NCT03875079 : An Open-Label, Multicenter, Phase Ib Study To Evaluate Safety And Therapeutic Activity Of RO6874281, An Immunocytokine, Consisting Of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), In Combination With Pembrolizumab (Anti-PD-1), In Participants With Advanced Or Metastatic Melanoma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Skin<br/>CancersCancer LocationSkin
Cancers

Systemic therapy | SkinCutaneous Squamous Cell Carcinoma (CSCC),Melanoma (Skin),Squamous cell carcinoma

Trial Overview Read MoreRead more

This phase I trial is testing the safety and activity of two immunotherapies (RO6874281 and Pembrolizumab) in patients with advanced Melanoma that has spread to other parts of the body.
 

This trial is treating patients with melanoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

An Open-Label, Multicenter, Phase Ib Study To Evaluate Safety And Therapeutic Activity Of RO6874281, An Immunocytokine, Consisting Of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), In Combination With Pembrolizumab (Anti-PD-1), In Participants With Advanced Or Metastatic Melanoma

Commercial Sponsor

Hoffmann-La Roche

Summary

Eligible participants will be randomised to three parts: a safety run-in (split into cohort 1.1 (for CPI and experienced melanoma participants) and 1.2 (for CPI experienced melanoma participants only) and two expansion parts (part 2 and part 3). Part 2 will commence once all participants in cohort 1.1 have completed observation; part 3 will commence once all participants in cohorts 1.1 and 1.2 have completed observation.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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