T Cell based treatment for patients with Renal Cell Carcinoma

Phase 1

• Conditions: Advanced Renal Cell Carcinoma; MedDRA version: 20.0Level: LLTClassification code 10038409Term: Renal cell carcinoma NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001454-18-DK
• Lead Sponsor: Center for Cancer Immune Therapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-19
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. 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.
2. Metastatic disease irrespective of number of previous treatment lines. Treatment naïve pt’s can be included.
3. Age: 18 – 70 years.
4. ECOG performance status of =1.
5. IMDC prognostic group ‘Favorable’ or ‘Intermediary’
6. Life expectancy of > 6 months.
7. At least one measurable parameter after surgery in accordance with RECIST 1.1 –criteria’s.
8. No significant toxicities or side effects (CTC = 1) from previous treatments.
9. Normal ejection fraction (EF) measured by a multigated acquisition (MUGA) scan.
10. Crom EDTA clearance >40 ml/min
11. Sufficient organ function.
12. LDH = 5 times upper normal limit as a measure of tumor burden
13. 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.
14. Signed statement of consent after receiving oral and written study information. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research
15. Willingness to participate in the planned controls.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1. A history of prior malignancies, exept 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.
2. Patients with cerebral metastases.
3. Patients with widespread bone or bone only metastases.
4. Known hypersensitivity to one of the active drugs or one or more of the excipients.
5. Severe medical conditions, such as severe asthma/COLD, ischemic hearth disease/significant cardiac disease (e.g. NYHA class =2), poorly regulated insulin dependent diabetes mellitus among others, which can interfere with patient compliance and/or significantly increase the risk of side effects upon investigators clinical judgement.
6. Acutte/chronic infection with HIV, hepatitis, tuberculosis among others.
7. Severe allergies or previous anaphylactic reactions.
8. Active autoimmune disease, such as autoimmune neutropenia/thrombocytopenia or hemolytic anemia, systemic lupus erythematosis, Sjögren’s syndrome, sclerodermia, myasthenia gravis, Goodpasteur’s disease, Addison’s disease, Hashimotos thyroiditis, active Graves disease.
9. Pregnant women and women breastfeeding.
10. Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone, methotrexate among others).
11. Simultaneous treatment with other experimental drugs.
12. Simultaneous treatment with other systemic anti-cancer treatments.
13. Patients with active and uncontrollable hypercalcaemia.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate toxicity (according to CTCAE version 4.0) and feasibility.;Secondary Objective: To evaluate treatment related immune responses<br>To evaluate clinical response (according to RECIST 1.1 - response rate,<br>progressionfree survival and overall survival);Primary end point(s): The primary endpoint is toxicity (according to CTCAE 4.0).;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated before treatment, during<br>treatment and at follow-up visits untill 6 months after treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints are treatment related immune response and clinical response (according to RECIST 1.1 - response rate, progressionfree<br>survival and overall survival).;Timepoint(s) of evaluation of this end point: The secondary endpoints will be evaluated after all patients have<br>received treatment and clinical response is evaluated. Estimated 1 year<br>after treatment of last patient.