A Phase I Open-label Study to Evaluate Safety and Immunologic Response of COMBIG-DC Administered Intratumorally in Patients With Metastatic Renal Cell Carcinoma
1. Be informed of the nature of the study and have provided written informed consent
2. At least 18 years of age.
3. Diagnosis of renal cell carcinoma with at least one distant metastasis, and/or one
distant lymph node metastasis.
4. Tumor size (renal cell carcinoma; primary tumor) at least 4.0 cm in longest diameter
as measured by CT. Distant metastasis at least 1 cm diameter as measured by CT or a
distant lymph node metastasis at least 2,5 cm diameter as measured by CT. Clinical
stage 'T1b or more; NX; M1'
5. Adequate hematological parameters, i.e:
B-Leukocyte count ≥ 4.5 x 109/L B-Platelet count ≥ 150 x109/L B-Haemoglobin ≥ 100 g/L
6. Women of Childbearing Potential (WOCBP) should use adequate contraception (oral or
injectable contraceptives, hormone releasing intrauterine device) throughout the
1. Performance status > ECOG 2 after optimization of analgesics
2. Adequate coagulation parameters, i.e: P-Prothrombin complex (PK), P-APT time
3. Ongoing treatment with systemic corticosteroids (inhaled, intranasal and local
steroids accepted) within 28 days before first vaccination.
4. Previously known or ongoing active autoimmune disease which requires treatment with
systemic immunosuppressive agents. E.g. inflammatory bowel disease, multiple
sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid
arthritis, SLE, vasculitis, Sjögren's syndrome, scleroderma, autoimmune hepatitis,
and other rheumatological diseases.
5. Patients with previous or ongoing skin malignancy (basal-cell carcinoma, squamous
cell carcinoma, melanoma), other hematological or solid malignancy or blood
6. Ongoing infection that requires treatment with antibiotics.
7. Known major reaction/adverse event in connection with previously made vaccination
(e.g. asthma, anaphylaxis or other serious reaction)
8. Known malignancy in CNS.
9. Active or latent virus disease (HIV, HBV and HCV).
10. Ongoing pregnancy or lactation. Females needs to have negative pregnancy test at
11. Life expectancy less than 3 months.
12. Concomitant exposure to other investigational products.
13. Any reason that, in the opinion of the investigator, contraindicates that the patient
participates in the study.