Last updated on December 2019

TIL Therapy for Metastatic Renal Cell Carcinoma


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Metastatic Renal Cell Carcinoma
  • Age: Between 18 - 70 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Histological proven mRCC with the possibility of surgical removal of tumor tissue of > 1 cm3. Histology must include a clear cell component with or without a sarcomatoid dedifferentiation.
  • Metastatic disease irrespective of number of previous treatment lines. Treatment nave pt's can be included.
  • ECOG performance status of 1.
  • IMDC prognostic group 'Favorable' or 'Intermediary'.
  • Life expectancy of > 6 months.
  • At least one measurable parameter after surgery in accordance with RECIST 1.1 -criteria's.
  • No significant toxicities or side effects (CTC 1) from previous treatments.
  • Normal ejection fraction (EF) measured by a multigated acquisition (MUGA) scan.
  • Crom EDTA clearance >40 ml/min.
  • Adequate renal, hepatic and hematological function.
  • LDH 5 times upper normal limit as a measure of tumor burden.
  • Women in the fertile age must use effective contraception. Likewise, men included in the study, as well as their partners, 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.
  • Able to comprehend the information given and willing to sign informed consent.
  • Willingness to participate in the planned controls.

Exclusion Criteria:

  • A history of prior malignancies, except curatively treated non-melanoma skin cancer and CIS of the cervix uteri. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 3 years after treatment.
  • Patients with cerebral metastases.
  • Patients with widespread bone or bone only metastases.
  • Severe allergies, history of anaphylaxis or known allergies to the administered drugs.
  • Severe medical conditions or psychiatric comorbidity.
  • Acute/chronic infection with HIV, hepatitis, tuberculosis among others.
  • Severe and active autoimmune disease.
  • Pregnant women and women breastfeeding.
  • Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone, methotrexate among others).
  • Simultaneous treatment with other experimental drugs.
  • Simultaneous treatment with other systemic anti-cancer treatments.
  • Patients with active and uncontrollable hypercalcaemia.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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