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



September 2017

Letztes Update:

CV8102, CV8102 + anti-PD-1 therapy

Indikation (Clinical Trials):
Carcinoma, Melanoma, Carcinoma, Squamous Cell, Skin Neoplasms, Carcinoma, Adenoid Cystic, Squamous Cell Carcinoma of Head and Neck


Erwachsene (18+)

Phase 1

CureVac AG

Syneos Health


Thomas Eigentler, Prof. Dr.
Principal Investigator


Thomas Eigentler, Prof. Dr.
Phone: +49 7071 298 4553
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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.


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


- 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


- 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


- 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


- histologically confirmed advanced hnSCC

- indication for treatment with first-line pembrolizumab (patients naive to


- PD-L1 combined positive score ≥ 1% according to local practice

5. Presence of at least one injectable tumor lesion that is measurable according to


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


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)


Primary outcome:

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:

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


  • Experimental: Cohort A
    Dose escalation of CV8102
  • Experimental: Cohort B
    Optional expansion cohorts of CV8102
  • Experimental: Cohort C
    Dose escalation of CV8102 + anti-PD-1 therapy
  • Experimental: Cohort D
    Optional expansion of CV8102 + anti-PD-1 therapy

Geprüfte Regime

  • CV8102:
    CV8102 alone
  • CV8102 + anti-PD-1 therapy:
    CV8102 in combination with standard of care anti-PD-1 therapy


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