Clinical Trial 21667

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT05444530

Phase: Phase I
Principal Investigator: Kuykendall, Andrew

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Overview

Study Title

A Phase 1 Study of VAC85135, a Neoantigen Vaccine Regimen, Concurrently Administered with Ipilimumab for the Treatment of Myeloproliferative Neoplasms

Summary

The purpose of this study is to evaluate the safety of VAC85135 administered with ipilimumab for the treatment of myeloproliferative neoplasms (MPNs).

Objective

The primary objective is to evaluate the safety of VAC85135 administered with ipilimumab in participants withMPNs. Key secondary endpoints are to evaluate the immunogenicity and anti-tumor clinical activity

Treatments

Therapies

Antibody-Drug Conjugate; Vaccine

Medications

Ipilimumab (); VAC85135 (); Yervoy (Ipilimumab)

Inclusion Criteria

Inclusion Criteria:

Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 or 2

Have the following hematologic laboratory values: Leukocytes greater than or equal to (>=) 1.5*10^9 per liter, Neutrophils >=1.0*10^9 per liter, Platelets >=20*10^9 per liter, Hemoglobin greater than (>) 7 gram per deciliter (g/dL) Have the following chemistry laboratory values: Alanine aminotransferase (ALT): less than or equal to (=40 milliliter per minute (mL/min)

A female participant of childbearing potential must agree to all the following during the study and for 6 months after the last dose of study treatment: use a barrier method of contraception, use a highly effective preferably user-independent method of contraception, not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction, not plan to become pregnant, not to breast-feed

A male participant must agree to all the following during the study and for 90 days after the last dose of study treatment: wear a condom when engaging in any activity that allows for passage of ejaculate to another person, not to father a child, not to donate sperm or freeze for future use for the purpose of reproduction.

Other criteria apply

Exclusion Criteria

Exclusion Criteria:

History of any significant medical condition per investigators judgment (example: severe asthma/chronic obstructive pulmonary disease (COPD), poorly regulated heart condition, insulin dependent diabetes mellitus)

Serious known clinically relevant allergies or earlier anaphylactic reactions

Currently pregnant or breastfeeding

Prior treatment with any Janus kinase 2 (JAK2) inhibitor

Known sensitivity or contraindications to the use of Ipilimumab per local prescribing information

Other criteria may apply

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