Symptoms and General Pathology

All Conditions

Neoplasms

Infections

Recurrence

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Papilloma

Virus Diseases

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Vaccines

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.

BNT113 in combination with pembrolizumab.

BNT113

BioNTech clinical trials patient information

BioNTech Responsible Person

An open-label, controlled, multi-site, interventional, 2-arm, Phase II trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand -1 (PD-L1) with combined positive score (CPS) ≥1.

This trial has two parts.

Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab.

Part B, the Randomized part of the trial to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1.

For Part B, an optional pre-screening phase is available for all patients where patients' tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial.

A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1

An Open Label Phase II Randomized Trial of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy as a First Line Therapy in Patients With Unresectable Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Which is Positive for Human Papilloma Virus 16 (HPV16+) and Expresses PD-L1 (AHEAD-MERIT)

PRO scores derived from the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire as change from baseline.

PRO scores derived from EORTC QLQ-H\&N35 questionnaire as change from baseline.

Time to deterioration in PRO scores derived from EORTC QLQ-C30 questionnaire.

Time to deterioration in PRO scores derived from EORTC QLQ-H\&N35 questionnaire.

TEAE assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) including Grade ≥3, serious, fatal TEAE by relationship.

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

ORR defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per response evaluation criteria in solid tumors \[RECIST 1.1\]) is observed as best overall response.

ORR defined as the proportion of patients in whom a CR or PR (per RECIST 1.1) is observed as best overall response.

PFS defined as the time from randomization to the first objective tumor progression (per RECIST 1.1) or death from any cause, whichever occurs first.

DCR defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1, assessed at least 6 weeks after first dose) is observed as best overall response.

DOR defined as the time from first objective response CR or PR (per RECIST 1.1) to first occurrence of objective tumor progression (progressive disease (PD) per RECIST 1.1) or death from any cause, whichever occurs first.

TEAEs assessed according to CTCAE v5.0 including Grade ≥3, serious, fatal TEAE by relationship.

BNT113 in combination with pembrolizumab compared to pembrolizumab monotherapy.

BioNTech SE

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Hormones

CV9103 is applied intradermally into the thigh and upper arm of either side of the body at week 1, week 3, week 7, week 15, week 23

Over a period of 23 weeks 5 vaccinations with CV9103 will be administered.

CV9103

Kurt Miller, Professor

The purpose of this study is to determine the efficacy and safety of a new vaccine in hormone refractory prostate cancer

Immunotherapy of prostate cancer is a promising approach for the treatment of advanced or recurrent forms of prostate cancer. Recently, immunotherapy of prostate cancer has been facilitated by the identification of a number of prostate specific antigens that are expressed in healthy and tumor prostate tissues. For prostatectomized patients, such antigens offer ideal targets for immunotherapy as they are only present in tumor but not in healthy tissue. The use of prostate specific antigens in a cancer vaccine is one attractive option for cancer immunotherapy.

Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease

CureVac

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Cemiplimab

BNT111

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).

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1	NCT04534205	Unresectable He... Metastatic Head... Recurrent Head ...	BNT113 Pembrolizumab	18 Years -	BioNTech SE
Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease	NCT00831467	Hormonal Refrac...	CV9103	18 Years - 75 Years	CureVac
Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease	NCT00831467	Hormonal Refrac...	CV9103	18 Years - 75 Years	CureVac
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	NCT04526899	Melanoma Stage ... Melanoma Stage ... Unresectable Me...	BNT111 Cemiplimab	18 Years -	BioNTech SE
Safety and Efficacy Trial of a RNActive®-Derived Prostate Cancer Vaccine in Hormone Refractory Disease	NCT00831467	Hormonal Refrac...	CV9103	18 Years - 75 Years	CureVac

Spots Global Cancer Trial Database for rna vaccine

Every month we try and update this database with for rna vaccine 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 rna vaccine

Every month we try and update this database with for rna vaccine 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 rna vaccine 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.