A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Mela… (NCT05578872) | Clinical Trial Compass
CompletedPhase 1/2
A Study of ANV419 Alone or in Combination With Approved Treatment in Patients With Cutaneous Melanoma (OMNIA-1).
United States29 participantsStarted 2022-12-16
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of ANV419 monotherapy or the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult participants with advanced (unresectable or metastatic) cutaneous melanoma. The study has 3 parts. Part 1 to evaluate ANV419 in monotherapy and Parts 2 and 3 to evaluate ANV419 in combination with anti-PD1 antibody or anti-CTLA4 antibody. Parts 2 and 3 were not initiated, as the prespecified efficacy criteria to graduate to Part 2 were not met at the interim analysis of Part 1.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Must provide written informed consent for the study;
* Must be able to comply with the Protocol as judged by the Investigator;
* Are ≥18 years of age on day of signing informed consent;
* Have histologically confirmed Stage 3 (unresectable) or Stage 4 (metastatic) CM, as per the American Joint Committee on Cancer staging system, eighth edition;
* Have documented radiological progression on prior systemic therapy;
* Have previously received anti-PD-1/L1 as monotherapy or in combination. A maximum of 2 prior lines of systemic therapy is allowed for BRAF wild-type disease and a maximum of 3 prior lines of systemic therapy is allowed for BRAFV600 positive disease;
* Have measurable disease based on RECIST;
* Have a performance status of 0 or 1 on the ECOG Performance Status;
* Have adequate organ functions as defined per protocol;
* Female patients of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative (urine or serum) pregnancy test within 72 hours prior to study Day 1. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required and must be negative for the patient to be eligible;
* Female patients who are not postmenopausal, and who have not undergone surgical sterilization, must agree to use highly effective methods of contraception during the treatment period and for 6 months after the last dose of study drug. They must also agree not to donate eggs (ova, oo…
What they're measuring
1
Monotherapy Dose Expansion: Objective Response Rate (ORR) as Defined by RECIST v1.1