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A Clinical Study to Evaluate Safety and Immunologic Response of COMBIG-DC, in Patients With Metastatic Kidney Cancer

Primary Purpose

Metastatic Renal Cell Carcinoma

Status

Completed

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

Combig-DC (allogeneic dendritic cells) Cancer Vaccine

About this trial

This is an interventional treatment trial for Metastatic Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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'
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.

Sites / Locations

Dept of Oncology, University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combig-DC Cancer Vaccine

Arm Description

Two vaccinations of Combig-DC (allogeneic dendritic cells) Cancer Vaccine given before nephrectomy.

Outcomes

Primary Outcome Measures

Registration of adverse events as a measure of safety and tolerability

Changes in vital signs from baseline (heart rate, blood pressure, body temperature) as a measure of safety and tolerability

Changes in lab parameters from baseline as a measure of safety and tolerability

Secondary Outcome Measures

Immunologic response in blood (immunologic panel) measured with ELISPOT.

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.

CT-evaluation of the size of the metastasis(-es) 3 months post nephrectomy

CT evaluation to evaluate number of metastases 3 months post nephrectomy.

Changes in body weight 3 months post nephrectomy vs. baseline.

Changes in WHO-ECOG 3 months post nephrectomy vs. baseline.

Full Information

NCT ID

NCT01525017

First Posted

January 20, 2012

Last Updated

October 9, 2015

Sponsor

Mendus

1. Study Identification

Unique Protocol Identification Number

NCT01525017

Brief Title

A Clinical Study to Evaluate Safety and Immunologic Response of COMBIG-DC, in Patients With Metastatic Kidney Cancer

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 Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mendus

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective of this study is to answer the question "Is it possible to inject the Combig-DC vaccine in a renal tumour without getting unacceptable side effects"? Patients newly diagnosed with metastatic renal cell carcinoma will get Combig-DC vaccinations at two occasions in a two weeks period (day 1 and day 14). After another two weeks the kidney will be eliminated. Adverse events will be registered, as well as changes in vital signs(heart rate, blood pressure and body temperature) and lab parameters. Immunologic response will be evaluated by measuring immunologic markers in blood and tumour tissue, and measuring the size of the metastases three months after nephrectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Renal Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combig-DC Cancer Vaccine

Arm Type

Experimental

Arm Description

Two vaccinations of Combig-DC (allogeneic dendritic cells) Cancer Vaccine given before nephrectomy.

Intervention Type

Biological

Intervention Name(s)

Combig-DC (allogeneic dendritic cells) Cancer Vaccine

Intervention Description

Cryopreserved dendritic cell suspension of 10 million cells per ml in heat-inactivated plasma, supplemented with 10% dimethyl sulfoxide (DMSO).

Primary Outcome Measure Information:

Title

Registration of adverse events as a measure of safety and tolerability

Time Frame

1 year 3 months (Feb 2012-May 2013)

Title

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)

Title

Changes in lab parameters from baseline as a measure of safety and tolerability

Time Frame

1 year 3 months (Feb 2012 - May 2013)

Secondary Outcome Measure Information:

Title

Immunologic response in blood (immunologic panel) measured with ELISPOT.

Description

Time Frame

1 year 3 months (Feb 2012 - May 2013)

Title

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)

Title

CT-evaluation of the size of the metastasis(-es) 3 months post nephrectomy

Time Frame

1 year 3 months (Feb 2012 - March 2013)

Title

CT evaluation to evaluate number of metastases 3 months post nephrectomy.

Time Frame

1 year 3 months (Feb 2012 - May 2013)

Title

Changes in body weight 3 months post nephrectomy vs. baseline.

Time Frame

1 year 3 months (Feb 2012 - May 2013)

Title

Changes in WHO-ECOG 3 months post nephrectomy vs. baseline.

Time Frame

1 year 3 months (Feb 2012 - may 2013)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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' 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Laurell, MD, PhD

Organizational Affiliation

Dept of Oncology , Uppsala University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept of Oncology, University Hospital

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

28642820

Citation

Laurell A, Lonnemark M, Brekkan E, Magnusson A, Tolf A, Wallgren AC, Andersson B, Adamson L, Kiessling R, Karlsson-Parra A. Intratumorally injected pro-inflammatory allogeneic dendritic cells as immune enhancers: a first-in-human study in unfavourable risk patients with metastatic renal cell carcinoma. J Immunother Cancer. 2017 Jun 20;5:52. doi: 10.1186/s40425-017-0255-0. eCollection 2017.

Results Reference

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A Clinical Study to Evaluate Safety and Immunologic Response of COMBIG-DC, in Patients With Metastatic Kidney Cancer

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