Abstract 3305
Background
Intratumoral injection of immunomodulating agents is a promising approach to prime antitumor immune responses and to control tumor growth while avoiding major systemic toxicities. Intratumoral CV8102, a TLR7/8/RIG-1 agonist based on noncoding single stranded RNA showed dose dependent single agent activity and synergism with PD-1 blockade in preclinical models.
Trial design
CV-8102-008 (NCT03291002) is a phase I, open-label, dose escalation and expansion study of intratumoral CV8102 in patients with advanced, inoperable cutaneous melanoma (cMEL), squamous cell carcinoma of the skin (cSCC) or head and neck (hnSCC) or adenoid cystic carcinoma (ACC). Eight intratumoral injections of CV8102 are provided over a 12 weeks period, unless disease progression requiring initiation of next-line therapy or unacceptable toxicity occurs. Patients showing evidence of clinical benefit on single agent CV8102 are eligible for further treatment. Currently the first part of the trial, with escalating doses of single agent CV8102 and CV8102 in combination with anti-PD-1 antibodies to determine the maximum tolerated/ recommended dose (MTD/RCD) guided by a Bayesian logistic regression model with overdose control. and flexible cohort sizes is ongoing. Safety, biological and tumor response according to RECIST 1.1/ir RECIST of CV8102 alone/in combination with anti-PD-1 antibodies will be further characterized in expansion cohorts including anti-PD-1 naïve and refractory patients.
Clinical trial identification
NCT03291002.
Editorial acknowledgement
Legal entity responsible for the study
CureVac AG.
Funding
CureVac AG.
Disclosure
J. Krauss: Advisory / Consultancy: Vaccibody; Advisory / Consultancy: Zelluna; Research grant / Funding (self): Heidelberg ImmunoTherapeutics. T. Eigentler: Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony: Pierre Fabre; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb. C. Weishaupt: Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony: Amgen; Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): BMS; Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony: CureVac; Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony: La Roche Posay; Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony: Leo Pharma; Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD; Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony: Pierre Fabre; Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony: Sanofi; Honoraria (institution), Advisory / Consultancy, Speaker Bureau / Expert testimony: Takeda. P. Terheyden: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre-Fabre; Honoraria (self), Advisory / Consultancy: Roche; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Merck Serono; Honoraria (self): CureVac. L. Heinzerling: Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Amgen; Advisory / Consultancy: MSD; Advisory / Consultancy: BMS; Advisory / Consultancy: Roche; Advisory / Consultancy: CureVac; Advisory / Consultancy: Pierre-Fabre; Advisory / Consultancy: Sanofi. P. Mohr: Advisory / Consultancy, Shareholder / Stockholder / Stock options: Pierre Fabre; Advisory / Consultancy, Research grant / Funding (institution), Shareholder / Stockholder / Stock options: Merck; Advisory / Consultancy, Shareholder / Stockholder / Stock options: Roche; Advisory / Consultancy, Shareholder / Stockholder / Stock options: GSK; Advisory / Consultancy, Research grant / Funding (institution), Shareholder / Stockholder / Stock options: BMS; Advisory / Consultancy, Shareholder / Stockholder / Stock options: Novartis; Advisory / Consultancy: LEO; Advisory / Consultancy, Shareholder / Stockholder / Stock options: Amgen. B. Weide: Advisory / Consultancy: CureVac GmbH; Advisory / Consultancy, Research grant / Funding (self): BMS; Advisory / Consultancy, Research grant / Funding (self): MSD. S. Ochsenreither: Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: CureVac; Honoraria (self), Advisory / Consultancy: Glenmark; Honoraria (self), Advisory / Consultancy: Incyte. R. Gutzmer: Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Johnson&Johnson; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Merck-Serono; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche Pharma; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-MyersSquibb; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Almirall-Hermal; Honoraria (self), Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: SUN; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre-Fabre; Honoraria (self), Advisory / Consultancy: LEO; Honoraria (self), Advisory / Consultancy: 4SC; Honoraria (self), Advisory / Consultancy: Incyte; Honoraria (self), Advisory / Consultancy: Takeda. J.C. Becker: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Amgen; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Merck Serono; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Honoraria (self), Advisory / Consultancy: CureVac; Honoraria (self), Advisory / Consultancy: eTheRNA; Honoraria (self), Advisory / Consultancy: Lytix; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Rigontec; Honoraria (self), Advisory / Consultancy: Takeda; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: 4SC; Research grant / Funding (institution): Alcedis; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Bristol-Myers Squibb; Travel / Accommodation / Expenses: Incyt. F. Funkner: Full / Part-time employment: CureVac AG. R. Heidenreich: Full / Part-time employment: CureVac AG. S. Kays: Full / Part-time employment: CureVac AG. U. Klinkhardt: Full / Part-time employment, Former: CureVac; Full / Part-time employment: Boehringer Ingelheim. U.S. Gnad-Vogt: Full / Part-time employment, Officer / Board of Directors: CureVac AG. B. Scheel: Full / Part-time employment: CureVac AG. O. Schönborn-Kellenberger: Full / Part-time employment, consultant to CureVac AG: Cogitars GmbH. T. Seibel: Full / Part-time employment: CureVac AG. All other authors have declared no conflicts of interest.
Resources from the same session
3157 - Efficacy and safety of anlotinib in advanced leiomyosarcoma: Subgroup analysis of a phase IIB trial (ALTER0203)
Presenter: Yihebali Chi
Session: Poster Display session 1
Resources:
Abstract
3710 - The effect of treatment line on the efficacy of Anlotinib hydrochloride in advanced alveolar soft part sarcoma patients
Presenter: Zhiwei Fang
Session: Poster Display session 1
Resources:
Abstract
3184 - Prior exposure to pazopanib (PAZ) did not minor efficacy of regorafenib (REG) in non-adipocytic soft tissue sarcoma patients (pts)
Presenter: Nicolas Penel
Session: Poster Display session 1
Resources:
Abstract
798 - Pexidartinib (Pex) for locally advanced tenosynovial giant cell tumor (TGCT): characterization of hepatic adverse reactions (ARs)
Presenter: Sebastian Bauer
Session: Poster Display session 1
Resources:
Abstract
6117 - VEGFR2 and ITGA polymorphisms as novel pan-sarcoma biomarkers for sensitivity prediction as well as toxicity prevention anti-angiogenesis therapy in pediatric and young adult
Presenter: Qiyuan Bao
Session: Poster Display session 1
Resources:
Abstract
5450 - Reversion of resistance to mTOR inhibitors with the addition of exemestane in patients with malignant PEComa.
Presenter: Roberta Sanfilippo
Session: Poster Display session 1
Resources:
Abstract
4279 - Efficacy and Safety of VEGFR2 Inhibitor Apatinib combined with chemotherapy for Sarcoma in Stage IV
Presenter: Zhiwu Ren
Session: Poster Display session 1
Resources:
Abstract
5929 - Outcomes of metastatic soft tissue sarcoma treated with Pazopanib from dedicated medical oncology sarcoma clinic: A holistic care approach from a developing country
Presenter: Akhil Kapoor
Session: Poster Display session 1
Resources:
Abstract
2469 - Inhibition of mTOR signaling enhances Trabectedin activity in Soft Tissue Sarcoma
Presenter: David Moura
Session: Poster Display session 1
Resources:
Abstract
4210 - Efficacy and safety of apatinib for advanced gastrointestinal stromal tumors after failure of imatinib and sunitinib: An open-label, multicenter, single-arm, phase II trial
Presenter: Zhaolun Cai
Session: Poster Display session 1
Resources:
Abstract