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MelanomaPhase 2NCT02285413

Platin-based Chemotherapeutics to Enhance Dendritic Cell Vaccine Efficacy in Melanoma Patients

A Phase 2 study testing DC vaccination and DC vaccination with cisplatinum in people with Melanoma, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

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

Official record
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Trial summary

This is an exploratory study and the primary objective is the immunogenicity and feasibility of combined chemotherapy-DC vaccination. The secondary objectives are the toxicity and clinical efficacy. This study will provide important data on the immunological efficacy of DC immunochemotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Melanoma
What is being tested?
DC vaccination and DC vaccination with cisplatinum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteNetherlands
Study dates
Feb 2011to Apr 2016
Phase
Phase 2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients:
  • histologically documented evidence of melanoma
  • stage III or IV melanoma according to the 2001 AJCC criteria
  • melanoma expressing gp100. Tyrosinase is not mandatory but will be assessed.
  • WHO performance status 0-1 (Karnofsky 100-70)
  • life expectancy ≥3 months
Show all 16Show fewer
  • age 18-70 years
  • no clinical signs or symptoms of CNS metastases
  • WBC >3x10^9/l, lymphocytes >0.8x10^9/l, platelets >100x10^9/l, serum creatinine <150 µmol/l, serum bilirubin <25 µmol/l
  • normal serum LDH (<450 U/l)
  • expected adequacy of follow-up
  • no pregnant or lactating women
  • written informed consent
  • and in addition: Stage III melanoma
  • radical regional lymphnode dissection is performed Stage IV melanoma
  • at least one unidimensional measurable target lesions according to RECIST, not previously irradiated, and no significant symptoms of disease requiring other palliative treatments

Who cannot join

  • any prior chemotherapy, immunotherapy or radiotherapy is allowed if completed more than 4 weeks prior to planned vaccination
  • history of any second malignancy in the previous 5 years, with the exception of adequately treated basal cell carcinoma or carcinoma in situ of the cervix
  • serious active infections, known HbsAg or HIV positive, or autoimmune diseases or organ allografts
  • concomitant use of immunosuppressive drugs
  • known allergy to shell fish (since it contains KLH)
  • rapidly progressive symptomatic disease
  • any serious clinical condition that may interfere with the safe administration of DC

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud University Nijmegen Medical Centre

    Nijmegen, Gelderland, 6500 HB

Other trials in Netherlands

About this study

Official title: Immunochemotherapy: Do Platin-based Chemotherapeutics Enhance Dendritic Cell Vaccine Efficacy in Melanoma Patients?

This is an exploratory study and the primary objective is the immunogenicity and feasibility of combined chemotherapy-DC vaccination. The secondary objectives are the toxicity and clinical efficacy. This study will provide important data on the immunological efficacy of DC immunochemotherapy.

Read the detailed description
  1. Rationale Investigators have explored immunotherapy and have now vaccinated well over 200 stage III and IV melanoma patients in the Netherlands with monocyte-derived dendritic cell (DC) vaccines and proved that DC therapy is safe with minimal side effects. Cytotoxic chemotherapy and radiotherapy have long been viewed as strategies that directly impact the viability of the tumor cell, and that the immune system contributed little to their efficacy. The commonly held opinion was that chemotherapy and immunotherapy could not be combined because of the myelo-suppressive effect of most chemotherapeutic agents. However, it becomes increasingly obvious that chemotherapy also possess the capacity to trigger tumor antigen release and danger signals in a manner that provokes engagement of innate and adaptive immunity that may be capitalized upon. Small proof-of-concept clinical trials in cancer patients indicate that the efficacy of anti-cancer vaccines may indeed be enhanced by chemotherapy [2]. Also preliminary observations indicate that chemotherapeutic agents, in particular platinum compounds (cisplatin, carboplatin and oxaliplatin) are immunogenic and may contribute to reverse tumor cell induced immunosuppression/immune deviation. Investigators hypothesize that DC vaccination, when combined with other more conventional anti-tumor treatments such as chemotherapy, that eradicate large numbers of cancer cells, may allow the T cells to clear the remaining cancer cells and to provide immunological memory to prevent relapse.
  2. Objectives This is an exploratory study and the primary objective is the immunogenicity and feasibility of combined chemotherapy-DC vaccination. The secondary objectives are the toxicity and clinical efficacy. This study will provide important data on the immunological efficacy of DC immunochemotherapy.
  3. Study design This study is an open label randomized phase II study.
  4. Study population Our study population consists of melanoma patients, with expression of melanoma associated tumor antigens gp100 and tyrosinase. Melanoma patients with regional lymph node metastasis in whom a radical lymph node dissection is performed within 2 months of inclusion in this study (further referred to as stage III) and melanoma patients with measurable distant metastases (further referred to as stage IV) will be included.
  5. Main study endpoints The primary objective of the study is to investigate the immunogenicity and feasibility of combined chemotherapy-DC vaccination. The secondary objective is to investigate the toxicity and clinical responses (only in stage IV) upon DC immunochemotherapy.
Conditions
Melanoma
Being tested
DC vaccination, DC vaccination with cisplatinum
Keywords
Melanoma, Dendritic cells, Cisplatin, Vaccine, Immunotherapy
Medical subject headings
Melanoma

What participants receive

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

  • DC vaccinationBiological

    DC vaccination without cisplatinum

  • DC vaccination with cisplatinumBiological

    DC vaccination with cisplatinum

Study groups in NCT02285413
Study groupRoleWhat they receive
DC vaccinationExperimentalmature DC injected intradermally and intravenously loaded with mRNA encoding tumor-associated antigens gp100 and tyrosinase
Receives: Biological: DC vaccination
DC vaccination with cisplatinumExperimentalmature DC injected intradermally and intravenously loaded with mRNA encoding tumor-associated antigens gp100 and tyrosinase. each DC vaccine will be preceded by cisplatin infusion: 50 mg/m2, 1-2h before DC injection.
Receives: Biological: DC vaccination with cisplatinum

What is being measured

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

  1. Immunogenicity: number of participants with KLH and/or tumor-specific antigens immune responses.

    Measured: 5 years

  2. Feasibility: % of vaccines meeting the release criteria.

    Measured: 5 years

Secondary outcomes (4)

  1. Toxicity: number of Participants with Adverse Events.

    Measured: 5 years

  2. Progression-free survival

    Measured: 5 years

  3. Overall survival

    Measured: 5 years

  4. Best objective response (only in stage IV)

    Measured: 5 years

Timeline

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

  1. First posted7 Nov 2014 (estimated)
  2. Study startFeb 2011
  3. Primary completionOct 2015
  4. Study completionApr 2016

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02285413
Sponsor's protocol ID
NL32381.000.10
Status last verified
May 2016
First submitted
11 May 2013
Last updated
4 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DC vaccination and DC vaccination with cisplatinum in people with Melanoma, run by Radboud University Medical Center at 1 site in Netherlands.

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 16 inclusion and 7 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 4 May 2016. 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 Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Immunogenicity: number of participants with KLH and/or tumor-specific antigens immune responses. (time frame: 5 years). The study lists 2 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 NCT02285413.

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 4 May 2016.

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