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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03291002
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : April 17, 2020
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
CureVac AG

Tracking Information
First Submitted Date  ICMJE September 15, 2017
First Posted Date  ICMJE September 25, 2017
Last Update Posted Date April 17, 2020
Actual Study Start Date  ICMJE September 25, 2017
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2017)
  • 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 anti-PD-1 therapy
  • Incidence of treatment related (Serious) Adverse Events (Tolerability and Safety profile) [ Time Frame: up to 9 months (end of study) ]
    • Tolerability and safety profile of CV8102 alone and in combination with anti-PD-1 therapy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2017)
  • Tumor response [ Time Frame: up to 9 months (end of study) ]
    • Anti-tumor activity of CV8102 per irRECIST and RECIST 1.1
  • Disease status [ Time Frame: 6 months ]
    • Tumor Assessment
  • Tumor response [ Time Frame: up to 9 months (end of study) ]
    • Extent of tumor response at injected and non-injected lesions, if applicable
  • Survival [ Time Frame: up to 9 months (end of study) ]
    • Survival time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Melanoma (Skin)
  • Squamous Cell Carcinoma of the Skin
  • Carcinoma, Squamous Cell of Head and Neck
  • Carcinoma, Adenoid Cystic
Intervention  ICMJE
  • Biological: CV8102
    CV8102 alone
  • Biological: CV8102 + anti-PD-1 therapy
    CV8102 in combination with standard of care anti-PD-1 therapy
Study Arms  ICMJE
  • Experimental: Cohort A
    Dose escalation of CV8102
    Intervention: Biological: CV8102
  • Experimental: Cohort B
    Optional expansion cohorts of CV8102
    Intervention: Biological: CV8102
  • Experimental: Cohort C
    Dose escalation of CV8102 + anti-PD-1 therapy
    Intervention: Biological: CV8102 + anti-PD-1 therapy
  • Experimental: Cohort D
    Optional expansion of CV8102 + anti-PD-1 therapy
    Intervention: Biological: CV8102 + anti-PD-1 therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2020)
233
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2017)
104
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 resection or locoregional radiation therapy with curative intent
    • failed approved standard therapies or for whom no standard therapy is available
    • at least 1 line of anti-cancer therapy for advanced disease (except adenoid cystic carcinoma)
  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
  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 (Cohort D1b)
  4. Patients enrolled into Cohort D2 (CV8102 in combination with anti-PD-1 therapy) must have

    • histologically confirmed advanced hnSCC
    • patients refractory to anti-PD-1
  5. Presence of at least one injectable lesion that is measurable acc. to RECIST 1.1
  6. Recovered from prior toxicities to grade ≤ 1
  7. ECOG PS 0 or 1
  8. 18 years of age or older
  9. Adequate hematologic, renal, hepatic and coagulation function
  10. 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 administered 2-4 weeks prior to the first dose of study drug depending on the indication
  6. Tumors to be injected lying 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 full dose anticoagulation within one week prior to enrollment; patients with melanoma and cutaneous squamous cell carcinoma with controlled oral anticoagulation are eligible
  9. Treatment with any investigational anticancer agent within 4 weeks prior to the first dose of study drug
  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. Systemic treatment with corticosteroids or other immunosuppressive medication 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)
  14. Known malignancies or other types 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas Eigentler, Prof. Dr. +49 7071 298 4553 thomas.eigentler@med.uni-tuebingen.de
Listed Location Countries  ICMJE France,   Germany,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03291002
Other Study ID Numbers  ICMJE CV-8102-008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CureVac AG
Study Sponsor  ICMJE CureVac AG
Collaborators  ICMJE Syneos Health
Investigators  ICMJE
Principal Investigator: Thomas Eigentler, Prof. Dr. thomas.eigentler@med.uni-tuebingen.de
PRS Account CureVac AG
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP