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Melanoma (Skin)Phase 1NCT03291002

Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC

A Phase 1 study testing CV8102 and CV8102 + anti-PD-1 therapy in people with Melanoma (Skin) and Squamous Cell Carcinoma of the Skin, run by CureVac at 22 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study evaluates intratumoral administration of CV8102 in patients with advanced melanoma, squamous cell carcinoma of the skin, squamous cell carcinoma of the head and neck, or adenoid cystic carcinoma. Patients will receive CV8102 as single agent or in combination with SoC anti-PD-1 therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CV8102 and CV8102 + anti-PD-1 therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
22 sitesin 5 countries
Study dates
25 Sep 2017to Feb 2023
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

  • Patients enrolled into Cohorts A and B (single agent CV8102) must have:
  • histologically confirmed advanced cutaneous melanoma, cutaneous squamous cell carcinoma, head and neck squamous cell carcinoma, or adenoid cystic carcinoma with documented disease progression
  • not amenable to surgical resection or locoregional radiation therapy with curative intent
  • at least 1 line of anti-cancer therapy for advanced disease (except adenoid cystic carcinoma) and documented Progression
  • cutaneous melanoma Cohort B3: Willing to undergo baseline and post-baseline biopsy of the lesion which is to be injected
  • Patients enrolled into Cohort C (CV8102 in combination with anti-PD-1 therapy) must have
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  • histologically confirmed advanced cMEL or hnSCC
  • indication for anti-PD-1 therapy or currently receiving anti-PD-1 therapy with stable of slowly progressing disease after at last 8 weeks (hnSCC) or 12 weeks (cMEL) of anti-PD-1 therapy prior to Day 1
  • Patients enrolled into Cohort D1 (CV8102 in combination with anti-PD-1 therapy) must have
  • histologically confirmed advanced cMEL
  • either anti-PD-1 naive patients with indication for anti-PD-1 therapy (Cohort D1a) or patients refractory to anti-PD-1 therapy (Cohort D1b)
  • Presence of measurable lesion(s) according to RECIST 1.1, not intended for injection
  • Willing to undergo tumor biopsies at specific timepoints (Cohort D1a: baseline; Cohort D1b baseline and post-baseline biopsy of the injected lesion - only for selected sites)
  • Patients enrolled into Cohort D2 (CV8102 in combination with anti-PD-1 therapy) must have
  • histologically confirmed advanced hnSCC
  • indication for treatment with first-line pembrolizumab (patients naive to anti-PD-1/anti-PD-L1)
  • PD-L1 combined positive score ≥ 1% according to local practice
  • Presence of at least one injectable tumor lesion that is measurable according to RECIST 1.1
  • Recovered from prior toxicities to CTCAE grade ≤ 1 or grade ≤ 2
  • Resolution of CPI-related adverse effects, if applicable (including irAEs) back to CTCAE grade 0/1
  • ECOG PS 0 or 1
  • 18 years of age or older
  • Adequate hematologic, renal, hepatic and coagulation function
  • Use of effective contraception

Who cannot join

  • Rapidly progressing multi-focal metastatic or acutely life threatening disease
  • Prior use of topical/localTLR-7/8 agonists within the past 6 months
  • Clinically active central nervous system metastases and/or carcinomatous meningitis (patients with stable brain metastases are eligible)
  • Ocular and mucosal melanoma
  • Prior anti-cancer therapy within specified time-periods depending on the indication
  • Tumor lesions that are to be injected close to major blood vessels or nerves, or whose injection could potentially result in clinical adverse effects if post-treatment tumor swelling or inflammation were to occur
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  • Lesions that are to be injected in previously irradiated areas unless progressive tumor growth has been demonstrated (no prior irradiation of injected lesions on patients with melanoma)
  • History of active coagulation or bleeding disorder or need for ongoing therapeutic anticoagulation that cannot be safely interrupted at th etime of IT injection or biopsy du eto Underlying medical conditions; patients with melanoma and cutaneous squamous cell carcinoma with controlled oral anticoagulation are eligible
  • Treatment with any investigational anticancer agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or planned during the study
  • Acute hypophysitis or endocrinopathies that are not adequately controlled by hormonal replacement therapy or thyreostatic treatment
  • Use of immune modulating drugs or immunologically active topical therapies within 28 days of administration of the first dose of study drug
  • Chronic systemic immunosuppressive therapy including chronic corticosteroids within 28 days of the first dose of study drug (except physiological maintenance/replacement steroid doses, topical steroids outside the injected lesion or inhaled steroids); patients are eligible if steroid requirement is < 10 mg/day of prednisone (or equivalent) for at least 2 weeks
  • History of active autoimmune disease requiring immunosuppressive medication (except Vitiligo and except CPI-mediated irAEs)
  • Known hematologic malignancy or malignant primary solid tumor that have occured or reoccurred within the previous 5 years
  • Recent thromboembolic complications, or clinically significant cardiovascular disease, or any other uncontrolled illness that would pose a risk to patient safety
  • Severe infection or acute inflammatory state
  • Seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) surface antigen (except in previously vaccinated patients) or hepatitis C virus (HCV)

Trial locations and contacts

22 sites in 5 countries.

22 sites in 5 countries

Germany9 sites

  • Charité Benjamin Franklin

    Berlin

  • Medizinische Klinik III, Universitätsklinikum Bonn, Hämatologie, Immunonkologie und Rheumatologie

    Bonn

  • Elbe-Klinikum-Buxtehude, Hautkrebszentrum

    Buxtehude

  • Universitätsklinikum Erlangen,Hautklinik, Internistisches Zentrum (INZ)

    Erlangen

  • Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg

    Heidelberg

  • Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Allergologie und Venerologie

    Lübeck

  • Fachklinik Hornheide

    Münster

  • Universitätsklinikum Münster, Klinik für Hautkrankheiten, ZiD- Zentrum für innovative Dermatologie

    Münster

  • Universitäts-Hautklinik, Abtl. Dermatologische Onkologie

    Tübingen

Other trials in Germany

Spain5 sites

  • Hospital Duran i Reynals - Institut Catala dOncologia ICO

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital Ramon y Cajal

    Madrid

  • Hospital Universitario Virgen de la Victoria

    Málaga

  • Hospital Universitario Marqus de Valdecilla Santander

    Santander

Other trials in Spain

Russia4 sites

  • Center for Personalized Oncology, I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation

    Moscow

  • FSBI "National Medical Research Center of Oncology n.a. N.N. Blokhin" of the Ministry of Healthcare of the Russian Federation

    Moscow

  • FSBI "National Medical Research Oncology Center n.a. N.N. Petrov

    Saint Petersburg

  • Saint-Petersburg State University, Clinic of advanced medical technologies n. a. Nicolay I. Pirogov.

    Saint Petersburg

Other trials in Russia

Austria2 sites

  • Medical University of Graz

    Graz

  • Universitätsklinik für Dermatologie der Paracelsus medizinischen Privatuniversität Salzburg

    Salzburg

Other trials in Austria

France2 sites

  • Hôpital Saint Louis

    Paris

  • Institut Gustave Roussy

    Paris

Other trials in France

About this study

Official title: Phase I Study of Intratumoral CV8102 in Patients With Advanced Melanoma, Squamous Cell Carcinoma of the Skin, Squamous Cell Carcinoma of the Head and Neck, or Adenoid Cystic Carcinoma

This study evaluates intratumoral administration of CV8102 in patients with advanced melanoma, squamous cell carcinoma of the skin, squamous cell carcinoma of the head and neck, or adenoid cystic carcinoma.

Patients will receive CV8102 as single agent or in combination with SoC anti-PD-1 therapy.

Being tested
CV8102, CV8102 + anti-PD-1 therapy
Medical subject headings
Melanoma, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Adenoid Cystic

What participants receive

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

  • CV8102Biological

    CV8102 alone

  • CV8102 + anti-PD-1 therapyBiological

    CV8102 in combination with standard of care anti-PD-1 therapy

Study groups in NCT03291002
Study groupRoleWhat they receive
Cohort AExperimentalDose escalation of CV8102
Receives: Biological: CV8102
Cohort BExperimentalOptional expansion cohorts of CV8102
Receives: Biological: CV8102
Cohort CExperimentalDose escalation of CV8102 + anti-PD-1 therapy
Receives: Biological: CV8102 + anti-PD-1 therapy
Cohort DExperimentalOptional expansion of CV8102 + anti-PD-1 therapy
Receives: Biological: CV8102 + anti-PD-1 therapy

What is being measured

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

  1. Dose determination for dose escalation cohorts

    • Maximum tolerated dose (MTD) and recommended dose (RD), respectively, for CV8102 alone
    • MTD and recommended combination dose (RCD) for CV8102 in combination with the standard dose of an anti-PD-1 antagonist

    Measured: 2 weeks

  2. Incidence of treatment related (Serious) Adverse Events (Tolerability and Safety profile)

    • Tolerability and safety profile of CV8102 alone and in combination with anti-PD-1 antagonists

    Measured: up to 12 months (end of study)

Secondary outcomes (4)

  1. Tumor response

    • Anti-tumor activity of CV8102 per irRECIST and RECIST 1.1

    Measured: up to 12 months (end of study)

  2. Disease status

    • Tumor Assessment

    Measured: 6 months

  3. Tumor response

    • Extent of tumor response at injected and non-injected lesions, if applicable

    Measured: up to 12 months (end of study)

  4. Survival

    • Survival time

    Measured: up to 12 months (end of study)

Timeline

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

  1. First posted25 Sep 2017
  2. Study start25 Sep 2017
  3. Primary completionOct 2022 (estimated)
  4. Study completionFeb 2023 (estimated)

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
Non-randomised
Intervention model
Single group
Model description
Open-label, cohort-based, dose escalation and expansion study
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03291002
Sponsor's protocol ID
CV-8102-008
Status last verified
Nov 2021
First submitted
15 Sep 2017
Last updated
4 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eigentler T, Thomas I, Samoylenko I, Erdmann M, Heinzerling L, Ochsenreither S, Krauss J, Oberoi A, Robert C, Lebbe C, Martin-Liberal J, Koch L, Richtig E, Terheyden P, Weishaupt C, Mohr P, Semiletova Y, Perez CL, Brossart P, Bauernfeind FG, Fluck M, Poltoratskiy A, Sekacheva M, Soria A, Schmitt-Bormann B, Gonzalez M, Hess J, Wengenmayer P, Seibel T, Koch SD, Quintini G, Codo P, Falk M, Schonborn-Kellenberger O, Gnad-Vogt U. Phase I study of intratumoral administration of CV8102 in patients with advanced melanoma, squamous cell carcinoma of the skin, squamous cell carcinoma of the head and neck, or adenoid cystic carcinoma. J Immunother Cancer. 2025 Feb 4;13(2):e009352. doi: 10.1136/jitc-2024-009352.

    PubMed 39904560

  • Lutz J, Meister M, Habbeddine M, Fiedler K, Kowalczyk A, Heidenreich R. Local immunotherapy with the RNA-based immune stimulator CV8102 induces substantial anti-tumor responses and enhances checkpoint inhibitor activity. Cancer Immunol Immunother. 2023 May;72(5):1075-1087. doi: 10.1007/s00262-022-03311-4. Epub 2022 Nov 2.

    PubMed 36319717

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CV8102 and CV8102 + anti-PD-1 therapy in people with Melanoma (Skin) and Squamous Cell Carcinoma of the Skin, run by CureVac at 22 sites in 5 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 24 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Germany, Spain, Russia, Austria, France. 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?

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?

Dose determination for dose escalation cohorts (time frame: 2 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 NCT03291002, which also lists 2 linked publications.

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 Nov 2021.

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