A Clinical Study to Evaluate Safety and Immunologic Response of COMBIG-DC, in Patients With Metastatic Kidney Cancer
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ClinicalTrials.gov Identifier: NCT01525017 |
Recruitment Status :
Completed
First Posted : February 2, 2012
Last Update Posted : October 12, 2015
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Renal Cell Carcinoma | Biological: Combig-DC (allogeneic dendritic cells) Cancer Vaccine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Open-label Study to Evaluate Safety and Immunologic Response of COMBIG-DC Administered Intratumorally in Patients With Metastatic Renal Cell Carcinoma |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
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Experimental: Combig-DC Cancer Vaccine
Two vaccinations of Combig-DC (allogeneic dendritic cells) Cancer Vaccine given before nephrectomy.
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Biological: Combig-DC (allogeneic dendritic cells) Cancer Vaccine
Cryopreserved dendritic cell suspension of 10 million cells per ml in heat-inactivated plasma, supplemented with 10% dimethyl sulfoxide (DMSO). |
- Registration of adverse events as a measure of safety and tolerability [ Time Frame: 1 year 3 months (Feb 2012-May 2013) ]
- Changes in vital signs from baseline (heart rate, blood pressure, body temperature) as a measure of safety and tolerability [ Time Frame: 1 year 3 months (Feb 2012 - May 2013) ]
- Changes in lab parameters from baseline as a measure of safety and tolerability [ Time Frame: 1 year 3 months (Feb 2012 - May 2013) ]
- Immunologic response in blood (immunologic panel) measured with ELISPOT. [ Time Frame: 1 year 3 months (Feb 2012 - May 2013) ]Time for sampling: just before first injection and second injection, 2 weeks post second injection (in connection with the hospitalization for nephrectomy) and at 3 months post nephrectomy. ELISPOT assessment will be made at time of nephrectomy (after the second vaccination) at earliest.
- Examination of immunohistology parameters (macrophage marker, CD3, CD4, CD8, CD56) of the renal tumor post nephrectomy. [ Time Frame: 1 year 3 months (Feb 2012 - May 2013) ]
- CT-evaluation of the size of the metastasis(-es) 3 months post nephrectomy [ Time Frame: 1 year 3 months (Feb 2012 - March 2013) ]
- CT evaluation to evaluate number of metastases 3 months post nephrectomy. [ Time Frame: 1 year 3 months (Feb 2012 - May 2013) ]
- Changes in body weight 3 months post nephrectomy vs. baseline. [ Time Frame: 1 year 3 months (Feb 2012 - May 2013) ]
- Changes in WHO-ECOG 3 months post nephrectomy vs. baseline. [ Time Frame: 1 year 3 months (Feb 2012 - may 2013) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Be informed of the nature of the study and have provided written informed consent
- At least 18 years of age.
- Diagnosis of renal cell carcinoma with at least one distant metastasis, and/or one distant lymph node metastasis.
- 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'
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Adequate hematological parameters, i.e:
B-Leukocyte count ≥ 4.5 x 109/L B-Platelet count ≥ 150 x109/L B-Haemoglobin ≥ 100 g/L
- Women of Childbearing Potential (WOCBP) should use adequate contraception (oral or injectable contraceptives, hormone releasing intrauterine device) throughout the study period.
Exclusion Criteria:
- Performance status > ECOG 2 after optimization of analgesics
- Adequate coagulation parameters, i.e: P-Prothrombin complex (PK), P-APT time
- Ongoing treatment with systemic corticosteroids (inhaled, intranasal and local steroids accepted) within 28 days before first vaccination.
- 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.
- Patients with previous or ongoing skin malignancy (basal-cell carcinoma, squamous cell carcinoma, melanoma), other hematological or solid malignancy or blood dysfunctions.
- Ongoing infection that requires treatment with antibiotics.
- Known major reaction/adverse event in connection with previously made vaccination (e.g. asthma, anaphylaxis or other serious reaction)
- Known malignancy in CNS.
- Active or latent virus disease (HIV, HBV and HCV).
- Ongoing pregnancy or lactation. Females needs to have negative pregnancy test at screening visit.
- Life expectancy less than 3 months.
- Concomitant exposure to other investigational products.
- Any reason that, in the opinion of the investigator, contraindicates that the patient participates in the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525017
Sweden | |
Dept of Oncology, University Hospital | |
Uppsala, Sweden, 751 85 |
Principal Investigator: | Anna Laurell, MD, PhD | Dept of Oncology , Uppsala University Hospital |
Responsible Party: | Immunicum AB |
ClinicalTrials.gov Identifier: | NCT01525017 |
Other Study ID Numbers: |
IM-101 2011-002039-25 ( EudraCT Number ) |
First Posted: | February 2, 2012 Key Record Dates |
Last Update Posted: | October 12, 2015 |
Last Verified: | October 2015 |
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |