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NCT ID: NCT03725059 Active, not recruiting - Breast Cancer Clinical Trials

Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)

Start date: December 27, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.

NCT ID: NCT03725007 Active, not recruiting - Clinical trials for Juvenile Idiopathic Arthritis (JIA)

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

SELECT-YOUTH
Start date: June 24, 2019
Phase: Phase 1
Study type: Interventional

This is a study to evaluate pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with polyarticular course juvenile idiopathic arthritis. This study consists of three parts: Part 1 is multiple-cohort study that consists of two sequential multiple dose groups. Participants benefiting from the study drug with no ongoing adverse events of special interest or serious adverse events will have option to enroll in Part 2. Part 2 is open-label, long term extension study to evaluate safety and tolerability. Part 3 is an additional safety cohort to evaluate long-term safety and tolerability.

NCT ID: NCT03709680 Active, not recruiting - Solid Tumors Clinical Trials

Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors

Start date: May 24, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors (phase 1). Neuroblastoma tumor specific cohort to further evaluate antitumor activity of palbociclib in combination with topotecan and cyclophosphamide in children, adolescents, and young adults with recurrent or refractory neuroblastoma. Phase 2 to learn about the efficacy of palbociclib in combination with irinotecan and temozolomide when compared with irinotecan and temozolomide alone in the treatment of children, adolescents, and young adults with recurrent or refractory Ewing sarcoma (EWS).

NCT ID: NCT03701334 Active, not recruiting - Early Breast Cancer Clinical Trials

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

NATALEE
Start date: December 7, 2018
Phase: Phase 3
Study type: Interventional

A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer (EBC)

NCT ID: NCT03690388 Active, not recruiting - Clinical trials for Differentiated Thyroid Cancer

A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

Start date: October 5, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the effect of cabozantinib compared with placebo on progression free survival (PFS) and objective response rate (ORR) in subjects with Radioiodine-Refractory Differentiated Thyroid Cancer (DTC) who have progressed after prior vascular endothelial growth factor receptor (VEGFR)-Targeted therapy.

NCT ID: NCT03682536 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve

COMMANDS
Start date: January 2, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).

NCT ID: NCT03682068 Active, not recruiting - Clinical trials for Metastatic Urothelial Cancer

Study of Durvalumab Given With Chemotherapy, Durvalumab in Combination With Tremelimumab Given With Chemotherapy, or Chemotherapy in Patients With Unresectable Urothelial Cancer

NILE
Start date: September 27, 2018
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).

NCT ID: NCT03675737 Active, not recruiting - Stomach Neoplasms Clinical Trials

Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

Start date: November 8, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).

NCT ID: NCT03673501 Active, not recruiting - Clinical trials for Gastrointestinal Stromal Tumors

A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib

INTRIGUE
Start date: February 8, 2019
Phase: Phase 3
Study type: Interventional

This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).

NCT ID: NCT03671148 Active, not recruiting - Clinical trials for Psoriatic Arthritis (PsA)

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)

KEEPsAKE2
Start date: March 7, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).