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Clinical trials
catalyst calendar across sponsors →Studies where BNTX is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
72 interventional · 1 observational · 27 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate CancerNCT07365995rPFS assessed by BICRRandomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: BNT324, Docetaxel, Prednisone/prednisolone | Metastatic Castration-resistant Prostate Cancer | 736 | Feb 2031 | ≤ 1,653 d | 2026-07-20 |
| A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal CancerNCT07079631Phase I - Part A: Occurrence of dose limiting toxicities (DLTs) during the DLT observation periodRandomized · Open-label · Treatment | Phase 1/2 | Recruiting | Biological: BNT314 · Drug: Pumitamig, SoC chemotherapy treatment 1, SoC chemotherapy treatment 2, Bevacizumab | Metastatic Colorectal Cancer | 482 | Dec 2030 | ≤ 1,594 d | 2026-07-01 |
| Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid TumorsNCT07455734All parts - Number and percentage of participants with treatment emergent adverse events (TEAEs)Randomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: BNT3214 | Advanced Solid Tumor Cancer | 533 | Oct 2030 | ≤ 1,533 d | 2026-08-13 |
| 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 CA19-9NCT07186842Parts A and B - Occurrence of dose-limiting toxicities within a participantRandomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: BNT329, CA19-9-targeting monoclonal antibody | Advanced Solid Cancers | 245 | May 2030 | ≤ 1,380 d | 2026-07-17 |
| Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung CancerNCT05142189Cohorts 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, EGFR and ALK/RET: Occurrence of Dose-Limiting Toxicities (DLTs) During the DLT Observation PeriodNon-randomized · Open-label · Treatment | Phase 1 | Recruiting | Biological: BNT116, Cemiplimab, 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, Osimertinib, ALK-inhibitor or RET-inhibitor · Drug: Docetaxel, Carboplatin, Paclitaxel | Non-Small Cell Lung Cancer | 320 | Feb 2030 | ≤ 1,288 d | 2026-07-22 |
| ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast CancerNCT07173751Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Pumitamig, Nab-paclitaxel/Paclitaxel, Gemcitabine, Carboplatin, Eribulin, Matching placebo | Breast Neoplasms | 558 | Dec 2029 | ≤ 1,229 d | 2026-08-03 |
| 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 CancerNCT06827236Part 1 - Occurrence of dose limiting toxicities (DLTs)Randomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: BNT323, BNT327 | Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer | 380 | Aug 2029 | ≤ 1,107 d | 2026-07-21 |
| 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-L1NCT04534205Part A - Occurrence of treatment-emergent adverse event (TEAE) - BNT113 in combination with pembrolizumabRandomized · Open-label · Treatment | Phase 2/3 | Recruiting | Biological: BNT113, Pembrolizumab | Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer | 350 | Apr 2029 | ≤ 984 d | 2026-07-21 |
| Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung CancerNCT06712316Phase 2 - Occurrence of treatment-emergent adverse events (TEAE) (including Grade ≥3), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-emergent serious adverse events (SAE), and treatment-related treatment emergent SAEsRandomized · Open-label · Treatment | Phase 2/3 | Recruiting | Drug: Pumitamig, Pembrolizumab, Carboplatin, Pemetrexed, Paclitaxel | Non-small Cell Lung Cancer | 1,580 | Jan 2029 | ≤ 895 d | 2026-08-13 |
| Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung CancerNCT06712355Overall survival (OS)Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Pumitamig, Atezolizumab, Etoposide, Carboplatin (or cisplatin if carboplatin is not tolerated) | Extensive-stage Small-cell Lung Cancer | 621 | Dec 2028 | ≤ 864 d | 2026-07-24 |
| 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)NCT07111520Part 1 - Occurrence of dose limiting toxicities (DLTs) within a participantRandomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: BNT326, Pumitamig | Non-small Cell Lung Cancer | 880 | Nov 2028 | ≤ 833 d | 2026-08-05 |
| 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 TreatmentNCT06841055Part 1 - Occurrence of dose limiting toxicities (DLTs)Non-randomized · Open-label · Treatment | Phase 2 | Recruiting | Drug: Pumitamig, Docetaxel | Non-small Cell Lung Cancer | 60 | Oct 2028 | ≤ 803 d | 2026-04-24 |
| A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung CancerNCT06892548Part 1 - Occurrence of dose limiting toxicities (DLTs) by dose levelRandomized · Open-label · Treatment | Phase 1/2 | Recruiting | Biological: BNT324, BNT327 | Advanced Lung Cancer | 594 | Sep 2028 | ≤ 772 d | 2026-07-16 |
| Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With ChemotherapyNCT06449222Occurrence of treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), treatment emergent serious adverse events (SAEs)Randomized · Open-label · Treatment | Phase 2 | Active, not recruiting | Drug: BNT327 Dose Level 1 (DL1), BNT327 Dose Level 1 (DL2), Nab-placlitaxel, Carboplatin, Gemcitabine, Paclitaxel, Eribulin, BNT327 Optimized Dose, BNT327 Equivalent Q3W Dose | Locally Advanced Breast Cancer, Triple Negative Breast Cancer, Metastatic Triple Negative Breast Cancers | 83 | Aug 2028 | ≤ 742 d | 2026-06-30 |
| Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid TumorsNCT06750185Occurrence of DLTsNon-randomized · Open-label · Treatment | Phase 1 | Recruiting | Biological: BNT317 DL1, BNT317 DL2, BNT317 DL3, BNT317 DL4, BNT317 DL5 (intermediate), BNT317 DL6 (intermediate), BNT317 DL7 (additional) | Advanced Solid Tumor | 39 | Jun 2028 | ≤ 680 d | 2026-02-11 |
| A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine CancerNCT06340568Cohort 1: PFS assessed by blinded independent central review (BICR) in participants with HER2 IHC 1+/2+ recurrent endometrial cancerRandomized · Open-label · Treatment | Phase 3 | Recruiting | Drug: BNT323/DB-1303, Doxorubicin, Paclitaxel, Docetaxel | Endometrial Cancer | 480 | Mar 2028 | ≤ 589 d | 2026-07-21 |
| 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 TumorsNCT07070232Parts 1 and 2 - All cohorts except Cohort 1F - Occurrence of treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), treatment emergent serious adverse events (TESAEs), and treatment related serious adverse events (TRSAEs)Randomized · Open-label · Treatment | Phase 1/2 | Recruiting | Drug: BNT326, Pumitamig, Itraconazole, Paroxetine | Advanced Solid Tumor | 1,438 | Mar 2028 | ≤ 589 d | 2026-07-22 |
| A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent GlioblastomaNCT07297212Confirmed overall response rate (ORR)Randomized · Open-label · Treatment | Phase 2 | Recruiting | Drug: Pumitamig, Bevacizumab, Temozolomide | Recurrent Glioblastoma | 75 | Jan 2028 | ≤ 529 d | 2026-04-29 |
| A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIVNCT07698600Occurrence of at least one adverse eventRandomized · Quadruple-masked · Treatment | Phase 1 | Not yet recruiting | Biological: BNT168 · Other: Placebo | HIV -1 Infection | 126 | Jan 2028 | ≤ 529 d | 2026-07-13 |
| A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic CancerNCT07255404Confirmed overall response rateRandomized · Open-label · Treatment | Phase 2 | Recruiting | Drug: Pumitamig, Nab-paclitaxel, Gemcitabine, mFOLFIRINOX | Pancreatic Ductal Adenocarcinoma (PDAC) | 105 | Dec 2027 | ≤ 498 d | 2026-07-28 |
| A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid TumorsNCT07147348Parts A and C - Occurrence of dose limiting toxicities (DLTs) within a participant during the DLT observation periodNon-randomized · Open-label · Treatment | Phase 1/2 | Recruiting | Biological: BNT3212, Pumitamig | Advanced Solid Tumor | 375 | Nov 2027 | ≤ 467 d | 2026-06-15 |
| A Study to Learn About a COVID-19 Vaccine in Healthy Adults 18 Through 64 Years of AgeNCT07730450Percentage of participants reporting local reactions or systemic eventsRandomized · Open-label · Prevention | Phase 4 | Recruiting | Biological: BNT162b2 Vaccine, Tdap Vaccine | COVID-19 Vaccines | 200 | 2027-08-20 | in 365 d | 2026-08-07 |
| Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid TumorsNCT06150183Occurrence of dose-limiting toxicity within a cohortOpen-label · Treatment | Phase 1 | Active, not recruiting | Biological: BNT314 | Advanced Malignant Solid Tumor | 41 | Jun 2027 | ≤ 314 d | 2026-01-23 |
| Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With ChemotherapyNCT06449209Occurrence of treatment emergent adverse events (TEAEs), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-related serious adverse events (SAEs) and treatment-related treatment emergent SAEsRandomized · Open-label · Treatment | Phase 2 | Active, not recruiting | Drug: BNT327 Dose Level 1 (DL1), BNT327 Dose Level 2 (DL2), Etoposide, Carboplatin, Paclitaxel, Topotecan | Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer | 110 | Jun 2027 | ≤ 314 d | 2026-04-17 |
| A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in AfricaNCT07379580Number (and percentage) of participants with at least one solicited local reaction (pain, erythema/redness, induration/swelling)Randomized · Quadruple-masked · Prevention | Phase 2 | Recruiting | Biological: BNT166a · Other: Placebo | Mpox (Monkeypox), Smallpox, Orthopoxvirus Infection | 310 | Jun 2027 | ≤ 314 d | 2026-08-11 |
| 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 CancerNCT04486378Disease-free survival (DFS)Randomized · Open-label · Treatment | Phase 2 | Active, not recruiting | Drug: RO7198457 intravenous (IV) · Other: Observational group (no intervention) | Colorectal Cancer Stage II, Colorectal Cancer Stage III | 327 | Nov 2026 | ≤ 102 d | 2026-07-15 |
| A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIVNCT07392372Parts A and B - Occurrence of at least one adverse event (AE)Randomized · Quadruple-masked · Treatment | Phase 1 | Recruiting | Drug: BNT351, Placebo, BNT351, Placebo | HIV -1 Infection | 67 | Nov 2026 | ≤ 102 d | 2026-08-12 |
| 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 LesionsNCT05432583Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each doseRandomized · Triple-masked · Prevention | Phase 1 | Active, not recruiting | Biological: BNT163 · Other: Placebo | Genital Herpes Simplex Type 2 | 318 | Oct 2026 | ≤ 72 d | 2025-10-20 |
| A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of AgeNCT07300839Percentage of participants reporting local reactions or systemic eventsRandomized · Quadruple-masked · Prevention | Phase 3 | Active, not recruiting | Biological: BNT162b2 Vaccine, Placebo | COVID-19, SARS-COV-2 Infection | 5,240 | 2026-07-31 | — | 2026-04-13 |
| Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated VolunteersNCT05547464Frequency of solicited local reactions (pain, erythema/redness, induration/swelling) at the injection site up to 7 days after each doseRandomized · Triple-masked · Prevention | Phase 1/2 | Active, not recruiting | Biological: BNT164a1, BNT164b1 · Other: Placebo | Tuberculosis | 497 | 2026-03-12actual | — | 2026-03-18 |
| 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 SpermNCT06940804Safety Lead-in Part: Occurrence of treatment emergent adverse events (TEAEs) including Grade ≥3, adverse events of special interest (AESIs) and serious or fatal TEAEs by casual relationship to study treatmentRandomized · Open-label · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Sponsor decision | Biological: CLDN6 CAR-T, CLDN6 RNA-LPX | Testicular Germ Cell Tumor, Extragonadal Germ Cell Tumor | 0 | Jun 2042 | ≤ 5,793 d | 2025-07-02 |
| 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-19NCT07222384Percentage of participants reporting local reactionsOpen-label · Prevention | Phase 3 | Completed | Biological: BNT162b2 (2025/2026 formulation) | COVID-19, SARS-COV-2 Infection | 344 | 2026-07-24actual | — | 2026-08-07 |
| A Study to Learn About Bivalent COVID-19 RNA Vaccine Candidate(s) in Healthy Infants and ChildrenNCT05630352Substudy A - Percentage of participants reporting local reactions in each dose levelNon-randomized · Open-label · Prevention | Phase 1 | Withdrawnsponsor's stated reason: Bivalent vaccine no longer epidemiologically relevant. | Biological: 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 | COVID-19 | 0 | 2026-07-13 | — | 2024-03-18 |
| A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy ChildrenNCT05543616Substudy A (SSA) - Ph 1 dose finding, percentage of participants reporting local reactionsNon-randomized · Open-label · Prevention | Phase 3 | Completed | Biological: 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 | SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19 | 4,338 | 2026-07-10actual | — | 2026-08-06 |
| 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 YearsNCT07069309Percentage of participants reporting local reactionsOpen-label · Prevention | Phase 3 | Completed | Biological: BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) | COVID-19, SARS-COV-2 Infection | 774 | 2026-05-01actual | — | 2026-06-01 |
| Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid TumorsNCT05262530Occurrence of treatment emergent adverse events (TEAEs) including Grade ≥3, serious, or fatal TEAEs by causal relationship to study treatmentOpen-label · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Sponsor decision | Biological: BNT142 | Solid Tumor | 73 | 2025-12-22actual | — | 2026-04-08 |
| A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy PeopleNCT06821061Percentage of participants reporting prompted local reactions within 7 days following investigational product administrationRandomized · Quadruple-masked · Prevention | Phase 1/2 | Completed | Biological: Investigational Influenza Vaccine, Investigational COVID-19 Vaccine, Licensed Influenza Vaccine 1, Licensed Influenza Vaccine 2, Licensed Influenza Vaccine 3, Licensed COVID-19 Vaccine · Combination product: Investigational Influenza and COVID-19 Combination Vaccine | Influenza, COVID-19 (Coronavirus Disease 2019) | 2,650 | 2025-12-17actual | — | 2026-01-26 |
| Dose Escalation Trial of BNT152+153 in Patients With CancerNCT04710043Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by causal relationship to trial treatmentNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: BNT152, BNT153 | Solid Tumor | 86 | 2025-09-10actual | — | 2025-09-25 |
| A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox VaccinesNCT05988203SSA, SSB, and SSD - Proportion (%) of participants reporting solicited local reactions at the injection site (pain, erythema/redness, induration/swelling)Non-randomized · Open-label · Prevention | Phase 1/2 | Completed | Biological: BNT166a | Monkeypox | 96 | 2025-08-25actual | — | 2026-03-27 |
| 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 VaginosisNCT06469164Part A - Percentage of participants with adverse events (AEs) with onset after first treatment dose and until 7 days post-doseRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: BNT331 · Other: Placebo | Bacterial Vaginosis | 102 | 2025-07-31actual | — | 2025-08-07 |
| A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy PeopleNCT06683352results2026-08-19Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following VaccinationRandomized · Quadruple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Biological: Investigational Influenza Vaccine, COVID-19 Vaccine, Licensed Influenza Vaccine 1, Licensed Influenza Vaccine 2 · Combination product: Investigational Influenza/COVID-19 Vaccine · Other: Placebo | Influenza,Human, COVID-19 | 1,353 | 2025-07-15actual | — | 2026-08-19 |
| Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy VolunteersNCT05537038Frequency of solicited local reactions (pain, erythema/redness, induration/swelling) at the injection site up to 7 days after each doseRandomized · Quadruple-masked · Prevention | Phase 1 | Completed | Biological: BNT164a1, BNT164b1 · Other: Placebo | Tuberculosis | 120 | 2025-06-06actual | — | 2025-12-22 |
| A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against MalariaNCT06069544Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each doseRandomized · Quadruple-masked · Prevention | Phase 1/2 | Completed | Biological: BNT165e · Other: Placebo | Malaria | 163 | 2025-05-28actual | — | 2026-04-15 |
| 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 ChemotherapyNCT04813627observationalOccurrence of ctDNA positivity in the post-surgery/pre-AdCTx blood sample | — | Completed | Procedure: Regular blood sample collection for ctDNA assessment | Colorectal Cancer Stage II, Colorectal Cancer Stage III | 2,079 | 2025-04-23actual | — | 2026-05-22 |
| A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy IndividualsNCT05997290results2026-04-28Percentage of Participants With Local Reactions Within 7 Days After Vaccination: SSAOpen-label · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Biological: BNT162b2 (Omi XBB.1.5), BNT162b2 (Omi JN.1), BNT162b2 (Omi KP.2) | SARS-CoV-2 Infection, COVID-19 | 1,051 | 2025-03-13actual | — | 2026-04-28 |
| A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.NCT06178991results2025-12-04Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination in Investigational Vaccine ExtremityRandomized · Double-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: Influenza and COVID-19 Combination A, Licensed influenza vaccine, COVID-19 Vaccine, Influenza and COVID-19 Combination B, Placebo, Investigational influenza vaccine | Influenza, COVID-19 | 8,795 | 2024-11-26actual | — | 2025-12-04 |
| Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy PeopleNCT05541861results2026-01-13Number of Participants With Solicited Local Reactions- Post Dose 1Randomized · Triple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Biological: 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 | SARS-CoV-2 Infection, COVID-19 | 383 | 2024-11-22actual | — | 2026-01-13 |
| Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic AdenocarcinomaNCT06069778results2025-10-31Phase 1 - The Number and Percentage of Participants With at Least One Dose of Investigational Medicinal Product (IMP) Reporting Treatment Emergent Adverse Events (TEAEs)Randomized · Single-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: Sponsor decision | Drug: BNT321 0.5 mg/kg, BNT321 DL 2, mFOLFIRINOX, BNT321 RP2D | Pancreatic Cancer | 1 | 2024-09-18actual | — | 2025-10-31 |
| BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid TumorsNCT04455620results2025-07-02Number of Participants With Dose Limiting Toxicities (DLTs) During the DLT Evaluation Period in Part 1Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: Sponsor decision | Biological: BNT151 | Solid Tumor | 49 | 2024-05-28actual | — | 2025-07-02 |
| A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy IndividualsNCT05472038results2025-10-01Cohort 1: Percentage of Participants Reporting Local Reactions Within 7 Days After Study VaccinationRandomized · Quadruple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Biological: 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) | SARS-CoV-2 Infection, COVID-19 | 1,453 | 2024-03-26actual | — | 2025-10-01 |
| Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against MalariaNCT05581641results2025-09-03Number of Participants With Solicited Local ReactionsRandomized · Triple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Biological: BNT165b1 · Other: Placebo | Malaria | 60 | 2024-02-23actual | — | 2025-09-03 |
| 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 TreatmentNCT04526899results2025-12-15Arm 1: Objective Response Rate (ORR)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Biological: BNT111, Cemiplimab | Melanoma Stage III, Melanoma Stage IV, Unresectable Melanoma | 184 | 2024-01-25actual | — | 2026-01-08 |
| PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)NCT04382898results2025-03-20Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)Randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: Sponsor decision | Biological: BNT112 · Drug: Cemiplimab | Prostate Cancer | 75 | 2024-01-23actual | — | 2025-03-20 |
| Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411NCT04101357results2025-03-18Number of Participants With Dose Limiting Toxicities (DLTs)Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: Sponsor decision | Drug: BNT411, Atezolizumab, Carboplatin, Etoposide | Solid Tumor, Extensive-stage Small Cell Lung Cancer | 54 | 2024-01-19actual | — | 2025-03-18 |
| A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and InfluenzaNCT05596734results2025-07-23SSA: Percentage of Participants With Local Reactions up to 7 Days Following Vaccination (18-64 Years)Randomized · Open-label · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5), qIRV (22/23), QIV, bIRV, tIRV | Influenza, Human, COVID-19 | 1,019 | 2023-12-28actual | — | 2025-07-23 |
| Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy ChildrenNCT04816643results2026-05-28Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of AgeNon-randomized · Open-label · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, BNT162b2 30mcg, Biological/Vaccine: BNT162b2 3mcg · Other: Placebo | SARS-CoV-2 Infection, COVID-19 | 11,837 | 2023-10-04actual | — | 2026-05-28 |
| Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy ParticipantsNCT05004181results2024-11-22All Parts - Percentage of Participants Reporting Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling)Non-randomized · Open-label · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Biological: 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) · Other: Observational | SARS-CoV-2 Infection, COVID-19, SARS-CoV-2 Acute Respiratory Disease, SARS (Disease) | 1,380 | 2023-08-16actual | — | 2024-11-22 |
| Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract TumorsNCT04683939results2024-10-02Occurrence of Treatment-emergent Adverse Events (TEAEs) Within a Patient Including Grade ≥ 3, Serious, Fatal TEAE by RelationshipNon-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Terminatedsponsor's stated reason: Sponsor decision | Drug: BNT141, Nab-paclitaxel, Gemcitabine | Solid Tumor, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, Pancreatic Cancer, Biliary Tract Cancer, Cholangiocarcinoma, Metastatic Cancer | 13 | 2023-07-24actual | — | 2024-10-02 |
| Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 YearsNCT04895982results2024-10-09Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Neutralizing Titers at 1 Month After Vaccination 3 in Participants Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 InfectionOpen-label · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Biological: BNT162b2 | SARS-CoV-2 Infection, COVID19 | 124 | 2023-07-23actual | — | 2024-10-09 |
| Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced MelanomaNCT02410733Number of Adverse Events as a Measure of safety and tolerabilityOpen-label · Treatment | Phase 1 | Completed | Biological: Lipo-MERIT | Melanoma | 119 | 2023-06-20actual | — | 2026-03-12 |
| To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.NCT04955626results2025-11-10SSA: Occurrence of First COVID-19 Infection After Booster Dose Per 1000 Person-Years of Blinded Follow-up Without Evidence of Past SARS-CoV-2 Infection at Interim Analysis: Evaluable Efficacy PopulationRandomized · Triple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan: substudy A ↗ · Statistical Analysis Plan: substudy B ↗ · Statistical Analysis Plan: substudy C ↗ · Statistical Analysis Plan: substudy D ↗ · Statistical Analysis Plan: substudy E ↗ · Statistical Analysis Plan: substudy F ↗ | Phase 3 | Completed | Biological: BNT162b2, BNT162b2 OMI, Combination BNT162b2 and BNT162b2 OMI, Combination (Bivalent) BNT162b2 and BNT162b2 OMI · Other: Placebo | SARS-CoV-2 Infection, COVID-19 | 16,372 | 2023-05-25actual | — | 2025-11-10 |
| Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy IndividualsNCT04368728results2026-03-25Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Phase 1Randomized · Triple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Biological: BNT162b1, BNT162b2, BNT162b2SA · Other: Placebo | SARS-CoV-2 Infection, COVID-19 | 46,969 | 2023-02-10actual | — | 2026-03-25 |
| Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of AgeNCT05310084results2023-11-24Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1Randomized · Quadruple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: BNT162b2, Seasonal Inactivated Influenza Vaccine · Other: Placebo | SARS-CoV-2 Infection, COVID-19 | 1,134 | 2022-10-05actual | — | 2024-06-12 |
| To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and OlderNCT04754594results2024-12-06Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1Randomized · Triple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Biological: BNT162b2 · Other: Placebo | SARS-CoV-2 Infection, COVID-19, Maternal Immunization | 726 | 2022-07-15actual | — | 2024-12-06 |
| 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 SubjectsNCT04949490results2024-09-19The Number and Percentage of Participants in Each Treatment Group With at Least One Serious Adverse Event (SAE) or Adverse Events of Special Interest (AESIs)Randomized · Open-label · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Biological: BNT162b2s01, BNT162b2 | COVID-19, SARS-CoV-2 Infection | 137 | 2022-04-14actual | — | 2024-09-19 |
| A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy AdultsNCT04816669results2022-12-23Geometric Mean Titers (GMTs) of Full-Length S-Binding IgG Concentrations of Lyophilized Formulation SDVs and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2Randomized · Triple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: BNT162b2 | SARS-CoV-2 Infection, COVID-19 | 629 | 2021-12-01actual | — | 2022-12-23 |
| Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese AdultsNCT04588480results2023-02-01Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1Randomized · Double-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Biological: BNT162b2 · Other: Placebo | SARS-CoV-2 Infection, COVID-19 | 160 | 2021-11-25actual | — | 2023-02-01 |
| 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 ParticipantsNCT04713553results2022-12-22Geometric Mean Ratios (GMRs) of Full-Length S-Binding Immunoglobulin G (IgG) Concentrations Between Individual US Lots 1, 2, and 3 at 1 Month After Dose 2: Primary StudyRandomized · Triple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Biological: BNT162b2, BNT162b2.B.1.351 | SARS-CoV-2 Infection, COVID-19 | 1,574 | 2021-07-22actual | — | 2022-12-22 |
| A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 in Healthy and Immunocompromised AdultsNCT04380701results2024-07-12Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP Dose.Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Biological: BNT162a1, BNT162b1, BNT162b2, BNT162c2 | Infections, Respiratory, Virus Diseases, Infection Viral, Vaccine Adverse Reaction, RNA Virus Infections, Protection Against COVID-19 and Infections With SARS CoV 2 | 512 | 2021-06-30actual | — | 2024-07-12 |
| A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy AdultsNCT04537949results2022-03-24Number of Participants With Solicited Local Reactions at the Injection Site (Pain, Tenderness, Erythema/Redness, Induration/Swelling) Recorded up to 7 Days After Each IMP DoseNon-randomized · Open-label · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1/2 | Completed | Biological: BNT162b3 | Covid-19, Protection Against COVID-19 | 96 | 2021-03-12actual | — | 2024-01-05 |
| Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy PopulationNCT04649021SARS-CoV-2 serum neutralizing titers - Seroconversion rates (SCR)Randomized · Quadruple-masked · Prevention | Phase 2 | Completed | Biological: BNT162b2 · Other: Placebo | SARS-CoV-2 | 960 | 2021-02-07actual | — | 2026-03-20 |
| Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy SubjectsNCT04523571results2023-09-18Number of Participants With Solicited Local Adverse Events (AEs) (e.g., Injection Site Pain, Redness, Induration, Swelling) Recorded up to 14 Days After Each Dose of BNT162b1 or Placebo.Randomized · Triple-masked · PreventionStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Biological: BNT162b1 · Other: Placebo | SARS-CoV-2 | 144 | 2020-09-30actual | — | 2023-09-18 |
| RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uIDNCT02316457Number of Adverse Events as a Measure of Safety and Tolerability of IVAC_W_bre1_uIDNon-randomized · Open-label · Treatment | Phase 1 | Completed | Biological: IVAC_W_bre1_uID, IVAC_W_bre1_uID/IVAC_M_uID | Breast Cancer (Triple Negative Breast Cancer (TNBC)) | 42 | 2020-05-13actual | — | 2026-03-13 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19