About this trial

This study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy.

Eligibility criteria

Qualifiers

Written informed consent.

Male or female, ≥18 years of age.

Inoperable/metastatic cutaneous malignant melanoma

Relapsed or newly diagnosed locally advanced inoperable/metastatic TNBC

Disqualifiers

Receipt of any oncolytic virus treatment, or administration of a vaccine containing live virus within 4 weeks before Day 1.

Use of significant immunosuppressive medication, including high dose corticosteroid (defined as the equivalent of >10 mg/day prednisone) within 4 weeks before Day 1. Inhaled or topical corticosteroid use is allowed.

Prior or concomitant radiotherapy within 4 weeks before Day 1.

Participation in a study with an investigational drug or device within 4 weeks prior to Day 1.

Trial design

Treatments tested in this trial

  • PeptiCRAd-1
  • Cyclophosphamide
  • Pembrolizumab

Treatment groups

15 Participants
are divided into 2 treatment groups

Locations

7
Germany
Krankenhaus Nordwest Frankfurt Germany
National Center for Tumor Diseases Heidelberg Germany
Universitätsklinikum Tübingen Tübingen Germany
Italy
Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS Candiolo Italy

Sponsors and collaborators

Valo Therapeutics Oy

Lead sponsor