NCT04526899 : Open-label, Randomized Phase II Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD1-refractory/Relapsed, Unresectable Stage III or IV Melanoma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Skin<br/>CancersCancer LocationSkin
Cancers

Systemic therapy | SkinMelanoma (Skin)

Trial Overview Read MoreRead more

This Phase II trial is evaluating how safe and effective a targeted therapy (BNT111) is when used by itself or combined with immunotherapy (cemiplimab) in people with anti-PD1-refractory or relapsed melanoma.
 

This trial is treating patients with anti-PD1-refractory or relapsed unresectable stage III or IV melanoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

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

Open-label, Randomized Phase II Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD1-refractory/Relapsed, Unresectable Stage III or IV Melanoma

Commercial Sponsor

BioNTech SE

Summary

This is a randomised trial with three experimental arms. In Experimental Arm 1, participants will receive BNT111 (via intravenous injection) in combination with cemiplimab (via intravenous infusion). In Experimental Arm 2, participants will receive BNT111 by itself (via intravenous injection). In Experimental Arm 3, participants will receive cemiplimab by itself (via intravenous infusion).

Recruiting Hospitals Read MoreRead more

Border Medical Oncology
Albury
Ms Nyree Sarakis
Nsarkis@bordermedonc.com.au
02 6064 1493

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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