Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Vaccines

Cemiplimab

Antineoplastic Agents, Immunological

BNT111

BioNTech Responsible Person

This is an open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-programmed death protein 1 (PD-1)/anti-programmed death ligand 1 (PD-L1)-refractory/relapsed patients with unresectable Stage III or IV melanoma. The contributions of BNT111 and cemiplimab will be delineated in single agent calibrator arms. Patients will be randomized in a 2:1:1 ratio to Arm 1 (BNT111 + cemiplimab) and calibrator Arm 2 (BNT111 monotherapy), and Arm 3 (cemiplimab monotherapy). Patients in single agent calibrator arms (Arms 2 and 3), who experience centrally verified disease progression under single agent treatment, may be offered addition of the other compound to the ongoing treatment after re-consent.

Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma

Open-label, Randomized Phase II Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma

ORR defined as the proportion of patients in whom a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) is observed as best overall response by blinded independent central review (BICR).

ORR defined as the proportion of patients in whom a CR or PR according to RECIST 1.1 is observed as best overall response by BICR.

DOR defined as the time from first objective response (CR or PR) to first occurrence of objective tumor progression (progressive disease, PD) by BICR or death from any cause (whichever occurs first).

DCR defined as the proportion of patients in whom a CR, PR or stable disease (SD; assessed at least 6 weeks +/- 1 week after first dose) is observed as best overall response by BICR.

TTR defined as the time from randomization to the first objective tumor response (CR or PR) by BICR.

PFS defined as the time from randomization to first objective tumor progression (PD) by BICR or death from any cause (whichever occurs first).

OS defined as the time from randomization to death from any cause.

Blood samples will be collected for the assessment of hematology parameters.

Blood samples will be collected for the assessment of clinical chemistry parameters.

Blood samples will be collected for the assessment of coagulation factors.

Blood samples will be collected for the assessment of endocrine tests.

Blood samples will be collected for the assessment of serology parameters.

Urine samples will be collected for the assessment of urinalysis parameters.

Body temperature (in °C) will be assessed.

Pulse rate (in beats per minute \[bpm\]) will be assessed.

Blood pressure (systolic/diastolic, in mmHg) will be assessed.

Spots Global Cancer Trial Database for libtayo®

Every month we try and update this database with for libtayo® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for libtayo®

Every month we try and update this database with for libtayo® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for libtayo® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.