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This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.

Conditions:
Gastric Cancer | Melanoma | Colorectal Cancer | Esophageal Cancer | Cervical Cancer | NSCLC | Urothelial Carcinoma |...
Emplacement:
  • Sir Mortimer B Davis Jewish General Hospital, Montreal, Quebec, Canada
  • Princess Margaret Cancer Centre, Toronto, Ontario, Canada
  • British Columbia Cancer Agency, Vancouver, British Columbia, Canada
  • Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada
Sexe:
ALL
Âges:
Over 18

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants. Risankizumab is an approved drug for adults with CD. This study comprises of a Period A, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. In Period C, eligible participants will receive open-label risankizumab SC Dose D. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally. Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.

Conditions:
Crohn's Disease
Emplacement:
  • QE II Health Sciences Centre /ID# 257072, Halifax, Nova Scotia, Canada
  • Allen Whey Khye Lim Professional Corporation /ID# 261155, Edmonton, Alberta, Canada
  • Toronto Digestive Disease Associates /ID# 260532, Vaughan, Ontario, Canada
  • University of Calgary /ID# 264640, Calgary, Alberta, Canada
Sexe:
ALL
Âges:
Over 18

This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of enlicitide decanoate, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of enlicitide decanoate compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.

Conditions:
Arteriosclerosis | Hypercholesterolaemia
Emplacement:
  • Cambridge Cardiac Care Centre ( Site 0508), Cambridge, Ontario, Canada
  • Ecogene-21 ( Site 0510), Chicoutimi, Quebec, Canada
  • OCT Research ULC ( Site 0512), Kelowna, British Columbia, Canada
  • Corcare ( Site 0511), Toronto, Ontario, Canada
  • Diex Recherche Trois-Rivieres ( Site 0505), Trois-Rivieres, Quebec, Canada
  • North York Diagnostic and Cardiac Centre ( Site 0514), North York, Ontario, Canada
  • Institut de Cardiologie de Montreal ( Site 0506), Montreal, Quebec, Canada
  • Oakville Cardiovascular Research LP ( Site 0507), Oakville, Ontario, Canada
  • Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur. ( Site 050, Terrebonne, Quebec, Canada
Sexe:
ALL
Âges:
Over 18

This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma.

Conditions:
Neuroblastoma | Ganglioneuroblastoma, Nodular
Emplacement:
  • Alberta Children's Hospital, Calgary, Alberta, Canada
  • McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada
  • Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada
  • IWK Health Centre, Halifax, Nova Scotia, Canada
  • The Montreal Children's Hospital of the MUHC, Montreal, Quebec, Canada
  • University of Alberta Hospital, Edmonton, Alberta, Canada
  • Children's Hospital, London, Ontario, Canada
  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke, Quebec, Canada
  • CancerCare Manitoba, Winnipeg, Manitoba, Canada
  • Hospital for Sick Children, Toronto, Ontario, Canada
Sexe:
ALL
Âges:
Under 30

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.

Conditions:
Cancer
Emplacement:
  • Local Institution, Vancouver, British Columbia, Canada
  • Local Institution - 0040, Montreal, Quebec, Canada
  • Local Institution - 0111, Edmonton, Alberta, Canada
  • Princess Margaret Cancer Centre, Toronto, Ontario, Canada
  • Local Institution - 0308, Montreal, Quebec, Canada
  • Local Institution, Halifax, Nova Scotia, Canada
  • Local Institution - 0168, Oshawa, Ontario, Canada
Sexe:
ALL
Âges:
Over 18

This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.

Conditions:
Primary Mediastinal Large B-Cell Lymphoma
Emplacement:
  • IWK Health Centre, Halifax, Nova Scotia, Canada
  • Hospital for Sick Children, Toronto, Ontario, Canada
  • Janeway Child Health Centre, Saint John's, Newfoundland and Labrador, Canada
  • Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont, Sherbrooke, Quebec, Canada
  • University of Alberta Hospital, Edmonton, Alberta, Canada
  • McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada
  • The Montreal Children's Hospital of the MUHC, Montreal, Quebec, Canada
  • CancerCare Manitoba, Winnipeg, Manitoba, Canada
  • Children's Hospital, London, Ontario, Canada
  • Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada
Sexe:
ALL
Âges:
Over 2

The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).

Conditions:
Oligometastatic Prostate Cancer (OMPC)
Emplacement:
  • Novartis Investigative Site, Ottawa, Ontario, Canada
  • Novartis Investigative Site, London, Ontario, Canada
  • Novartis Investigative Site, Montreal, Quebec, Canada
  • Novartis Investigative Site, Toronto, Ontario, Canada
  • Novartis Investigative Site, Montreal, Quebec, Canada
Sexe:
MALE
Âges:
18 - 100

The purpose of this study is to evaluate the efficacy and safety of AAA617 alone (Lutetium \[177Lu\] vipivotide tetraxetan) and in combination with an Androgen Receptor Pathway Inhibitors (ARPI) in participants with PSMA-positive, castration-resistant prostate cancer and no evidence of metastasis in conventional imaging (CI) (i.e., CT/MRI and bone scans). Approximately 120 participants will be randomized.

Conditions:
Prostatic Neoplasm
Emplacement:
  • Novartis Investigative Site, Montreal, Quebec, Canada
  • Novartis Investigative Site, Toronto, Ontario, Canada
  • Novartis Investigative Site, Montreal, Quebec, Canada
Sexe:
MALE
Âges:
18 - 100

In the phase I part, to determine the recommended doses (RD) and dosing regimens of \[177Lu\]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary anti-tumor activity of two different doses/regimens of \[177Lu\]Lu-NeoB in combination with capecitabine (dose optimization).

Conditions:
Breast Cancer
Emplacement:
  • Novartis Investigative Site, Toronto, Ontario, Canada
  • Novartis Investigative Site, Montreal, Quebec, Canada
Sexe:
ALL
Âges:
18 - 100

This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Conditions:
Multiple Sclerosis | Rheumatoid Arthritis | Dermatomyositis | Systemic Lupus Erythematosus | Autoimmune...
Emplacement:
  • University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
Sexe:
ALL
Âges:
Over 18