Quebec

NO LONGER Recruiting – active locations in Quebec:

• Jewish General Hospital (Dr. Petr Kavan: 514-340-8222, Ext. 4210; Inna Zhylina: 514-340-8222, Ext. 28437)

ID Number: NCT03465722

Links:

• Canadian Cancer Trials
• ClinicalTrials.gov

Description: This study looks at the drug Avapritnib (BLU-285) for patients with advanced or metastatic a Gastrointestinal Stromal Tumor (GIST) compared to Regorafenib. Patients will take one of the two study drugs over 2 months and the researchers will compare their survival and disease status over time to decide which medication is more effective.

• Group A will receive Avapritnib.
• Group B will receive a Regorafenib.

Intervention: Both of the drugs being compared in this study are meant to stop cancer cells from spreading. Regorafenib is a kinase inhibitor. This means that it stops cancer cells from producing certain proteins they need to survive and divide. It is widely used to treat various types of cancer. Avapritnib looks like a promising new treatment which can stop cancer cells from dividing. This trial will help to figure out if it is helpful in treating a specific type of gastric cancer.

Can I consider participating?

• Yes: adult patients with an unresectable GIST who have already been treated with a medication called imatinib, as well as 1-2 other medications which are tyrosine kinase inhibitors (TKIs)
• No: patients who have been treated with Avapritnib or Regorafenib in the past; patients who have tried 3 or more TKI medications in the past

Publications: Robust Activity of Avapritinib, Potent and Highly Selective Inhibitor of Mutated KIT, in Patient-derived Xenograft Models of Gastrointestinal Stromal Tumors

Recruiting locations in Quebec:

• Sherbrooke – Centre Hospitalier universitaire de Sherbrooke (Dr Frédéric Lemay, MD: 819-346-1110)
• Montreal – Jewish Central Hospital (Dr Petr Kavan, MD: 514-340-8222 Ext. 4210)
• Montreal – Maisonneuve Hospital (Dr. Mai-Kim Gervais, 418-525-4444, Ext. 22644)

ID Number: NCT03221426

Links:

• ClinicalTrials.gov
• Canadian Cancer Trials

Description: This study will be looking at the effects of the drug Pembrolizumab as part of pre-surgical treatment. The drug will be given before and after gastric cancer surgery with different chemotherapy routines. This study will be comparing two things. First, Pembrolizumab with chemotherapy will be compared to a placebo with chemotherapy. This is done to determine if it is helpful in general. Next, Pembrolizumab given with systemic chemotherapy will be compared to Pembrolizumab given with FLOT chemotherapy. FLOT is a commonly prescribed chemotherapy routine for gastric cancer patients. There will be four groups in this experiment:

• Group A – Pembrolizumab and systemic chemotherapy
• Group B – placebo and systemic chemotherapy
• Group C – Pembrolizumab and FLOT chemotherapy
• Group D – placebo and FLOT chemotherapy

The researchers think that this drug can improve outcomes for patients, by increasing overall survival and event-free survival. This means patients will live longer without a recurrence of cancer.

Intervention:

• Pembrolizumab: Sometimes, cancer cells stop our immune system from recognizing the growth of a tumor.  This way, the cancer is effectively able to “hide” from our body’s defense mechanisms. Pembrolizumab reverses this effect of the cancer cells so they can be detected and fought off by our body.
• Systemic Chemotherapy: Cisplatin and Capecitabine/5-Fluorouracil
• FLOT: Docetaxel, Oxaliplatin, 5-Fluorouracil and Leucovorin

Can I consider participating?

• Yes: patients with a T3 gastric tumor and some cancerous lymph nodes, but no metastases. Have never been treated before and are planning on having surgery.
• No: patients who are not eligible for surgery (e.g.: metastatic disease), have ever had pneumonitis, have a current infection, have ever had treatment with other immune or cancer therapies (chemo/radiation)

Publications: KEYNOTE-585: Phase 3 study of preoperative chemotherapy with or without pembrolizumab for gastric cancer. 

Recruiting location in Quebec:

• Montreal – Nouveau Centre Hospitalier universitaire de Montreal (Dr. Rahima Jamal: 514-890-8000, Ext. 20688)

ID Number: NCT02554812

Link:

• ClinicalTrials.gov
• Canadian Cancer Trials

Description: This is a Phase II trial. It is looking at the effects of the drug Avelumab combined with other cancer therapies for treating advanced gastric tumors. There are many treatment groups in this trial, because the researchers are interested in testing various dosages of each drug, as well as different combinations. The drug combinations they will be testing are:

• A: Avelumab and Utomilumab
• B: Avelumab and PF-04518600
• C: Avelumab and PD-0360324
• D: Avelumab, Utomilumab and PF-04518600

Intervention: All of the medications involved in this trial are immunotherapeutic. They help our immune system’s T cells recognize and attack tumor cells. This trial is trying to understand the effects of the drugs in combination with each other, as well as determine the appropriate dose for each medication.

Can I consider participating?

• Yes: patients with an advanced gastric tumor who have a life expectancy of at least 3 months. The tumor has not been treated with radiation or systemic chemotherapy within 1 year.
• No: patients who are currently having immunotherapy, recently had surgery (within 4 weeks), current infection

Recruiting location in Quebec:

• Montreal – CIUSSS de l’Est de L Ile de Montreal – Hopital Maisonneuve-Rosemont (contact: Dr. Mai-Kim Gervais, 514-252-3400)
• Montreal – Jewish General Hospital (contact: Dr. Petr Kavan, 514-340-8222 Ext. 4210)
• Sherbrooke – CIUSSS de l’Estrie – CHUS – Centre Hosp. Univ. Sherbrooke (contact: Dr. Frédéric Lemay, 819-346-1110)

ID Number: NCT03221426

Links:

• Clinical Trials.gov
• CanadianCancerTrials.ca

Description:This study is looking at the drug pembrolizumab (MK-3745) and its effectiveness before and after surgery treatment for gastric and gastroesophageal junction (GEJ) adenocarcinoma. 

Group A: Pembrolizumab and Chemotherapy

Group B: Placebo and Chemotherapy

Group C: Pembrolizumab and FLOT (docetaxel, oxaliplatin, 5-fluorouracil, leucovorin)

Group D: Placebo and FLOT

Intervention:Pembrolizuma is a drug which helps the immune system cells to attack and get rid of cancer cells. It is an immunotherapy medication.  FLOT are combination chemotherapy drugs that attack the cancerous cells.

Can I consider participating?

• YES: patients who have untreated localized gastric or GEJ adenocarcinoma
• NO: patients who have infections, autoimmune disease, prior anti-cancer therapy

NO LONGER recruiting – active locations in Quebec:

• Rimouski – CISSS du Bas-Saint-Laurent – Hopital regional Rimouski (contact: Sophie Savary Belanger, 418-724-3000)

Actively Recruiting Locations in Quebec:

• Chicoutimi – CIUSSS du Saguenay-Lac-Saint-Jean – Hopital de Chicoutimi (contact: Veronick Tremblay 418-541-1234 Ext. 2708)

ID Number: NCT03653507

Links:

• Clinical Trials.gov
• CanadianCancerTrials.ca

Description: This study is looking at how effective the drug zolbetuximab will be with capecitabine and oxaliplatin (CAPOX) as first line treatment versus just CAPOX.

Group A: zolbetuximab + CAPOX

Group B: placebo + CAPOX

Intervention: Zolbetuximab is an immunotherapy drug that helps the body’s immune system to attack and fight off the cancer cells. CAPOX are a combination of chemotherapy drugs that target cancer cells.

Can I consider participating?

• YES: patients who have a diagnosis of locally advanced unresectable or metastatic disease gastric or GEJ adenocarcinoma, tumor expresses Claudin 18.2 and is HER2-negative
• NO: patients who have received chemotherapy or radiotherapy for tumor, significant cardiovascular disease, active infection

Recruiting location in Quebec:

• Quebec – The Research Institute of the McGill University Health Centre (contact: Thierry Alcindor, thiery.alcindor@mcgill.ca)

ID Number: NCT02773524

Links:

• Clinical Trials.gov

Description: This study is looking to determine if regorafenib improves survival in patients with advanced gastro-oesophageal carcinoma.

A: Regorafenib

B: Placebo

Intervention: Regorafenib is a targeted chemotherapy drug that is a tyrosine kinase inhibitor. It slows down or stops the growth of cancer cells.

Can I consider participating?

• YES: patients who have advanced (metastatic or locally recurrent) gastro-oesophageal carcinoma that has not responded to minimum of 2 lines of prior anti-cancer therapy
• NO: patients who have malabsorption syndromes, poorly-controlled hypertension, significant active infection

NO LONGER Recruiting – active location in Quebec:

• Montreal – CIUSSS de l’Ouest-de-l’Île-de-Montréal – St. Mary’s Hospital Center (contact: Dr. Richard Dalfen, 514-345-3511 Ext 3793)
• Montreal – MUHC Glen site (contact: Dr. Thierry Alcindor, 514-934-1934 Ext 43118)

ID Number: NCT03504397

Links:

• Clinical Trials.gov
• CanadianCancerTrials.ca

Description: This study is looking at the effect of zolbetuximab with mFOLFOX6 in patients with unresectable or metastatic gastric or GEJ adenocarcinoma. Patients will be assigned to one of two groups:

A: zolbetuximab with mFOLFOX6

B: placebo with mFOLFOX6

Intervention: FOLFOX6 is a combination of chemotherapy drugs that attack cancer cells. Zolbetuximab is a chemotherapy drug that attaches to Claudin 18.2 on cancer cells to cause cell death.

Can I consider participating?

• YES: patients who have HER2-negative tumor, Claudin 18.2 is expressed on tumor
• NO: patients who have received prior chemotherapy treatment for unresectable or metastatic gastric or GEJ adenocarcinoma, significant cardiovascular disease

NO LONGER Recruiting – active location in Quebec:

• Quebec – CHU de Quebec – Hotel-Dieu de Quebec (contact: Dr. Maxime Chénard-Poirier, 418-525-4444)

ID Number: NCT03797326

Links:

• Clinical Trials.gov
• Canadian Cancer Trials

Description:This study is looking at the safety and effectiveness of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/Mk-7902).

Group A: Pembrolizumab and lenvatinib

Intervention: Pembrolizumab is an immunotherapy drug that will help immune system cells to attack and get rid of cancer cells. Lenvatinib is a targeted chemotherapy drug that is a tyrosine kinase inhibitor. It slows down or stops the growth of cancer cells.

Can I consider participating?

• YES:  patients who have a metastatic and/or unresectable solid tumor that is uncurable, has received 2 prior lines of therapy
• NO: patients who have gastrointestinal condition, active infection or autoimmune disease

Recruiting location in Quebec:

• Montreal – Jewish General Hospital (contact: Dr. Cristiano Ferrario, 514-340-8222 Ext 4210)

ID Number: NCT02892123

Links:

• Clinical Trials.gov
• Canadian Cancer Trials

Description: This study is looking the safety and effectiveness of ZW25 on its own and in combination with chemotherapy agents.

Group A: ZW25 and paclitaxel

Group B: ZW25 and capecitabine

Group C: ZW25 and vinorelbine

Intervention: ZW25 is an immunotherapy drug that helps the body’s immune system to attack and fight off the cancer cells. Paclitaxel, capecitabine, and vinorelbine are chemotherapy drugs that target cancer cells.

Can I consider participating?

• YES:  patients who have a HER2-expressing locally advanced (unresectable) and/or metastatic disease
• NO: patients who have untreated brain metastases, acute or chronic uncontrolled renal disease, pancreatitis or liver disease

Recruiting location in Quebec:

• Montreal – Montreal General Hospital (Dr. Carmen L Mueller, 514-677-6465)

ID Number: NCT03049345

Link:

• ClinicalTrials.gov

Description: This study is looking at the sensitivity and accuracy of sentinel lymph node sampling. Patients will undergo sentinel lymph node sampling surgery.

Intervention: Sentinel lymph nodes are the first few lymph nodes that a tumor drains into.

Can I consider participating?

• Yes: patients who are deemed healthy enough to withstand laparoscopic or open anatomic gastrectomy with extended regional (D2) lymphadenectomy
• No: patients who are not able to withstand surgery

Actively Recruiting in Rimouski, Quebec (Hopital Regional Rimouski – contact Dre Sophie Savaray Belanger or Mme Claire Gagnon at 418-724-3000)

ID Number: NCT03653507

Links:

Canada Cancer Trials

ClinicalTrials.gov

Description: This study is trying to determine whether 2 drugs together (Zolbetuximab + CAPOX) are better at treating cancer compared to just one (CAPOX). The main outcome that the researchers are looking at is progression-free survival (PFS). PFS measures the time from treatment that patients continue to live without their disease getting more severe. Patients will be randomized to 1 of 2 groups and will not know which group they are a part of.

• Group A will receive Zolbetuximab and CAPOX
• Group B will receive CAPOX and a placebo pill

Intervention: Zoletuximab is a cancer drug which targets the body’s immune system and helps it to find and destroy cancer cells. It is classified as a monoclonal antibody. CAPOX is a chemotherapy routine which includes capecitabine + oxaliplatin. These are both cytotoxic chemotherapy drugs which cause cancer cell death by stopping them from dividing.

Can I consider participating?

• Yes: patients with advanced gastric or gastroesophageal junction cancer who are not candidates for surgery and do not have a chance of becoming pregnant/agree to use contraception
• No: patients who have received previous chemotherapy within 6 months or radiation therapy within 2 weeks of the trial; patients who have been treated with other herbal medications within 1 month; recent surgical treatment within 1 month, etc.