Program Status
Active, not recruitingPhase
Phase 1/Phase 2Prior Immunotherapy Allowed
YesCRC-directed Trial
NoDrugs
Autologous tumor-infiltrating lymphocytes, Cyclophosphamide, Fludara, Ipilimumab, Nivolumab, proleukin, Opdivo, YervoyTags
MSS/ MMRpComments
Tumor-infiltrating lymphocyte (TIL)-based adoptive T-cell therapy in combination with checkpoint inhibition (ipilimumab, Yervoy, and nivolumab, Opdivo) on cancer patients across all cancer diagnoses.
”to synergistically maximize the immunological potential, we wish to combine ACT with an anti-CTLA-4 antibody (Ipilimumab) prior to tumor resection and an anti-PD-1 antibody (Nivolumab) in combination with TIL infusion.”
Similar concept to Dr Rosenberg’s trial (”TIL’S trial at NIH” NCT01174121); that trial adds an anti PD-1, nivolumab, to the TILs, but not anti CTLA4, as it is added in this trial in Denmark.
Location | Location Status |
---|---|
Denmark | |
Center for Cancer immune Therapy (CCIT), Dept. of Hematology and dept. of Oncology Copenhagen 2730 |
Active, not recruiting |
Inclusion Criteria
Inclusion Criteria:
Histologically verified metastatic or locally advanced cancer diagnosis
At least one lesion (>1 cm3) available for surgical resection
Not candidate for standard treatment options
Age of 18-70 years
Performance status of 1 or 0.
Life expectancy > 6 months
One or more measurable parameter according to RECIST 1.1.
No significant toxicity from previous cancer treatments (CTC≤1). Except aloplecia (CTC≤2) or neuropathy (CTC≤2)
Sufficient organ function, including:
Absolute neutrophil count (ANC) ≥ 1.500 /µl
Leucocyte count ≥ normal limit
Platelets ≥ 100.000 /µl and <700.000 /µl
Hemoglobin ≥ 6,0 mmol/l (regardless of prior transfusion)
S-creatinine < 140
S-bilirubin ≤ 1,5 times upper normal limit
ASAT/ALAT ≤ 2,5 times upper normal limit
Alkaline phosphatase ≤ 5 times upper normal limit
Lactate dehydrogenase (LDH) ≤ 5 times upper normal limit
Sufficient coagulation: PP-time>40 and INR<1,5
Women in the fertile age must use effective contraception. This applies from inclusion and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered safe contraceptives.
Signed statement of consent after receiving oral and written study information
Willingness to participate in the planned treatment and follow-up and capable of handling toxicities.
Exclusion Criteria
Exclusion Criteria:
A history of prior malignancies. Patients treated for another malignancy can only participate if they are without signs of disease for a minimum of 3 years after last treatment.
Primary brain tumor or verified brain metastases
Known hypersensitivity to one of the active drugs or excipients.
Significant medical conditions, including but not limited to severe asthma/COLD, significant cardiac disease, poorly regulated insulin dependent diabetes mellitus.
Creatinine clearance below 70 ml/min .
Acute or chronic infections with HIV, hepatitis, syphilis etc.
Severe allergies or previous anaphylactic reactions.
Active autoimmune disease, such as autoimmune neutropenia/thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, Sjögren's syndrome, sclerodermia, myasthenia gravis, goodpastures disease, addison's disease, hashimoto's thyroiditis, graves' disease etc.
Pregnant women and women who are breastfeeding.
Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone methotrexate etc.)
Simultaneous treatment with other experimental drugs.
Simultaneous treatment with other systemic anti-cancer treatments.
Patients with active or uncontrollable hypercalcemia.