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Showing 1–24 of 34 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Bintrafusp alfa/M7824 Clear all
Completed Phase 2 Interventional Results available

Bintrafusp Alfa Monotherapy in Platinum-Experienced Cervical Cancer

NCT04246489
View directory record Official record
Conditions
Uterine Cervical Neoplasms
Interventions
Bintrafusp alfa
Drug
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Industry
Eligibility
18 Years and older · Female only
Enrollment
146 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
11
States / cities
Fayetteville, Arkansas • Little Rock, Arkansas • Stanford, California + 8 more
Source: ClinicalTrials.gov public record
Updated Oct 22, 2023 · Synced Sep 23, 2026, 8:20 PM EDT
Withdrawn Phase 1Phase 2 Interventional

Aerosolized Azacytidine as Epigenetic Priming for Bintrafusp Alfa-Mediated Immune Checkpoint Blockade in Patients With Unresectable Pulmonary Metastases From Sarcomas, Germ Cell Tumors, or Epithelial Malignancies

NCT04648826
View directory record Official record
Conditions
Sarcomas, Melanomas, Germ Cell Tumors, Epithelial Malignancies (Excluding Lung and Renal Cell Carcinomas), Pulmonary Metastases
Interventions
AeroEclipse II Breath Actuated Nebulizer, Bintrafusp alfa, Azacytidine
Device · Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Dec 16, 2021 · Synced Sep 23, 2026, 8:20 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT)

NCT04574583
View directory record Official record
Conditions
Metastatic Cancer, Solid Tumors
Interventions
SX-682, M7824, MVA-BN-CV301, recombinant fowlpox viral (FPV)-CV301
Drug · Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Feb 2, 2025 · Synced Sep 23, 2026, 8:20 PM EDT
Terminated Phase 2 Interventional Results available

Bintrafusp Alfa With Chemotherapy for Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung Cancer

NCT04971187
View directory record Official record
Conditions
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Unresectable Lung Non-Squamous Non-Small Cell Carcinoma
Interventions
Bintrafusp Alfa, Pemetrexed, Carboplatin, Cisplatin
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
3 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 31, 2023 · Synced Sep 23, 2026, 8:20 PM EDT
Completed Phase 2 Interventional Results available

M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)

NCT03833661
View directory record Official record
Conditions
Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
Interventions
M7824
Drug
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Industry
Eligibility
18 Years and older
Enrollment
159 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
7
States / cities
Scottsdale, Arizona • San Francisco, California • Jacksonville, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated Oct 24, 2023 · Synced Sep 23, 2026, 8:20 PM EDT
Withdrawn Phase 2 Interventional

N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer

NCT05445882
View directory record Official record
Conditions
Castration Resistant Prostate Cancer
Interventions
Bintrafusp alfa, N-803, BN-Brachyury
Drug · Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years to 120 Years · Male only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Apr 1, 2024 · Synced Sep 23, 2026, 8:20 PM EDT
Completed Phase 1 Interventional

Radiation Therapy and M7824 in Treating Patients With Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer

NCT03524170
View directory record Official record
Conditions
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
Interventions
Bintrafusp Alfa, Radiation Therapy
Drug · Radiation
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Mar 6, 2022 · Synced Sep 23, 2026, 8:20 PM EDT
Completed Phase 1Phase 2 Interventional Results available

M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)

NCT03840915
View directory record Official record
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
Cisplatin, Carboplatin, Pemetrexed, Nab-paclitaxel, Gemcitabine, Docetaxel, M7824, Bintrafusp alfa, Paclitaxel
Drug
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Industry
Eligibility
18 Years and older
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
8
States / cities
Fountain Valley, California • San Marcos, California • Port Saint Lucie, Florida + 5 more
Source: ClinicalTrials.gov public record
Updated Aug 20, 2023 · Synced Sep 23, 2026, 8:20 PM EDT
Active, not recruiting Phase 2 Interventional

Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma

NCT04417660
View directory record Official record
Conditions
Thymic Epithelial Tumor, Recurrent Thymoma, Thymic Cancer
Interventions
M7824
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Aug 27, 2026 · Synced Sep 23, 2026, 8:20 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection

NCT04247282
View directory record Official record
Conditions
Head and Neck Cancer, Head and Neck Neoplasms
Interventions
M7824, N803, TriAd vaccine
Drug · Biological
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Jul 15, 2025 · Synced Sep 23, 2026, 8:20 PM EDT
Completed Phase 1Phase 2 Interventional Results available

M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability

NCT03436563
View directory record Official record
Conditions
Colon Adenocarcinoma, High-Frequency Microsatellite Instability, Metastatic Malignant Solid Neoplasm, Rectal Adenocarcinoma, Refractory Colorectal Carcinoma, Stage IV Colon Cancer AJCC v8, Stage IV Rectal Cancer AJCC v8, Stage IVA Colon Cancer AJCC v8, Stage IVA Rectal Cancer AJCC v8, Stage IVB Colon Cancer AJCC v8, Stage IVB Rectal Cancer AJCC v8
Interventions
Anti-PD-L1/TGFbetaRII Fusion Protein M7824
Biological
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2023
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Nov 26, 2024 · Synced Sep 23, 2026, 8:20 PM EDT
Completed Phase 3 Interventional Results available

M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)

NCT03631706
View directory record Official record
Conditions
Non-small Cell Lung Cancer
Interventions
M7824, Pembrolizumab
Drug
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Industry
Eligibility
18 Years and older
Enrollment
304 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
25
States / cities
Huntsville, Alabama • Los Angeles, California • Orange, California + 21 more
Source: ClinicalTrials.gov public record
Updated Apr 7, 2025 · Synced Sep 23, 2026, 8:20 PM EDT
Terminated Phase 2 Interventional Results available

Bintrafusp Alfa Before Surgery for the Treatment of Untreated Resectable Non-small Cell Lung Cancer

NCT04560686
View directory record Official record
Conditions
Resectable Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage IA1 Lung Cancer AJCC v8, Stage IA2 Lung Cancer AJCC v8, Stage IA3 Lung Cancer AJCC v8, Stage IB Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8
Interventions
Bintrafusp Alfa, Therapeutic Conventional Surgery
Drug · Procedure
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 27, 2022 · Synced Sep 23, 2026, 8:20 PM EDT
Active, not recruiting Phase 1 Interventional

Hypofractionated Radiation Therapy and Bintrafusp Alfa for the Treatment of Advanced Intrahepatic Cholangiocarcinoma

NCT04708067
View directory record Official record
Conditions
Locally Advanced Intrahepatic Cholangiocarcinoma, Metastatic Intrahepatic Cholangiocarcinoma, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8, Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
Interventions
Bintrafusp Alfa, Biopsy, Hypofractionated Radiation Therapy
Drug · Procedure · Radiation
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Sep 13, 2026 · Synced Sep 23, 2026, 8:20 PM EDT
Terminated Phase 2 Interventional Results available

A Phase II Study of Bintrafusp Alfa (M7824) in Checkpoint Inhibitor Naive and Refractory Subjects With Urothelial Carcinoma

NCT04501094
View directory record Official record
Conditions
Urothelial Cancer
Interventions
Bintrafusp alfa (M7824)
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Mar 21, 2022 · Synced Sep 23, 2026, 8:20 PM EDT
Completed Phase 2 Interventional Results available

Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers

NCT04491955
View directory record Official record
Conditions
Small Bowel Cancers, Colorectal Cancers
Interventions
CV301, MSB0011359C, N-803, NHS-IL12
Biological · Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Apr 23, 2025 · Synced Sep 23, 2026, 8:20 PM EDT
Completed Phase 1 Interventional Results available

Bintrafusp Alfa Combination Therapy in Participants With Cervical Cancer (INTR@PID 046)

NCT04551950
View directory record Official record
Conditions
Cervical Cancer
Interventions
M7824, Carboplatin, Paclitaxel, Bevacizumab, Cisplatin, Radiotherapy
Drug · Radiation
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Industry
Eligibility
18 Years and older · Female only
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
5
States / cities
Stanford, California • Augusta, Georgia • Henderson, Nevada + 2 more
Source: ClinicalTrials.gov public record
Updated Mar 7, 2024 · Synced Sep 23, 2026, 8:20 PM EDT
Terminated Phase 2 Interventional Results available

Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer

NCT04396535
View directory record Official record
Conditions
Advanced Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Interventions
Bintrafusp Alfa, Docetaxel
Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
3
States / cities
Scottsdale, Arizona • Jacksonville, Florida • Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Nov 16, 2025 · Synced Sep 23, 2026, 8:20 PM EDT
Terminated Phase 1 Interventional Results available

A Study to Evaluate the Efficacy and Safety of Bintrafusp Alfa (M7824) Monotherapy in Metastatic or Locally Advanced Urothelial Cancer

NCT04349280
View directory record Official record
Conditions
Neoplasms
Interventions
Bintrafusp alfa
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
18 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
2
States / cities
Lake Success, New York • Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Apr 17, 2024 · Synced Sep 23, 2026, 8:20 PM EDT
Terminated Phase 2 Interventional Results available

M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

NCT03840902
View directory record Official record
Conditions
Non-small Cell Lung Cancer
Interventions
M7824, Placebo, Durvalumab, Etoposide, Pemetrexed, Carboplatin, Paclitaxel, Cisplatin, Intensity Modulated Radiation Therapy (IMRT)
Drug · Radiation
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Industry
Eligibility
18 Years and older
Enrollment
153 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
21
States / cities
Orange, California • Santa Monica, California • Colorado Springs, Colorado + 17 more
Source: ClinicalTrials.gov public record
Updated Jan 15, 2024 · Synced Sep 23, 2026, 8:20 PM EDT
Active, not recruiting Phase 1 Interventional

Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies

NCT04235777
View directory record Official record
Conditions
Urothelial Cancer, Bladder Cancer, Genitourinary Cancer, Urogenital Neoplasms, Urogenital Cancer
Interventions
Stereotactic body radiation therapy (SBRT), PDS01ADC, M7824
Radiation · Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years to 120 Years
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2028
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Sep 7, 2026 · Synced Sep 23, 2026, 8:20 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)

NCT03493945
View directory record Official record
Conditions
Metastatic Castration-resistant Prostate Cancer, Prostate Cancer, Prostate Neoplasm, Advanced Solid Tumor, Solid Tumor, Non-metastatic Castration-resistant Prostate Cancer
Interventions
M7824, N-803, MVA-BN-Brachyury, FPV-Brachyury, Epacadostat, Acetaminophen, Ibuprofen, Naproxen, Benadryl, EKG, Bone scan, CT chest, abdomen and pelvis, MRI
Biological · Drug · Other + 1 more
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years to 120 Years
Enrollment
59 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Sep 29, 2025 · Synced Sep 23, 2026, 8:20 PM EDT
Terminated Phase 1Phase 2 Interventional Results available

Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases

NCT04789668
View directory record Official record
Conditions
Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Hematopoietic and Lymphoid Cell Neoplasm, Hormone Receptor Positive Breast Adenocarcinoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Triple-Negative Breast Carcinoma, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
Interventions
Bintrafusp Alfa, Pimasertib, Quality-of-Life Assessment
Drug · Other
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Mar 17, 2026 · Synced Sep 23, 2026, 8:20 PM EDT
Terminated Phase 2Phase 3 Interventional Results available

Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC

NCT04066491
View directory record Official record
Conditions
Biliary Tract Cancer, Cholangiocarcinoma, Gallbladder Cancer
Interventions
M7824, Placebo, Gemcitabine, Cisplatin
Drug
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Industry
Eligibility
18 Years and older
Enrollment
309 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
12
States / cities
Chandler, Arizona • Gilbert, Arizona • Phoenix, Arizona + 9 more
Source: ClinicalTrials.gov public record
Updated Nov 13, 2023 · Synced Sep 23, 2026, 8:20 PM EDT