Patients with metastatic solid cancers in stages III or IV regardless of diagnosis. MedDRA version: 20.0 Level: PT Classification code 10055099 Term: Ocular cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10055100 Term: Otic cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Clas
Conditions
Interventions
Product Name: Tumor Infiltrating Lymphocytes
Product Code: TIL
Pharmaceutical Form: Infusion
INN or Proposed INN: AUTOLOGUS TUMOR INFILTRATING LYMPHOCYTES
Other descriptive name: Tumor infiltrating ly
Sponsors
Center for cancer immune therapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o Histologically verified cancer diagnosis o Metastatic disease and at least one lesion (>1 cm3) available for surgical resection o Late stage disease (III-IV) without effective standard treatment options o Age of 18-70 years o ECOG performance status of 1 or 0. For information see appendix 2. o Life expectancy > 6 months o One or more measurable parameter in according to RECIST 1.1. o No significant toxicity from previous cancer treatments (CTC=1). Except alopleica (CTC=2) or neuropathy (CTC=2) o Sufficient organ function, including: o Absolute neutrophil count (ANC) = 1.500 /µl o Leucocyte count = normal limit o Platelets = 100.000 /µl and 40 and INR=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: o A history of prior malignancies. Patients treated for another malignancy can only participate if they are without signs of disease for a minimum of 5 years after last treatment. o Primary brain tumor or signs of brain metastases o Known hypersensitivity to one of the active drugs or excipients. o Severe medical conditions, such as severe asthma/COLD, significant cardiac disease, poorly regulated insulin dependent diabetes mellitus among others. o Creatinine clearence below 70 ml/min . o Acute or chronic infections with HIV, hepatitis, syphilis etc. o Severe allergies or previous anaphylactic reactions. o Active autoimmune disease, such as autoimmune neutropenia/thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, Sjögren’s syndrome, sclerodermia, myasthenia gravis, goodpasteures disease, addison’s disease, hashimoto’s thyroiditis, graves’ disease etc. o Pregnant women and women who are breastfeeding. o Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone methotrexate etc.) o Simultaneous treatment with other experimental drugs. o Simultaneous treatment with other systemic anti-cancer treatments. o Patients with active or uncontrollable hypercalcemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to determine the feasibility and safety of adoptive cell therapy in combination with checkpoint inhibition across different metastatic solid cancers. ;Secondary Objective: Secondary objectives are to evaluate treatment related immune response and clinical efficacy.;Primary end point(s): Toxicity: Registration of all AEs and unexpected events in relation to the treatment will be done in accordance with the common terminology criteria for adverse events (CTCAE) criteria as described in appendix 3. ;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated before treatment, during treatment and at follow-up visits untill 6 months after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immune evaluation: Continuous ex-vivo analyses of the specific immune reactivity against tumor antigens to evaluate the immunological effect of treatment. The immunological response against tumor antigens before and after treatment will be compared. These analyses will be done on blood samples and tumor biopsies. Clinical evaluation: The clinical efficacy of the treatment will be rated using the objective response rate in accordance with RECIST 1.1, overall survival (OS) and progression-free survival (PFS). Immune related RECIST (irRECIST) and PERCIST will only be used exploratory. ;Timepoint(s) of evaluation of this end point: Immune and clinical response is evaluated after treatment is given and at follow-up until 5 years after last treatment. | — |
Countries
Denmark
Contacts
Public ContactPrincipal investigator
Center for cancer immune therapy
Outcome results
None listed