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Prostate CancerPhase 1/2NCT01817738

Trial of RNActive®-Derived Prostate Cancer Vaccine in Metastatic Castrate-refractory Prostate Cancer

A Phase 1/2 study testing CV9104 in people with Prostate Cancer, run by CureVac at 48 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine whether the new RNActive®-derived prostate cancer vaccine CV9104 prolongs survival in patients with asymptomatic or minimally symptomatic metastatic prostate cancer that is castrate resistant. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
CV9104
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
197 participants
Where
48 sitesin 8 countries
Study dates
Aug 2012to Jan 2017
Phase
Phase 1/2
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male, age ≥18 years
  • Histologically confirmed castrate refractory metastatic adenocarcinoma of the prostate with progressive disease after surgical castration or during androgen suppression therapy including a GNRH agonist or antagonist and after at least 1 additional anti-hormonal manipulation; and serum testosterone level of < 50 ng/dL or < 1.7 nmol/L
  • Progression will be confirmed either
  • radiologically or
  • by 2 consecutive rises of PSA, measured at least 1 week apart, resulting at least in a 50% increase over the nadir and a PSA > 2 ng/mL.
  • An antiandrogen withdrawal response must have been excluded after discontinuation of antiandrogen therapy for at least 6 weeks.
  • Metastatic disease confirmed by imaging
  • ECOG performance status 0 or 1

Who cannot join

  • Previous immunotherapy for PCA (e.g. sipuleucel-T [Provenge®], experimental cancer vaccines or ipilimumab [Yervoy®]).
  • Treatment with any investigational anticancer agents within 4 weeks prior to first dose of study drug
  • Systemic treatment with immunosuppressive agents
  • Active skin disease (atopic eczema, psoriasis) in the areas for vaccine injection (upper arms or thighs) preventing the administration of i.d. injections into areas of healthy skin.
  • History of or current autoimmune disorders
  • Primary or secondary immune deficiency.
Show all 13Show fewer
  • Seropositive for human immunodeficiency virus, hepatitis B virus (except after hepatitis B vaccination) or hepatitis C virus infection.
  • Symptomatic congestive heart failure (New York Heart Association 3 or 4), unstable angina pectoris or myocardial infarction, significant cardiac arrhythmia, history of stroke or transient ischemic attack, all within 6 months prior to enrolment or severe hypertension according to WHO criteria or uncontrolled hypertension at the time of enrolment (systolic blood pressure ≥ 180 mm Hg)´
  • Previous chemotherapy for metastatic PCA.
  • Previous anti-hormonal treatment with abiraterone or any other investigational anti-hormonal treatment.
  • Cancer-related pain requiring opioid narcotics within 28 days before enrolment or an average pain score of > 3 on a visual analogue scale.
  • Presence of visceral metastases.
  • History of other malignancies other than PCA over the last 5 years (except basal cell carcinoma of the skin).

Trial locations and contacts

48 sites in 8 countries.

48 sites in 8 countries

Germany16 sites

  • Universitätsklinikum Aachen Klinik für Urologie

    Aachen, D-52074

  • Vivantes Klinikum Am Urban Klinik für Urologie

    Berlin, D-10967

  • Medizinisches Zentrum Friedensplatz

    Bonn, 53111

  • Universitätsklinikum Dresden Klinik und Poliklinik für Urologie

    Dresden, D-01307

  • Chirurgische Universitätsklinik Freiburg Klinik für Urologie

    Freiburg im Breisgau, D-79106

  • Urologikum Hamburg

    Hamburg, 22081

  • Nationales Zentrum für Tumorerkrankungen Medizinische Onkologie

    Heidelberg, D-69120

  • Urologie am Nordplatz

    Leipzig, 04105

  • UMM Universitätsmedizin Mannheim

    Mannheim, 68167

  • Praxis Dr.schulze

    Marklleeberg, 04416

  • Urologische Klinik und Poliklinik der Technischen Universität München Klinikum Rechts der Isar

    Munich, D-81675

  • Universitätsklinikum Münster Klinik und Poliklinik für Urologie

    Münster, D-48149

  • Studienpraxis für Urologie

    Nürtingen, D-72622

  • Ortenau Klinikum Urologie und Kinderurologie

    Offenburg, 77654

  • Urologische Klinik Dr. Castingius München

    Planegg, 82152

  • Universitätsklinik für Urologie

    Tübingen, D-72076

Other trials in Germany

Poland8 sites

  • Medica Pro Familia Krakow

    Krakow, 30-002

  • Centrum Urologiczne Sp. z o.o.

    Mysłowice, 41-400

  • Centralny Szpital Kliniczny MSWiA, Klinika Onkologii I Hematologii

    Warsaw, 02-507

  • Szpital Sw. Elżbiety - Mokotowskie Centrum Medyczne

    Warsaw, 02-616

  • Instytut M. Curie-Skłodowskiej Centrum Onkologii

    Warsaw, 02-781

  • NZOZ Magodent, Centrum Medyczne Ostrobramska, Oncologii Klinicznej i Chemíoterapii

    Warsaw, 04-125

  • Profesorskie Centrum Medyczne OPTIMUM Wrocław

    Wroclaw, 50-421

  • Szpital Uniwersytecki, Katedra i Klinika Urologii i Onkologii Urologicznej

    Wroclaw, 50-556

Other trials in Poland

Czechia5 sites

  • Krajská zdravotní, a.s. - Nemocnice Chomutov, o.z.Onkologické oddělení

    Chomutov, 430 12

  • Fakultní nemocnice Olomouc, Urologická klinika

    Olomouc, 779 00

  • Multiscan, a.s, Oddělení klinické a radiační onkologie

    Pardubice, 532 03

  • Thomayerova nemocnice, Urologické oddělení

    Prague, 140 59

  • Krajská zdravotní, a.s. - Masarykova nemocnice Ústí nad Labem

    Ústí nad Labem, 401 13

Other trials in Czechia

Spain5 sites

  • Hospital de Madrid Norte Sanchinarro Centro Integral Oncológico Clara Campal (CIOCC)

    Madrid, 28050

  • Hospital Clínico Virgen de la Victoria Campus Universitario de Teatinos s/n

    Málaga, 29010

  • Clínica Universitaria de Navarra Departamento de Oncología

    Pamplona, 31008

  • Complejo Hospitalario Universitario Santiago Departamento de Oncología

    Santiago de Compostela, 15703

  • Instituto Valenciano de Oncología Unidad de Investigación Clínica

    Valencia, 46009

Other trials in Spain

Sweden5 sites

  • "Sahlgrenska Universitetssjukhuset Urologmottagningen

    Gothenburg, 41345

  • Skånes Universitetssjukhus Malmö Urologmottagningen

    Malmö, 20502

  • Universitetssjukhuset Örebro Urologmottagningen

    Örebro, 70185

  • Karolinska Universitetssjukhuset Solna Urologiska kliniken

    Stockholm, 17176

  • Akademiska sjukhuset Urologmottagningen

    Uppsala, 75185

Other trials in Sweden

Switzerland4 sites

  • Universitätsspital Basel Medizinische Onkologie

    Basel, 4031

  • Kantonsspital Graubünden Department Innere Medizin Hämatologie und Onkologie

    Chur, 7000

  • CHUV Centre Pluridisciplinaire d'Oncologie

    Lausanne, 1011

  • Kantonsspital St. Gallen Department Innere Medizin Hämatologie Medizinische Onkologie

    Sankt Gallen, 9007

Other trials in Switzerland

United Kingdom4 sites

  • Royal Free Hospital

    London, NW32QC

  • Nottingham City Hospital Department of Oncology

    Nottingham, NG5 1PB

  • Clatterbridge Cancer Centre

    Wirral, Merseyside, CH63 4JY

  • York Hospital

    York, Y03 8HE

Other trials in United Kingdom

France1 site

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Phase I/II Trial of RNActive®-Derived Cancer Vaccine (CV9104) in Asymptomatic or Minimally Symptomatic Patients With Metastatic Castrate-refractory Prostate Cancer

The purpose of this study is to determine whether the new RNActive®-derived prostate cancer vaccine CV9104 prolongs survival in patients with asymptomatic or minimally symptomatic metastatic prostate cancer that is castrate resistant.

Read the detailed description

The study is the first clinical study with the new prostate cancer vaccine CV9104. This vaccine is composed of 6RNActive®-based compounds, each encoding for an antigen that is overexpressed in prostate cancer compared to healthy tissues. RNActive®-based vaccines are a novel class of vaccines based on messenger RNA.

The study is a double-blind randomized placebo-controlled phase I/II trial in men with asymptomatic- minimally symptomatic metastatic castrate-refractory prostate cancer.

The phase 1 (safety lead- in) part of the trial has the primary objective to assess the safety of CV9104 and to determine the dose for the randomized phase II part.

The primary objective of the phase II part is to compare overall survival in patients treated with CV9104 compared to patients treated with placebo.

Conditions
Prostate Cancer
Being tested
CV9104, Placebo
Keywords
Metastatic, Castrate-refractory
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

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

  • CV9104Biological

    Intradermal injection of CV9104

  • PlaceboBiological

    Intradermal injection of placebo

Study groups in NCT01817738
Study groupRoleWhat they receive
CV9104Active comparatorCV9104 intradermal injection
Receives: Biological: CV9104
PlaceboPlacebo comparatorPlacebo intradermal injection
Receives: Biological: Placebo

What is being measured

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

  1. Phase I (Safety Lead-In): Occurrence of dose-limiting toxicity (DLT) during the first 4 weeks of treatment (after administration of 3 vaccinations and after a 1 week observation period

    Safety Lead in Portion:

    Patients will receive CV9104 at a starting dose of 1920 µg in weeks 1, 2 and 3. Safety lead-in patients will be observed for DLTs until 1 week after Vaccination 3 (week 4). In case no DLTs will be observed vaccinations will continue in weeks 5, 7, 9, 12, 15, 18 and 24, then every 6 weeks for up to 12 months after the first vaccination and then every 3 months thereafter until one of the criteria for study treatment discontinuation is met

    Measured: Up to 4 weeks

  2. Phase II (Randomised Portion): Overall Survival from time of randomisation- up to 3.5-4 years.

    Measured: Overall survival will be assessed during the lifetime of the study

Secondary outcomes (7)

  1. Progression free survival from date of randomisation

    Measured: Every 3 months for up to 2 years

  2. Progression free survival from start of first subsequent systemic therapy

    Measured: Every 6 months until 2 years

  3. Percent change to maximal and to minimal PSA from baseline and before start of first subsequent systemic cancer therapy and from start of first systemic therapy to end of first subsequent systemic therapy

    Measured: Every 3 months up to 2 years

  4. Cellular and humoral immune response rate against the 6 antigens encoded by CV9104

    Measured: Immune responses will be assessed at baseline, in week 6 and week 24 after start of vaccination

  5. Time to symptom progression based on FACT P score and subscores

    Measured: Assessments at baseline, weeks 5, 9,18, 24 and every 3 months for up to 2 years

  6. Absolute change and area under the curve from baseline EQ-5D score and pain sub-score

    Measured: Assessments at baseline, weeks 5, 9,18, 24 and thereafter every 3 months for up to 2 years

  7. Progression free survival from randomisation until second progression on first subsequent therapy

    Measured: Every 3 and 6 months up to 2 years

Timeline

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

  1. First posted25 Mar 2013 (estimated)
  2. Study startAug 2012
  3. Primary completionAug 2016
  4. Study completionJan 2017

Why it stopped: Follow up period after primary analysis was prematurely stopped because more mature data will not impact the study outcome

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01817738
Sponsor's protocol ID
CV-9104-004
Status last verified
Apr 2016
First submitted
8 Feb 2013
Last updated
17 Feb 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CV9104 in people with Prostate Cancer, run by CureVac at 48 sites in 8 countries.

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 8 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: stopped early, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Germany, Poland, Czechia, Spain, Sweden and 3 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

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 was stopped early (reason given: Follow up period after primary analysis was prematurely stopped because more mature data will not impact the study outcome). Results are not available in the source record.

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?

Phase I (Safety Lead-In): Occurrence of dose-limiting toxicity (DLT) during the first 4 weeks of treatment (after administration of 3 vaccinations and after a 1 week observation period (time frame: Up to 4 weeks). 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 NCT01817738.

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 17 Feb 2017.

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