaxel or docetaxel in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Irinotecan

paclitaxel

docetaxel

참가자는 첫 번째 주기(3주) 동안 BL-B01D1을 정맥 주입으로 투여받습니다. 임상적 효과가 있는 참가자는 추가 주기 치료를 받을 수 있습니다. 투여는 질병 진행, 참을 수 없는 독성 발생 또는 기타 사유로 인해 중단됩니다.

참가자는 첫 번째 주기(3주)에 이리노테칸, 파클리탁셀 또는 도세탁셀을 투여받습니다. 임상적 효과가 있는 참가자는 추가 주기 치료를 받을 수 있습니다. 치료는 질병 진행, 참을 수 없는 독성 발생 또는 기타 사유로 인해 중단됩니다.

이리노테칸

파클리탁셀

도세탁셀

재발성 또는 전이성 식도 편평세포암 환자에서 BL-B01D1과 의사 선택 항암화학요법을 비교하는 연구

위암 환자를 대상으로 기존 항암제와 새로운 항체를 함께 사용해 치료 효과를 살펴보는 임상시험입니다.

TST001 + Pembrolizumab + Chemotherapy (FOLFOX6 or CapOx)

Placebo will be administered i.v. Q3W along with standard prescribing dose of pembrolizumab Q3W + standard prescribed regimens for FOLFOX6 or CapOx.

Pembrolizumab and either Capcecitabine + Oxaliplatin or Oxaliplatin+Leucovorin + 5-fluorouracil

Placebo + Pembrolizumab + Chemotherapy (FOLFOX6 or CapOx)

TST001 will be administered i.v. Q3W along with standard prescribing dose of pembrolizumab Q3W + standard prescribed regimens for FOLFOX6 or CapOx.

TST001 + 펨브롤리주맙 + 화학요법(FOLFOX6 또는 CapOx)

펨브롤리주맙과 캡세시타빈 + 옥살리플라틴 또는 옥살리플라틴 + 류코보린 + 5-플루오로우라실 병용 요법

위약 + 펨브롤리주맙 + 화학요법(FOLFOX6 또는 CapOx)

진행성 또는 전이성 위암/위식도접합부 선암의 1차 치료로서 오세미타맙(TST001), 펨브롤리주맙 및 화학요법 병용 요법

망막 질환을 가진 환자에게 주사한 치료제의 장기 안전성과 효과를 비교하는 시험입니다.

Participants previously treated with sub-retinal injection of BIIB111 in antecedent studies 273CH301 (NCT03496012) and 273CH203 (NCT03507686) will be enrolled. Participants previously treated with this same sub-retinal injection (rAAV2-REP1) in antecedent studies 20150371 (NCT02553135), Pro00028599 (NCT02077361), THOR-TUE-01 (NCT02671539), CHM09/01 (NCT01461213) and REGEN2015 (NCT02407678) will also be invited for enrollment. This is a follow-up study, investigational product was administered in the previous study.

Administered as specified in the treatment arm.

BIIB111

Participants previously treated with sub-retinal injection of BIIB112 in the antecedent study 274RP101 (NCT03116113) will be enrolled. This is a follow-up study, investigational product was administered in the previous study.

BIIB112

Untreated participants who served as controls in the antecedent study 273CH301 (NCT03496012), investigating treatment with BIIB111, will be enrolled. This is a follow-up study, participants will not be administered study medication nor receive a sham surgery.

선행 연구 273CH301(NCT03496012) 및 273CH203(NCT03507686)에서 BIIB111의 망막하 주사 치료를 받은 참가자가 등록될 예정입니다. 선행 연구 20150371(NCT02553135), Pro00028599(NCT02077361), THOR-TUE-01(NCT02671539), CHM09/01(NCT01461213) 및 REGEN2015(NCT02407678)에서 동일한 망막하 주사(rAAV2-REP1) 치료를 받은 참가자도 등록될 예정입니다. 본 연구는 후속 연구이며, 연구용 의약품은 이전 연구에서 투여되었습니다.

선행 연구 274RP101(NCT03116113)에서 BIIB112의 망막하 주사 치료를 받은 참가자가 등록될 예정입니다. 본 연구는 후속 연구이며, 연구용 의약품은 이전 연구에서 투여되었습니다.

BIIB111 치료를 조사하는 선행 연구 273CH301(NCT03496012)에서 대조군으로 참여했던 미치료 참여자가 등록될 예정입니다. 본 연구는 추적 연구이며, 참여자에게는 연구 약물이 투여되지 않으며, 가짜 수술도 시행되지 않습니다.

맥락막변성증 치료를 위한 BIIB111과 X연관성 색소성 망막염 치료를 위한 BIIB112의 장기 안전성 및 효능 추적 조사

Patients receive rituximab IV on day -1 of cycle 1, then on day 1 of cycles 2-6. Patients also receive venetoclax PO QD on days 1-14 and bortezomib IV or SC on day -1 of cycle 1, then on days 1, 8, and 15 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles for rituximab and up to 26 cycles for venetoclax and bortezomib in the absence of disease progression or unacceptable toxicity.

Bortezomib

Rituximab

Venetoclax

Rutgers, The State University of New Jersey

Metformin, started at 500 mg per day per os and titrated up to 2000 mg during 2 years (increase of 500 mg every two weeks)

Metformin

Placebo (coated tablet similar to metformin tablet titrated following the same schedule as in the experimental arm), started at 500 mg per day per os and titrated up to 2000 mg during 2 years (increase of 500 mg every two weeks)

Control group : Placebo (coated tablet similar to metformin tablet titrated following the same schedule as in the experimental arm) started at 500 mg per day per os and titrated up to 2000 mg during 2 years (increase of 500 mg every two weeks)

anaesthetic and steroid injection into the SIJ through US guidance

sacroiliac injection with local anaesthetic and corticosteroids

sacroiliac injection

Patients receiving efgartigimod PH20 subcutaneous (SC) treatment

Subcutaneous injection with efgartigimod PH20 SC

efgartigimod PH20 SC

treatment arm (fruquintinib+paclitaxel) : Fruquintinib once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle.

treatment arm(fruquintinib +paclitaxel)- subjects will receive Fruquintinib orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/㎡ at day 1,8,15 of 4-week cycle. Patients will receive a cycles of 4 weeks of study treatment or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.

fruquintinib +paclitaxel

control arm (placebo+paclitaxel): Fruquintinib placebo once daily, 3 weeks on/1week off combined with Paclitaxel 80mg/㎡ day1, 8, 15 of 4 weeks cycle.

control arm(fruquintinib placebo + paclitaxel)- subjects will receive Fruquintinib placebo orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/㎡ at day 1,8,15 of 4-week cycle. Patients will receive a cycles of 4 weeks of study treatment or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment criteria.

fruquintinib placebo + paclitaxel

baricitinib treatment

adalimumab at 40 mg every 2 weeks or etanercept 50 mg per week according to treatments history

anti-TNF therapy

40 mg every 2 weeks during 6 months only during Period A

Alexia HOURDILLE, MD

Anne LOHSE, MD

Luca SEMERANO, Prof

Christophe RICHEZ, Prof

Thomas BARNETCHE, PhD

Divi CORNEC, Prof

André BASCH, MD

Anne TOURNADRE, Prof

Emilie SHIPLEY, MD

Grégoire CORMIER, MD

Raphaele SEROR, Prof

Guillaume DIREZ, MD

Emmanuelle DERNIS, MD

Benjamin CASTAGNE, MD

Damien COYRAL, MD

Tristan PASCART, Prof

Thao PHAM, Prof

Damien ROCHE, MD

Jacques MOREL, Prof

Jacques MOREL, MOREL

Christian ROUX, Prof

Christian LORMEAU, MD

Cécile GAUJOUX-VIALA, Prof

Carine SAILLOT, MD

Philippe DIEUDE, Prof

Jérôme AVOUAC, MD

Bruno FAUTREL, Prof

Jéremie SELLAM, Prof

Vincent GERMAIN, MD

Cyrille CONFAVREUX, Prof

Omar AL TABAA, MD

Jean-Hugues SALMON, Prof

Hubert MAROTTE, Prof

Guillaume COIFFIER, MD

Jacques-Eric GOTTENBERG, Prof

Adeline RUYSSEN-WITRAND, Prof

Denis MULLEMAN, MD

Guillermo CARVALAL-ALEGRIA, MD

Damien LOEUILLE, Prof

Damien LOEUILLE, MD

Olivier BROCQ, MD

Participants with normal hepatic function (Serum bilirubin and Aspartate aminotransferase \[AST\] less than or equal to \[\<=\] Upper limit of normal \[ULN\]) will be administered with Belantamab mafodotin

Belantamab mafodotin will be administered

Belantamab mafodotin

Participants with moderate hepatic impairment (Serum bilirubin greater than \>1.5 - 3 times ULN and any AST) will be administered with Belantamab mafodotin

Participants with severe hepatic impairment (Serum bilirubin \>3 times ULN and any AST) will be administered with Belantamab mafodotin

도세탁셀과 병용된 트릴라시클리브

운동

GSK4528287, 위약

셀렉시파그, 플라시보

식도암에 대한 신틸리맙과 화학요법 유도 후 동시항암방사선요법 병용 치료와 동시항암방사선요법 단독 치료의 비교: 무작위 대조 3상 임상 연구

광범위/제한적 림프절 절제를 동반한 근치적 전립선 절제술, 제한적/림프절 절제 없음

슈윈드 아마리스 엑시머 레이저, 각막 콜라겐 교차결합 상피세포 제거 가속 시술

TAK-755, 표준 치료법

대변 미생물 이식(FMT), 가짜 이식(위약)

다라투무맙, 벨케이드, 레날리도마이드, 덱사메타손

재발성 또는 전이성 식도 편평세포암 환자에서 BL-B01D1과 의사 선택 항암화학요법을 비교하는 연구

진행성 또는 전이성 위암/위식도접합부 선암의 1차 치료로서 오세미타맙(TST001), 펨브롤리주맙 및 화학요법 병용 요법

맥락막변성증 치료를 위한 BIIB111과 X연관성 색소성 망막염 치료를 위한 BIIB112의 장기 안전성 및 효능 추적 조사

보르테조밉, 리툭시맙, 베네토클락스

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