NCT04382898 (PRO-MERIT) is a Phase 1, PHASE2 clinical trial of BNT112 in Prostate Cancer, sponsored by BioNTech SE.

Who is sponsoring NCT04382898?

NCT04382898 is sponsored by BioNTech SE.

What drugs are being tested in NCT04382898?

Interventions in NCT04382898: BNT112, Cemiplimab.

What condition does NCT04382898 study?

NCT04382898 studies Prostate Cancer.

Is NCT04382898 still recruiting?

NCT04382898 is currently terminated. Last updated 20 March 2025.

Are results published for NCT04382898?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-03-20 · How we verify

NCT04382898: PRO-MERIT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)

Terminated Phase 1, PHASE2 Results posted Last updated 20 March 2025

What this trial tests

Phase 1, PHASE2 trial testing BNT112 in Prostate Cancer in 75 participants. Terminated before completion.

Timeline

19 December 2019

Primary endpoint
23 January 2024

23 January 2024

Quick facts

Lead sponsor	BioNTech SE
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	19 December 2019
Primary completion	23 January 2024
Estimated completion	23 January 2024
Sites	22 locations across United Kingdom, United States, Germany, Hungary

Drugs / interventions tested

BNT112 — full drug profile →
Cemiplimab (CEMIPLIMAB) — full drug profile →

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

BioNTech SE — full company profile →

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) Primary · Cycle 1 (21 days)

DLT criteria were defined as following: any treatment-emergent adverse events (TEAE) of Grade 5 intensity; hematological toxicities (Grade 3 and 4 febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 and 4 hemorrhage associated with thrombocytopenia of Grade greater than or equal to \[\>=\] 3, Grade 4 anemia); and non-hematological toxicities (Grade 4 cytokine release syndrome \[CRS\], Grade 3 CRS which has not improved to Grade 1 or resolved within 48 hours; any Grade \>=3 non-hematological TEAE at least possibly related which occurs during the first BNT112 cancer vaccine treatment cycle).

Group	Value	95% CI
Part 1 (mCRPC): BNT112	2

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure Primary · From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arms 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month)

TEAE: any adverse event (AE) with an onset date on or after the first administration of investigational medicinal product (IMP) or worsened after first administration of IMP. AEs with an onset date more than 30 days after last dose of BNT112 or 90 days after last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) were only considered as TEAEs if assessed as related to IMP by the investigator. Serious adverse event (SAE): any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resu

TEAEs

Group	Value	95% CI
Part 1 (mCRPC): BNT112	8
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	28
Part 2 (mCRPC): Arm 1b: BNT112	26
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	5
Part 2 (LPC): Arm 3: BNT112	6

Serious TEAE

Group	Value	95% CI
Part 1 (mCRPC): BNT112	5
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	5
Part 2 (mCRPC): Arm 1b: BNT112	9
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	2
Part 2 (LPC): Arm 3: BNT112	2

Grade >= 3 TEAEs

Group	Value	95% CI
Part 1 (mCRPC): BNT112	7
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	15
Part 2 (mCRPC): Arm 1b: BNT112	15
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	1
Part 2 (LPC): Arm 3: BNT112	4

Grade 5 TEAEs

Group	Value	95% CI
Part 1 (mCRPC): BNT112	2
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	0
Part 2 (mCRPC): Arm 1b: BNT112	1
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	0
Part 2 (LPC): Arm 3: BNT112	0

TEAEs related to trial procedure

Group	Value	95% CI
Part 1 (mCRPC): BNT112	1
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	1
Part 2 (mCRPC): Arm 1b: BNT112	0
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	1
Part 2 (LPC): Arm 3: BNT112	2

Part 2 Arm 1a: Objective Response Rate (ORR) Primary · From start of treatment up to 46 weeks

ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as per Prostate Cancer Working Group 3 (PCWG3) criteria as determined by the investigator. Participants not meeting the criteria for CR or PR, including those without any post-baseline tumor assessments, were considered as non-responders. CR was defined as the disappearance of all target lesions, with a reduction in short axis to \<10 mm in any pathological lymph nodes and no new lesions. PR was defined as 30% decrease in the sum of the longest diameter of target lesions.

Group	Value	95% CI
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	0	0.0 – 12.8

Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels Secondary · Day8 (Cycles1&2 only), Day1 Cycle 2 & Day 15 (Cycles1,2 & 8 only) (each cycle of 21-days), & EOT (30 days after last dose of BNT112 [Part 1 & Part 2 Arms 1b & 3] or 90 days after last dose of cemiplimab [Part 2, Arm 1a & Arm 2] [up to 4 years & 1 months])

Participants blood samples were tested for levels of PSA to track the progression of prostate cancer. PSA decline categories of No decline, 0 to 25%, \>25% to 50%, and \>50% compared to baseline during treatment according to PCWG3 (as reported by the investigator) are reported in this outcome measure. EOT in the timeframe below refers to End of treatment.

Cycle 1 Day 8: No decline

Group	Value	95% CI
Part 2 (LPC): Arm 3: BNT112	1

Cycle 1 Day 8: 0 to 25%

Group	Value	95% CI
Part 2 (LPC): Arm 3: BNT112	0

Cycle 1 Day 8: Greater than (>) 25% to 50%

Group	Value	95% CI
Part 2 (LPC): Arm 3: BNT112	0

Cycle 1 Day 8: >50%

Group	Value	95% CI
Part 2 (LPC): Arm 3: BNT112	0

Cycle 1 Day 15: No decline

Group	Value	95% CI
Part 2 (LPC): Arm 3: BNT112	0

Cycle 1 Day 15: 0 to 25%

Group	Value	95% CI
Part 2 (LPC): Arm 3: BNT112	0

Cycle 1 Day 15: >25% to 50%

Group	Value	95% CI
Part 2 (LPC): Arm 3: BNT112	1

Cycle 1 Day 15: >50%

Group	Value	95% CI
Part 2 (LPC): Arm 3: BNT112	0

Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) Secondary · Cycle 4 Day 1, Cycle 8 Day 1, Cycle 12 Day 1 (each cycle duration=21 days)

Participants blood samples were tested for levels of PSA to track the progression of prostate cancer. PSADT was calculated using a linear regression model of the natural logarithm of PSA values and time. PSA doubling time compared to baseline during the treatment period for the following categories: 0 - 3 months; \>3 - 6 months; \>6 - 9 months; \>9 - 12 months; \>12 - 18 months; \>18 - 24 months; \>24 months and declining are reported in this outcome measure.

Cycle 4 Day 1: 0 - 3 months

Group	Value	95% CI
Part 1 (mCRPC): BNT112	5
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	16
Part 2 (mCRPC): Arm 1b: BNT112	11
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	1
Part 2 (LPC): Arm 3: BNT112	0

Cycle 4 Day 1: >3 - 6 months

Group	Value	95% CI
Part 1 (mCRPC): BNT112	0
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	2
Part 2 (mCRPC): Arm 1b: BNT112	2
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	0
Part 2 (LPC): Arm 3: BNT112	0

Cycle 4 Day 1: >6 - 9 months

Group	Value	95% CI
Part 1 (mCRPC): BNT112	1
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	1
Part 2 (mCRPC): Arm 1b: BNT112	2
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	0
Part 2 (LPC): Arm 3: BNT112	0

Cycle 4 Day 1: >9 - 12 months

Group	Value	95% CI
Part 1 (mCRPC): BNT112	0
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	0
Part 2 (mCRPC): Arm 1b: BNT112	0
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	0
Part 2 (LPC): Arm 3: BNT112	0

Cycle 4 Day 1: >12 - 18 months

Group	Value	95% CI
Part 1 (mCRPC): BNT112	0
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	0
Part 2 (mCRPC): Arm 1b: BNT112	0
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	0
Part 2 (LPC): Arm 3: BNT112	0

Cycle 4 Day 1: >18 - 24 months

Group	Value	95% CI
Part 1 (mCRPC): BNT112	0
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	0
Part 2 (mCRPC): Arm 1b: BNT112	1
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	0
Part 2 (LPC): Arm 3: BNT112	0

Cycle 4 Day 1: >24 months

Group	Value	95% CI
Part 1 (mCRPC): BNT112	0
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	0
Part 2 (mCRPC): Arm 1b: BNT112	0
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	0
Part 2 (LPC): Arm 3: BNT112	0

Cycle 4 Day 1: Declining

Group	Value	95% CI
Part 1 (mCRPC): BNT112	0
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	2
Part 2 (mCRPC): Arm 1b: BNT112	3
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	4
Part 2 (LPC): Arm 3: BNT112	5

Number of Participants With PSA Decline of >=50% Secondary · Day8 (Cycles1&2 only), Day1 Cycle 2 & Day 15 (Cycles1,2 & 8 only) (each cycle of 21-days), & EOT (30 days after last dose of BNT112 [Part 1 & Part 2 Arms 1b & 3] or 90 days after last dose of cemiplimab [Part 2, Arm 1a & Arm 2] [up to 4 years & 1 months])

Participants blood samples were tested for levels of PSA to track the progression of prostate cancer. Participants with PSA decline of \>=50% compared to baseline according to PCWG3 (as reported by the investigator) are reported in this outcome measure. EOT in the timeframe below refers to End of treatment.

Cycle 1 Day 8

Group	Value	95% CI
Part 2 (LPC): Arm 3: BNT112	0

Cycle 1 Day 15

Group	Value	95% CI
Part 2 (LPC): Arm 3: BNT112	0

Cycle 2 Day 1

Group	Value	95% CI
Part 1 (mCRPC): BNT112	0
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	0
Part 2 (mCRPC): Arm 1b: BNT112	1
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	3
Part 2 (LPC): Arm 3: BNT112	4

Cycle 2 Day 8

Group	Value	95% CI
Part 1 (mCRPC): BNT112	0
Part 2 (LPC): Arm 3: BNT112	1

Cycle 2 Day 15

Group	Value	95% CI
Part 2 (LPC): Arm 3: BNT112	1

Cycle 8 Day 15

Group	Value	95% CI
Part 2 (mCRPC): Arm 1b: BNT112	0

EOT

Group	Value	95% CI
Part 1 (mCRPC): BNT112	0
Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab	0
Part 2 (mCRPC): Arm 1b: BNT112	0
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	4
Part 2 (LPC): Arm 3: BNT112	3

Part 1: Objective Response Rate (ORR) Secondary · From start of treatment up to 27 weeks

ORR was defined as the percentage of participants with a CR or PR as per PCWG3 criteria as determined by the investigator. Participants not meeting the criteria for CR or PR, including those without any post-baseline tumor assessments, were considered as non-responders. CR was defined as the disappearance of all target lesions, with a reduction in short axis to \<10 mm in any pathological lymph nodes and no new lesions. PR was defined as 30% decrease in the sum of the longest diameter of target lesions.

Group	Value	95% CI
Part 1 (mCRPC): BNT112	0	0.0 – 33.6

Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment Secondary · From start of treatment up to 25 weeks (Arm 2) and up to 26 weeks (Arm 3)

The best overall response was defined as a single best response status at any tumor response assessment after first administration of IMP and prior to or at the start date of the first subsequent anti-cancer therapy. Overall response of progressive disease within 14 days after the start date of first subsequent anti-cancer therapy was considered. The following order of tumor response categories were used, where "Complete Response" is the best category: Complete Response (CR) - Partial Response (PR) - Stable Disease (SD) - Progressive Disease (PD) - Not Evaluable (NE) - Missing. CR: disappearan

Complete Response (CR)

Group	Value	95% CI
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	0
Part 2 (LPC): Arm 3: BNT112	0

Partial Response (PR)

Group	Value	95% CI
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	3
Part 2 (LPC): Arm 3: BNT112	3

Stable Disease (SD)

Group	Value	95% CI
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	2
Part 2 (LPC): Arm 3: BNT112	2

Progressive Disease (PD)

Group	Value	95% CI
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	0
Part 2 (LPC): Arm 3: BNT112	0

Not Evaluable (NE)

Group	Value	95% CI
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	0
Part 2 (LPC): Arm 3: BNT112	0

Missing

Group	Value	95% CI
Part 2 (LPC): Arm 2: BNT112 + Cemiplimab	0
Part 2 (LPC): Arm 3: BNT112	1

Part 2 Arm 1b: Objective Response Rate (ORR) Primary · From start of treatment up to 104 weeks

Group	Value	95% CI
Part 2 (mCRPC): Arm 1b: BNT112	12.0	2.5 – 31.2

Adverse events — posted to ClinicalTrials.gov

Time frame: From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arm 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month). As per the protocol, non-SAEs with an onset date more than 30 days after the last dose of BNT112 or 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) are only reported below if assessed as related to IMP by the investigator.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1 (mCRPC): BNT112

Serious: 5/9 (56%)

Deaths: 7/9

Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab

Serious: 5/28 (18%)

Deaths: 17/28

Part 2 (mCRPC): Arm 1b: BNT112

Serious: 9/27 (33%)

Deaths: 13/27

Part 2 (LPC): Arm 2: BNT112 + Cemiplimab

Serious: 2/5 (40%)

Deaths: 1/5

Part 2 (LPC): Arm 3: BNT112

Serious: 2/6 (33%)

Deaths: 0/6

Serious adverse events (32 terms)

Reaction	System	Part 1 (mCRPC): BNT112	Part 2 (mCRPC): Arm 1a: BN…	Part 2 (mCRPC): Arm 1b: BN…	Part 2 (LPC): Arm 2: BNT11…	Part 2 (LPC): Arm 3: BNT112
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—
Right ventricular failure	Cardiac disorders	—	—	—	—	—
Supraventricular tachycardia	Cardiac disorders	—	—	—	—	—
Tinnitus	Ear and labyrinth disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Chest pain	General disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Systemic inflammatory response syndrome	General disorders	—	—	—	—	—
Appendicitis perforated	Infections and infestations	—	—	—	—	—
Pelvic abscess	Infections and infestations	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—
Septic shock	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Electrocardiogram QT prolonged	Investigations	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—
Diabetic ketoacidosis	Metabolism and nutrition disorders	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—
Spinal cord compression	Nervous system disorders	—	—	—	—	—

Other adverse events (86 terms — click to expand)

Reaction	System	Part 1 (mCRPC): BNT112	Part 2 (mCRPC): Arm 1a: BN…	Part 2 (mCRPC): Arm 1b: BN…	Part 2 (LPC): Arm 2: BNT11…	Part 2 (LPC): Arm 3: BNT112
Pyrexia	General disorders	—	—	—	—	—
Chills	General disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Influenza like illness	General disorders	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—
Eastern Cooperative Oncology Group performance status worsened	Investigations	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—
General physical health deterioration	General disorders	—	—	—	—	—
Oral herpes	Infections and infestations	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—
Blood pressure increased	Investigations	—	—	—	—	—
C-reactive protein increased	Investigations	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—

Most-reported serious reactions: Anaemia, Infusion related reaction, Prostate cancer, Syncope, Thrombocytopenia, Right ventricular failure, Supraventricular tachycardia, Tinnitus.

Data from ClinicalTrials.gov NCT04382898 adverse events section.

Sponsor's own description

Open-label, multicenter, dose titration and four-arm expansion trial to evaluate the safety, tolerability, immunogenicity, and preliminary efficacy of BNT112 cancer vaccine (BNT112) monotherapy or in combination with cemiplimab in patients with metastatic castration resistant prostate cancer (mCRPC: Part 1 and Part 2 Arms 1A and 1B) and in patients with high-risk, localized prostate cancer (LPC). As of February 2023, the trial only recruited LPC patients and no longer mCRPC patients.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Cancer vaccines as promising immuno-therapeutics: platforms and current progress.
Liu J, Fu M, Wang M, Wan D, et al · · 2022 · cited 497× · PMID 35303904 · DOI 10.1186/s13045-022-01247-x
Lipids and Lipid Derivatives for RNA Delivery.
Zhang Y, Sun C, Wang C, Jankovic KE, et al · · 2021 · cited 423× · PMID 34279087 · DOI 10.1021/acs.chemrev.1c00244
Advances in COVID-19 mRNA vaccine development.
Fang E, Liu X, Li M, Zhang Z, et al · · 2022 · cited 368× · PMID 35322018 · DOI 10.1038/s41392-022-00950-y
Clinical advances and ongoing trials on mRNA vaccines for cancer treatment.
Lorentzen CL, Haanen JB, Met Ö, Met Ö, et al · · 2022 · cited 362× · PMID 36174631 · DOI 10.1016/s1470-2045(22)00372-2
Therapeutic cancer vaccines: advancements, challenges, and prospects.
Fan T, Zhang M, Yang J, Zhu Z, et al · · 2023 · cited 314× · PMID 38086815 · DOI 10.1038/s41392-023-01674-3
mRNA therapeutics in cancer immunotherapy.
Beck JD, Reidenbach D, Salomon N, Sahin U, et al · · 2021 · cited 266× · PMID 33858437 · DOI 10.1186/s12943-021-01348-0
Non-viral vectors for RNA delivery.
Yan Y, Liu XY, Lu A, Wang XY, et al · · 2022 · cited 213× · PMID 35016918 · DOI 10.1016/j.jconrel.2022.01.008
Nanoparticles in the clinic: An update post COVID-19 vaccines.
Anselmo AC, Mitragotri S. · · 2021 · cited 211× · PMID 34514159 · DOI 10.1002/btm2.10246

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04382898 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BioNTech SE
Last refreshed: 20 March 2025

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