Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

Lewis Y Nivo-CAR-T : A Pilot Study Assessing Safety and Tolerability of Lewis Y (LeY) targeting Chimeric Antigen Receptor (CAR) T cells in combination with Nivolumab in Patients With LeY Expressing Solid Tumours

Male or<br/>FemaleGender Male or

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer

Systemic therapy | Blood / Myeloma / Lymphoma,Bowel (colorectum),Brain and spinal cord,Breast,CUP,Female reproductive organs,Head and neck,Lung,Sarcoma,Skin,Stomach and upper gastrointestinal tract,Urinary systemAcute Lymphoblastic Lymphoma,Adrenocortical carcinoma,Anus,Astrocytoma,Basal cell carcinoma,B-Cell Non Hodgkin Lymphoma,Bile duct,Bladder,Bone,Brain,Brain stem,Breast,Cancer of Unknown Primary,Central Nervous System,Cervix,Chondrosarcoma,Colon,Colorectum,Cutaneous Squamous Cell Carcinoma (CSCC),Diffuse Large Cell Lymphoma,Endometrium,Ependymomas,Epithelial,Ewing's Sarcoma,Fallopian tube,Follicular Lymphoma,Gallbladder,Gastrointestinal stromal tumour (GIST),Gastrointestinal stromal tumors (GISTs),Gastro-oesophageal junction ,Germ cell and sex cord stromal cell,Germ cell tumour,Glioblastoma (GBM) ,Glioma,Head and neck,Hodgkin's Disease (Hodgkin's Lymphoma),Kidney,Langerhans Cell Histiocytosis,Leiomyosarcoma,Liposarcoma,Liver,Lung,Lymphoma,Mantle Cell Lymphoma,Medullablastoma,Melanoma (Ocular),Melanoma (Skin),Meningioma,Merkel cell,Mesothelioma,Mouth (including tonsil, tongue, soft palate, cheeks, lips, gum),Neuroblastoma,Neuroendocrine tumours,Non-Small Cell Lung Cancer,Nose (nasopharynx),Oesophagus,Oral cavity,Oropharynx,Osteosarcoma,Ovary,Pancreas,Penis,Peritoneal,Prostate,Rectum,Renal cell carcinoma,Rhabdomyosarcoma,Salivary glands,Sarcoma,Skin Lymphoma,Small Cell Lung Cancer,Soft Tissue Sarcoma,Spinal Cord,Squamous cell carcinoma ,Stomach,Synovial Sarcoma,T-Cell Lymphoma,Testis,Throat (hypopharynx),Thyroid,Urinary tract,Urothelial,Uterus,Vagina,Voice box (larynx),Vulva,Wilm's tumour

Trial Overview Read MoreRead more

This phase I study is testing a new cancer treatment that targets the tumour marker Lewis Y ('Lewis Y Chimeric Antigen Receptor T-cell Therapy') in combination with a commonly used immunotherapy drug (nivolumab) in people with Lewis Y-expressing solid cancers.

This trial is treating patients with Lewis-Y expressing solid cancers.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Pilot Study Assessing Safety and Tolerability of Lewis Y (LeY) targeting Chimeric Antigen Receptor (CAR) T cells in combination with Nivolumab in Patients With LeY Expressing Solid Tumours

Other Non-Commercial Sponsor

Peter MacCallum Cancer Centre


All eligible participants will receive treatment with Lewis Y Chimeric Antigen Receptor T-Cell Therapy and nivolumab. Prior to treatment, participants will have blood collected to generate the T-cells required for treatment. Participants will then follow a chemotherapy regimen designed to reduce the number of the body's T-cells so that the newly generated T-cells can be administered. This will involve intravenous (IV) infusions of the drugs fludarabine and cyclophosphamide once per day for 3 consecutive days in the week prior to T-cell therapy. People enrolled in this study will be part of one of two groups: Dose Escalation or Dose Expansion. In the Dose Escalation phase, different dose levels of the cell therapy will be tested. Each participant will receive one dose only by IV infusion. The doses tested will be increased or decreased for additional participants enrolled until a safe dose is determined. This safe dose will then be used for the Dose Expansion phase. In Dose Expansion, participants may receive up to two doses of cells infused one hour apart by IV infusion. Nivolumab will be administered to all participants by IV infusion on the day prior to T-cell therapy, and on days 14, 28 and 42 after T-cell therapy.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Nathan Reader Wilson

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.