Durvalumab
Clinical Trials Overview
37 trials found
About Durvalumab
Durvalumab is a human monoclonal antibody immunotherapy agent that blocks the PD-L1 (programmed death-ligand 1) pathway to enhance immune system recognition of cancer cells. In colorectal cancer, durvalumab is primarily being evaluated in microsatellite instability-high (MSI-H) tumors and in combination with radiation therapy or chemotherapy in both metastatic and preoperative settings. Current research focuses on its use as neoadjuvant therapy in resectable rectal cancer combined with chemoradiation, and in molecularly selected patients with specific mutations including KRAS, BRAF, and HER2 alterations.
Category
Immunotherapy
Brand Name
Imfinzi
Mechanism
Durvalumab binds to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking the interaction between PD-L1 and its receptors PD-1 and CD80. This blockade prevents PD-L1 from suppressing T-cell immune responses, allowing cytotoxic T-lymphocytes to maintain their anti-tumor activity and enhance immune-mediated destruction of cancer cells.
Efficacy Data by Mutation
Response rates and survival outcomes by patient molecular profile
MSI-H dMMR
Level 2B
30%
ORR
11.5m
PFS
n=28
Sample
MSS pMMR
Level 2B
8%
ORR
2.8m
PFS
6.6m
OS
n=65
Sample
37
Total Trials
3
Recruiting
8
Active
26
Completed
2,947
Total Enrollment
15
Countries
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Number of trials started per year
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med_trials_active_sites
Recruiting sites
15 countries
Phase:
NCT05845450
Phase 2
Recruiting
197 patients
Medications:
Amivantamab
Balstilimab
Botensilimab
Durvalumab
Nivolumab
Panitumumab
Sotorasib
Trastuzumab deruxtecan
Vorbipiprant
This is a window-of-opportunity umbrella platform trial enrolling non-metastatic resectable colorectal patients selected for the presence of a specific targetable molecular alteration. The study aims to test the activity of specific targeted agents/c...
Italy
NCT06680739
Phase 2
Recruiting
60 patients
Medications:
Durvalumab
Tremelimumab
The SERPENTINE trial (ESR 21-21165) is a phase II clinical study aiming to evaluate the efficacy of durvalumab and tremelimumab, alone or in combination, in patients with colorectal or endometrial cancer. The trial targets patients with microsatellit...
Spain
NCT03539822
Phase 1
Recruiting
117 patients
The investigators propose to evaluate the safety of drug combinations in patients with advanced gastroesophageal cancer and other gastrointestinal (GI) malignancies. Finding effective novel therapies for patients with advanced gastric cancer and othe...
United States
NCT04230759
Phase 2
Active
180 patients
Medications:
Durvalumab
The RADIANCE multicenter, randomized phase II trial will assess the efficacy of durvalumab, a PD-L1 immune checkpoint inhibitor, in combination with primary mitomycin C (MMC)/5-fluorouracil (5-FU)-based radiochemotherapy (RCT) in patients with locall...
Austria, Germany, Switzerland
NCT04068610
Phase 1
Active
61 patients
COLUMBIA-1 is a Phase 1b/2 platform study to evaluate the safety and efficacy of standard of care (FOLFOX plus bevacizumab) alone and in combination with novel oncology therapies in first-line metastatic microsatellite-stable colorectal cancer (MSS-C...
United States, Australia, Canada, France, Spain
NCT03851614
Phase 2
Active
90 patients
This is a phase 2, single-centre, randomized, multi-cohort trial of subjects with advanced Mismatch Repair Proficient Colorectal Cancer (MMRp-CRC), Pancreatic Adenocarcinoma (PA), and Leiomyosarcoma (LMS). Subjects will be stratified based on their p...
Canada
NCT03228667
Phase 2
Active
40 patients
QUILT-3.055 is a Phase 2b, open-label, multicohort study investigating combination immunotherapies in patients with advanced solid tumors who have previously been treated with PD-1/PD-L1 checkpoint inhibitors. The study aims to evaluate the safety an...
United States
NCT02888743
Phase 2
Active
110 patients
Medications:
Durvalumab
Tremelimumab
This randomized phase II trial studies the side effects of durvalumab and tremelimumab and to see how well they work with or without high or low-dose radiation therapy in treating patients with colorectal or non-small cell lung cancer that has spread...
United States, Canada
NCT02983578
Phase 2
Active
39 patients
Medications:
Danvatirsen
Durvalumab
This phase II trial studies how well danvatirsen and durvalumab work in treating patients with pancreatic cancer, non-small cell lung cancer and mismatch repair deficient colorectal cancer that has spread to other places in the body and does not resp...
United States
NCT02671435
Phase 1
Active
383 patients
This is a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, pharmacokinetic (PK), pharmacodynamics, and immunogenicity of durvalumab (MEDI4736) in combination...
United States, Australia, Belgium, Canada, France, Hungary, Italy, New Zealand, South Korea, Spain,
NCT02484404
Phase 1
Active
268 patients
Background:
\- Durvalumab is a drug that may help people s immune systems respond to and kill cancer cells. Olaparib is a drug that may inhibit repairing DNA damage of cancer cells. Cediranib is a drug that may stop the blood vessel growth of cancer...
United States
NCT06304597
Phase 1
Completed
18 patients
Medications:
Durvalumab
Nivolumab
Colorectal cancer (CRC) claims 10% of global cancer-related deaths annually, with rising incidence. Locally advanced rectal cancer (LARC) requires improved diagnostic techniques. This study focuses on dual-wavelength quantitative fluorescence molecul...
Netherlands
NCT04705818
Phase 2
Completed
173 patients
Medications:
Durvalumab
Tazemetostat
Umbrella study structure to independently and simultaneously assess the effects of the association of durvalumab and tazemetostat in multiple solid tumors.
France
NCT04696848
Phase 1
Completed
25 patients
Medications:
CKD-516
Durvalumab
This is a single center, open-label, nonrandomized, Phase 1b, dose-escalation study designed to determine maximum tolerated dose (MTD) of CKD-516 in combination with durvalumab and evaluate the safety and tolerability profile, efficacy of CKD-516 and...
South Korea
A Trial of Durvalumab (MEDI 4736) in Combination With Extended Neoadjuvant Regimens in Rectal Cancer
NCT04621370
Phase 2
Completed
48 patients
PRIME-RT is an open label, multi-centre phase II randomised trial with 1:1 allocation between arm A and arm B. The principal research question is whether the addition of durvalumab to FOLFOX chemotherapy and radiation treatment (either SCRT or LCRT) ...
NCT04108481
Phase 1
Completed
5 patients
Medications:
Durvalumab
This clinical trial will be conducted as a single-center, open-label, Phase I/2 trial to evaluate the feasibility and safety of Yttrium-90 radioembolization (Y90-RE) in combination with a fixed dose of of immunotherapy (durvalumab - 750 mg) in subjec...
United States
NCT04083365
Phase 2
Completed
Medications:
Capecitabine
Durvalumab
This is a prospective phase II, open label, single arm, multi-centre study to evaluate activity of an innovative sequence on capecitabine plus concomitant radiation therapy followed by durvalumab in patients with operable rectal cancer. The enrollmen...
Italy
NCT03101475
Phase 2
Completed
22 patients
Medications:
Durvalumab
Tremelimumab
This is a single-arm, open-label, multi-center early phase II study. This proof of concept study will investigate whether the combined use of local tumor ablation/radiation plus immunomodulating drugs may induce a significant immune response in patie...
Austria, France, Germany, Netherlands, Sweden, Switzerland
NCT03439085
Phase 2
Completed
41 patients
Medications:
Durvalumab
This phase II trial studies how well deoxyribonucleic acid (DNA) plasmid-encoding interleukin-12/human papillomavirus (HPV) DNA plasmids therapeutic vaccine INO-3112 and durvalumab work in treating patients with human papillomavirus associated cancer...
United States
NCT03376659
Phase 1
Completed
8 patients
This is a dual arm, open label phase I/II study to evaluate the safety and clinical activity of the combination of durvalumab with CV301 in combination with maintenance chemotherapy for patients with metastatic colorectal or pancreatic cancer whose d...
United States
NCT03435107
Phase 2
Completed
33 patients
Medications:
Durvalumab
The POLE mutations represent high somatic mutation loads in patients with colorectal cancer, especially in those with MMR proficient or MSS, therefore, tumors harbouring POLE mutations might be susceptible to immune checkpoint blockade.
Based on the...
South Korea
NCT03428126
Phase 2
Completed
29 patients
Medications:
Durvalumab
Trametinib
The goal of this clinical research study is to learn if durvalumab and trametinib can help to control microsatellite stable (MSS) colorectal cancer. The safety of these drugs will also be studied.
This is an investigational study. Durvalumab is FDA ...
United States
NCT03206073
Phase 1
Completed
34 patients
Background:
* Immune-based approaches in colorectal cancer have unfortunately with the notable exception of immune checkpoint inhibition in microsatellite instable (MSI-hi) disease been largely unsuccessful. The reasons for this are unclear but no d...
United States
NCT02963831
Phase 1
Completed
67 patients
This is a two-part Phase 1/2 dose escalation and dose expansion study of an Adenovirus Vector (Ad5/3-D24-GMCSF), Expressing GM-CSF (GM-CSF-encoding adenovirus), ONCOS-102, in combination with anti-programmed death ligand-1 (PD-L1) antibody, durvaluma...
United States
NCT03202758
Phase 1
Completed
57 patients
Colo-rectal cancer is still one of the leading causes of cancer death worldwide. In France, approximately 40 500 new cases are diagnosed each year. With more than 17 500 deaths in France in 2011, colo-rectal cancer is responsible for more than 12% of...
France
NCT03007407
Phase 2
Completed
33 patients
Medications:
Durvalumab
Tremelimumab
This study is being done to look at the safety and response to the combination of two investigational drugs, tremelimumab and durvalumab, when given after radiation therapy for patients with microsatellite stable (MSS) metastatic colorectal cancer. T...
United States
NCT03005002
Phase 1
Completed
9 patients
Medications:
Durvalumab
Tremelimumab
This pilot clinical trial studies the side effects and how well durvalumab and tremelimumab work in treating patients with microsatellite stable colorectal cancer that has spread to the liver. Monoclonal antibodies, such as durvalumab and tremelimuma...
United States
NCT03122509
Phase 2
Completed
25 patients
Medications:
Durvalumab
Tremelimumab
The purpose of this study is to test the safety and effectiveness of two investigational drugs (drugs that are not currently approved by the FDA) given in combination with radiation therapy or ablation.
United States
NCT02870920
Phase 2
Completed
180 patients
Medications:
Durvalumab
Tremelimumab
The standard or usual treatment for this disease is treatment with drugs and other treatments that may help to make a patient better or may improve their quality of life. This treatment is known as "best supportive care" (BSC). Although patients with...
Canada
NCT02669914
Phase 2
Completed
4 patients
Medications:
Durvalumab
Brain metastases are the most common intracranial malignancy occurring in 20-40% of all cancers, and the presence of CNS metastases is associated with a poor prognosis. As such, the median overall survival of patients with symptomatic brain lesions i...
United States
NCT02811497
Phase 2
Completed
28 patients
Medications:
Azacitidine
Durvalumab
This is a phase 2 study of investigational drug, durvalumab given in combination with azacitidine (CC-486). The main purpose of this phase 2 study is to assess the antitumor activity of azacitidine in combination with durvalumab patients with microsa...
Canada
NCT02754856
Phase 1
Completed
24 patients
Medications:
Durvalumab
Tremelimumab
This phase I trial studies the side effects and how well tremelimumab and durvalumab work in treating patients with colorectal cancer that has spread to the liver and can be removed by surgery. Immunotherapy with monoclonal antibodies, such as tremel...
United States
NCT02740985
Phase 1
Completed
313 patients
This is a Phase 1, open-label, multicenter study of continuous oral dosing of AZD4635 administered to patients with advanced solid malignancies. Dosing will be escalated until a maximum-tolerated dose (MTD) is determined in patients. The MTD will be ...
United States
NCT02777710
Phase 1
Completed
48 patients
Medications:
Durvalumab
Pexidartinib
Colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) are the most common gastrointestinal cancers in Western countries and are both associated with significant morbidity and mortality. An intriguing similarity between CRC and PDAC is t...
France
NCT02586987
Phase 1
Completed
58 patients
This is a Phase I, open-label, multi-centre, drug combination study of double and triple combination oral selumetinib (AZD6244 Hyd-sulfate) plus intravenous (IV) MEDI4736 and oral selumetinib plus IV MEDI4736 and IV tremelimumab in patients with adva...
United States
NCT02227667
Phase 2
Completed
16 patients
Medications:
Durvalumab
The purpose of this study is to find out what effects, good and/or bad, MEDI4736 has on the patient and cancer.
MEDI4736 is a type of medication called an antibody. Antibodies are normal proteins in the body that help fight infections and possibly c...
United States
NCT01975831
Phase 1
Completed
104 patients
Medications:
Durvalumab
Tremelimumab
This was a Phase 1, open-label, nonrandomized, multicenter study of durvalumab and tremelimumab in subjects with advanced cancers who were not eligible for, declined, or failed standard treatment. The primary study objective was to determine the maxi...
United States