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DRUG:

Imjudo (tremelimumab-actl)

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Other names: PF06753388, CP675206, CP 675206, CP-675206, CP-675,206, CP-675, PF-06753388, CP 675, CP675, PF 06753388
Company:
AstraZeneca, Pfizer
Drug class:
CTLA4 inhibitor
4d
KIM-1 in Advanced Papillary and Clear Cell Renal Cell Carcinoma. (PubMed, Eur Urol)
CALYPSO (NCT02819596) was a prospective, multi-arm trial that evaluated durvalumab alone or in combination with tremelimumab or savolitinib in metastatic ccRCC and pRCC. Also, an increase in KIM-1 during therapy was linked to worse progression-free survival (HR 1.7; 95% CI, 1.13-2.58; p = 0.01) and OS (HR 1.95; 95% CI, 1.23-3.08; p = 0.004) in ccRCC. This exploratory analysis supports the utility of KIM-1 in advanced ccRCC and pRCC.
Journal • PD(L)-1 Biomarker
|
KIM1 (Kidney injury molecule 1)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab-actl) • Orpathys (savolitinib)
6d
INFINITY: TremelImumab aNd Durvalumab For the Non-operatIve Management (NOM) of MSI-high Resectable GC/GEJC. (clinicaltrials.gov)
P2, N=31, Active, not recruiting, Gruppo Oncologico del Nord-Ovest | Not yet recruiting --> Active, not recruiting
Enrollment closed • MSI-H
|
MSI-H/dMMR
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Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
7d
Systemic immune profiling uncovers divergent mechanisms and predictive biomarkers of response to combination immunotherapies in hepatocellular carcinoma. (PubMed, J Immunother Cancer)
Our findings reveal regimen-specific systemic immune mechanisms in advanced HCC: Atez/Bev amplifies monocyte-NK cytotoxic axes, whereas Dur/Tre enhances monocyte-T cell inflammatory networks and TCR repertoire diversity. These insights highlight distinct predictive biomarkers and support regimen-tailored immunotherapy in HCC.
Journal • PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8) • PRKCH (Protein Kinase C Eta) • CD14 (CD14 Molecule) • HLA-E (Major Histocompatibility Complex, Class I, E)
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
8d
TRITON: A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS (clinicaltrials.gov)
P2, N=100, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | Phase classification: P3 --> P2 | N=280 --> 100 | Trial completion date: Mar 2031 --> Dec 2027 | Trial primary completion date: Aug 2027 --> Dec 2026
Enrollment closed • Phase classification • Enrollment change • Trial completion date • Trial primary completion date
|
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-actl) • pemetrexed
9d
New P1 trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR wild-type • ALK wild-type
|
Imfinzi (durvalumab) • Imjudo (tremelimumab-actl) • ceralasertib (AZD6738)
11d
Durvalumab With or Without Tremelimumab in Advanced Incurable Solid Malignancies Given With or Without Standard Chemotherapy Regimens (clinicaltrials.gov)
P1, N=153, Active, not recruiting, Canadian Cancer Trials Group | Trial completion date: Jan 2026 --> Dec 2026
Trial completion date
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PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
19d
Favorable Response to Chemotherapy with Durvalumab plus Tremelimumab in Two Cases of KRAS G12C-Positive Pulmonary Sarcomatoid Carcinoma: A Case Report. (PubMed, Intern Med)
They thereafter achieved excellent clinical outcomes, including complete and partial responses, with sustained benefits. The POSEIDON regimen may represent a potent therapeutic option for this rare patient population with multiple negative prognostic factors.
Journal • PD(L)-1 Biomarker
|
KRAS (KRAS proto-oncogene GTPase)
|
KRAS mutation • KRAS G12C • KRAS G12
|
Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
19d
Trial initiation date
|
Imfinzi (durvalumab) • Imjudo (tremelimumab-actl) • RBS2418
28d
Imfinzi/Imjudo uHCC Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study (clinicaltrials.gov)
P=N/A, N=1200, Completed, AstraZeneca | Recruiting --> Completed | N=300 --> 1200 | Trial completion date: Dec 2026 --> Jul 2025 | Trial primary completion date: Dec 2026 --> Jul 2025
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
|
Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)
28d
Trial completion date • Tumor mutational burden • Platinum sensitive
|
BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
|
BRCA2 mutation • BRCA1 mutation
|
Lynparza (olaparib) • Imjudo (tremelimumab-actl)
1m
DNA Repair gene alterations and efficacy from gemcitabine and nab-paclitaxel with/without durvalumab and tremelimumab in metastatic pancreatic ductal adenocarcinoma. (PubMed, Nat Commun)
Partial response was observed in 7/11 (63.64%) patients with concurrent DNA damage repair gene mutations in the immunotherapy arm. As a prospective study in PDAC identifying a potential biomarker beyond mismatch repair deficiency for benefit from immunotherapy, these data highlight an actionable subgroup of mPDAC.
Journal • BRCA Biomarker • PD(L)-1 Biomarker • IO biomarker
|
BRCA1 (Breast cancer 1, early onset) • ATM (ATM serine/threonine kinase) • FANCA (FA Complementation Group A)
|
BRCA1 mutation • ATM mutation
|
Imfinzi (durvalumab) • gemcitabine • albumin-bound paclitaxel • Imjudo (tremelimumab-actl)
1m
Trial completion date • Tumor mutational burden • IO biomarker
|
ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • MSH6 (MutS homolog 6)
|
Imfinzi (durvalumab) • Imjudo (tremelimumab-actl)