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DRUG:

Imfinzi (durvalumab)

i
Other names: MEDI4736, MEDI-4736, MEDI 4736
Company:
AstraZeneca
Drug class:
PD-L1 inhibitor
Related drugs:
2d
ESR-22-21719: Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma (clinicaltrials.gov)
P2, N=0, Withdrawn, Georgetown University | N=28 --> 0 | Recruiting --> Withdrawn
Enrollment change • Trial withdrawal
|
cisplatin • Imfinzi (durvalumab) • gemcitabine • Imjudo (tremelimumab)
2d
Durvalumab Plus Tremelimumab for the Treatment of Patients with Progressive, Refractory Advanced Thyroid Carcinoma -The DUTHY Trial (clinicaltrials.gov)
P2, N=79, Terminated, Grupo Espanol de Tumores Neuroendocrinos | Trial completion date: Dec 2025 --> Nov 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2025 --> Nov 2024; In compliance with current legislation applicable to Clinical Trials, following the instructions of the Spanish Agency for Medicines and Health Products.
Trial completion date • Trial termination • Trial primary completion date • Metastases
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
2d
Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies (clinicaltrials.gov)
P1/2, N=19, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=12 --> 19
Enrollment closed • Enrollment change • Combination therapy • Metastases
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • plinabulin (BPI 2358)
6d
New P2 trial
|
Imfinzi (durvalumab) • ceralasertib (AZD6738)
6d
Gemcitabine, Nab-paclitaxel, Durvalumab, and Oleclumab Before Surgery for the Treatment of in Resectable/Borderline Resectable Primary Pancreatic Cancer (clinicaltrials.gov)
P2, N=13, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=30 --> 13
Enrollment closed • Enrollment change • Surgery
|
Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • oleclumab (MEDI9447)
7d
Esophagomediastinal fistula during durvalumab plus tremelimumab with chemotherapy in angiotensin-converting enzyme 2-positive non-small cell lung cancer: a case report. (PubMed, Transl Lung Cancer Res)
The treatment regimen comprised durvalumab, tremelimumab, carboplatin, and nab-paclitaxel. Clinicians should be aware that COVID-19 might be associated with the development of severe irAEs and unexpectedly enhanced antitumor effects. The findings also suggest new fields of study regarding the interaction between viral infection and tumor immune response, which may inform future therapeutic approaches.
Journal • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
EGFR mutation
|
carboplatin • Imfinzi (durvalumab) • albumin-bound paclitaxel • Imjudo (tremelimumab)
8d
Assess the Safety of Immunotherapy Induction With Tremelimumab and Durvalumab Prior to Chemoradiotherapy and/or Resection in the Treatment (clinicaltrials.gov)
P1, N=18, Terminated, The Netherlands Cancer Institute | N=34 --> 18 | Trial completion date: Jan 2021 --> Nov 2024 | Unknown status --> Terminated | Trial primary completion date: Jan 2021 --> Nov 2024; Based on initially defined safety rules not continued with expansion phase of study (too much toxicity with neo-adjuvant immunotherapy)
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
|
cisplatin • Imfinzi (durvalumab) • Imjudo (tremelimumab) • pemetrexed
9d
First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours (clinicaltrials.gov)
P1, N=60, Completed, AstraZeneca | Active, not recruiting --> Completed | Trial completion date: Jan 2025 --> Oct 2024 | Trial primary completion date: Jan 2025 --> Oct 2024
Trial completion • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Imfinzi (durvalumab) • AZD8701
10d
CALYPSO: MEDI4736 Combinations in Metastatic Renal Cell Carcinoma (clinicaltrials.gov)
P2, N=69, Completed, Queen Mary University of London | Active, not recruiting --> Completed | N=181 --> 69 | Trial completion date: Mar 2023 --> Jul 2024 | Trial primary completion date: Mar 2023 --> Jul 2024
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab) • Orpathys (savolitinib)
10d
DRP-104 (Glutamine Antagonist) in Combination With Durvalumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC) (clinicaltrials.gov)
P1/2, N=27, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Feb 2027 --> Aug 2029 | Trial primary completion date: Feb 2027 --> Aug 2028
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
DNAJB1 (DnaJ Heat Shock Protein Family (Hsp40) Member B1) • PRKACA (Protein Kinase CAMP-Activated Catalytic Subunit Alpha)
|
DNAJB1-PRKACA fusion
|
Imfinzi (durvalumab) • sirpiglenastat (DRP-104)
10d
NEXIS: Neoadjuvant Durvalumab and Tremelimumab Plus Radiation for High Risk Soft-Tissue Sarcoma (clinicaltrials.gov)
P1/2, N=22, Terminated, University of Maryland, Baltimore | Trial completion date: Jun 2037 --> Jun 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2032 --> Jun 2024; Limited Accrual
Trial completion date • Trial termination • Trial primary completion date
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
11d
Durvalumab Following Chemoradiotherapy for Stage III Non-small Cell Lung Cancer: Differences in Survival Based on Age and Post-Progression Systemic Therapy. (PubMed, Target Oncol)
In the studied cohort, OS was significantly shorter for patients ≥ 75 years of age treated with cCRT followed by durvalumab compared to those < 65 years. Post-progression systemic therapy was associated with modest efficacy, underscoring the need for new therapies.
Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Imfinzi (durvalumab)
13d
A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study (clinicaltrials.gov)
P2, N=54, Recruiting, Australasian Gastro-Intestinal Trials Group | Trial completion date: Jan 2028 --> Jul 2029
Trial completion date
|
carboplatin • Imfinzi (durvalumab)
13d
Enrollment change
|
Imfinzi (durvalumab)
13d
A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors (clinicaltrials.gov)
P1/2, N=383, Active, not recruiting, MedImmune LLC | Trial completion date: Sep 2024 --> Sep 2025
Trial completion date
|
BRAF (B-raf proto-oncogene)
|
Avastin (bevacizumab) • Erbitux (cetuximab) • Imfinzi (durvalumab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • monalizumab (IPH2201)
14d
New P2 trial • Combination therapy • Metastases
|
carboplatin • Imfinzi (durvalumab) • paclitaxel
15d
WNT/β-catenin Signaling and CD8+ Tumor-infiltrating Lymphocytes in Tremelimumab Plus Durvalumab for Advanced Hepatocellular Carcinoma. (PubMed, In Vivo)
Although the present study involved a small number of patients, the findings suggest that the efficacy of tremelimumab plus durvalumab may be affected by WNT/β-catenin signaling and CD8+ TIL infiltration.
Journal • Tumor-infiltrating lymphocyte • PD(L)-1 Biomarker • IO biomarker • Metastases
|
CD8 (cluster of differentiation 8)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
15d
Durvalumab-Induced Immune Thrombocytopenia in Patients with Advanced Cholangiocarcinoma Undergoing Yttrium-90 Radioembolization. (PubMed, Case Rep Oncol)
Two patients, a 67-year-old female and a 60-year-old man, with biopsy-proven advanced unresectable cholangiocarcinoma, received a combination of systemic therapy with durvalumab, gemcitabine, and cisplatin and subsequently Y90-RE...Immunotherapy in the form of durvalumab and now pembrolizumab alongside chemotherapy is an approved first-line standard of care...This report highlights the development of ITP in 2 patients who received durvalumab alongside Y90-RE. Awareness of this as a potential immune-mediated event is important to allow for close monitoring of platelet counts and for early intervention/management when this occurs.
Journal • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • Imfinzi (durvalumab) • gemcitabine
15d
OlympiaN: Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer (clinicaltrials.gov)
P2, N=50, Active, not recruiting, AstraZeneca | Trial primary completion date: May 2024 --> Nov 2024
Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
|
BRCA2 mutation • BRCA1 mutation • ER negative • BRCA mutation
|
Lynparza (olaparib) • Imfinzi (durvalumab)
17d
A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers (clinicaltrials.gov)
P=N/A, N=60, Recruiting, Jiangsu Healthy Life Innovation Medical Technology Co., Ltd | Not yet recruiting --> Recruiting
Enrollment open
|
cisplatin • Imfinzi (durvalumab) • gemcitabine
17d
AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
P1/2, N=12, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Aug 2025 --> Oct 2024
Trial completion • Trial completion date
|
Imfinzi (durvalumab) • batiraxcept (AVB-500)
17d
Chemo-Immunotherapy Followed by Durvalumab and Ceralasertib in Treatment Naïve Patients With Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov)
P2, N=30, Recruiting, Muhammad Furqan | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
Trial completion date • Trial primary completion date
|
cisplatin • carboplatin • Imfinzi (durvalumab) • etoposide IV • ceralasertib (AZD6738)
17d
Trial completion • Real-world evidence • Real-world
|
Imfinzi (durvalumab)
21d
A comprehensive review of immune checkpoint inhibitors for cancer treatment. (PubMed, Int Immunopharmacol)
Immune checkpoint inhibitors (ICIs) have shown great success, with FDA-approved drugs like PD-1 inhibitors (Nivolumab, Pembrolizumab, Cemiplimab), PD-L1 inhibitors (Atezolizumab, Durvalumab, Avelumab), and CTLA-4 inhibitors (Ipilimumab, Tremelimumab), alongside LAG-3 inhibitor Relatlimab. This review aims to fill this gap by providing an analysis of the current clinical status of ICIs, emerging biomarkers, mechanisms of resistance, strategies to enhance therapeutic efficacy, and assessment of adverse effects. This review is crucial to furthering our understanding of ICIs and optimizing their application in cancer therapy.
Review • Journal • Checkpoint inhibition • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
|
TMB (Tumor Mutational Burden) • IFNG (Interferon, gamma) • LAG3 (Lymphocyte Activating 3) • CD276 (CD276 Molecule) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • BTLA (B And T Lymphocyte Associated)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Imjudo (tremelimumab) • Libtayo (cemiplimab-rwlc) • relatlimab (BMS-986016)
23d
A case of successful conversion surgery for unresectable gallbladder cancer treated with durvalumab in combination with gemcitabine plus cisplatin. (PubMed, Clin J Gastroenterol)
The patient continued adjuvant chemotherapy with single-agent durvalumab every 4 weeks and maintained a relapse-free survival of 8 months postoperatively. The utility of durvalumab in combination with gemcitabine plus cisplatin in unresectable gallbladder cancer independent of programmed death ligand-1 expression has been confirmed and may be an important option in future multimodal treatment, including conversion surgery.
Journal • Combination therapy • PD(L)-1 Biomarker • Surgery
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
cisplatin • Imfinzi (durvalumab) • gemcitabine
23d
Autoimmune encephalitis following treatment with durvalumab for small-cell lung cancer. (PubMed, J Int Med Res)
This current case report describes a male patient in his late 50s with ES-SCLC who developed autoimmune encephalitis associated with durvalumab treatment after three cycles of combination chemotherapy. This current case furthers the understanding of autoimmune encephalitis caused by durvalumab treatment.
Journal
|
PD-L1 (Programmed death ligand 1)
|
Imfinzi (durvalumab)
24d
Tremelimumab and durvalumab with chemotherapy in first-line treatment for metastatic non-small cell lung cancer: a US-based cost-effectiveness analysis. (PubMed, Transl Lung Cancer Res)
Scenario analysis confirmed the study's primary findings, with the exception of a scenario where durvalumab was offered at no cost. The findings suggests that T + D + CT may not be a cost-effectiveness first-line treatment for EGFR/ALK wild-type mNSCLC in the US, given its high ICERs and limited cost-effectiveness in the majority of PD-L1 expression subgroups.
Journal • HEOR • PD(L)-1 Biomarker • IO biomarker • Cost-effectiveness • Cost effectiveness • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression • EGFR wild-type • ALK wild-type
|
Imfinzi (durvalumab) • Imjudo (tremelimumab)
24d
NEOCATS: NEoadjuvant Olaparib Combination OvArian Cancer Targeted Study (clinicaltrials.gov)
P2, N=40, Not yet recruiting, British Columbia Cancer Agency
New P2 trial • Metastases
|
BRCA (Breast cancer early onset)
|
Avastin (bevacizumab) • Lynparza (olaparib) • Imfinzi (durvalumab)
24d
MOZART: MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov)
P2, N=38, Recruiting, Hirva Mamdani | Trial completion date: Jun 2025 --> Jan 2027 | Trial primary completion date: Sep 2024 --> Jan 2026
Trial completion date • Trial primary completion date • Combination therapy
|
cisplatin • carboplatin • Imfinzi (durvalumab) • etoposide IV • monalizumab (IPH2201)
26d
Targeted and cytotoxic inhibitors used in the treatment of lung cancers. (PubMed, Pharmacol Res)
On the order of 20% of NSCLCs bear activating mutations in EGFR and are treated with osimertinib and other kinase antagonists...Local treatment options to control thoracic disease include radiotherapy and surgery. In patients with extensive-stage disease, a platinum agent (cisplatin or carboplatin) combined with etoposide and an anti-PDL1 inhibitor (atezolizumab or durvalumab) for four cycles followed by anti-PDL1 maintenance therapy is the recommended first-line regimen.
Review • Journal • PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
|
EGFR mutation • BRAF mutation • ALK translocation
|
Mekinist (trametinib) • cisplatin • Tagrisso (osimertinib) • Tecentriq (atezolizumab) • Tafinlar (dabrafenib) • carboplatin • Imfinzi (durvalumab) • Vitrakvi (larotrectinib) • Rozlytrek (entrectinib) • Alecensa (alectinib) • Retevmo (selpercatinib) • pemetrexed • etoposide IV • Tabrecta (capmatinib)
27d
Olaparib and Durvalumab (MEDI4736) in Patients with Metastatic Pancreatic Cancer and DNA Damage Repair Genes Alterations (clinicaltrials.gov)
P2, N=40, Active, not recruiting, Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) | Recruiting --> Active, not recruiting
Enrollment closed • Metastases
|
HRD (Homologous Recombination Deficiency) • RAD51 (RAD51 Homolog A)
|
HRD
|
Lynparza (olaparib) • Imfinzi (durvalumab)
29d
Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer (SWOG-Fall 2024)
Participants must not have received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, biologic, or hormonal therapy, and must be candidates for doxorubicin, paclitaxel, and durvalumab therapy. No participants are currently ineligible. There have been no Grade 4 or higher adverse events reported among the 26 participants assessed for adverse events.
Clinical • P3 data
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HR positive • HER-2 negative • PGR positive • EGFR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive • HER-2 negative + PGR positive
|
MammaPrint
|
Imfinzi (durvalumab) • paclitaxel • doxorubicin hydrochloride
29d
Trial completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1)
|
KRAS mutation • EGFR mutation • STK11 mutation • ALK fusion • KEAP1 mutation
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • Imfinzi (durvalumab) • Imjudo (tremelimumab) • pemetrexed
29d
Enrollment open • Metastases
|
Imfinzi (durvalumab) • oleclumab (MEDI9447)
29d
Radiotherapy and Durvalumab/Durvalumab Combo (Tremelimumab/Olaparid) for Small Cell Lung Cancer (clinicaltrials.gov)
P1, N=25, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Sep 2024 --> Jan 2025
Trial completion date
|
Lynparza (olaparib) • Imfinzi (durvalumab) • Imjudo (tremelimumab)
29d
Durvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer (clinicaltrials.gov)
P1/2, N=79, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
Trial completion date • Trial primary completion date • Surgery
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
carboplatin • Imfinzi (durvalumab) • paclitaxel • Imjudo (tremelimumab)
30d
New P4 trial
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Herceptin (trastuzumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • Imfinzi (durvalumab) • Rituxan (rituximab) • Truxima (rituximab-abbs)
30d
Trial completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • STK11 (Serine/threonine kinase 11) • KEAP1 (Kelch Like ECH Associated Protein 1)
|
KRAS mutation • EGFR mutation • STK11 mutation • ALK fusion • KEAP1 mutation
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • Imfinzi (durvalumab) • Imjudo (tremelimumab) • pemetrexed
30d
Durvalumab for MSI-H or POLE Mutated Metastatic Colorectal Cancer (clinicaltrials.gov)
P2, N=33, Completed, Asan Medical Center | Active, not recruiting --> Completed
Trial completion • Mismatch repair • Tumor mutational burden • Metastases
|
POLE (DNA Polymerase Epsilon) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
|
MSI-H/dMMR • POLE mutation
|
Imfinzi (durvalumab) • oxaliplatin • irinotecan
30d
SOUND: Savolitinib Combine With Durvalumab in EGFR Wild-type Locally Advanced or Metastatic NSCLC (clinicaltrials.gov)
P2, N=47, Active, not recruiting, AstraZeneca | Suspended --> Active, not recruiting | Trial completion date: Dec 2024 --> Aug 2025 | Trial primary completion date: Oct 2024 --> Aug 2025
Enrollment closed • Trial completion date • Trial primary completion date • Metastases
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
MET amplification • EGFR wild-type • MET exon 14 mutation • MET overexpression • MET mutation
|
Imfinzi (durvalumab) • Orpathys (savolitinib)
30d
Trial suspension
|
Imfinzi (durvalumab)
1m
Trial primary completion date • Surgery
|
HER-2 (Human epidermal growth factor receptor 2) • BRCA (Breast cancer early onset)
|
HER-2 negative • BRCA mutation
|
Lynparza (olaparib) • cisplatin • carboplatin • Imfinzi (durvalumab) • gemcitabine • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate)