Study of Intratumoral CV8102 in cMEL cSCC hnSCC and ACC

  • STATUS
    Recruiting
  • End date
    Feb 28, 2023
  • participants needed
    98
  • sponsor
    CureVac AG
Updated on 29 January 2021
Investigator
Thomas Eigenlter, Dr.
Primary Contact
Investigative Site (9.4 mi away) Contact
+29 other location
cancer
measurable disease
carcinoma
melanoma skin
squamous cell carcinoma
non-melanoma skin cancer
pembrolizumab
squamous cell carcinoma of the head and neck
carcinoma of the head and neck
head and neck carcinoma
malignant melanoma of skin

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.

Details
Condition Adenoid Cystic Carcinoma, melanoma, skin cancer, Metastatic Melanoma, Squamous Cell Carcinoma of the Skin, Cutaneous Squamous Cell Carcinoma, Skin Squamous Cell Carcinoma, Carcinoma, Squamous Cell of Head and Neck, Carcinoma, Squamous Cell of Head and Neck, Carcinoma, Squamous Cell of Head and Neck, Malignant Melanoma, Carcinoma, Squamous Cell of Head and Neck, Carcinoma, Squamous Cell of Head and Neck, Carcinoma, Squamous Cell of Head and Neck, Carcinoma, Squamous Cell of Head and Neck, Carcinoma, Squamous Cell of Head and Neck, Carcinoma, Squamous Cell of Head and Neck, squamous cell skin cancer, Carcinoma, Squamous Cell of Head and Neck
Treatment CV8102, CV8102 + anti-PD-1 therapy
Clinical Study IdentifierNCT03291002
SponsorCureVac AG
Last Modified on29 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Metastatic Melanoma or Adenoid Cystic Carcinoma or skin cancer or Malignant Melanoma or Squamous Cell Carcinoma of the Skin or Carcinoma, Squamous Cel...?
Do you have any of these conditions: melanoma or Adenoid Cystic Carcinoma or squamous cell skin cancer or skin cancer or Cutaneous Squamous Cell Carcinoma or Squamous Cell Carcinoma of th...?
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
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
Patients enrolled into Cohort D2 (CV8102 in combination with anti-PD-1 therapy) must have
histologically confirmed advanced hnSCC
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)
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
ECOG PS 0 or 1
18 years of age or older
Presence of at least one injectable tumor lesion that is measurable according to RECIST 1.1
Adequate hematologic, renal, hepatic and coagulation function
Recovered from prior toxicities to CTCAE grade 1 or grade 2
Use of effective contraception
Resolution of CPI-related adverse effects, if applicable (including irAEs) back to CTCAE grade 0/1

Exclusion Criteria

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
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)
Prior anti-cancer therapy within specified time-periods depending on the indication
Acute hypophysitis or endocrinopathies that are not adequately controlled by hormonal replacement therapy or thyreostatic treatment
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
Use of immune modulating drugs or immunologically active topical therapies within 28 days of administration of the first dose of study drug
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
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
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
Seropositivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) surface antigen (except in previously vaccinated patients) or hepatitis C virus (HCV)
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