Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC
NCT ID: NCT03291002
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
98 participants
INTERVENTIONAL
2017-09-25
2023-02-28
Brief Summary
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Patients will receive CV8102 as single agent or in combination with SoC anti-PD-1 therapy.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort A
Dose escalation of CV8102
CV8102
CV8102 alone
Cohort B
Optional expansion cohorts of CV8102
CV8102
CV8102 alone
Cohort C
Dose escalation of CV8102 + anti-PD-1 therapy
CV8102 + anti-PD-1 therapy
CV8102 in combination with standard of care anti-PD-1 therapy
Cohort D
Optional expansion of CV8102 + anti-PD-1 therapy
CV8102 + anti-PD-1 therapy
CV8102 in combination with standard of care anti-PD-1 therapy
Interventions
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CV8102
CV8102 alone
CV8102 + anti-PD-1 therapy
CV8102 in combination with standard of care anti-PD-1 therapy
Eligibility Criteria
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Inclusion Criteria
* 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
2. Patients enrolled into Cohort C (CV8102 in combination with anti-PD-1 therapy) must have
* 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
3. 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)
4. 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
5. Presence of at least one injectable tumor lesion that is measurable according to RECIST 1.1
6. Recovered from prior toxicities to CTCAE grade ≤ 1 or grade ≤ 2
7. Resolution of CPI-related adverse effects, if applicable (including irAEs) back to CTCAE grade 0/1
8. ECOG PS 0 or 1
9. 18 years of age or older
10. Adequate hematologic, renal, hepatic and coagulation function
11. Use of effective contraception
Exclusion Criteria
2. Prior use of topical/localTLR-7/8 agonists within the past 6 months
3. Clinically active central nervous system metastases and/or carcinomatous meningitis (patients with stable brain metastases are eligible)
4. Ocular and mucosal melanoma
5. Prior anti-cancer therapy within specified time-periods depending on the indication
6. 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
7. 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)
8. 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
9. 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
10. Acute hypophysitis or endocrinopathies that are not adequately controlled by hormonal replacement therapy or thyreostatic treatment
11. Use of immune modulating drugs or immunologically active topical therapies within 28 days of administration of the first dose of study drug
12. 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
13. History of active autoimmune disease requiring immunosuppressive medication (except Vitiligo and except CPI-mediated irAEs)
14. Known hematologic malignancy or malignant primary solid tumor that have occured or reoccurred within the previous 5 years
15. Recent thromboembolic complications, or clinically significant cardiovascular disease, or any other uncontrolled illness that would pose a risk to patient safety
16. Severe infection or acute inflammatory state
17. Seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) surface antigen (except in previously vaccinated patients) or hepatitis C virus (HCV)
18 Years
ALL
No
Sponsors
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Syneos Health
OTHER
Cromos Pharma LLC
INDUSTRY
CureVac
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Medical University of Graz
Graz, , Austria
Universitätsklinik für Dermatologie der Paracelsus medizinischen Privatuniversität Salzburg
Salzburg, , Austria
Hôpital Saint Louis
Paris, , France
Institut Gustave Roussy
Paris, , France
Charité Benjamin Franklin
Berlin, , Germany
Medizinische Klinik III, Universitätsklinikum Bonn, Hämatologie, Immunonkologie und Rheumatologie
Bonn, , Germany
Elbe-Klinikum-Buxtehude, Hautkrebszentrum
Buxtehude, , Germany
Universitätsklinikum Erlangen,Hautklinik, Internistisches Zentrum (INZ)
Erlangen, , Germany
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
Heidelberg, , Germany
Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Allergologie und Venerologie
Lübeck, , Germany
Fachklinik Hornheide
Münster, , Germany
Universitätsklinikum Münster, Klinik für Hautkrankheiten, ZiD- Zentrum für innovative Dermatologie
Münster, , Germany
Universitäts-Hautklinik, Abtl. Dermatologische Onkologie
Tübingen, , Germany
Center for Personalized Oncology, I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation
Moscow, , Russia
FSBI "National Medical Research Center of Oncology n.a. N.N. Blokhin" of the Ministry of Healthcare of the Russian Federation
Moscow, , Russia
FSBI "National Medical Research Oncology Center n.a. N.N. Petrov
Saint Petersburg, , Russia
Saint-Petersburg State University, Clinic of advanced medical technologies n. a. Nicolay I. Pirogov.
Saint Petersburg, , Russia
Hospital Duran i Reynals - Institut Catala dOncologia ICO
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Marqus de Valdecilla Santander
Santander, , Spain
Countries
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References
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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.
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.
Other Identifiers
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CV-8102-008
Identifier Type: -
Identifier Source: org_study_id