BioNTech SE
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Clinical Trials (117)
| Trial | Conditions | Phase | Status | Enrollment | Design | Drug |
|---|---|---|---|---|---|---|
| NCT07300839 A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age | COVID-19, SARS-COV-2 Infection | P3 | Recruiting | 25,500 | RCT, Double-blind | BNT162b2 Vaccine, Placebo |
| NCT07221357 A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer | Untreated, Unresectable, or Metastatic Colorectal Cancer | P2P3 | Recruiting | 990 | RCT, Double-blind | Pumitamig, FOLFOX, FOLFIRI, Bevacizumab, CAPOX |
| NCT07361497 A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201) | Non-small Cell Lung Cancer (NSCLC) | P3 | Recruiting | 850 | RCT, Open-label | Pumitamig, Durvalumab |
| NCT06340568 A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer | Endometrial Cancer | P3 | Recruiting | 480 | RCT, Open-label | BNT323/DB-1303, Doxorubicin, Paclitaxel, Docetaxel |
| NCT07221149 A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204) | Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma | P2P3 | Recruiting | 690 | RCT, Double-blind | Pumitamig, Folfox, Capox, Nivolumab |
| NCT07361510 A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202) | Non-Small Cell Lung Cancer (NSCLC) | P3 | Recruiting | 750 | RCT, Double-blind | Pumitamig, Pembrolizumab |
| NCT07173751 ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer | Breast Neoplasms | P3 | Recruiting | 558 | RCT, Double-blind | Pumitamig, Nab-paclitaxel/Paclitaxel, Gemcitabine, Carboplatin, Eribulin, Matching placebo |
| NCT06018337 A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) | Metastatic Breast Cancer | P3 | Active | 541 | RCT, Open-label | DB-1303/BNT323, Capecitabine, Paclitaxel, Nab-paclitaxel |
| NCT04534205 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 | Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer | P2P3 | Recruiting | 350 | RCT, Open-label | BNT113, Pembrolizumab |
| NCT06712316 Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer | Non-small Cell Lung Cancer | P2P3 | Recruiting | 1,260 | RCT, Open-label | Pumitamig, Pembrolizumab, Carboplatin, Pemetrexed, Paclitaxel |
| NCT06712355 Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer | Extensive-stage Small-cell Lung Cancer | P3 | Recruiting | 621 | RCT, Double-blind | Pumitamig, Atezolizumab, Etoposide, Carboplatin (or cisplatin if carboplatin is not tolerated) |
| NCT05671510 ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors | Non Small Cell Lung Cancer | P3 | Recruiting | 630 | RCT, Open-label | Gotistobart, Docetaxel |
| NCT07222384 A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That Are Considered at Higher Risk of Severe COVID-19 | COVID-19, SARS-COV-2 Infection | P3 | Active | 343 | Open-label | BNT162b2 (2025/2026 formulation) |
| NCT07069309 A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 Years | COVID-19, SARS-COV-2 Infection | P3 | Active | 760 | Open-label | BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) |
| NCT05543616 A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children | SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2 | P2P3 | Recruiting | 4,292 | Single-blind | Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose, Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose, Variant-adapted BNT162b2 (Omicron XBB.1.5) 6 microgram dose, Variant-adapted BNT162b2 (Omicron XBB.1.5) 10 microgram dose, Variant-adapted BNT162b2 (Omicron KP.2) 10 microgram dose |
| NCT06265428 A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer | HER2-positive Breast Cancer | P3 | Active | 228 | RCT, Open-label | DB-1303/BNT323, T-DM1 |
| NCT04486378 A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer | Colorectal Cancer Stage II, Colorectal Cancer Stage III | P2 | Recruiting | 327 | RCT, Open-label | RO7198457 intravenous (IV) |
| NCT05557591 A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1) | Advanced Non-Small Cell Lung Cancer | P2 | Active | 51 | RCT, Open-label | BNT116, Cemiplimab |
| NCT06069544 A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria | Malaria | P1P2 | Active | 163 | RCT, Double-blind | BNT165e |
| NCT07291076 A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206) | Hepatocellular Carcinoma (HCC) | P1P2 | Recruiting | 129 | RCT, Open-label | Pumitamig, Ipilimumab, Atezolizumab, Bevacizumab |
| NCT05914116 A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors | Advanced Solid Tumors | P1P2 | Recruiting | 862 | Open-label | DB-1311, Lopinavir and Ritonavir Tablets, itraconazole, Enzalutamide, Abiraterone |
| NCT05438329 First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors | Advanced Solid Tumor | P1P2 | Recruiting | 1,123 | Open-label | DB-1305/BNT325, BNT327 |
| NCT06449222 Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy | Locally Advanced Breast Cancer, Triple Negative Breast Cancer | P2 | Active | 83 | RCT, Open-label | BNT327 Dose Level 1 (DL1), BNT327 Dose Level 1 (DL2), Nab-placlitaxel, Carboplatin, Gemcitabine, Paclitaxel, Eribulin, BNT327 Optimized Dose, BNT327 Equivalent Q3W Dose |
| NCT07455734 Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors | Advanced Solid Tumor Cancer | P1P2 | Recruiting | 533 | RCT, Open-label | BNT3214 |
| NCT07293351 A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208) | Advanced Renal Cell Carcinoma (RCC) | P1P2 | Recruiting | 234 | RCT, Open-label | Pumitamig, Ipilimumab, Cabozantinib, Nivolumab |
| NCT06827236 A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer | Locally Advanced Breast Cancer, Unresectable Breast Carcinoma | P1P2 | Recruiting | 380 | RCT, Open-label | BNT323, BNT327 |
| NCT07111520 A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC) | Non-small Cell Lung Cancer | P1P2 | Recruiting | 420 | RCT, Open-label | BNT326, BNT327, Pembrolizumab, SoC |
| NCT07147348 A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors | Advanced Solid Tumor | P1P2 | Recruiting | 375 | Open-label | BNT3212, Pumitamig |
| NCT06953089 DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors | Solid Tumors | P2 | Recruiting | 492 | RCT, Open-label | DB-1311/BNT324, BNT327, DB-1305/BNT325 |
| NCT04083599 GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors | Malignant Solid Tumor, Non-Small Cell Lung Cancer (NSCLC) | P1P2 | Active | 350 | Open-label | GEN1042, Pembrolizumab, Cisplatin, Carboplatin, 5-FU, Gemcitabine, Nab paclitaxel, Pemetrexed, Paclitaxel |
| NCT07297212 A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma | Recurrent Glioblastoma | P2 | Recruiting | 75 | RCT, Open-label | Pumitamig, Bevacizumab, Temozolomide |
| NCT06841055 Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment | Non-small Cell Lung Cancer | P2 | Recruiting | 60 | Open-label | Pumitamig, Docetaxel |
| NCT05968326 A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC | Adenocarcinoma, Pancreatic Ductal | P2 | Recruiting | 260 | RCT, Open-label | Autogene cevumeran, Atezolizumab, mFOLFIRINOX |
| NCT07079631 A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer | Metastatic Colorectal Cancer | P1P2 | Recruiting | 482 | RCT, Open-label | BNT314, BNT327, SoC chemotherapy treatment 1, SoC chemotherapy treatment 2, Bevacizumab |
| NCT05150691 A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors | HER2-positive Advanced Solid Tumor | P1P2 | Recruiting | 796 | RCT, Open-label | DB-1303/BNT323, Pertuzumab Injection, Ritonavir, Itraconazole |
| NCT06534983 A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-risk Muscle-invasive Urothelial Carcinoma (MIUC) | Muscle-invasive Urothelial Carcinoma | P2 | Recruiting | 362 | RCT, Double-blind | Autogene Cevumeran, Nivolumab, Saline |
| NCT05547464 Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers | Tuberculosis | P1P2 | Active | 497 | RCT, Double-blind | BNT164a1, BNT164b1 |
| NCT07379580 A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa | Mpox (Monkeypox), Smallpox | P2 | Recruiting | 310 | RCT, Double-blind | BNT166a |
| NCT06449209 Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy | Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer | P2 | Active | 110 | RCT, Open-label | BNT327 Dose Level 1 (DL1), BNT327 Dose Level 2 (DL2), Etoposide, Carboplatin, Paclitaxel, Topotecan |
| NCT07186842 A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9 | Advanced Solid Cancers | P1P2 | Recruiting | 245 | RCT, Open-label | BNT329, CA19-9-targeting monoclonal antibody |
| NCT07255404 A Clinical Trial Testing the Safety of BNT327 (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer | Pancreatic Ductal Adenocarcinoma (PDAC) | P2 | Recruiting | 105 | RCT, Open-label | Pumitamig, Nab-paclitaxel, Gemcitabine, mFOLFIRINOX |
| NCT07070232 A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors | Advanced Solid Tumor | P1P2 | Recruiting | 980 | RCT, Open-label | BNT326, Pumitamig, Itraconazole, Paroxetine |
| NCT06892548 A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer | Advanced Lung Cancer | P1P2 | Recruiting | 594 | RCT, Open-label | BNT324, BNT327 |
| NCT07392372 A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV | HIV -1 Infection | P1 | Recruiting | 61 | RCT, Double-blind | BNT351, Placebo, BNT351, Placebo |
| NCT06750185 Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors | Advanced Solid Tumor | P1 | Recruiting | 39 | Open-label | BNT317 DL1, BNT317 DL2, BNT317 DL3, BNT317 DL4, BNT317 DL5 (intermediate), BNT317 DL6 (intermediate), BNT317 DL7 (additional) |
| NCT06150183 Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors | Advanced Malignant Solid Tumor | P1 | Active | 41 | Open-label | BNT314 |
| NCT03219450 A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated CLL. | Lymphocytic Leukemia | P1 | Recruiting | 15 | Open-label | NeoVax, Cyclophosphamide, Pembrolizumab |
| NCT05653752 A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer | Non Small Cell Lung Cancer, Breast Cancer | P1 | Active | 80 | Open-label | YL202 |
| NCT06057038 A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors | Malignant Solid Tumor | P1 | Active | 42 | Open-label | GEN1042, Pembrolizumab, Cisplatin, Carboplatin, 5-Fluorouracil |
| NCT05432583 A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions | Genital Herpes Simplex Type 2 | P1 | Active | 318 | RCT, Double-blind | BNT163 |
| NCT05142189 Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer | Non-Small Cell Lung Cancer | P1 | Recruiting | 280 | Open-label | BNT116, Cemiplimab, Docetaxel, Carboplatin, Paclitaxel, BNT316, anti-B7-H3 antibody conjugated to topoisomerase I inhibitor, anti-HER3 antibody conjugated to topoisomerase I inhibitor, Bispecific antibody for PD-L1 and VEGF-A |
| NCT04503278 A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors | Solid Tumor | P1 | Recruiting | 214 | Open-label | CLDN6 CAR-T, CLDN6 uRNA-LPX/CLDN6 modRNA-LPX |
| NCT04813627 Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy | Colorectal Cancer Stage II, Colorectal Cancer Stage III | Active | 2,200 | — | — | |
| NCT04588480 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults | SARS-CoV-2 Infection, COVID-19 | P4 | Completed | 160 | RCT, Double-blind | BNT162b2 |
| NCT05997290 A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals | SARS-CoV-2 Infection, COVID-19 | P2P3 | Completed | 1,051 | Open-label | BNT162b2 (Omi XBB.1.5), BNT162b2 (Omi JN.1), BNT162b2 (Omi KP.2) |
| NCT04713553 A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants | SARS-CoV-2 Infection, COVID-19 | P3 | Completed | 1,574 | RCT, Double-blind | BNT162b2, BNT162b2.B.1.351 |
| NCT04754594 To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older | SARS-CoV-2 Infection, COVID-19 | P2P3 | Completed | 726 | RCT, Double-blind | BNT162b2 |
| NCT04955626 To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age. | SARS-CoV-2 Infection, COVID-19 | P3 | Completed | 16,372 | RCT, Double-blind | BNT162b2, BNT162b2 OMI, Combination BNT162b2 and BNT162b2 OMI, Combination (Bivalent) BNT162b2 and BNT162b2 OMI |
| NCT04368728 Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals | SARS-CoV-2 Infection, COVID-19 | P2P3 | Completed | 46,969 | RCT, Double-blind | BNT162b1, BNT162b2, BNT162b2SA |
| NCT05310084 Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age | SARS-CoV-2 Infection, COVID-19 | P3 | Completed | 1,134 | RCT, Double-blind | BNT162b2, Seasonal Inactivated Influenza Vaccine |
| NCT04816643 A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children | SARS-CoV-2 Infection, COVID-19 | P2P3 | Completed | 11,837 | Open-label | Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, BNT162b2 30mcg, Biological/Vaccine: BNT162b2 3mcg |
| NCT07365995 A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer | Metastatic Castration-resistant Prostate Cancer | P3 | Not Yet Recruiting | 736 | RCT, Open-label | BNT324, Docetaxel, Prednisone/prednisolone |
| NCT05472038 A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals | SARS-CoV-2 Infection, COVID-19 | P2P3 | Completed | 1,453 | RCT, Double-blind | BNT162b5 Bivalent (WT/OMI BA.2), BNT162b2 Bivalent (WT/OMI BA.1), BNT162b2 Bivalent (WT/OMI BA.4/BA.5), BNT162b5 Bivalent (Original/OMI BA.4/BA.5), BNT162b6 Bivalent (Original/OMI BA.4/BA.5), BNT162b7 Bivalent (Original/OMI BA.4/BA.5), BNT162b7 Monovalent (OMI BA.4/BA.5) |
| NCT06178991 A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza. | Influenza, COVID-19 | P3 | Completed | 8,795 | RCT, Double-blind | Influenza and COVID-19 Combination A, Licensed influenza vaccine, COVID-19 Vaccine, Influenza and COVID-19 Combination B, Placebo, Investigational influenza vaccine |
| NCT04816669 A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults | SARS-CoV-2 Infection, COVID-19 | P3 | Completed | 629 | RCT, Double-blind | BNT162b2 |
| NCT04537949 A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults | Covid-19, Protection Against COVID-19 | P1P2 | Completed | 96 | Open-label | BNT162b3 |
| NCT06069778 Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma | Pancreatic Cancer | P1P2 | Terminated | 1 | RCT, Single-blind | BNT321 0.5 mg/kg, BNT321 DL 2, mFOLFIRINOX, BNT321 RP2D |
| NCT04683939 Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors | Solid Tumor, Gastric Cancer | P1P2 | Terminated | 13 | Open-label | BNT141, Nab-paclitaxel, Gemcitabine |
| NCT05004181 Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants | SARS-CoV-2 Infection, COVID-19 | P2 | Completed | 1,380 | Open-label | BNT162b2, Multivalent BNT162b2 (B.1.1.7 + B.1.617.2), Monovalent BNT162b2 (B.1.1.7), Monovalent BNT162b2 (B.1.617.2), Monovalent BNT162b2 (B.1.1.529.1) |
| NCT04101357 Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411 | Solid Tumor, Extensive-stage Small Cell Lung Cancer | P1P2 | Terminated | 54 | Open-label | BNT411, Atezolizumab, Carboplatin, Etoposide |
| NCT05703607 A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults | Shingles, Herpes Zoster Infection | P1P2 | Terminated | 485 | RCT, Double-blind | Candidate 1: PF-07915234: VZV modRNA Powder for Suspension for Injection, Candidate 1: PF-07915234: VZV modRNA Suspension for Injection, Candidate 2: PF-07921188: VZV modRNA Suspension for Injection, Candidate 3: PF-07921186: VZV modRNA Suspension for Injection, Shingrix, Candidate 2: PF-07921188: VZV modRNA Powder for Suspension for Injection |
| NCT05491317 A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors | Non-CNS Tumor | P1P2 | Terminated | 13 | RCT, Open-label | GEN1042, Pembrolizumab |
| NCT04382898 PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy) | Prostate Cancer | P1P2 | Terminated | 75 | RCT, Open-label | BNT112, Cemiplimab |
| NCT04455620 BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors | Solid Tumor | P1P2 | Terminated | 49 | Open-label | BNT151 |
| NCT05596734 A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza | Influenza, Human, COVID-19 | P2 | Completed | 1,019 | RCT, Open-label | bivalent BNT162b2 (original/Omi BA.4/BA.5), qIRV (22/23), QIV, bIRV, tIRV |
| NCT04526899 A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment | Melanoma Stage III, Melanoma Stage IV | P2 | Completed | 184 | RCT, Open-label | BNT111, Cemiplimab |
| NCT05262530 Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid Tumors | Solid Tumor | P1P2 | Terminated | 73 | Open-label | BNT142 |
| NCT03418480 HARE-40: HPV Anti-CD40 RNA vaccinE | Human Papilloma Virus Related Carcinoma, Head and Neck Neoplasm | P1P2 | Completed | 32 | Open-label | BNT113 |
| NCT05988203 A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines | Monkeypox | P1P2 | Completed | 96 | Open-label | BNT166a |
| NCT06940804 A Clinical Study Investigating the Therapeutic Effects and Safety of an Investigational Cell Therapy Given With and Without an Additional Investigational Product in Males With Testicular Cancer or a Form of Cancer That Developed From Sperm | Testicular Germ Cell Tumor, Extragonadal Germ Cell Tumor | P2 | Withdrawn | — | RCT, Open-label | CLDN6 CAR-T, CLDN6 RNA-LPX |
| NCT05435339 A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy | Solid Tumor, Adult | P1P2 | Terminated | 31 | Open-label | GEN1053 |
| NCT06683352 A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People | Influenza,Human, COVID-19 | P1P2 | Completed | 1,353 | RCT, Double-blind | Investigational Influenza Vaccine, COVID-19 Vaccine, Licensed Influenza Vaccine 1, Licensed Influenza Vaccine 2 |
| NCT04949490 A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects | COVID-19, SARS-CoV-2 Infection | P2 | Completed | 137 | RCT, Open-label | BNT162b2s01, BNT162b2 |
| NCT07133750 PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer | CRC (Colorectal Cancer) | P2 | Not Yet Recruiting | 40 | RCT, Open-label | PM8002, Chemotherapy Regimen 1, Chemotherapy Regimen 2 |
| NCT06046274 GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer | Advanced Endometrial Cancer | P2 | Withdrawn | — | Open-label | Pembrolizumab, Acasunlimab |
| NCT04649021 Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population | SARS-CoV-2 | P2 | Completed | 960 | RCT, Double-blind | BNT162b2 |
| NCT06391775 Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy | Malignant Solid Tumor | P1P2 | Terminated | 21 | Open-label | GEN1055, Pembrolizumab, Standard Chemotherapy |
| NCT04895982 Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years | SARS-CoV-2 Infection, COVID19 | P2 | Completed | 124 | Open-label | BNT162b2 |
| NCT04380701 A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 in Healthy and Immunocompromised Adults | Infections, Respiratory, Virus Diseases | P1P2 | Completed | 512 | Open-label | BNT162a1, BNT162b1, BNT162b2, BNT162c2 |
| NCT06821061 A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People | Influenza, COVID-19 (Coronavirus Disease 2019) | P1P2 | Completed | 2,650 | RCT, Double-blind | Investigational Influenza Vaccine, Investigational COVID-19 Vaccine, Licensed Influenza Vaccine 1, Licensed Influenza Vaccine 2, Licensed Influenza Vaccine 3, Licensed COVID-19 Vaccine |
| NCT03815058 A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma. | Advanced Melanoma | P2 | Completed | 131 | RCT, Open-label | Autogene cevumeran, Pembrolizumab |
| NCT04883775 Study of a New Technique for Imaging Pancreatic Cancer | Pancreatic Cancer, Tumors That Express CA19-9 | P1 | Completed | 4 | Open-label | MVT-2163, MVT-5873 |
| NCT02897765 A Personal Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder Cancer | Urinary Bladder Cancer, Bladder Tumors | P1 | Completed | 34 | Open-label | NEO-PV-01, Nivolumab |
| NCT04163094 Ovarian Cancer Treatment With a Liposome Formulated mRNA Vaccine in Combination With (Neo-)Adjuvant Chemotherapy | Ovarian Cancer | P1 | Terminated | 8 | Open-label | W_ova1 Vaccine |
| NCT04710043 Dose Escalation Trial of BNT152+153 in Patients With Cancer | Solid Tumor | P1 | Completed | 86 | Open-label | BNT152, BNT153 |
| NCT02149225 GAPVAC Phase I Trial in Newly Diagnosed Glioblastoma Patients | Glioblastoma | P1 | Completed | 16 | Open-label | APVAC1 vaccine plus Poly-ICLC and GM-CSF, APVAC2 vaccine plus Poly-ICLC and GM-CSF |
| NCT05630352 A Study to Learn About Bivalent COVID-19 RNA Vaccine Candidate(s) in Healthy Infants and Children | COVID-19 | P1 | Withdrawn | — | Open-label | Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 1 microgram dose |
| NCT03597282 A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma | Metastatic Melanoma | P1 | Terminated | 22 | Open-label | NEO-PV-01, Nivolumab, APX005M, ipilimumab |
| NCT03118349 Study of 177Lu Human Monoclonal Antibody 5B1 (MVT-1075) in Combination With a Blocking Dose of MVT-5873 as Radioimmunotherapy | Pancreatic Carcinoma, Tumors That Express CA 19-9 | P1 | Terminated | 4 | Open-label | MVT-1075, MVT-5873 |
| NCT02672917 Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies | Pancreatic Cancer | P1 | Terminated | 118 | Open-label | MVT-5873, modified FOLFIRINOX (mFOLFIRINOX), gemcitabine + nab-paclitaxel |
| NCT01684241 RBL001/RBL002 Phase I Clinical Trial | Melanoma | P1 | Completed | 29 | Open-label | RBL001/RBL002 |
| NCT02316457 RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID | Breast Cancer (Triple Negative Breast Cancer (TNBC)) | P1 | Completed | 42 | Open-label | IVAC_W_bre1_uID, IVAC_W_bre1_uID/IVAC_M_uID |
| NCT05541861 Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People | SARS-CoV-2 Infection, COVID-19 | P1 | Completed | 383 | RCT, Double-blind | BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 mcg, BNT162b4 5 mcg, BNT162b4 10 mcg, BNT162b4 15 mcg, BNT162b4 30 mcg, BNT162b2 Monovalent (OMI XBB.1.5) 30 mcg |
| NCT04625205 A Clinical Study of the Safety and Activity of the Investigational Cell Therapy NEO-PTC-01 in Patients With Advanced Melanoma | Unresectable Melanoma, Metastatic Melanoma | P1 | Terminated | 22 | Open-label | NEO-PTC-01, IL-2, PD-1 Inhibitors |
| NCT03380871 A Personal Cancer Vaccine (NEO-PV-01) With Pembrolizumab and Chemotherapy for Patients With Lung Cancer | Carcinoma, Non-Small-Cell Lung, Lung Cancer | P1 | Completed | 38 | Open-label | NEO-PV-01, Pembrolizumab, Carboplatin, Pemetrexed |
| NCT04523571 Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects | SARS-CoV-2 | P1 | Completed | 144 | RCT, Double-blind | BNT162b1 |
| NCT05586321 Study of Safety and Antitumor Activity of GEN1056 in Participants With Advanced Solid Tumors | Solid Tumor, Adult | P1 | Completed | 26 | Open-label | GEN1056 |
| NCT02410733 Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced Melanoma | Melanoma | P1 | Completed | 119 | Open-label | Lipo-MERIT |
| NCT03289962 A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors | Melanoma, Non-Small Cell Lung Cancer | P1 | Completed | 272 | Open-label | Autogene cevumeran, Atezolizumab |
| NCT05537038 Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers | Tuberculosis | P1 | Completed | 120 | RCT, Double-blind | BNT164a1, BNT164b1 |
| NCT02035956 IVAC MUTANOME Phase I Clinical Trial | Melanoma | P1 | Completed | 15 | Open-label | IVAC MUTANOME, RBL001/RBL002 |
| NCT06469164 A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis | Bacterial Vaginosis | P1 | Completed | 102 | RCT, Double-blind | BNT331 |
| NCT02687230 Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With HuMab-5B1 | Pancreatic Carcinoma, Tumors That Express CA19-9 | P1 | Terminated | 15 | Open-label | MVT-2163, MVT-5873 |
| NCT05581641 Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria | Malaria | P1 | Completed | 60 | RCT, Double-blind | BNT165b1 |
| NCT03871348 A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors | Metastatic Neoplasm | P1 | Terminated | 77 | Open-label | SAR441000, Cemiplimab REGN2810 |
| NCT02449993 Re-Examination of Tumor Material and Re-Evaluation of Patient Data From Patients Treated With Neo-adjuvant Therapy | Breast Cancer | Completed | 101 | — | — | |
| NCT02244580 Re-Evaluation of Tumor Samples From Women With Breast Cancer With the in Vitro Diagnostic Kit "MammaTyperTM" | Invasive Breast Cancer | N/A | Completed | 1,010 | Open-label | — |