AzTrials
AzTrials

Metastatic Renal Cell CarcinomaPhase 1NCT01525017

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

A Phase 1 study testing Combig-DC (allogeneic dendritic cells) Cancer Vaccine in people with Metastatic Renal Cell Carcinoma, run by Mendus at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Renal Cell Carcinoma
What is being tested?
Combig-DC (allogeneic dendritic cells) Cancer Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSweden
Study dates
Feb 2012to Dec 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Dept of Oncology, University Hospital

    Uppsala, 751 85

Other trials in Sweden

About this study

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

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.

Being tested
Combig-DC (allogeneic dendritic cells) Cancer Vaccine
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combig-DC (allogeneic dendritic cells) Cancer VaccineBiological

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

Study groups in NCT01525017
Study groupRoleWhat they receive
Combig-DC Cancer VaccineExperimentalTwo vaccinations of Combig-DC (allogeneic dendritic cells) Cancer Vaccine given before nephrectomy.
Receives: Biological: Combig-DC (allogeneic dendritic cells) Cancer Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Registration of adverse events as a measure of safety and tolerability

    Measured: 1 year 3 months (Feb 2012-May 2013)

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

    Measured: 1 year 3 months (Feb 2012 - May 2013)

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

    Measured: 1 year 3 months (Feb 2012 - May 2013)

Secondary outcomes (6)

  1. 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.

    Measured: 1 year 3 months (Feb 2012 - May 2013)

  2. Examination of immunohistology parameters (macrophage marker, CD3, CD4, CD8, CD56) of the renal tumor post nephrectomy.

    Measured: 1 year 3 months (Feb 2012 - May 2013)

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

    Measured: 1 year 3 months (Feb 2012 - March 2013)

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

    Measured: 1 year 3 months (Feb 2012 - May 2013)

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

    Measured: 1 year 3 months (Feb 2012 - May 2013)

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

    Measured: 1 year 3 months (Feb 2012 - may 2013)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01525017
Sponsor's protocol ID
IM-101
Other IDs
2011-002039-25
Status last verified
Oct 2015
First submitted
20 Jan 2012
Last updated
12 Oct 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28642820

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Combig-DC (allogeneic dendritic cells) Cancer Vaccine in people with Metastatic Renal Cell Carcinoma, run by Mendus at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Registration of adverse events as a measure of safety and tolerability (time frame: 1 year 3 months (Feb 2012-May 2013)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01525017, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in