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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03291002
Recruitment Status : Active, not recruiting
First Posted : September 25, 2017
Last Update Posted : November 4, 2021
Sponsor:
Collaborators:
Syneos Health
Cromos Pharma LLC
Information provided by (Responsible Party):
CureVac

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Melanoma (Skin) Squamous Cell Carcinoma of the Skin Carcinoma, Squamous Cell of Head and Neck Carcinoma, Adenoid Cystic Biological: CV8102 Biological: CV8102 + anti-PD-1 therapy Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, cohort-based, dose escalation and expansion study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A
Dose escalation of CV8102
 Biological: CV8102
CV8102 alone
Experimental: Cohort B
Optional expansion cohorts of CV8102
 Biological: CV8102
CV8102 alone
Experimental: Cohort C
Dose escalation of CV8102 + anti-PD-1 therapy
 Biological: CV8102 + anti-PD-1 therapy
CV8102 in combination with standard of care anti-PD-1 therapy
Experimental: Cohort D
Optional expansion of CV8102 + anti-PD-1 therapy
 Biological: CV8102 + anti-PD-1 therapy
CV8102 in combination with standard of care anti-PD-1 therapy


Outcome Measures
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Primary Outcome Measures :
  1. Dose determination for dose escalation cohorts [ Time Frame: 2 weeks ]
    • 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

  2. Incidence of treatment related (Serious) Adverse Events (Tolerability and Safety profile) [ Time Frame: up to 12 months (end of study) ]
    • Tolerability and safety profile of CV8102 alone and in combination with anti-PD-1 antagonists


Secondary Outcome Measures :
  1. Tumor response [ Time Frame: up to 12 months (end of study) ]
    • Anti-tumor activity of CV8102 per irRECIST and RECIST 1.1

  2. Disease status [ Time Frame: 6 months ]
    • Tumor Assessment

  3. Tumor response [ Time Frame: up to 12 months (end of study) ]
    • Extent of tumor response at injected and non-injected lesions, if applicable

  4. Survival [ Time Frame: up to 12 months (end of study) ]
    • Survival time


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. 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

  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

Key Exclusion Criteria:

  1. Rapidly progressing multi-focal metastatic or acutely life threatening disease
  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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291002


Locations
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Sponsors and Collaborators
CureVac
Syneos Health
Cromos Pharma LLC
Investigators
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Principal Investigator: Thomas Eigentler, Prof. Dr. thomas.eigentler@charite.de
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: CureVac
ClinicalTrials.gov Identifier: NCT03291002    
Other Study ID Numbers: CV-8102-008
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Melanoma
Carcinoma, Squamous Cell
Skin Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
 Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Squamous Cell
Neoplasms by Site
Skin Diseases
Head and Neck Neoplasms
Adenocarcinoma